Free PLR Content Directory Saba: August 2012

Wednesday, 29 August 2012

Imodium

Pronunciation: loe-PER-a-mide
Generic Name: Loperamide
Brand Name: Imodium

Imodium is used for:

Treating symptoms of certain types of diarrhea. It is also used to decrease the amount of discharge from an ileostomy. It may also be used for to treat other conditions as determined by your doctor.

Imodium is an antidiarrheal agent. It works by slowing the movement of bowel contents.

Do NOT use Imodium if:

you are allergic to any ingredient in Imodium

you have stomach pain without diarrhea

you have constipation, stomach bloating, or bloody stools

the patient is a child younger than 2 years (24 months) old

Contact your doctor or health care provider right away if any of these apply to you.

Before using Imodium:

Some medical conditions may interact with Imodium. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding

if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement

if you have allergies to medicines, foods, or other substances

if you have bloody diarrhea; mucus in your stool; fever; bowel problems (eg, inflammation, blockage, enlarged colon); or diarrhea caused by food poisoning, antibiotic use, or bacterial infection

if you have AIDS or liver problems

Some MEDICINES MAY INTERACT with Imodium. Tell your health care provider if you are taking any other medicines, especially any of the following:

Quinidine or ritonavir because they may increase the risk of Imodium's side effects

Saquinavir because its effectiveness may be decreased by Imodium

This may not be a complete list of all interactions that may occur. Ask your health care provider if Imodium may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Imodium:

Use Imodium as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Take Imodium by mouth with or without food.

Drinking extra fluids is recommended while you have diarrhea. Check with your doctor if you have questions.

If you miss a dose of Imodium and are taking it regularly, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Imodium.

Important safety information:

Imodium may cause drowsiness, dizziness, or tiredness. These effects may be worse if you take it with alcohol or certain medicines. Use Imodium with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.

Do not take more than the recommended dose or use for longer than 48 hours without checking with your doctor.

If your diarrhea does not get better within 48 hours or if it gets worse, contact your doctor.

If you develop a fever, stomach bloating or swelling, or blood in your stools, contact your doctor.

Imodium is used to treat the symptoms of diarrhea, but will not treat the condition causing the diarrhea. Check with your doctor if you have any questions or concerns about the cause of your diarrhea.

Caution is advised when using Imodium in CHILDREN; they may be more sensitive to its effects, especially dehydration.

Do not use Imodium in CHILDREN younger than 2 years old; safety and effectiveness in these children have not been confirmed.

PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Imodium while you are pregnant. Imodium is found in breast milk. Do not breast-feed while taking Imodium.

Possible side effects of Imodium:

All medicines may cause side effects, but many people have no, or minor, side effects. No COMMON side effects have been reported with this product. Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); constipation; decreased urination; red, swollen, blistered, or peeling skin; stomach bloating, swelling, or pain.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Imodium side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include constipation; decreased urination; nausea; severe drowsiness or constipation; vomiting.

Proper storage of Imodium:

Store at room temperature, between 59 and 77 degrees F (15 and 25 degrees C), in a tightly closed container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Imodium out of the reach of children and away from pets.

General information:

If you have any questions about Imodium, please talk with your doctor, pharmacist, or other health care provider.

Imodium is to be used only by the patient for whom it is prescribed. Do not share it with other people.

If your symptoms do not improve or if they become worse, check with your doctor.

Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Imodium. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

More Imodium resources

Imodium Side Effects (in more detail)
Imodium Dosage
Imodium Use in Pregnancy & Breastfeeding
Imodium Drug Interactions
Imodium Support Group
0 Reviews for Imodium - Add your own review/rating

Imodium Prescribing Information (FDA)

Imodium Consumer Overview

Imodium Advanced Consumer (Micromedex) - Includes Dosage Information

Loperamide Prescribing Information (FDA)

Loperamide Hydrochloride Monograph (AHFS DI)

Compare Imodium with other medications

Diarrhea
Diarrhea, Acute
Diarrhea, Chronic
Traveler's Diarrhea

Tuesday, 28 August 2012

sulfisoxazole

Generic Name: sulfisoxazole (sul fi SOX a zole)

Brand names: Gantrisin, Gantrisin Pediatric, Truxazole

What is sulfisoxazole?

Sulfisoxazole is a sulfonamide ("sulfa") antibiotic that helps keep bacteria from growing in your body.

Sulfisoxazole is used to treat or prevent many different types of infections caused by bacteria, such as bladder infections, ear infections, or meningitis.

Sulfisoxazole may also be used for purposes not listed in this medication guide.

What is the most important information I should know about sulfisoxazole?

Take this medication for the full prescribed length of time. Your symptoms may get better before the infection is completely cleared. Sulfisoxazole will not treat a viral infection such as the common cold or flu. Do not share this medication with another person, even if they have the same symptoms you have.

Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or bloody, stop taking sulfisoxazole and call your doctor. Do not use anti-diarrhea medicine unless your doctor tells you to.

What should I discuss with my health care provider before taking sulfisoxazole?

You should not use this medication if you are allergic to sulfisoxazole or to any other sulfa drugs such as Azulfidine, Bactrim, Cotrim, Septra, or Sulfazine. Women who are in late pregnancy or are breast-feeding should not take sulfisoxazole.

To make sure you can safely take sulfisoxazole, tell your doctor if you have any of these other conditions:

asthma;

diabetes;

liver disease;

kidney disease;

anemia (a lack of red blood cells);

an enzyme deficiency called G6PD (glucose-6-phosphate dehydrogenase) deficiency;

a history of any type of allergy; or

if you are unable to urinate.

FDA pregnancy category C. It is not known whether sulfisoxazole will harm an unborn baby. Sulfisoxazole can cause jaundice (yellowing of the skin or eyes) and other problems in a newborn if the mother has taken this medication late in pregnancy. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. Sulfisoxazole can pass into breast milk and may harm a nursing baby. You should not breast-feed while you are taking sulfisoxazole, especially if your baby is younger than 2 months old. Do not give this medicine to a child younger than 2 months old without the advice of a doctor.

How should I take sulfisoxazole?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

You may take sulfisoxazole with or without food.

Shake the oral suspension (liquid) well just before you measure a dose. Measure the liquid with a special dose-measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one. While you are taking sulfisoxazole, drink 6 to 8 glasses of water each day. This will help prevent kidney stones or crystals in the urine.

To be sure this medication is helping your condition, your blood may need to be tested often. Visit your doctor regularly.

If you need surgery, tell the surgeon ahead of time that you are using sulfisoxazole. You may need to stop using the medicine for a short time. Take this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Sulfisoxazole will not treat a viral infection such as the common cold or flu. Do not share this medication with another person, even if they have the same symptoms you have. Store at room temperature away from moisture and heat.

See also: Sulfisoxazole dosage (in more detail)

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include headache, drowsiness, nausea, vomiting, stomach pain, loss of appetite, fever, blood in your urine, pale skin, easy bruising or bleeding, flu symptoms, feeling light-headed, or fainting.

What should I avoid while taking sulfisoxazole?

Sulfisoxazole may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Avoid exposure to sunlight or tanning beds. Sulfisoxazole can make you sunburn more easily. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

Sulfisoxazole side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have a serious side effect such as:

diarrhea that is watery or bloody;

fever, chills, body aches, flu symptoms;

cough, feeling short of breath, pale skin, joint pain, unusual bruising;

fast or pounding heartbeat;

blue lips or fingernails, feeling light-headed, fainting;

swelling around your neck or throat;

urinating more or less than usual;

severe pain in your side or lower back, blood in your urine;

nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

fever, sore throat, and headache with a severe blistering, peeling, and red skin rash;

agitation, confusion, unusual thoughts or behavior; or

seizure (black-out or convulsions).

Less serious side effects may include:

mild stomach pain, bloating, gas;

headache, dizziness;

ringing in your ears; or

swollen, black, or "hairy" tongue.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Sulfisoxazole Dosing Information

Usual Adult Dose for Cystitis:

1 to 2 g orally every 6 hours for 3 to 7 days

Usual Adult Dose for Inclusion Conjunctivitis:

1 to 2 g orally every 6 hours for 21 days

Usual Adult Dose for Trachoma:

1 to 2 g orally every 6 hours for 21 days

Usual Adult Dose for Malaria:

2 g orally every 6 hours for 7 to 10 days; used only as adjunctive therapy in chloroquine-resistant Plasmodium falciparum

Usual Adult Dose for Nocardiosis:

2 g orally every 4 to 6 hours for at least 6 months
Immunocompromised patients may require up to 1 year or longer of treatment.

Usual Adult Dose for Otitis Media:

2 g orally every 6 hours for 10 to 14 days

Usual Adult Dose for Pelvic Inflammatory Disease:

500 mg orally every 6 hours for 21 days
Use in combination with ceftriaxone.

Usual Adult Dose for Pyelonephritis:

2 g orally every 6 hours for 14 days

Usual Adult Dose for Toxoplasmosis:

2 g orally every 6 hours with pyrimethamine 75 mg one time followed by 25 mg orally once a day
Folinic acid 3 to 9 mg orally 2 to 3 times a week is recommended to prevent bone marrow toxicity. Therapy should be continued for 2 to 4 months.

Usual Adult Dose for Meningitis -- Meningococcal:

2 g orally every 6 hours
Therapy should be continued for approximately 14 days, depending on the nature and severity of the infection.

