potassium bicarbonate and potassium citrate

Generic Name: potassium bicarbonate and potassium citrate (poe TASS ee um bye KAR boe nate and poe TASS ee um SIT rate)

Brand names: K-Lyte, Effer-K (obsolete), Klor-Con/EF (obsolete), K-Lyte DS, K-vescent (obsolete)

What is potassium bicarbonate and potassium citrate?

Potassium is a mineral that is found in many foods and is needed for several functions of your body, especially the beating of your heart.

Potassium bicarbonate and potassium citrate is used to prevent or to treat low blood levels of potassium (hypokalemia). Potassium levels can be low as a result of a disease or from taking certain medicines, or after a prolonged illness with diarrhea or vomiting.

Potassium bicarbonate and potassium citrate may also be used for other purposes other than those listed in this medication guide.

What is the most important information I should know about potassium bicarbonate and potassium citrate?

You should not use this medication if you have kidney failure, Addison's disease, severe burns or other tissue injury, if you are dehydrated, if you take certain diuretics (water pills), or if you have high levels of potassium in your blood (hyperkalemia). Do not chew the effervescent tablet or swallow it whole. It must be dissolved in water or fruit juice before you take it. Avoid lying down for at least 30 minutes after you take this medication. Take this medication with food or just after a meal.

To be sure this medication is helping your condition, your blood may need to be tested often. Your heart rate may also be checked using an electrocardiograph or ECG (sometimes called an EKG) to measure electrical activity of the heart. This test will help your doctor determine how long to treat you with potassium. Do not miss any scheduled appointments.

Serious side effects of potassium include uneven heartbeat, muscle weakness or limp feeling, severe stomach pain, and numbness or tingling in your hands, feet, or mouth.

Do not stop taking this medication without first talking to your doctor. If you stop taking potassium suddenly, your condition may become worse.

What should I discuss with my healthcare provider before taking potassium bicarbonate and potassium citrate?

You should not use this medication if you are allergic to it, or if you have certain conditions. Be sure your doctor knows if you have:

• 
  

  high levels of potassium in your blood (hyperkalemia);

  
  


• 
  

  kidney failure;

  
  


• 
  

  Addison's disease (an adrenal gland disorder);

  
  


• 
  

  a large tissue injury such as a severe burn;

  
  


• 
  

  if you are severely dehydrated; or

  
  


• 
  

  if you are taking a "potassium-sparing" diuretic (water pill) such as amiloride (Midamor, Moduretic), spironolactone (Aldactone, Aldactazide), triamterene (Dyrenium, Dyazide, Maxzide).

  
  

Before using potassium bicarbonate and potassium citrate, tell your doctor if you are allergic to any drugs, or if you have:

• kidney disease;


• 
  

  heart disease or high blood pressure;

  
  


• 
  

  a blockage in your stomach or intestines; or

  
  


• 
  

  chronic diarrhea (such as ulcerative colitis, Crohn's disease).

  
  

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

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. It is not known whether potassium passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take potassium bicarbonate and potassium citrate?

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

Do not chew the effervescent tablet or swallow it whole. Drop the tablet into a glass and add at least 4 ounces (one-half cup) of cold water or fruit juice. When the tablet has completely dissolved, begin drinking the mixture slowly, over 5 to 10 minutes in all.

To make sure you get the entire dose, add a little more water to the same glass, swirl gently and drink right away.

Take this medication with food or just after a meal. Your treatment may include a special diet. It is very important to follow the diet plan created for you by your doctor or nutrition counselor. You should become very familiar with the list of foods you should eat or avoid to help control your condition.

Potassium-rich foods include: squash, baked potatoes (skin on), spinach, lentils, broccoli, brussels sprouts, zucchini, kidney or navy beans, raisins, watermelon, orange juice, bananas, cantaloupe, and low-fat milk or yogurt. Consume only the daily amounts recommended by your doctor or nutrition counselor.

To be sure this medication is helping your condition, your blood may need to be tested often. Your heart rate may also be checked using an electrocardiograph or ECG (sometimes called an EKG) to measure electrical activity of the heart. This test will help your doctor determine how long to treat you with potassium. Do not miss any scheduled appointments.

Do not stop taking this medication without first talking to your doctor. If you stop taking potassium suddenly, your condition may become worse. Store potassium bicarbonate and potassium citrate at room temperature away from moisture and heat. Keep the medication in a closed container.

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, wait until then to take the medicine and skip the missed dose. 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 heavy feeling in your arms or legs, confusion, weak or shallow breathing, slow or uneven heartbeat, seizure (convulsions), or feeling like you might pass out.

What should I avoid while taking potassium bicarbonate and potassium citrate?

Avoid lying down for at least 30 minutes after you take this medication.

Avoid taking potassium supplements or using other products that contain potassium without first asking your doctor. Salt substitutes or low-salt dietary products often contain potassium. If you take certain products together you may accidentally get too much potassium. Read the label of any other medicine you are using to see if it contains potassium.

Potassium bicarbonate and potassium citrate 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 using this medication and call your doctor at once if you have any of these serious side effects:

• 
  

  confusion, anxiety, feeling like you might pass out;

  
  


• 
  

  uneven heartbeat;

  
  


• 
  

  extreme thirst, increased urination;

  
  


• 
  

  leg discomfort;

  
  


• 
  

  muscle weakness or limp feeling;

  
  


• 
  

  numbness or tingly feeling in your hands or feet, or around your mouth;

  
  


• 
  

  severe stomach pain, ongoing diarrhea or vomiting;

  
  


• 
  

  black, bloody, or tarry stools; or

  
  


• 
  

  coughing up blood or vomit that looks like coffee grounds.

  
  

Less serious side effects may include:

• 
  

  mild nausea or upset stomach;

  
  


• 
  

  mild or occasional diarrhea; or

  
  


• 
  

  slight tingling in your hands or feet.

  
  

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect.

What other drugs will affect potassium bicarbonate and potassium citrate?