Usual Adult Dose for Meningitis -- Haemophilus influenzae:

2 g orally every 6 hours
Therapy should be continued for approximately 14 days, depending on the nature and severity of the infection.

Usual Adult Dose for Chancroid:

2 g orally every 6 hours for approximately 7 days, depending on the nature and severity of the infection

The patient's sexual partner(s) should be evaluated. It is wise to also culture for gonococcus and to screen for syphilis.

Sulfisoxazole is not considered a drug of choice and is no longer recommended by the Centers for Disease Control and Prevention (CDC) to treat chancroid.

Usual Pediatric Dose for Bacterial Infection:

2 months or older: 75 mg/kg orally for 1 dose, followed by 120 to 150 mg/kg/day in divided doses every 4 to 6 hours
Maximum dose: 6 g/day

Usual Pediatric Dose for Chlamydia Infection:

2 months or older: 100 mg/kg/day orally in divided doses every 6 hours
Maximum dose: 2 g/day

Usual Pediatric Dose for Toxoplasmosis:

Congenital: Initial loading dose: 1/2 of the 24 hour dose
Maintenance dose: 150 mg/kg/day or 4 g/m2/day orally in 4 to 6 divided doses; used in conjunction with pyrimethamine
Maximum dose: 6 g/day

Usual Pediatric Dose for Pelvic Inflammatory Disease:

2 months or older: 100 mg/kg/day orally in divided doses every 6 hours; recommended to be used in combination with ceftriaxone

What other drugs will affect sulfisoxazole?

Tell your doctor about all other medicines you use, especially:

a blood thinner such as warfarin (Coumadin);

methotrexate (Rheumatrex, Trexall); or

diabetes medications such as acetohexamide (Dymelor), chlorpropamide (Diabinese), glimepiride (Amaryl, Avandaryl, Duetact), glipizide (Glucotrol), glyburide (DiaBeta, Glynase PresTab, Micronase), tolazamide (Tolinase), or tolbutamide (Orinase).

This list is not complete and other drugs may interact with sulfisoxazole. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More sulfisoxazole resources

Sulfisoxazole Dosage
Sulfisoxazole Use in Pregnancy & Breastfeeding
Drug Images
Sulfisoxazole Drug Interactions
Sulfisoxazole Support Group
0 Reviews for Sulfisoxazole - Add your own review/rating

sulfisoxazole Advanced Consumer (Micromedex) - Includes Dosage Information

Gantrisin Prescribing Information (FDA)

Gantrisin Suspension MedFacts Consumer Leaflet (Wolters Kluwer)

Sulfisoxazole MedFacts Consumer Leaflet (Wolters Kluwer)

Sulfisoxazole Professional Patient Advice (Wolters Kluwer)

Compare sulfisoxazole with other medications

Bacterial Infection
Bladder Infection
Chancroid
Chlamydia Infection
Inclusion Conjunctivitis
Kidney Infections
Malaria
Meningitis, Haemophilus influenzae
Meningitis, Meningococcal
Nocardiosis
Otitis Media
Pelvic Inflammatory Disease
Toxoplasmosis
Trachoma

Where can I get more information?

Your pharmacist can provide more information about sulfisoxazole.

Sunday, 26 August 2012

atropine, hyoscyamine, methenamine, methylene blue, phenyl salicylate, and benzoic acid

AT-roe-peen SUL-fate, hye-oh-SYE-a-meen SUL-fate, meth-EN-a-meen, METH-i-leen BLOO, FEN-il sal-I-si-late, ben-ZOE-ik AS-id

Commonly used brand name(s)

In the U.S.

Prosed EC

Trac Tabs

Urised

Available Dosage Forms:

Tablet

Tablet, Enteric Coated

Therapeutic Class: Urinary Antispasmodic

Pharmacologic Class: Atropine

Chemical Class: Salicylate, Non-Aspirin

Uses For atropine, hyoscyamine, methenamine, methylene blue, phenyl salicylate, and benzoic acid

Atropine , hyoscyamine , methenamine , methylene blue, phenyl salicylate , and benzoic acid combination medicine is an anticholinergic, anti-infective, and analgesic. It is given by mouth to help relieve the discomfort caused by urinary tract infections; however, it will not cure the infection itself. This combination medicine may also be used for other conditions as determined by your doctor.

atropine, hyoscyamine, methenamine, methylene blue, phenyl salicylate, and benzoic acid is available only with your doctor's prescription.

Before Using atropine, hyoscyamine, methenamine, methylene blue, phenyl salicylate, and benzoic acid

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For atropine, hyoscyamine, methenamine, methylene blue, phenyl salicylate, and benzoic acid, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to atropine, hyoscyamine, methenamine, methylene blue, phenyl salicylate, and benzoic acid or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Unusual excitement, nervousness, restlessness or irritability, and unusual warmth, dryness, and flushing of skin are more likely to occur in children, who are usually more sensitive to the effects of atropine and hyoscyamine (contained in this combination medicine). Also, when atropine and hyoscyamine are given to children during hot weather, a rapid increase in body temperature may occur. In infants and children, especially those with spastic paralysis or brain damage, atropine, hyoscyamine, methenamine, methylene blue, phenyl salicylate, and benzoic acid may be more likely to cause severe side effects.

Geriatric

Confusion or memory loss, constipation, difficult urination, excitement, agitation, drowsiness, or dryness of mouth may be more likely to occur in elderly patients, who are usually more sensitive than younger adults to the effects of atropine and hyoscyamine. Also, this combination medicine may cause eye pain in patients who have untreated glaucoma.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	X	Studies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities. This drug should not be used in women who are or may become pregnant because the risk clearly outweighs any possible benefit.

Breast Feeding

Benzoic Acid

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Methylene BlueBenzyl BenzoateMethenamineAtropineHyoscyamine

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking atropine, hyoscyamine, methenamine, methylene blue, phenyl salicylate, and benzoic acid, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using atropine, hyoscyamine, methenamine, methylene blue, phenyl salicylate, and benzoic acid with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Ambenonium

Amitriptyline

Amoxapine

Bupropion

Citalopram

Clomipramine

Desipramine

Desvenlafaxine

Doxepin

Duloxetine

Escitalopram

Fluoxetine

Fluvoxamine

Imipramine

Isocarboxazid

Linezolid

Maprotiline

Mirtazapine

Nortriptyline

Paroxetine

Phenelzine

Potassium

Protriptyline

Selegiline

Sertraline

Tranylcypromine

Trimipramine

Venlafaxine

Vilazodone

Using atropine, hyoscyamine, methenamine, methylene blue, phenyl salicylate, and benzoic acid with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Buspirone

Nefazodone

Trazodone

Using atropine, hyoscyamine, methenamine, methylene blue, phenyl salicylate, and benzoic acid with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Arbutamine

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Proper Use of atropine, hyoscyamine, methenamine, methylene blue, phenyl salicylate, and benzoic acid

While you are taking this combination medicine, it is important for your urine to be acidic. To do this, your doctor may recommend that you eat more protein and such foods as cranberries (especially cranberry juice with vitamin C added), plums, or prunes. You should avoid foods that make the urine more alkaline, such as most fruits (especially citrus fruits and juices), milk, and other dairy products.

Take atropine, hyoscyamine, methenamine, methylene blue, phenyl salicylate, and benzoic acid only as directed. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.

Each dose should be taken with a full glass (8 ounces) of water or other liquid (except citrus juices and milk). Drink plenty of water or other liquids every day, unless otherwise directed by your doctor. Drinking enough liquids will help your kidneys work better and lessen your discomfort.

To help clear up your infection completely, keep taking atropine, hyoscyamine, methenamine, methylene blue, phenyl salicylate, and benzoic acid for the full time of treatment even if you begin to feel better after a few days. Do not miss any doses.

In order for atropine, hyoscyamine, methenamine, methylene blue, phenyl salicylate, and benzoic acid to work well, your urine must be acid (pH 5.5 or below). To make sure that your urine is acid:

Before you start taking atropine, hyoscyamine, methenamine, methylene blue, phenyl salicylate, and benzoic acid, check your urine with phenaphthazine paper or another test to see if it is acid. If you have any questions about this, check with your health care professional.

You may need to change your diet; however, check with your doctor first if you are on a special diet (for example, for diabetes). To help make your urine more acid you should avoid most fruits (especially citrus fruits and juices), milk and other dairy products, and other foods which make the urine more alkaline. Eating more protein and foods such as cranberries (especially cranberry juice with vitamin C added), plums, or prunes may also help. If your urine is still not acid enough, check with your doctor.

Dosing

The dose of atropine, hyoscyamine, methenamine, methylene blue, phenyl salicylate, and benzoic acid will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of atropine, hyoscyamine, methenamine, methylene blue, phenyl salicylate, and benzoic acid. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For oral dosage form (tablets):
- For relief of urinary tract symptoms:
  - Adults and children 12 years of age and older—1 to 2 tablets four times a day.
  - Children 6 to 12 years of age—Dose must be determined by the doctor.
  - Children up to 6 years of age—Use is not recommended.

Missed Dose

If you miss a dose of atropine, hyoscyamine, methenamine, methylene blue, phenyl salicylate, and benzoic acid, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using atropine, hyoscyamine, methenamine, methylene blue, phenyl salicylate, and benzoic acid

If your symptoms do not improve within a few days or if they become worse, check with your doctor.

These medicines may make you sweat less, causing your body temperature to increase. Use extra care not to become overheated during exercise or hot weather while you are taking atropine, hyoscyamine, methenamine, methylene blue, phenyl salicylate, and benzoic acid, since overheating may result in heat stroke. Also, hot baths or saunas may make you dizzy or faint while you are taking atropine, hyoscyamine, methenamine, methylene blue, phenyl salicylate, and benzoic acid.

atropine, hyoscyamine, methenamine, methylene blue, phenyl salicylate, and benzoic acid may cause some people to have blurred vision. Make sure you know how you react to atropine, hyoscyamine, methenamine, methylene blue, phenyl salicylate, and benzoic acid before you drive, use machines, or do anything else that could be dangerous if you are not able to see well. If your vision continues to be blurred, check with your doctor.

atropine, hyoscyamine, methenamine, methylene blue, phenyl salicylate, and benzoic acid may cause dryness of the mouth. For temporary relief, use sugarless candy or gum, melt bits of ice in your mouth, or use a saliva substitute. However, if your mouth continues to feel dry for more than 2 weeks, check with your dentist. Continuing dryness of the mouth may increase the chance of dental disease, including tooth decay, gum disease, and fungus infections.

Do not take atropine, hyoscyamine, methenamine, methylene blue, phenyl salicylate, and benzoic acid within 2 or 3 hours of taking antacids or medicine for diarrhea. Taking antacids or antidiarrhea medicines and atropine, hyoscyamine, methenamine, methylene blue, phenyl salicylate, and benzoic acid too close together may prevent atropine, hyoscyamine, methenamine, methylene blue, phenyl salicylate, and benzoic acid from working properly.

atropine, hyoscyamine, methenamine, methylene blue, phenyl salicylate, and benzoic acid Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

Less common or rare

Blurred vision

eye pain

skin rash or hives

Symptoms of overdose

Blood in urine and/or stools

diarrhea

dizziness

drowsiness (severe)

fast heartbeat

flushing or redness of face

headache (severe or continuing)

lower back pain

pain or burning while urinating

ringing or buzzing in the ears

shortness of breath or troubled breathing

sweating

unusual tiredness or weakness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

Difficult urination (more common with large doses taken over a prolonged period of time)

dryness of mouth, nose, or throat

nausea or vomiting

stomach upset or pain (more common with large doses taken over a prolonged period of time)

atropine, hyoscyamine, methenamine, methylene blue, phenyl salicylate, and benzoic acid may cause your urine and/or stools to turn blue or blue-green. This is to be expected while you are taking atropine, hyoscyamine, methenamine, methylene blue, phenyl salicylate, and benzoic acid.

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

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More atropine, hyoscyamine, methenamine, methylene blue, phenyl salicylate, and benzoic acid resources

Atropine, hyoscyamine, methenamine, methylene blue, phenyl salicylate, and benzoic acid Use in Pregnancy & Breastfeeding
Atropine, hyoscyamine, methenamine, methylene blue, phenyl salicylate, and benzoic acid Drug Interactions
Atropine, hyoscyamine, methenamine, methylene blue, phenyl salicylate, and benzoic acid Support Group
16 Reviews for Atropine, hyoscyamine, methenamine, methylene blue, phenyl salicylate, and benzoic acid - Add your own review/rating

Compare atropine, hyoscyamine, methenamine, methylene blue, phenyl salicylate, and benzoic acid with other medications

Urinary Tract Infection

Sumavel DosePro

Generic Name: sumatriptan (Nasal route)

soo-ma-TRIP-tan

Commonly used brand name(s)

In the U.S.

Imitrex

Available Dosage Forms:

Spray

Therapeutic Class: Antimigraine

Pharmacologic Class: Serotonin Receptor Agonist, 5-HT1

Uses For Sumavel DosePro

Sumatriptan nasal spray is used to treat acute migraine attacks in adults. It does not prevent migraine attacks nor treat certain types of migraine headaches (e.g., hemiplegic or basilar type).

Many people find that their headaches go away completely after they take sumatriptan. Other people find that their headaches are much less painful, and that they are able to go back to their normal activities even though their headaches are not completely gone. Sumatriptan often relieves other symptoms that occur together with a migraine headache, such as nausea, vomiting, sensitivity to light, and sensitivity to sound.

Sumatriptan is not an ordinary pain reliever. It will not relieve any kind of pain other than migraine headaches. This medicine is usually used for people whose headaches are not relieved by acetaminophen, aspirin, or other pain relievers.

Sumatriptan has caused serious side effects in some people, especially people who have heart or blood vessel disease. Be sure that you discuss with your doctor the risks of using this medicine as well as the good that it can do.

This medicine is available only with your doctor's prescription.

Before Using Sumavel DosePro

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of sumatriptan nasal spray in the pediatric population. Safety and efficacy have not been established.

Geriatric

Use of sumatriptan nasal spray is not recommended in elderly patients with kidney problems, heart or blood vessel disease, or high blood pressure, and should not be used by elderly patients with liver problems.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Almotriptan

Dihydroergotamine

Eletriptan

Ergoloid Mesylates

Ergonovine

Ergotamine

Frovatriptan

Isocarboxazid

Linezolid

Methylergonovine

Methysergide

Naratriptan

Phenelzine

Procarbazine

Rizatriptan

Tranylcypromine

Zolmitriptan

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Citalopram

Desvenlafaxine

Dexfenfluramine

Duloxetine

Escitalopram

Fluoxetine

Fluvoxamine

Milnacipran

Paroxetine

Reboxetine

Sertraline

Sibutramine

St John's Wort

Tapentadol

Venlafaxine

Vilazodone

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Proper Use of sumatriptan

This section provides information on the proper use of a number of products that contain sumatriptan. It may not be specific to Sumavel DosePro. Please read with care.

Do not use this medicine for a headache that is different from your usual migraines. Instead, check with your doctor.

To relieve your migraine as soon as possible, use this medicine as soon as the headache pain begins. Even if you get warning signals of a coming migraine (an aura), you should wait until the headache pain starts before using sumatriptan. Using sumatriptan during the aura probably will not prevent the headache from occurring. However, even if you do not use sumatriptan until your migraine has been present for several hours, the medicine will still work.

Lying down in a quiet, dark room for a while after you use this medicine may help relieve your migraine.

If you are not much better in 1 or 2 hours after using this medicine, do not use any more of this medicine for the same migraine. A migraine that is not relieved by the first dose of sumatriptan probably will not be relieved by a second dose, either. Ask your doctor ahead of time about other medicine to be taken if sumatriptan does not work. After taking the other medicine, check with your doctor as soon as possible. Headaches that are not relieved by sumatriptan are sometimes caused by conditions that need other treatment. However, even if sumatriptan does not relieve one migraine, it may still relieve the next one.

If you feel much better after a dose of sumatriptan, but your headache comes back or gets worse after a while, you may use more sumatriptan. However, use this medicine only as directed by your doctor. Do not use more of it, and do not use it more often, than directed. Using too much sumatriptan may increase the chance of side effects.

Your doctor may direct you to take another medicine to help prevent headaches. It is important that you follow your doctor's directions, even if your headaches continue to occur. Headache-preventing medicines may take several weeks to start working. Even after they do start working, your headaches may not go away completely. However, your headaches should occur less often, and they should be less severe and easier to relieve. This can reduce the amount of sumatriptan or pain relievers that you need. If you do not notice any improvement after several weeks of headache-preventing treatment, check with your doctor.

This medicine comes with a patient information leaflet. Read and follow the instructions carefully. Ask your doctor if you have any questions.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

For nasal dosage form (nasal solution):
- For migraine headaches:
  - Adults—5 milligrams (mg) (1 spray into one nostril) or 10 mg (2 sprays in one nostril or 1 spray in each nostril) or 20 mg (1 spray into one nostril). If pain is not relieved, another spray (5 mg, 10 mg, or 20 mg) should not be used for the same migraine attack. Another spray (5 mg, 10 mg, or 20 mg) may be used for a migraine that occurs at a later time as long as it has been at least 2 hours since the last spray. Do not use more than 40 mg in a 24-hour period (one day).
  - Children—Use and dose must be determined by your doctor.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using Sumavel DosePro

Check with your doctor if you have used this medicine and have not had good relief. Also, check with your doctor if your migraine headaches are worse, or if they are occurring more often, than before you started using this medicine.

Make sure your doctor knows if you are pregnant. Your doctor may want you to join a pregnancy registry for patients taking this medicine.

This medicine may increase your risk of having a heart attack or stroke. This is more likely to occur if you already have a heart disease, if you smoke, if you are over 40, or if you have gone through menopause. People who use this medicine for a long time might also have a higher risk.

You should not take this medicine if you have used an MAO inhibitor (MAOI) such as isocarboxacid (Marplan®), phenelzine (Nardil®), selegiline (Eldepryl®), or tranylcypromine (Parnate®) within the past two weeks. Do not use this medicine if you have taken other migraine medicines (e.g., almotriptan, frovatriptan, naratriptan, rizatriptan, zolmitriptan, Axert™, Frova®, Amerge®, Maxalt®, or Zomig®) or an ergotamine medicine (e.g., methysergide, D.H.E. 45®, or Migranal®) within the past 24 hours.

Make sure your doctor knows about all the other medicines you are using. Sumatriptan may cause a serious condition called serotonin syndrome when taken with some medicines. This especially includes medicines used to treat depression, such as citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine, olanzapine, paroxetine, sertraline, venlafaxine, Celexa®, Cymbalta®, Effexor®, Lexapro®, Luvox®, Paxil®, Prozac®, Sarafem®, Symbyax®, or Zoloft®. Check with your doctor first before taking any other medicines.