The following drugs can interact with potassium bicarbonate and potassium citrate. Tell your doctor if you are using any of these:

• 
  

  eplerenone (Inspra);

  
  


• 
  

  digoxin (digitalis, Lanoxin);

  
  


• 
  

  quinidine (Quinaglute, Quinidex, Quin-Release);

  
  


• 
  

  a bronchodilator such as ipratroprium (Atrovent) or tiotropium (Spiriva);

  
  


• 
  

  an ACE inhibitor such as benazepril (Lotensin), captopril (Capoten), fosinopril (Monopril), enalapril (Vasotec), lisinopril (Prinivil, Zestril), moexipril (Univasc), perindopril (Aceon), quinapril (Accupril), ramipril (Altace), or trandolapril (Mavik); or

  
  


• 
  

  any type of diuretic (water pill) such as bumetanide (Bumex), chlorothiazide (Diuril), chlorthalidone (Hygroton, Thalitone), ethacrynic acid (Edecrin), furosemide (Lasix), hydrochlorothiazide (HCTZ, HydroDiuril, Hyzaar, Lopressor, Vasoretic, Zestoretic), indapamide (Lozol), metolazone (Mykrox, Zarxolyn), or torsemide (Demadex).

  
  

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

More potassium bicarbonate and potassium citrate resources

• Potassium bicarbonate and potassium citrate Drug Interactions
• Potassium bicarbonate and potassium citrate Support Group
• 0 Reviews for Potassium bicarbonate and potassium citrate - Add your own review/rating

Compare potassium bicarbonate and potassium citrate with other medications

• Hypokalemia
• Prevention of Hypokalemia

Where can I get more information?

• Your pharmacist can provide more information about potassium bicarbonate and potassium citrate.

Thyrolar

Pronunciation: LYE-oh-triks
Generic Name: Liotrix
Brand Name: Thyrolar

Thyrolar, used alone or in combination with other medicines, should not be used to treat obesity or for weight loss. Large doses may cause serious or life-threatening side effects, particularly when used with other medicines that reduce the appetite.

Thyrolar is used for:

Treating low thyroid activity, treating or suppressing different types of goiters, and aiding diagnosis of certain thyroid conditions. It may also be used to treat other conditions as determined by your doctor.

Thyrolar is a thyroid hormone. It works by supplementing the natural thyroid hormones in the body.

Do NOT use Thyrolar if:

• you are allergic to any ingredient in Thyrolar


• you have had or are having a heart attack, you have thyrotoxicosis (a condition characterized by chest pain, increased heartbeat, pounding in the chest, excessive sweating, heat intolerance, and nervousness), or untreated adrenal gland problems

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

Before using Thyrolar:

Some medical conditions may interact with Thyrolar. 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 are planning to have surgery


• if you have heart disease, high blood pressure, diabetes, an overactive thyroid, a long-standing condition of underactive thyroid, or myxedema (a condition characterized by chest pain, increased heart rate, pounding in the chest, excessive sweating, heat intolerance, and nervousness)

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

• Estrogens or iron salts (eg, ferrous sulfate) because the effectiveness of Thyrolar may be decreased


• Anticoagulants (eg, warfarin) because the actions and side effects may be increased by Thyrolar


• Digitalis glycosides (eg, digoxin), hypoglycemics (eg, glipizide), or insulin because the effectiveness may be decreased by Thyrolar

This may not be a complete list of all interactions that may occur. Ask your health care provider if Thyrolar 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 Thyrolar:

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

• Thyrolar may be taken with or without food.


• Try to take Thyrolar at the same time each day.


• Take Thyrolar at least 4 hours apart from calcium salts (eg, calcium carbonate), cholestyramine, or colestipol.


• It may take several (4 to 6) weeks for you to notice the benefits of Thyrolar.


• If you miss a dose of Thyrolar, 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 Thyrolar.

Important safety information:

• Check with your doctor if you experience trembling or shaking of hands, nervousness, difficulty sleeping, headache, change in appetite, diarrhea, weight loss, increased sweating, increased sensitivity to heat, increased heart rate, chest pain, or shortness of breath. These symptoms may mean that your dose needs to be adjusted. Do not adjust your dose or stop taking Thyrolar without checking with your doctor.


• Thyrolar is usually taken for life, except in the cases of temporary low thyroid activity associated with thyroid inflammation or if you are taking Thyrolar on a trial basis.


• If you are taking blood thinners when you start taking Thyrolar, lab tests will be required to determine a dose adjustment in the blood thinners.


• Before you have any medical or dental treatments, emergency care, or surgery, tell the doctor or dentist that you are using Thyrolar.


• Diabetes patients - Thyrolar may affect your blood sugar. Check blood sugar levels closely and ask your doctor before adjusting the dose of your diabetes medicine.


• LAB TESTS, including thyroid function tests, may be performed to monitor your progress. Be sure to keep all doctor and lab appointments.


• Use Thyrolar with caution in the ELDERLY because they may be more sensitive to its effects.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, discuss with your doctor the benefits and risks of using Thyrolar during pregnancy. Thyrolar is excreted in breast milk. If you are or will be breast-feeding, check with your doctor to discuss the risks to your baby.

Possible side effects of Thyrolar:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Partial, temporary hair loss in children.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); changes in appetite; changes in menstrual periods; changes in weight; chest pain; diarrhea; excessive sweating; inability to tolerate warm or hot room/weather conditions; increased heart rate; nervousness; pounding in the chest; tremors; vomiting.

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: Thyrolar 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 diarrhea; fast heart rate; nervousness; stomach cramps; trouble sleeping; weight loss.

Proper storage of Thyrolar:

Store Thyrolar in the refrigerator, between 36 and 46 degrees F (2 and 8 degrees C). Do not freeze. Keep in a tight, light-resistant container. Keep Thyrolar out of the reach of children and away from pets.

General information:

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


• Thyrolar 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 Thyrolar. 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

Copyright © 2012 Wolters Kluwer Health, Inc.