This medicine may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis requires immediate medical attention. The most serious signs of this reaction are very fast or irregular breathing, gasping for breath, wheezing, or fainting. Other signs may include changes in color of the skin of the face; very fast but irregular heartbeat or pulse; hive-like swellings on the skin; and puffiness or swellings of the eyelids or around the eyes. If these side effects occur, get emergency help at once.

Check with your doctor immediately if blurred vision, difficulty in reading, or any other change in vision occurs during or after your treatment. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).

Check with your doctor right away if you have chest discomfort, jaw or neck tightness after using this medicine. Tell your doctor if you have burning, numbness, pain, soreness, or irritation of the nose or throat after using the nasal spray.

Drinking alcoholic beverages can make headaches worse or cause new headaches to occur. People who suffer from severe headaches should probably avoid alcoholic beverages, especially during a headache.

This medicine may cause some people to become dizzy, drowsy, or less alert than they are normally. If any of these side effects occur, do not drive, use machines, or do anything else that could be dangerous if you are dizzy or are not alert while you are using this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Sumavel DosePro Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common

Chest pain (mild)

difficulty with swallowing

heaviness, tightness, or pressure in the chest or neck

pounding heartbeat

skin rash, hives, itching, or bumps on the skin

Rare

Chest pain (severe)

changes in skin color on the face

convulsions (seizures)

fast or irregular breathing

puffiness or swelling of the eyelids, area around the eyes, face, or lips

shortness of breath, troubled breathing, or wheezing

More common

Burning, discharge, pain, or soreness in the nose

change in taste

discomfort in the jaw, mouth, tongue, throat, nose, or sinuses

dizziness

drowsiness

feeling of burning, warmth, heat, numbness, tightness, or tingling

feeling cold, “strange,” or weak

flushing

lightheadedness

muscle aches, cramps, or stiffness

nausea or vomiting

unusual or unpleasant (after) taste

Less common

Feeling of constant movement of self or surroundings

sensation of spinning

Less common or rare

Anxiety

burning sensation

discomfort of the nasal cavity and throat

general feeling of illness or tiredness

vision changes

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Sumavel DosePro side effects (in more detail)

More Sumavel DosePro resources

Sumavel DosePro Side Effects (in more detail)
Sumavel DosePro Use in Pregnancy & Breastfeeding
Sumavel DosePro Drug Interactions
14 Reviews for Sumavel DosePro - Add your own review/rating

Sumavel DosePro MedFacts Consumer Leaflet (Wolters Kluwer)

Sumavel DosePro Consumer Overview

Alsuma Consumer Overview

Alsuma Prescribing Information (FDA)

Imitrex Prescribing Information (FDA)

Imitrex Monograph (AHFS DI)

Imitrex MedFacts Consumer Leaflet (Wolters Kluwer)

Imitrex Consumer Overview

Sumatriptan Professional Patient Advice (Wolters Kluwer)

Sumatriptan Prescribing Information (FDA)

Sumavel Dosepro Prescribing Information (FDA)

Compare Sumavel DosePro with other medications

Cluster Headaches
Migraine

Thursday, 23 August 2012

Eryped

Generic Name: erythromycin (Oral route, Parenteral route)

e-rith-roe-MYE-sin

Commonly used brand name(s)

In the U.S.

E.E.S. 200

E.E.S. 400

E.E.S. Granules

Eryped

Eryped 200

Eryped 400

Erythrocin

Erythrocin Stearate

Ilosone

In Canada

E.E.S. 100

Ees 200

Novo-Rythro Estolate Suspension

Novo-Rythro Ethyl Succinate Suspension

Novo-Rythro Stearate

Available Dosage Forms:

Suspension

Powder for Suspension

Tablet

Tablet, Chewable

Capsule

Uses For Eryped

Erythromycins are used to treat many kinds of infections. Erythromycins are also used to prevent "strep" infections in patients with a history of rheumatic heart disease who may be allergic to penicillin.

These medicines may also be used to treat Legionnaires' disease and for other problems as determined by your doctor. They will not work for colds, flu, or other virus infections.

Erythromycins are available only with your doctor's prescription.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, erythromycins are used in certain patients with the following medical conditions:

Acne

Actinomycosis

Anthrax

Chancroid

Gastroparesis

Lyme disease

Lymphogranuloma venereum

Relapsing fever

Before Using Eryped

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to medicines in this group or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

This medicine has been tested in children and, in effective doses, has not been shown to cause different side effects or problems in children than it does in adults.

Geriatric

This medicine has been tested and has not been shown to cause different side effects or problems in older people than it does in younger adults. However, older adults may be at increased risk of hearing loss, especially if they are taking high doses of erythromycin and/or have kidney or liver disease.

Pregnancy

Erythromycin estolate has caused side effects involving the liver in some pregnant women. However, none of the erythromycins has been shown to cause birth defects or other problems in human babies.

Breast Feeding

Erythromycins pass into the breast milk. However, erythromycins have not been shown to cause problems in nursing babies.

Interactions with Medicines

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Proper Use of erythromycin

This section provides information on the proper use of a number of products that contain erythromycin. It may not be specific to Eryped. Please read with care.

Generally, erythromycins are best taken with a full glass (8 ounces) of water on an empty stomach (at least 1 hour before or 2 hours after meals). If stomach upset occurs, these medicines may be taken with food. If you have questions about the erythromycin medicine you are taking, check with your health care professional.

For patients taking the oral liquid form of this medicine:

This medicine is to be taken by mouth even if it comes in a dropper bottle. If this medicine does not come in a dropper bottle, use a specially marked measuring spoon or other device to measure each dose accurately. The average household teaspoon may not hold the right amount of liquid

Do not use after the expiration date on the label. The medicine may not work properly after that date. Check with your pharmacist if you have any questions about this.

For patients taking the chewable tablet form of this medicine:

Tablets must be chewed or crushed before they are swallowed.

For patients taking the delayed-release capsule form (with enteric-coated pellets) or the delayed-release tablet form of this medicine:

Swallow capsules or tablets whole. Do not break or crush. If you are not sure about which type of capsule or tablet you are taking, check with your pharmacist.

To help clear up your infection completely, keep taking this medicine for the full time of treatment, even if you begin to feel better after a few days. If you have a "strep" infection, you should keep taking this medicine for at least 10 days. This is especially important in "strep" infections. Serious heart problems could develop later if your infection is not cleared up completely. Also, if you stop taking this medicine too soon, your symptoms may return.

This medicine works best when there is a constant amount in the blood. To help keep the amount constant, do not miss any doses. Also, it is best to take the doses at evenly spaced times day and night. For example, if you are to take 4 doses a day, the doses should be spaced about 6 hours apart. If this interferes with your sleep or other daily activities, or if you need help in planning the best times to take your medicine, check with your health care professional.

Dosing

The dose medicines in this class will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of these medicines. If your dose is different, do not change it unless your doctor tells you to do so.

For erythromycin base

For oral dosage forms (capsules, tablets):
- For treatment of infections:
  - Adults and teenagers—250 to 500 milligrams (mg) two to four times a day.
  - Children—Dose is based on body weight. The usual dose is 7.5 to 12.5 mg per kilogram (kg) (3.4 to 5.6 mg per pound) of body weight four times a day, or 15 to 25 mg per kg (6.8 to 11.4 mg per pound) of body weight two times a day.
- For prevention of heart infections:
  - Adults and teenagers—Take 1 gram two hours before your dental appointment or surgery, then 500 mg six hours after taking the first dose.
  - Children—Dose is based on body weight. The usual dose is 20 mg per kg (9.1 mg per pound) of body weight two hours before the dental appointment or surgery, then 10 mg per kg (4.5 mg per pound) of body weight six hours after taking the first dose.

For erythromycin estolate

For oral dosage forms (capsules, oral suspension, tablets):
- For treatment of infections:
  - Adults and teenagers—250 to 500 milligrams (mg) two to four times a day.
  - Children—Dose is based on body weight. The usual dose is 7.5 to 12.5 mg per kilogram (kg) (3.4 to 5.6 mg per pound) of body weight four times a day, or 15 to 25 mg per kg (6.8 to 11.4 mg per pound) of body weight two times a day.
- For prevention of heart infections:
  - Adults and teenagers—Take 1 gram two hours before your dental appointment or surgery, then 500 mg six hours after taking the first dose.
  - Children—Dose is based on body weight. The usual dose is 20 mg per kg (9.1 mg per pound) of body weight two hours before the dental appointment or surgery, then 10 mg per kg (4.5 mg per pound) of body weight six hours after taking the first dose.

For erythromycin ethylsuccinate

For oral dosage forms (oral suspension, tablets):
- For treatment of infections:
  - Adults and teenagers—400 to 800 milligrams (mg) two to four times a day.
  - Children—Dose is based on body weight. The usual dose is 7.5 to 12.5 mg per kilogram (kg) (3.4 to 5.6 mg per pound) of body weight four times a day, or 15 to 25 mg per kg (6.8 to 11.4 mg per pound) of body weight two times a day.
- For prevention of heart infections:
  - Adults and teenagers—Take 1.6 grams two hours before your dental appointment or surgery, then 800 mg six hours after taking the first dose.
  - Children—Dose is based on body weight. The usual dose is 20 mg per kg (9.1 mg per pound) of body weight two hours before the dental appointment or surgery, then 10 mg per kg (4.5 mg per pound) of body weight six hours after taking the first dose.

For erythromycin gluceptate

For injection dosage forms:
- For treatment of infections:
  - Adults and teenagers—250 to 500 milligrams (mg) injected into a vein every six hours; or 3.75 to 5 mg per kilogram (kg) (1.7 to 2.3 mg per pound) of body weight injected into a vein every six hours.
  - Children—Dose is based on body weight. The usual dose is 3.75 to 5 mg per kg (1.7 to 2.3 mg per pound) of body weight injected into a vein every six hours.

For erythromycin lactobionate

For injection dosage forms:
- For treatment of infections:
  - Adults and teenagers—250 to 500 milligrams (mg) injected into a vein every six hours; or 3.75 to 5 mg per kilogram (kg) (1.7 to 2.3 mg per pound) of body weight injected into a vein every six hours.
  - Children—Dose is based on body weight. The usual dose is 3.75 to 5 mg per kg (1.7 to 2.3 mg per pound) of body weight injected into a vein every six hours.

For erythromycin stearate

For oral dosage forms (oral suspension, tablets):
- For treatment of infections:
  - Adults and teenagers—250 to 500 milligrams (mg) two to four times a day.
  - Children—Dose is based on body weight. The usual dose is 7.5 to 12.5 mg per kilogram (kg) (3.4 to 5.6 mg per pound) of body weight four times a day; or 15 to 25 mg per kg (6.8 to 11.4 mg per pound) of body weight two times a day.
- For prevention of heart infections:
  - Adults and teenagers—Take 1 gram two hours before your dental appointment or surgery, then 500 mg six hours after taking the first dose.
  - Children—Dose is based on body weight. The usual dose is 20 mg per kg (9.1 mg per pound) of body weight two hours before the dental appointment or surgery, then 10 mg per kg (4.5 mg per pound) of body weight six hours after taking the first dose.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Keep out of the reach of children.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using Eryped

If your symptoms do not improve within a few days, or if they become worse, check with your doctor.

Eryped Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common

Fever

nausea

skin rash, redness, or itching

stomach pain (severe)

unusual tiredness or weakness

vomiting

yellow eyes or skin–with erythromycin estolate (rare with other erythromycins)

Less common - with erythromycin injection only

Pain, swelling, or redness at place of injection

Rare

Fainting (repeated)

irregular or slow heartbeat

loss of hearing (temporary)

More common

Abdominal or stomach cramping and discomfort

diarrhea

nausea or vomiting

Less common

Sore mouth or tongue

vaginal itching and discharge

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Eryped side effects (in more detail)

More Eryped resources

Eryped Side Effects (in more detail)
Eryped Use in Pregnancy & Breastfeeding
Drug Images
Eryped Drug Interactions
Eryped Support Group
0 Reviews for Eryped - Add your own review/rating

Erythromycin Monograph (AHFS DI)

Erythromycin Professional Patient Advice (Wolters Kluwer)

Erythromycin MedFacts Consumer Leaflet (Wolters Kluwer)

E.E.S. granules

Ery-Tab Prescribing Information (FDA)

Ery-Tab Delayed-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)

Ery-Tab Consumer Overview

EryPed Drops MedFacts Consumer Leaflet (Wolters Kluwer)

EryPed Prescribing Information (FDA)

Eryc Delayed-Release Particles Capsules MedFacts Consumer Leaflet (Wolters Kluwer)

Eryc Prescribing Information (FDA)

Compare Eryped with other medications

Bacterial Endocarditis Prevention
Bartonellosis
Bowel Preparation
Bronchitis
Bullous Pemphigoid
Campylobacter Gastroenteritis
Chancroid
Chlamydia Infection
Dental Abscess
Legionella Pneumonia
Lyme Disease
Lymphogranuloma Venereum
Mycoplasma Pneumonia
Nongonococcal Urethritis
Ocular Rosacea
Otitis Media
Pemphigoid
Pertussis
Pharyngitis
Pneumonia
Rheumatic Fever Prophylaxis
Skin Infection
Strep Throat
Syphilis, Early
Upper Respiratory Tract Infection

Saturday, 18 August 2012

piroxicam

Generic Name: piroxicam (peer OX i kam)

Brand Names: Feldene

What is piroxicam?

Piroxicam is in a group of drugs called nonsteroidal anti-inflammatory drugs (NSAIDs). Piroxicam works by reducing hormones that cause inflammation and pain in the body.

Piroxicam is used to treat pain or inflammation caused by arthritis.

Piroxicam may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about piroxicam?

This medicine can increase your risk of life-threatening heart or circulation problems, including heart attack or stroke. This risk will increase the longer you use piroxicam. Do not use this medicine just before or after having heart bypass surgery (also called coronary artery bypass graft, or CABG).

Seek emergency medical help if you have symptoms of heart or circulation problems, such as chest pain, weakness, shortness of breath, slurred speech, or problems with vision or balance.

This medicine can also increase your risk of serious effects on the stomach or intestines, including bleeding or perforation (forming of a hole). These conditions can be fatal and gastrointestinal effects can occur without warning at any time while you are taking piroxicam. Older adults may have an even greater risk of these serious gastrointestinal side effects.

Call your doctor at once if you have symptoms of bleeding in your stomach or intestines. This includes black, bloody, or tarry stools, or coughing up blood or vomit that looks like coffee grounds.

Do not use any other over-the-counter cold, allergy, or pain medication without first asking your doctor or pharmacist. Many medicines available over the counter contain aspirin or other medicines similar to piroxicam (such as ibuprofen, ketoprofen, or naproxen). If you take certain products together you may accidentally take too much of this type of medication. Read the label of any other medicine you are using to see if it contains aspirin, ibuprofen, ketoprofen, or naproxen. Do not drink alcohol while taking piroxicam. Alcohol can increase the risk of stomach bleeding caused by piroxicam. Avoid exposure to sunlight or artificial UV rays. Piroxicam can make your skin more sensitive to sunlight and sunburn may result.

What should I discuss with my healthcare provider before taking piroxicam?

Taking an NSAID can increase your risk of life-threatening heart or circulation problems, including heart attack or stroke. This risk will increase the longer you use an NSAID. Do not use this medicine just before or after having heart bypass surgery (also called coronary artery bypass graft, or CABG).

NSAIDs can also increase your risk of serious effects on the stomach or intestines, including bleeding or perforation (forming of a hole). These conditions can be fatal and gastrointestinal effects can occur without warning at any time while you are taking an NSAID. Older adults may have an even greater risk of these serious gastrointestinal side effects.

Do not use this medication if you are allergic to piroxicam, or if you have a history of allergic reaction to aspirin or other NSAIDs.

Before taking piroxicam, tell your doctor if you are allergic to any drugs, or if you have:

a history of heart attack, stroke, or blood clot;

heart disease, congestive heart failure, high blood pressure;

a history of stomach ulcers or bleeding;

liver or kidney disease;

asthma;

polyps in your nose;

a bleeding or blood clotting disorder; or

if you smoke.

If you have any of these conditions, you may need a dose adjustment or special tests to safely take piroxicam.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Taking piroxicam during the last 3 months of pregnancy may harm the unborn baby. Do not take piroxicam during pregnancy unless your doctor has told you to. Piroxicam can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Do not give this medicine to a child without the advice of a doctor.

How should I take piroxicam?

Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.

If you switch brands of piroxicam, your dose needs may change. Follow your doctor's instructions about how much medicine to take.

If you take piroxicam for a long period of time, your doctor may want to check you on a regular basis to make sure this medication is not causing harmful effects. Do not miss any scheduled visits to your doctor.

It may take up to 2 weeks of using this medicine before your symptoms improve. For best results, keep using the medication as directed. Talk with your doctor if your symptoms do not improve. Store piroxicam at room temperature away from moisture and heat.

See also: Piroxicam dosage (in more detail)

What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at your next regularly scheduled time. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine. Overdose symptoms may include nausea, vomiting, stomach pain, drowsiness, black or bloody stools, coughing up blood, shallow breathing, fainting, or coma.

What should I avoid while taking piroxicam?

Do not use any other over-the-counter cold, allergy, or pain medication without first asking your doctor or pharmacist. Many medicines available over the counter contain aspirin or other medicines similar to piroxicam (such as ibuprofen, ketoprofen, or naproxen). If you take certain products together you may accidentally take too much of this type of medication. Read the label of any other medicine you are using to see if it contains aspirin, ibuprofen, ketoprofen, or naproxen. Do not drink alcohol while taking piroxicam. Alcohol can increase the risk of stomach bleeding caused by piroxicam. Avoid prolonged exposure to sunlight. Piroxicam may increase the sensitivity of the skin to sunlight. Use a sunscreen and wear protective clothing when exposure to the sun is unavoidable.

Piroxicam side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop taking piroxicam and seek medical attention or call your doctor at once if you have any of these serious side effects:

chest pain, weakness, shortness of breath, slurred speech, problems with vision or balance;

black, bloody, or tarry stools;

coughing up blood or vomit that looks like coffee grounds;

swelling or rapid weight gain;

urinating less than usual or not at all;

nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

fever, sore throat, and headache with a severe blistering, peeling, and red skin rash;

bruising, severe tingling, numbness, pain, muscle weakness; or

fever, headache, neck stiffness, chills, increased sensitivity to light, purple spots on the skin, and/or seizure (convulsions).