More Thyrolar resources

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

• Liotrix Professional Patient Advice (Wolters Kluwer)


• liotrix Concise Consumer Information (Cerner Multum)


• Liotrix Monograph (AHFS DI)


• liotrix Advanced Consumer (Micromedex) - Includes Dosage Information

Compare Thyrolar with other medications

• Underactive Thyroid

Prenatabs Rx

Generic Name: prenatal multivitamins (PRE nay tal VYE ta mins)

Brand Names: Advance Care Plus, Bright Beginnings, Cavan Folate, Cavan One, Cavan-Heme OB, Cenogen Ultra, CitraNatal Rx, Co Natal FA, Complete Natal DHA, Complete-RF, CompleteNate, Concept OB, Docosavit, Dualvit OB, Duet, Edge OB, Elite OB 400, Femecal OB, Folbecal, Folcaps Care One, Folivan-OB, Foltabs, Gesticare, Icar Prenatal, Icare Prenatal Rx, Inatal Advance, Infanate DHA, Kolnatal DHA, Lactocal-F, Marnatal-F, Maternity, Maxinate, Mission Prenatal, Multi-Nate 30, Multinatal Plus, Nata 29 Prenatal, Natachew, Natafort, Natelle, Neevo, Nestabs, Nexa Select with DHA, Novanatal, NovaStart, O-Cal Prenatal, OB Complete, OB Natal One, Ob-20, Obtrex DHA, OptiNate, Paire OB Plus DHA, PNV Select, PNV-Total, PR Natal 400, Pre-H-Cal, Precare, PreferaOB, Premesis Rx, PrenaCare, PrenaFirst, PrenaPlus, Prenatabs OBN, Prenatabs Rx, Prenatal 1 Plus 1, Prenatal Elite, Prenatal Multivitamins, Prenatal Plus, Prenatal S, Prenatal-U, Prenate Advanced Formula, Prenate DHA, Prenate Elite, Prenavite FC, PreNexa, PreQue 10, Previte Rx, PrimaCare, Pruet DHA, RE OB Plus DHA, Renate, RightStep, Rovin-NV, Se-Care, Se-Natal One, Se-Plete DHA, Se-Tan DHA, Select-OB, Seton ET, Strongstart, Stuart Prenatal with Beta Carotene, Tandem OB, Taron-BC, Tri Rx, TriAdvance, TriCare, Trimesis Rx, Trinate, Triveen-PRx RNF, UltimateCare Advance, Ultra-Natal, Vemavite PRX 2, VeNatal FA, Verotin-BY, Verotin-GR, Vinacal OR, Vinatal Forte, Vinate Advanced (New Formula), Vinate AZ, Vinate Care, Vinate Good Start, Vinate II (New Formula), Vinate III, Vinate One, Vitafol-OB, VitaNatal OB plus DHA, Vitaphil, Vitaphil Aide, Vitaphil Plus DHA, Vitaspire, Viva DHA, Vol-Nate, Vol-Plus, Vol-Tab Rx, Vynatal F.A., Zatean-CH, Zatean-PN

What are Prenatabs Rx (prenatal multivitamins)?

There are many brands and forms of prenatal vitamin available and not all brands are listed on this leaflet.

Prenatal vitamins are a combination of many different vitamins that are normally found in foods and other natural sources.

Prenatal vitamins are used to provide the additional vitamins needed during pregnancy. Minerals may also be contained in prenatal multivitamins.

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

What is the most important information I should know about prenatal vitamins?

There are many brands and forms of prenatal vitamin available and not all brands are listed on this leaflet.

Never take more than the recommended dose of a multivitamin. Avoid taking any other multivitamin product within 2 hours before or after you take your prenatal vitamins. Taking similar vitamin products together at the same time can result in a vitamin overdose or serious side effects.

Many multivitamin products also contain minerals such as calcium, iron, magnesium, potassium, and zinc. Minerals (especially taken in large doses) can cause side effects such as tooth staining, increased urination, stomach bleeding, uneven heart rate, confusion, and muscle weakness or limp feeling. Read the label of any multivitamin product you take to make sure you are aware of what it contains.

Seek emergency medical attention if you think you have used too much of this medicine. An overdose of vitamins A, D, E, or K can cause serious or life-threatening side effects and can also harm your unborn baby. Certain minerals contained in a prenatal multivitamin may also cause serious overdose symptoms or harm to the baby if you take too much.

Overdose symptoms may include stomach pain, vomiting, diarrhea, constipation, loss of appetite, hair loss, peeling skin, tingly feeling in or around your mouth, changes in menstrual periods, weight loss, severe headache, muscle or joint pain, severe back pain, blood in your urine, pale skin, and easy bruising or bleeding.

Do not take this medication with milk, other dairy products, calcium supplements, or antacids that contain calcium. Calcium may make it harder for your body to absorb certain ingredients of the multivitamin.

What should I discuss with my healthcare provider before taking prenatal vitamins?

Many vitamins can cause serious or life-threatening side effects if taken in large doses. Do not take more of this medication than directed on the label or prescribed by your doctor.

Before taking prenatal vitamins, tell your doctor about all of your medical conditions.

You may need to continue taking prenatal vitamins if you breast-feed your baby. Ask your doctor about taking this medication while breast-feeding.

How should I take prenatal vitamins?

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Never take more than the recommended dose of prenatal vitamins.

Many multivitamin products also contain minerals such as calcium, iron, magnesium, potassium, and zinc. Minerals (especially taken in large doses) can cause side effects such as tooth staining, increased urination, stomach bleeding, uneven heart rate, confusion, and muscle weakness or limp feeling. Read the label of any multivitamin product you take to make sure you are aware of what it contains.

Take your prenatal vitamin with a full glass of water.

Swallow the regular tablet or capsule whole. Do not break, chew, crush, or open it.

The chewable tablet must be chewed or allowed to dissolve in your mouth before swallowing. You may also allow the chewable tablet to dissolve in drinking water, fruit juice, or infant formula (but not milk or other dairy products). Drink this mixture right away.