Less serious side effects may include:

upset stomach, mild heartburn or stomach pain, diarrhea, constipation;

bloating, gas;

dizziness, headache, nervousness;

skin itching or rash;

blurred vision; or

ringing in your ears.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

Piroxicam Dosing Information

Usual Adult Dose for Osteoarthritis:

20 mg orally once a day or 10 mg orally twice a day.

The recommended maximum daily dose is 20 mg.

Usual Adult Dose for Pain:

20 mg orally once a day or 10 mg orally twice a day.

The recommended maximum daily dose is 20 mg.

Usual Adult Dose for Rheumatoid Arthritis:

20 mg orally once a day or 10 mg orally twice a day.

The recommended maximum daily dose is 20 mg.

Usual Pediatric Dose for Pain:

0.2 to 0.3 mg/kg orally once a day. Maximum daily dose is 15 mg.

What other drugs will affect piroxicam?

Tell your doctor if you are taking an antidepressant such as citalopram (Celexa), duloxetine (Cymbalta), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem, Symbyax), fluvoxamine (Luvox), paroxetine (Paxil), sertraline (Zoloft), or venlafaxine (Effexor). Taking any of these drugs with piroxicam may cause you to bruise or bleed easily.

Before taking piroxicam, tell your doctor if you are taking any of the following drugs:

a blood thinner such as warfarin (Coumadin);

lithium (Eskalith, Lithobid);

methotrexate (Rheumatrex, Trexall);

diuretics (water pills) such as furosemide (Lasix);

steroids (prednisone and others);

aspirin or other NSAIDs (non-steroidal anti-inflammatory drugs) such as etodolac (Lodine), flurbiprofen (Ansaid), indomethacin (Indocin), ketoprofen (Orudis), ketorolac (Toradol), mefenamic acid (Ponstel), meloxicam (Mobic), nabumetone (Relafen), naproxen (Aleve, Naprosyn), and others; or

an ACE inhibitor such as benazepril (Lotensin), captopril (Capoten), fosinopril (Monopril), enalapril (Vasotec), lisinopril (Prinivil, Zestril), ramipril (Altace), and others.

This list is not complete and there may be other drugs that can interact with piroxicam. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

More piroxicam resources

Piroxicam Side Effects (in more detail)
Piroxicam Dosage
Piroxicam Use in Pregnancy & Breastfeeding
Drug Images
Piroxicam Drug Interactions
Piroxicam Support Group
15 Reviews for Piroxicam - Add your own review/rating

piroxicam Advanced Consumer (Micromedex) - Includes Dosage Information

Piroxicam Prescribing Information (FDA)

Piroxicam Professional Patient Advice (Wolters Kluwer)

Piroxicam Monograph (AHFS DI)

Piroxicam MedFacts Consumer Leaflet (Wolters Kluwer)

Feldene Prescribing Information (FDA)

Compare piroxicam with other medications

Frozen Shoulder
Osteoarthritis
Pain
Rheumatoid Arthritis
Temporomandibular Joint Disorder

Where can I get more information?

Your pharmacist can provide more information about piroxicam.

See also: piroxicam side effects (in more detail)

Thursday, 16 August 2012

Vascular Surgery Medications

There are currently no drugs listed for "Vascular Surgery". See Surgery.

Definition of Vascular Surgery: A branch of medicine dealing with the use of surgery to diagnose/treat diseases of the blood vessels.

Drug List:

Sprycel

Generic Name: Dasatinib
Class: Antineoplastic Agents
VA Class: AN900
Chemical Name: N - (2 - Chloro - 6 - methylphenyl) - 2 - [[6 - [4 - (2 - hydroxyethyl) - 1 - piperazinyl] - 2 - methyl - 4 - pyrimidinyl]amino] - 5 - thiazolecarboxamide, monohydrate
Molecular Formula: C₂₂H₂₆C₁N₇O₂S • H₂O
CAS Number: 863127-77-9

Special Alerts:

[Posted 10/11/2011] ISSUE: FDA notified healthcare professionals that dasatinib (Sprycel) may increase the risk of a rare but serious condition in which there is abnormally high blood pressure in the arteries of the lungs (pulmonary arterial hypertension [PAH]). Symptoms of PAH may include shortness of breath, fatigue, and swelling of the body (such as the ankles and legs). In reported cases, patients developed PAH after starting dasatinib, including after more than one year of treatment.

Information about this risk has been added to the Warnings and Precautions section of the dasatinib drug label.

BACKGROUND: Dasatinib is used to treat certain adult patients with Philadelphia chromosome-positive chronic myeloid leukemia (CML) or acute lymphoblastic leukemia (ALL).

RECOMMENDATION:Healthcare professionals should evaluate patients for signs and symptoms of underlying cardiopulmonary disease prior to starting dasatinib and also during treatment. If PAH is confirmed, dasatinib should be permanently discontinued. For more information visit the FDA website at: and .

Introduction

Antineoplastic agent; a kinase inhibitor.¹ ² ³

Uses for Sprycel

Chronic Myelogenous Leukemia (CML)

Treatment of CML in adults who are in myeloid or lymphoid blast crisis, in the accelerated phase, or in the chronic phase of the disease, after failure (secondary to resistance or intolerance) of prior therapy including imatinib (designated an orphan drug by FDA for this use).¹ ² ⁴ ¹¹ ¹² ¹³ ¹⁴ ¹⁶ ¹⁷

Acute Lymphocytic (Lymphoblastic) Leukemia (ALL)

Treatment of Philadelphia chromosome-positive (Ph⁺) ALL in adults following failure (secondary to resistance or intolerance) of prior therapy (designated an orphan drug by FDA for this use).¹ ² ⁴ ¹⁵

Sprycel Dosage and Administration

General

Use under supervision of a qualified clinician.¹

Optimal duration of therapy has not been clearly established.¹ Effect of discontinuance of treatment after achievement of a complete cytogenetic response has not been established.¹

Administration

Oral Administration

Administer orally once daily (morning or evening) without regard to meals.¹

Administer at the same time each day.¹

Swallow tablets whole; do not cut, chew, or crush.¹ ¹⁰

Dosage

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Adjustments may be necessary when used in conjunction with CYP3A4 inhibitors or inducers.¹ (See Drugs Affecting Hepatic Microsomal Enzymes under Interactions.)

Adults

CML

Chronic Phase

Oral

100 mg once daily.¹ If hematologic or cytogenetic response is not achieved, increase dosage to 140 mg once daily.¹

Continue treatment until evidence of disease progression or until no longer tolerated by the patient.¹

Accelerated Phase or Blast Crisis

Oral

140 mg once daily.¹ If hematologic or cytogenetic response is not achieved, increase dosage to 180 mg once daily.¹

Continue treatment until evidence of disease progression or until no longer tolerated by the patient.¹

ALL

Oral

140 mg once daily.¹ If hematologic or cytogenetic response is not achieved, increase dosage to 180 mg once daily.¹

Continue treatment until evidence of disease progression or until no longer tolerated by the patient.¹

Dosage Modification for Toxicity

Nonhematologic Adverse Effects

If a severe nonhematologic adverse reaction occurs, withhold dasatinib until the event has resolved or improved.¹ Thereafter, resume therapy, as appropriate, at a reduced dosage depending on the initial severity of the event.¹

Adverse Hematologic Effects

Temporary interruption, dosage reduction, or discontinuance is indicated in patients experiencing severe neutropenia and/or thrombocytopenia.¹ ¹⁰ Hematopoietic growth factor has been used in patients with resistant myelosuppression.¹

Dosage Adjustments for Neutropenia and Thrombocytopenia
Use (Initial Dosage)	Hematologic Measurements	Dosage Adjustment
Chronic phase CML (initial dosage: 100 mg once daily)¹	ANC <500/mm³ or platelets <50,000/mm³	1. Discontinue dasatinib until ANC ≥1000/mm³ and platelets ≥50,000/mm³¹ 2. Resume treatment at original dosage (100 mg once daily) if cytopenia resolves within 7 days ¹ 3. If recurrence of ANC <500/mm³ lasting >7 days or platelets <25,000/mm³ occurs, repeat step 1 and resume therapy at a reduced dosage of 80 mg once daily (following a second episode); permanently discontinue dasatinib following a third episode¹
Accelerated phase or blast phase CML and Ph⁺ ALL (initial dosage: 140 mg once daily¹	ANC <500/mm³ or platelets <10,000/mm³	1. If cytopenia is unrelated to leukemia (as determined by marrow aspirate or biopsy), discontinue dasatinib until ANC ≥1000/mm³ and platelets ≥20,000/mm³¹ 2. Resume treatment at original dosage (140 mg once daily)¹ 3. If recurrence of ANC <500/mm³ or platelets <10,000/mm³ occurs, repeat step 1 and resume therapy at a reduced dosage of 100 mg once daily (following a second episode) or 80 mg once daily (following a third episode)¹ 4. If cytopenia is related to leukemia (as determined by marrow aspirate or biopsy), consider increasing dosage to 180 mg once daily¹

Special Populations

Hepatic Impairment

Dosage adjustment not necessary.¹ (See Hepatic Impairment under Cautions.)

Renal Impairment

No special dosage recommendations at this time.¹ (See Renal Impairment under Cautions.)

Geriatric Patients

No special dosage recommendations at this time.¹ (See Geriatric Use under Cautions.)