Use prenatal vitamins regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

Store at room temperature away from moisture and heat. Keep prenatal vitamins in their original container. Storing vitamins in a glass container can ruin the medication.

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 if you think you have used too much of this medicine. An overdose of vitamins A, D, E, or K can cause serious or life-threatening side effects and can also harm your unborn baby. Certain minerals contained in a prenatal multivitamin may also cause serious overdose symptoms or harm to the baby if you take too much.

Overdose symptoms may include stomach pain, vomiting, diarrhea, constipation, loss of appetite, hair loss, peeling skin, tingly feeling in or around your mouth, changes in menstrual periods, weight loss, severe headache, muscle or joint pain, severe back pain, blood in your urine, pale skin, and easy bruising or bleeding.

What should I avoid while taking prenatal vitamins?

Avoid taking any other multivitamin product within 2 hours before or after you take your prenatal vitamins. Taking similar vitamin products together at the same time can result in a vitamin overdose or serious side effects.

Avoid the regular use of salt substitutes in your diet if your multivitamin contains potassium. If you are on a low-salt diet, ask your doctor before taking a vitamin or mineral supplement.

Do not take this medication with milk, other dairy products, calcium supplements, or antacids that contain calcium. Calcium may make it harder for your body to absorb certain ingredients of the prenatal vitamin.

Prenatal vitamins 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.

When taken as directed, prenatal vitamins are not expected to cause serious side effects. Less serious side effects may include:

• 
  

  upset stomach;

  
  


• 
  

  headache; or

  
  


• 
  

  unusual or unpleasant taste in your mouth.

  
  

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.

What other drugs will affect prenatal vitamins?

Vitamin and mineral supplements can interact with certain medications, or affect how medications work in your body. Before taking a prenatal vitamin, tell your doctor if you also use:

• 
  

  diuretics (water pills);

  
  


• 
  

  heart or blood pressure medications;

  
  


• 
  

  tretinoin (Vesanoid);

  
  


• 
  

  isotretinoin (Accutane, Amnesteen, Clavaris, Sotret);

  
  


• 
  

  trimethoprim and sulfamethoxazole (Cotrim, Bactrim, Gantanol, Gantrisin, Septra, TMP/SMX); or

  
  


• 
  

  an NSAID (non-steroidal anti-inflammatory drug) such as ibuprofen (Advil, Motrin), naproxen (Aleve, Naprosyn, Naprelan, Treximet), celecoxib (Celebrex), diclofenac (Cataflam, Voltaren), indomethacin (Indocin), meloxicam (Mobic), and others.

  
  

This list is not complete and other drugs may interact with prenatal vitamins. 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 Prenatabs Rx resources

• Prenatabs Rx Use in Pregnancy & Breastfeeding
• Prenatabs Rx Drug Interactions
• Prenatabs Rx Support Group
• 0 Reviews for Prenatabs Rx - Add your own review/rating

• Cal-Nate MedFacts Consumer Leaflet (Wolters Kluwer)


• CareNatal DHA MedFacts Consumer Leaflet (Wolters Kluwer)


• CitraNatal 90 DHA MedFacts Consumer Leaflet (Wolters Kluwer)


• CitraNatal Assure Prescribing Information (FDA)


• CitraNatal Harmony Prescribing Information (FDA)


• Concept DHA Prescribing Information (FDA)


• Docosavit Prescribing Information (FDA)


• Duet DHA with Ferrazone MedFacts Consumer Leaflet (Wolters Kluwer)


• Folbecal MedFacts Consumer Leaflet (Wolters Kluwer)


• Folcal DHA Prescribing Information (FDA)


• Folcaps Care One Prescribing Information (FDA)


• Gesticare DHA Prescribing Information (FDA)


• Gesticare DHA MedFacts Consumer Leaflet (Wolters Kluwer)


• Inatal Advance Prescribing Information (FDA)


• Inatal Ultra Prescribing Information (FDA)


• Multi-Nate DHA Prescribing Information (FDA)


• Multi-Nate DHA Extra Prescribing Information (FDA)


• MultiNatal Plus MedFacts Consumer Leaflet (Wolters Kluwer)


• Natelle One Prescribing Information (FDA)


• Neevo Caplets MedFacts Consumer Leaflet (Wolters Kluwer)


• Neevo DHA MedFacts Consumer Leaflet (Wolters Kluwer)


• OB Complete 400 MedFacts Consumer Leaflet (Wolters Kluwer)


• Paire OB Plus DHA Prescribing Information (FDA)


• PreNexa MedFacts Consumer Leaflet (Wolters Kluwer)


• PreNexa Prescribing Information (FDA)


• PreferaOB Prescribing Information (FDA)


• Prenatal Plus Prescribing Information (FDA)


• Prenatal Plus Iron Prescribing Information (FDA)


• Prenate Elite Prescribing Information (FDA)


• Prenate Elite MedFacts Consumer Leaflet (Wolters Kluwer)


• Prenate Elite tablets


• Prenate Essential Prescribing Information (FDA)


• PrimaCare Advantage MedFacts Consumer Leaflet (Wolters Kluwer)


• PrimaCare ONE capsules


• PrimaCare One MedFacts Consumer Leaflet (Wolters Kluwer)


• Renate DHA Prescribing Information (FDA)


• Se-Natal 19 Chewable Tablets MedFacts Consumer Leaflet (Wolters Kluwer)


• Se-Natal 19 Prescribing Information (FDA)


• Tandem DHA Prescribing Information (FDA)


• Tandem OB Prescribing Information (FDA)


• TriAdvance Prescribing Information (FDA)


• Triveen-One MedFacts Consumer Leaflet (Wolters Kluwer)


• Triveen-PRx RNF Prescribing Information (FDA)


• UltimateCare ONE NF Prescribing Information (FDA)


• Ultra NatalCare MedFacts Consumer Leaflet (Wolters Kluwer)


• Vinate AZ Prescribing Information (FDA)


• Vitafol-One MedFacts Consumer Leaflet (Wolters Kluwer)


• Zatean-CH Prescribing Information (FDA)

Compare Prenatabs Rx with other medications

• Vitamin/Mineral Supplementation during Pregnancy/Lactation

Where can I get more information?

• Your pharmacist can provide more information about prenatal vitamins.

Nevirapine Suspension

Pronunciation: ne-VIR-a-peen
Generic Name: Nevirapine
Brand Name: Viramune

Severe and sometimes fatal liver problems have occurred in patients taking Nevirapine Suspension. This may occur in men and women, but the risk may be greater in women or in patients with a high CD4 cell count at the start of treatment. Certain pregnant women and women with a CD4 cell count higher than 250 have the greatest risk. Liver function tests and CD4 cell counts may be performed while you take Nevirapine Suspension. Contact your doctor right away if you develop a rash, dark urine, yellowing of the eyes or skin, pale stools, stomach pain, nausea, loss of appetite, or unusual tiredness.

Nevirapine Suspension should only be used in patients who have been diagnosed with HIV. Do not use Nevirapine Suspension to prevent HIV infection if you have been exposed to the virus.

Nevirapine Suspension may cause serious and sometimes fatal skin reactions. Contact your doctor immediately if you develop a rash or red, swollen, blistered, or peeling skin.

The risk of liver and skin problems is greatest during the first 18 weeks of therapy, but these problems may occur at any time during treatment. Your doctor will check for side effects frequently during the first several months after you start Nevirapine Suspension. Be sure to keep all doctor and lab appointments. Take Nevirapine Suspension exactly as prescribed by your doctor. If you develop a liver or skin problem or if you have a severe allergic reaction to Nevirapine Suspension, you must not take it again.

Nevirapine Suspension is used for:

Treating HIV infection. It must be used along with other HIV medicines.

Nevirapine Suspension is a nonnucleoside reverse transcriptase inhibitor (NNRTI). It works by blocking the growth of HIV.

Do NOT use Nevirapine Suspension if:

• you are allergic to any ingredient in Nevirapine Suspension


• you have moderate to severe liver problems


• you have had a serious liver or skin reaction while taking Nevirapine Suspension


• you are taking another medicine that contains nevirapine


• you are taking efavirenz, certain HIV protease inhibitors (eg, atazanavir, fosamprenavir, lopinavir/ritonavir), itraconazole, ketoconazole, lurasidone, rifampin, or St. John's wort


• you have not been diagnosed with HIV

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

Before using Nevirapine Suspension:

Some medical conditions may interact with Nevirapine Suspension. 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 liver problems (eg, cirrhosis, hepatic fibrosis, hepatitis), abnormal liver function tests, or certain skin problems (eg, growths, rash)


• if you have kidney problems or are receiving dialysis


• if you have a fever, a high CD4 cell count, or an abnormally high level of white blood cells

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

• Prednisone because the risk of severe skin rash may be increased


• Fluconazole because it may increase the risk of Nevirapine Suspension's side effects


• Rifampin or St. John's wort because they may decrease Nevirapine Suspension's effectiveness


• Anticoagulants (eg, warfarin), HMG-CoA reductase inhibitors (eg, atorvastatin), or rifabutin because the risk of their side effects may be increased by Nevirapine Suspension


• Antiarrhythmics (eg, amiodarone, disopyramide), azole antifungals (eg, itraconazole, ketoconazole), calcium channel blockers (eg, diltiazem, nifedipine, verapamil), carbamazepine, cisapride, clarithromycin, clonazepam, cyclophosphamide, cyclosporine, efavirenz, ergot alkaloids (eg, ergotamine), ethosuximide, exemestane, fentanyl, HIV protease inhibitors (eg, atazanavir, indinavir, nelfinavir), hormonal contraceptives (eg, birth control pills), lurasidone, methadone, sirolimus, tacrolimus, tyrosine kinase receptor inhibitors (eg, dasatinib), or ulipristal because their effectiveness may be decreased by Nevirapine Suspension

This may not be a complete list of all interactions that may occur. Ask your health care provider if Nevirapine Suspension 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 Nevirapine Suspension:

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

• Nevirapine Suspension comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Nevirapine Suspension refilled.


• Take Nevirapine Suspension by mouth with or without food.


• Shake gently before each use.


• Use an oral dosing syringe or a dosing cup to take Nevirapine Suspension. Ask your pharmacist for help if you are unsure of how to measure your dose. If you are using a dosing cup, rinse it with water after you take your dose. Swallow the rinse water to be sure you receive the entire dose of medicine. If your dose is less than 1 teaspoon (5 mL), use a dosing syringe.


• Taking Nevirapine Suspension at the same time each day will help you remember to take it.


• Continue to take Nevirapine Suspension even if you feel well. Do not miss any doses.


• If you miss a dose of Nevirapine Suspension, 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. If you miss taking Nevirapine Suspension for more than 7 days, contact your doctor before you start to take it again.

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

Important safety information:

• Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.


• Nevirapine Suspension is not a cure for HIV infection. Patients may still get illnesses and infections associated with HIV. Remain under the care of your doctor.


• When your medicine supply is low, get more from your doctor or pharmacist as soon as you can. Do not stop taking Nevirapine Suspension, even for a short period of time. If you do, the virus may grow resistant to the medicine and become harder to treat.


• Nevirapine Suspension does not stop the spread of HIV to others through blood or sexual contact. Use barrier methods of birth control (eg, condoms) if you have HIV infection. Do not share needles, injection supplies, or items like toothbrushes or razors.


• Changes in body fat (eg, an increased amount of fat in the upper back, neck, breast, and trunk, and loss of fat from the legs, arms, and face) may occur in some patients taking Nevirapine Suspension. The cause and long-term effects of these changes are unknown. Discuss any concerns with your doctor.


• Nevirapine Suspension may improve immune system function. This may reveal hidden infections in some patients. Tell your doctor right away if you notice symptoms of infection (eg, fever, sore throat, weakness, cough, shortness of breath) after you start Nevirapine Suspension.