Cautions for Sprycel

Contraindications

No known contraindications.¹

Warnings/Precautions

Warnings

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Fetal/Neonatal Morbidity and Mortality

May cause fetal harm; teratogenicity and embryolethality demonstrated in animals.¹ Avoid pregnancy during therapy.¹ If used during pregnancy or if patient becomes pregnant, apprise of potential fetal hazard.¹

Use adequate forms of contraception during therapy.¹

Major Toxicities

Hematologic Effects

Myelosuppression (principally severe neutropenia, anemia, and thrombocytopenia) occurs commonly and is usually reversible;¹ more frequent in patients in the accelerated or blast phase of CML and in those with Ph⁺ ALL than in patients in the chronic phase of CML.¹ In patients with chronic phase CML, less frequent with once-daily dosing (100 mg once daily) than with other (e.g., twice-daily) dosing regimens.¹ ¹¹

Temporary suspension of therapy or dosage reduction may be required if hematologic toxicity occurs.¹ (See Dosage Modification for Toxicity under Dosage and Administration.)

Perform CBCs weekly during the first 2 months of therapy and monthly (or as clinically indicated) thereafter.¹

Hemorrhage

Risk of severe hemorrhage, including potentially fatal CNS hemorrhage and GI hemorrhage; usually associated with severe thrombocytopenia.¹

Severe GI hemorrhage may require treatment interruption and transfusions.¹

Use with caution in patients receiving anticoagulants or drugs that inhibit platelet function.¹ (See Drugs Affecting Coagulation under Interactions.)

Fluid Retention

Risk of potentially severe fluid retention (i.e., pleural effusion, pericardial effusion, pulmonary edema, ascites, generalized edema).¹ Less common with once-daily dosing than with other dosing schedules (e.g., twice daily).¹

Fluid retention generally managed with supportive care (e.g., diuretics, short course of corticosteroids).¹

Evaluate symptoms suggestive of pleural effusion (e.g., dyspnea, dry cough) by chest radiograph.¹ Severe pleural effusion may require thoracentesis and oxygen therapy.¹

General Precautions

Prolongation of QT Interval

May cause prolongation of the QT interval.¹ Use with caution in patients who have or may develop prolongation of the QT interval (e.g., hypokalemia, hypomagnesemia, congenital long QT syndrome, use of drugs known to prolong QT interval, cumulative high-dose anthracycline therapy).¹

Correct preexisting hypokalemia or hypomagnesemia prior to administration of dasatinib.¹

Lactose Intolerance

140-mg daily dosage (two 70-mg tablets) contains 189 mg of lactose monohydrate; 100-mg daily dosage (one 100-mg tablet) contains 135 mg of lactose monohydrate¹

Specific Populations

Pregnancy

Category D.¹ (See Fetal/Neonatal Morbidity and Mortality under Cautions.)

Lactation

Not known whether dasatinib is distributed into milk.¹ Discontinue nursing or the drug because of potential risk to nursing infants.¹

Pediatric Use

Safety and efficacy not established in patients <18 years of age.¹

Geriatric Use

No substantial differences in efficacy relative to younger adults; safety profile is similar to that in younger adults, but fluid retention and dyspnea are more common in patients ≥65 years of age.¹

Hepatic Impairment

Alterations in peak plasma concentrations and AUC reported but not considered clinically important (see Absorption: Special Populations under Pharmacokinetics).¹ Dosage adjustment is not necessary.¹ However, use with caution.¹

Renal Impairment

Not studied in patients with renal impairment; however, renal excretion of unchanged dasatinib and its metabolites is minimal (<4%).¹

Common Adverse Effects

Fluid retention (e.g., superficial and/or localized edema, generalized edema, pleural effusion, pericardial effusion, CHF or cardiac dysfunction, pulmonary edema),¹ ² neutropenia,¹ ² thrombocytopenia,¹ ² anemia,¹ hemorrhage (e.g., GI or CNS hemorrhage),¹ diarrhea,¹ ² vomiting,¹ ² abdominal pain,¹ nausea,¹ ² headache,¹ ² fatigue,¹ ² pyrexia,¹ musculoskeletal pain,¹ myalgia,¹ arthralgia,¹ rash,¹ ² dyspnea,¹ hypophosphatemia,¹ hypokalemia,¹ hypocalcemia,¹ febrile neutropenia,¹ infection (e.g., bacterial, viral, fungal).¹ ²

Interactions for Sprycel

Metabolized principally by CYP3A4; weak inhibitor of CYP3A4.¹

Does not inhibit CYP isoenzymes 1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, or 2E1; does not induce human CYP isoenzymes.¹

Drugs Affecting Hepatic Microsomal Enzymes

Inhibitors of CYP3A4: Potential pharmacokinetic interaction (increased plasma dasatinib concentrations). ¹ Consider alternative drugs with no or less enzyme inhibition potential.¹ If concomitant use with a potent CYP3A4 inhibitor cannot be avoided, consider reducing dasatinib dosage to 20 mg daily (if current dosage is 100 mg daily) or to 40 mg daily (if current dosage is 140 mg daily) based on pharmacokinetic considerations (no clinical data with these dosage adjustments available).¹ If dasatinib is not tolerated following dosage reduction, discontinue the CYP3A4 inhibitor or interrupt dasatinib therapy until treatment with the CYP3A4 inhibitor is completed.¹ Upon discontinuance of a potent CYP3A4 inhibitor, allow approximately 1 week to elapse before increasing dasatinib dosage.¹

Inducers of CYP3A4: Potential pharmacokinetic interaction (decreased plasma dasatinib concentrations).¹ Avoid concomitant use of potent CYP3A4 inducers; consider alternative drugs with no or less enzyme induction potential.¹ If concomitant therapy cannot be avoided, consider increase in dasatinib dosage and closely monitor patient for toxicity.¹

Drugs Affecting Coagulation

Potential for bleeding; use anticoagulants and drugs that inhibit platelet function concomitantly with caution.¹ Initial clinical trials of dasatinib excluded patients receiving such drugs; subsequent trials permitted use of anticoagulants, aspirin, and NSAIAs if patient’s platelet count exceeded 50,000–75,000/mm³.¹

Drugs Metabolized by Hepatic Microsomal Enzymes

Substrates of CYP3A4: Potential pharmacokinetic interaction (increased plasma substrate concentrations).¹ ¹⁰

Specific Drugs and Foods

Drug or Food	Interaction	Comments
Alfentanil	Possible increased plasma concentrations and AUC of alfentanil¹	Use concomitantly with caution¹
Antacids (e.g., calcium carbonate, aluminum hydroxide/magnesium hydroxide)	Possible decreased plasma dasatinib concentrations, secondary to apparent pH-dependence of dasatinib solubility¹	Administer antacids 2 hours before or 2 hours after a dose of dasatinib¹
Anticoagulants (e.g., warfarin)	Possible increased risk of hemorrhage¹	Use concomitantly with caution¹
Anticonvulsants (carbamazepine, phenobarbital, phenytoin)	Possible decreased plasma dasatinib concentrations¹	Avoid concomitant use if possible; if concomitant therapy necessary, consider increasing dasatinib dosage and closely monitor for toxicity¹
Antifungals, azoles (i.e., itraconazole, ketoconazole, voriconazole)	Possible increased plasma dasatinib concentrations and increased exposure to dasatinib¹	Avoid concomitant use if possible; if concomitant therapy necessary, closely monitor for toxicity and consider reducing dasatinib dosage to 20 mg daily (if current dosage is 100 mg daily) or 40 mg daily (if current dosage is 140 mg daily)¹ (see Drugs Affecting Hepatic Microsomal Enzymes under Interactions)
Antihistamines (terfenadine and astemizole [no longer commercially available])	Possible increased plasma concentrations of terfenadine and astemizole¹ ¹⁰
Cisapride	Possible increased plasma concentrations of cisapride¹ ¹⁰	Use concomitantly with caution¹
Dexamethasone	Possible decreased plasma dasatinib concentrations¹	Avoid concomitant use if possible; if concomitant therapy necessary, consider increasing dasatinib dosage and closely monitor for toxicity¹
Ergot alkaloids (dihydroergotamine, ergotamine)	Possible increased plasma concentrations of ergot alkaloids¹ ¹⁰	Use concomitantly with caution¹
Fentanyl	Possible increased plasma concentrations of fentanyl¹ ¹⁰	Use concomitantly with caution¹
Grapefruit juice	Possible increased plasma dasatinib concentrations¹	Avoid concomitant use¹
Histamine H₂-receptor antagonists (e.g., cimetidine, famotidine, ranitidine)	Possible decreased plasma dasatinib concentrations, secondary to apparent pH-dependence of dasatinib solubility¹	Concomitant use not recommended¹
HIV protease inhibitors (e.g., atazanavir, indinavir, nelfinavir, ritonavir, saquinavir)	Possible increased plasma dasatinib concentrations and increased exposure to dasatinib¹	Avoid concomitant use if possible; if concomitant therapy necessary, closely monitor for toxicity and consider reducing dasatinib dosage to 20 mg daily (if current dosage is 100 mg daily) or 40 mg daily (if current dosage is 140 mg daily)¹ (see Drugs Affecting Hepatic Microsomal Enzymes under Interactions)
Immunosuppressive agents (cyclosporine, sirolimus, tacrolimus)	Possible increased plasma concentrations of immunosuppressive agents¹ ¹⁰	Use concomitantly with caution¹
Macrolide antibiotics (i.e., clarithromycin, erythromycin, telithromycin)	Possible increased plasma dasatinib concentrations and increased exposure to dasatinib¹	Avoid concomitant use if possible; if concomitant therapy necessary, closely monitor for toxicity and consider reducing dasatinib dosage to 20 mg daily (if current dosage is 100 mg daily) or 40 mg daily (if current dosage is 140 mg daily)¹ (see Drugs Affecting Hepatic Microsomal Enzymes under Interactions)
Nefazodone	Possible increased plasma dasatinib concentrations and increased exposure to dasatinib¹	Avoid concomitant use if possible; if concomitant therapy necessary, closely monitor for toxicity and consider reducing dasatinib dosage to 20 mg daily (if current dosage is 100 mg daily) or 40 mg daily (if current dosage is 140 mg daily)¹ (see Drugs Affecting Hepatic Microsomal Enzymes under Interactions)
NSAIAs (e.g., aspirin)	Possible increased risk of hemorrhage¹	Use concomitantly with caution¹
Pimozide	Possible increased plasma concentrations of pimozide¹ ¹⁰	Use concomitantly with caution¹
Proton-pump inhibitors (e.g., esomeprazole, lansoprazole, omeprazole, pantoprazole, rabeprazole)	Possible decreased plasma dasatinib concentrations, secondary to apparent pH-dependence of dasatinib solubility¹	Concomitant use not recommended¹
Quinidine	Possible increased plasma concentrations of quinidine¹ ¹⁰	Use concomitantly with caution¹
Rifamycins (rifabutin, rifampin)	Possible decreased plasma dasatinib concentrations and AUC of dasatinib¹	Avoid concomitant use if possible; if concomitant therapy necessary, consider increasing dasatinib dosage and closely monitor for toxicity¹
St. John’s wort (Hypericum perforatum)	Potential for unpredictable decreases in plasma dasatinib concentrations¹	Concomitant use not recommended¹
Simvastatin	Possible increased plasma concentrations and AUC of simvastatin¹	Use concomitantly with caution¹