• Hormonal birth control (eg, birth control pills) may not work as well while you are using Nevirapine Suspension. To prevent pregnancy, use an extra form of birth control (eg, condoms).


• Lab tests, including liver and heart function, complete blood cell counts, and CD4 cell counts, may be performed while you use Nevirapine Suspension. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Nevirapine Suspension should be used with extreme caution in CHILDREN younger than 3 months; safety and effectiveness in these children have not been confirmed.


• Caution is advised when using Nevirapine Suspension in CHILDREN; they may be more sensitive to its effects, especially anemia.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of taking Nevirapine Suspension while you are pregnant. Nevirapine Suspension is found in breast milk. Mothers infected with HIV should not breast-feed. There is a risk of passing the HIV infection or Nevirapine Suspension to the baby.

Possible side effects of Nevirapine Suspension:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Diarrhea; headache; mild nausea or stomach pain; tiredness; vomiting.

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); change in the amount of urine produced; eye irritation, pain, redness, or swelling; fever, chills, or sore throat; general feeling of being unwell; mouth sores; muscle or joint aches or pain; red, swollen, peeling, or blistered skin (with or without fever); swollen lymph glands; symptoms of liver problems (eg, yellowing of the skin or eyes; dark urine; loss of appetite; pale stools; severe, persistent, or unusual nausea or stomach pain); unusual tiredness or weakness.

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: Nevirapine 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 dizziness; fever; nausea; rash; severe or persistent headache; swelling; trouble breathing; trouble sleeping; unexplained weight loss; unusual tiredness; vomiting.

Proper storage of Nevirapine Suspension:

Store Nevirapine Suspension at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store in a tightly closed container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Nevirapine Suspension out of the reach of children and away from pets.

General information:

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


• Nevirapine Suspension 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 Nevirapine Suspension. 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

Copyright © 2012 Wolters Kluwer Health, Inc.

More Nevirapine resources

• Nevirapine Side Effects (in more detail)
• Nevirapine Use in Pregnancy & Breastfeeding
• Nevirapine Drug Interactions
• Nevirapine Support Group
• 1 Review for Nevirapine - Add your own review/rating

Compare Nevirapine with other medications

• HIV Infection
• Reduction of Perinatal Transmission of HIV

Antipyrine/Benzocaine/Glycerin/Zinc Drops

Pronunciation: AN-tee-PYE-reen/BEN-zoe-kane/GLIS-er-in/zink
Generic Name: Antipyrine/Benzocaine/Glycerin/Zinc
Brand Name: Neotic

Antipyrine/Benzocaine/Glycerin/Zinc Drops are used for:

Relieving pain and inflammation in the ear caused by certain ear problems. It may be used with antibiotics to treat middle ear infections. It may also be used to help remove a buildup of ear wax.

Antipyrine/Benzocaine/Glycerin/Zinc Drops are an analgesic, anesthetic, ear wax removal agent, and skin protectant combination. It works by relieving pressure; reducing inflammation, congestion, pain, and discomfort; removing ear wax; and protecting the skin of the ear. An ingredient in Antipyrine/Benzocaine/Glycerin/Zinc Drops also helps the medicine penetrate into the skin.

Do NOT use Antipyrine/Benzocaine/Glycerin/Zinc Drops if:

• you are allergic to any ingredient in Antipyrine/Benzocaine/Glycerin/Zinc Drops or to similar medicines


• you have a discharge from the ear or your eardrum is perforated

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

Before using Antipyrine/Benzocaine/Glycerin/Zinc Drops:

Some medical conditions may interact with Antipyrine/Benzocaine/Glycerin/Zinc Drops. 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

Some MEDICINES MAY INTERACT with Antipyrine/Benzocaine/Glycerin/Zinc Drops. However, no specific interactions with Antipyrine/Benzocaine/Glycerin/Zinc Drops are known at this time.

Ask your health care provider if Antipyrine/Benzocaine/Glycerin/Zinc Drops 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 Antipyrine/Benzocaine/Glycerin/Zinc Drops:

Use Antipyrine/Benzocaine/Glycerin/Zinc Drops as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• For topical use in the ear canal only. Do not get Antipyrine/Benzocaine/Glycerin/Zinc Drops in the eyes, nose, or mouth. If you get Antipyrine/Benzocaine/Glycerin/Zinc Drops in your eyes, rinse right away with cool water.


• Before using, hold the ear drop container in your hand for a few minutes to avoid dizziness that may result from putting cold drops into the ear.


• To use ear drops, lie down or tilt your head so that the affected ear faces up. For adults, gently pull the earlobe up and back to straighten the ear canal. For children, gently pull the earlobe down and back to straighten the ear canal. Drop the medicine into the ear canal. Keep the ear facing up for several minutes so the medicine can run to the bottom of the ear canal. A clean cotton plug may be gently inserted into the ear canal to prevent medicine from leaking out. If you are using Antipyrine/Benzocaine/Glycerin/Zinc Drops for ear wax removal, moisten the cotton with Antipyrine/Benzocaine/Glycerin/Zinc Drops before inserting it into the ear.


• To prevent germs from getting into your medicine, do not touch the applicator to any surface, including the ear. Do not rinse dropper after use. Keep the container tightly closed.


• If Antipyrine/Benzocaine/Glycerin/Zinc Drops are brown or contains particles, do not use it.


• If you miss a dose of Antipyrine/Benzocaine/Glycerin/Zinc Drops, use 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 use 2 doses at once.

Ask your health care provider any questions you may have about how to use Antipyrine/Benzocaine/Glycerin/Zinc Drops.

Important safety information:

• Antipyrine/Benzocaine/Glycerin/Zinc Drops may cause harm if it is swallowed. If you may have taken it by mouth, contact your poison control center or emergency room right away.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Antipyrine/Benzocaine/Glycerin/Zinc Drops while you are pregnant. It is not known if Antipyrine/Benzocaine/Glycerin/Zinc Drops are found in breast milk. If you are or will be breast-feeding while you use Antipyrine/Benzocaine/Glycerin/Zinc Drops, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Antipyrine/Benzocaine/Glycerin/Zinc Drops:

All medicines may cause side effects, but many people have no, or minor, side effects. When used in small doses, 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); burning, stinging, redness, or new or worsening pain in or around the ears.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

See also: Antipyrine/Benzocaine/Glycerin/Zinc 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 (http://www.aapcc.org/), or emergency room immediately.

Proper storage of Antipyrine/Benzocaine/Glycerin/Zinc Drops:

Store Antipyrine/Benzocaine/Glycerin/Zinc Drops at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Protect from freezing. Keep the container tightly closed. Store away from heat and light. Keep Antipyrine/Benzocaine/Glycerin/Zinc Drops out of the reach of children and away from pets.

General information:

• If you have any questions about Antipyrine/Benzocaine/Glycerin/Zinc Drops, please talk with your doctor, pharmacist, or other health care provider.


• Antipyrine/Benzocaine/Glycerin/Zinc Drops are 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 Antipyrine/Benzocaine/Glycerin/Zinc Drops. 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

Copyright © 2012 Wolters Kluwer Health, Inc.

More Antipyrine/Benzocaine/Glycerin/Zinc resources

• Antipyrine/Benzocaine/Glycerin/Zinc Side Effects (in more detail)
• Antipyrine/Benzocaine/Glycerin/Zinc Use in Pregnancy & Breastfeeding
• Antipyrine/Benzocaine/Glycerin/Zinc Support Group
• 0 Reviews · Be the first to review/rate this drug

Codeine Linctus BP (Thornton & Ross Ltd)

1. Name Of The Medicinal Product

Codeine Linctus BP

2. Qualitative And Quantitative Composition

Codeine Phosphate BP 15mg/5ml dose.

3. Pharmaceutical Form

Linctus.

4. Clinical Particulars

4.1 Therapeutic Indications

Codeine is indicated in adults for relief of the symptoms of dry or irritating coughs.

4.2 Posology And Method Of Administration

Oral.

Recommended doses

Adults: one 5ml spoonful

The elderly: Use with caution, not exceeding the recommended adult dose.

Paediatric population

Codeine should not be used for the treatment of children under the age of 18 years.

Dosage schedule

The dose may be repeated after four hours if required, but not more than 4 doses in any 24 hours.

4.3 Contraindications

Contraindicated:

In cases of liver disease and respiratory depression.

In patients with raised intracranial pressure or head injury.

During an acute asthmatic attack

Hypersensitivity to codeine or to any of the other ingredients.

Concurrent use of monoamine oxidase inhibitors or within 2 weeks discontinuation of their use.

4.4 Special Warnings And Precautions For Use

Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

Use with caution in patients with large bowel disease, renal impairment or a history of asthma. Prolonged use could aggravate irritable bowel syndrome.

Use with caution in the elderly, as codeine may induce faecal impaction, producing incontinence, spurious diarrhoea, abdominal pain and, rarely, colonic obstruction.

Codeine is partially metabolised by CYP2D6. If a patient has a deficiency or is completely lacking this enzyme they will not obtain adequate analgesic effects. Estimates indicate that up to 7% of the caucasian population may have this deficiency. However, if the patient is an ultra-rapid metaboliser there is an increased risk of developing side effects of opioid toxicity even at low doses. General symptoms of opioid toxicity include nausea, vomiting, constipation, lack of appetite and somnolence. In severe cases this may include symptoms of circulatory and respiratory depression. Estimates indicate that up to 1 to 2% of the caucasian population may be ultra-rapid metabolisers.

Precautions/warnings to be declared on labels:

Do not exceed the stated dose.

Keep all medicines away from children.

Use with caution if elderly.

Do not take during pregnancy except on a doctor's advice.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Antagonism of the effects of metoclopramide; codeine phosphate has the opposing effect on gastro-intestinal activity. Opioid analgesics can antagonise the gastrointestinal effects of domperidone

May cause delayed absorption of flecainide and mexiletine, and potentiation of the effects of hypnotics and anxiolytics.

When used with monoamine-oxidase inhibitors this may cause CNS excitation and hypertension, the effects can occur up to two weeks after stopping MAOI'S.

The effects of alcohol may be enhanced and codeine phosphate can be absorbed by light kaolin.

Opioid analgesics may potentiate the depressant effects of anaesthetics, tricyclic antidepressants and antipsychotics.

4.6 Pregnancy And Lactation

The product should not be used during pregnancy unless considered necessary by the physician.

Opioid administration near term may cause respiratory depression in the newborn.

At normal therapeutic doses codeine and its active metabolites may be present in breast milk at very low doses and is unlikely to adversely affect the breast fed infant.

However, if the patient is an ultra-rapid metaboliser of CYP2D6, higher levels of the active metabolites may be present in breast milk and on very rare occasions may result in symptoms of opioid toxicity in the infant.

If symptoms of opioid toxicity develop in either the mother or the infant, then all codine containing medicines should be stopped and alternative non-opioid analgesics prescribed. In severe cases consideration should be given to prescribing naloxone to reverse these effects.

4.7 Effects On Ability To Drive And Use Machines

Using the dose recommended, codeine linctus is not considered to be a hazard, however the use of codeine phosphate may cause sedation, dizziness and nausea. If affected driving or operating of machinery would not be advised.

4.8 Undesirable Effects

Use may result in tolerance and dependence, sedation, dizziness, nausea and constipation.

Prolonged use could aggravate irritable bowel syndrome. use with caution in the elderly, as codeine may induce faecal impaction, producing incontinence, spurious diarrhoea; abdominal pain and, rarely, colonic obstruction.

Due to the histamine releasing effect, reactions such as urticaria and pruritus occur in some individuals.

4.9 Overdose

Following large doses of codeine, respiratory depression, hypotension with circulatory failure and deepening coma, excitement, and in children convulsions may occur.

Death may occur due to respiratory failure.

Toxic doses vary considerably with the individual addicts may tolerate large doses.

Treatment of overdose should consist of aspiration and gastric lavage together with supportive therapy such as replacement of fluids and electrolytes.