Sprycel Pharmacokinetics

Absorption

Onset

Following oral administration, peak plasma concentrations are attained within 0.5–6 hours.¹

Special Populations

In patients with moderate or severe hepatic impairment (Child-Pugh class B or C), peak plasma concentrations and AUC (normalized for differences in administered doses) are lower than in healthy individuals; differences not considered clinically important.¹

Distribution

Extent

Extensively distributed into the extravascular space.¹

Plasma Protein Binding

Approximately 96 and 93% for dasatinib and active metabolite, respectively.¹

Elimination

Metabolism

Metabolized in the liver, principally by CYP3A4, to an active metabolite and several inactive metabolites.¹

Elimination Route

Eliminated principally in feces (85%) mainly as metabolites and to a lesser extent in urine (4%). ¹

Half-life

3–5 hours.¹

Special Populations

No clinically relevant effects of age and gender on pharmacokinetics.¹

Stability

Storage

Oral

Tablets

25° C (may be exposed to 15–30°C).¹

Actions

Inhibits multiple tyrosine kinases including Bcr-Abl, the Src family (Src, Lck, Yes, Fyn), c-Kit, EphA-2, and platelet-derived growth factor (PDGFR)-β; predicted to bind to multiple conformations of the Abl kinase.¹

Inhibits Bcr-Abl tyrosine kinase, an abnormal protein created by the Philadelphia chromosome abnormality in CML and Ph⁺ ALL that exhibits enhanced tyrosine kinase activity (i.e., increased phosphorylation of tyrosine residues).⁵ ⁶ ⁷ ⁸ ⁹

Overcomes imatinib resistance resulting from Bcr-Abl kinase domain mutations, activation of alternate signaling pathways involving the Src family kinases (Lyn, Hck), and multidrug-resistance gene overexpression.¹

Advice to Patients

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Importance of taking only as prescribed.¹ Take at about the same time each day; do not discontinue therapy without first consulting clinician.¹

Importance of advising patients to swallow dasatinib tablets whole with water and not to break, chew, cut, or crush the tablets.¹ Importance of not drinking grapefruit juice while taking the drug.¹

Risk of severe fluid retention, bleeding, and cytopenia.¹ Importance of immediately informing clinician if fever, any bleeding or bruising, swelling, weight gain, or increasing shortness of breath occurs.¹

Importance of close medical supervision in patients receiving dasatinib.¹

Importance of informing clinicians if patient is lactose intolerant.¹

Importance of women informing their clinician if they are or plan to become pregnant or plan to breast-feed; necessity for clinicians to advise women to avoid pregnancy during therapy, advise pregnant women of risk to the fetus, and advise both males and females to utilize effective contraception during therapy.¹

Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs and herbal supplements, as well as any concomitant illnesses.¹

Importance of informing patients of other important precautionary information.¹ (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Dasatinib
Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	Tablets, film-coated	20 mg	Sprycel	Bristol Myers-Squibb
		50 mg	Sprycel	Bristol Myers-Squibb
		70 mg	Sprycel	Bristol Myers-Squibb
		100 mg	Sprycel	Bristol Myers-Squibb

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 10/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Sprycel 20MG Tablets (B-M SQUIBB U.S. (PRIMARY CARE)): 30/$2,304.00 or 90/$6,777.22

Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

References

1. Bristol Myers-Squibb Company. Sprycel (dasatinib) tablets prescribing information and patient information. Princeton, NJ; 2009 May.

2. Talpaz M, Shah NP, Kantarjian H et al. Dasatinib in imatinib-resistant Philadelphia chromosome-positive leukemias. N Engl J Med. 2006; 354:2531-41. [PubMed 16775234]

3. Shah NP. Loss of response to imatinib: mechanisms and management. Hematology Am Soc Hematol Educ Program. 2005; :183-7. [PubMed 16304378]

4. Food and Drug Administration. Orphan designations pursuant to Section 526 of the Federal Food and Cosmetic Act as amended by the Orphan Drug Act (P.L. 97-414). Rockville, MD; 2006 Mar 21. From FDA website. Accessed 2006 Jul 19.

5. Druker BJ, Lydon NB. Lessons learned from the development of an Abl tyrosine kinase inhibitor for chronic myelogenous leukemia. J Clin Investig. 2000; 105:3-7. [PubMed 10619854]

6. McGuire TR, Kazakoff PW. Chronic leukemias. In: DiPiro JT, Talbert RL, Yee GC et al., eds. Pharmacotherapy: a pathophysiologic approach. 4th ed. Stamford: Appleton and Lange; 1999:2169-80.

7. Druker BJ, Talpaz M, Resta DJ et al. Efficacy and safety of a specific inhibitor of the Bcr-Abl tyrosine kinase in chronic myeloid leukemia. N Engl J Med. 2001; 344:1031-7. [IDIS 461596] [PubMed 11287972]

8. Anon. Gleevec (STI-571) for chronic myeloid leukemia. Med Lett Drugs Ther. 2001; 43:49-50. [PubMed 11402258]

9. Weisberg E, Griffin J. Mechanisms of resistance imatinib (STI-571) in preclinical models and in leukemia patients. Drug Resistance Updates. 2001; 4:22-8. [PubMed 11512149]

10. Bristol-Myers Squibb, Plainsboro, NJ: Personal communication.

11. Shah NP, Kantarjian HM, Kim DW et al. Intermittent target inhibition with dasatinib 100 mg once daily preserves efficacy and improves tolerability in imatinib-resistant and -intolerant chronic-phase chronic myeloid leukemia. J Clin Oncol. 2008; 26:3204-12. [PubMed 18541900]

12. Kantarjian H, Cortes J, Kim DW et al. Phase 3 study of dasatinib 140 mg once daily versus 70 mg twice daily in patients with chronic myeloid leukemia in accelerated phase resistant or intolerant to imatinib: 15-month median follow-up. Blood. 2009; 113:6322-9. [PubMed 19369231]

13. Kantarjian H, Pasquini R, Hamerschlak N et al. Dasatinib or high-dose imatinib for chronic-phase chronic myeloid leukemia after failure of first-line imatinib: a randomized phase 2 trial. Blood. 2007; 109:5143-50. [PubMed 17317857]

14. Hochhaus A, Baccarani M, Deininger M et al. Dasatinib induces durable cytogenetic responses in patients with chcronic myelogenous leukemia in chronic phase with resistance or intolerance to imatinib. Leukemia. 2008; 22:1200-6. [PubMed 18401416]

15. Ottmann O, Dombret H, Martinelli G et al. Dasatinib induces rapid hematologic and cytogenetic responses in adult patients with Philadelphia chromosome positive acute lymphoblastic leukemia with resistance or intolerance to imatinib: interim results of a phase 2 study. Blood. 2007; 110:2309-15. [PubMed 17496201]

16. Cortes J, Kim DW, Raffoux E et al. Efficacy and safety of dasatinib in imatinib-resistant or -intolerant patients with chronic myeloid leukemia in blast phase. Leukemia. 2008; 22:2176-83. [PubMed 18754032]

17. Guilhot F, Apperley J, Kim DW et al. Dasatinib induces significant hematologic and cytogenetic responses in patients with imatinib-resistant or -intolerant chronic myeloid leukemia in accelerated phase. Blood. 2007; 109:4143-50. [PubMed 17264298]

18. Food and Drug Administration. Center for Drug Evaluation and Research: Application number 21-986 and 22-072: Medical Review(s). From FDA website.

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Sunday, 26 August 2012

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