Naloxone may be given to counteract respiratory depression.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Codeine depresses the cough reflex, partly by a direct effect on a cough centre in the medulla; the exact mechanism is not entirely clear. It has been suggested that the usual doses of opioids produce their major effect on the patients subjective reactions to the cough, rather than on the frequency and intensity of coughing.

5.2 Pharmacokinetic Properties

Codeine phosphate is absorbed from the gastro-intestinal tract, it is metabolised by O- and N-Demethylation in the liver to morphine and norcodeine. Codeine and its metabolites are excreted almost entirely by the kidney, mainly as conjugates with glucuronic acid.

Ingestion of codeine phosphate produces peak plasma - codeine concentrations in about one hour. The plasma half-life has been reported to be between 2½ and 4 hours after ingestion.

5.3 Preclinical Safety Data

None.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Citric Acid Monohydrate BP, Purified Water BP, Lemon Oil Terpeneless BP, Chloroform BP, Ethanol (96%) BP, Benzoic Acid Solution BP, Invert Syrup BP, Quinoline Yellow Solution Compound, Syrup BP.

6.2 Incompatibilities

Codeine phosphate is incompatible with bromides, iodides and salts of heavy metals.

It is incompatible with phenobarbitone sodium, forming a codeine-phenobarbitone complex.

6.3 Shelf Life

100ml: 24 months unopened

200ml: 24 months unopened

500ml: 24 months unopened

2000 ml: 24 months unopened

6.4 Special Precautions For Storage

Protect from light.

Store below 25°C.

6.5 Nature And Contents Of Container

100ml: Amber glass bottle with polypropylene cap or white 28mm child-resistant cap with tamper evident band and EPE/Saranex liner.

200ml: Amber glass bottle with polypropylene cap or white 28mm Child-resistant cap with Tamper Evident band and EPE/Saranex Liner.

500ml: Amber glass bottle with plastic cap and saranex/epe liner or white 28mm Child-resistant cap with Tamper Evident band and EPE/Saranex Liner.

2000ml: Amber glass bottle with plastic cap and saranex/epe liner or white 28mm Child-resistant cap with Tamper Evident band and EPE/Saranex Liner.

6.6 Special Precautions For Disposal And Other Handling

None.

7. Marketing Authorisation Holder

L.C.M. LIMITED

Linthwaite Laboratories

Huddersfield

HD7 5QH

8. Marketing Authorisation Number(S)

PL 12965/0009

9. Date Of First Authorisation/Renewal Of The Authorisation

21.7.1993

10. Date Of Revision Of The Text

09/12/2010

Lamisil AT Gel

terbinafine

Dosage Form: gel
Drug Facts

Active ingredient

Terbinafine1%

Purpose

Antifungal

Uses

• cures most athlete’s foot (tinea pedis) between the toes.
  

  Effectiveness on the bottom or sides of foot is unknown.

  
  


• cures most jock itch (tinea cruris) and ringworm (tinea corporis)


• relieves itching, burning, cracking and scaling which accompany these conditions

Warnings

For external use only

Do not use

• on nails or scalp


• in or near the mouth or eyes


• for vaginal yeast infections

Ask Doctor before use if you have

Ask a doctor or pharmacist

When using this product

do not get into eyes. If eye contact occurs, rinse thoroughly with water.

Stop use and ask a doctor

do not get into eyes. If eye contact occurs, rinse thoroughly with water.

Keep Out of Reach of Children

If swallowed, get medical help or contact a poison control center right away.

Directions

• adults and children 12 years and over
  
  • use the tip of the cap to break the seal and open the tube
  
  
  • wash the affected skin with soap and water and dry completely before applying
  
  
  • for athlete’s footbetween the toes: apply once a day at bedtime for 1 week or as directed by a doctor. Wear well-fitting, ventilated shoes. Change shoes and socks at least once daily 
  
  
  • 
    

    1 week between the toes

    
    
    
    
  
  
  • for jock itch and ringworm: apply once a day (morning or night) for 1 week or as directed by a doctor.
  
  
  • wash hands after each use
  
  


• children under 12 years: ask a doctor

Other information

• do not use if seal on tube is broken or is not visible


• store at or below 30°C (86°F)

Inactive ingredients

benzyl alcohol, butylated hydroxytoluene, carbomer 974 P, ethanol, isopropyl myristate, polysorbate 20, purified water, sodium hydroxide, sorbitan monolaurate

Questions

Questions? call 1-800-452-0051

 

Distributed by:

Novartis Consumer Health, Inc.

Parsippany, NJ 07054-0622

Principal Display Panel

[Enter image caption here]

LAMISIL AT  ANTIFUNGAL terbinafine  gel

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 0067-6239 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TERBINAFINE (TERBINAFINE) TERBINAFINE 10 mg  in 1 g

Inactive Ingredients Ingredient Name Strength ALCOHOL   BENZYL ALCOHOL   BUTYLATED HYDROXYTOLUENE   ISOPROPYL MYRISTATE   POLYSORBATE 20   SODIUM HYDROXIDE   SORBITAN MONOLAURATE   WATER

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 0067-6239-42 1 TUBE In 1 CONTAINER contains a TUBE 1 12 g In 1 TUBE This package is contained within the CONTAINER (0067-6239-42) 2 0067-6239-21 1 TUBE In 1 CONTAINER contains a TUBE 2 6 g In 1 TUBE This package is contained within the CONTAINER (0067-6239-21)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA021958	01/01/2010

Labeler - Novartis Consumer Health, Inc. (879821635)

Revised: 01/2010Novartis Consumer Health, Inc.

More Lamisil AT Gel resources

• Lamisil AT Gel Side Effects (in more detail)
• Lamisil AT Gel Use in Pregnancy & Breastfeeding
• Lamisil AT Gel Support Group
• 4 Reviews for Lamisil AT - Add your own review/rating

Compare Lamisil AT Gel with other medications

• Tinea Corporis
• Tinea Cruris
• Tinea Pedis