Norvir Oral Solution

1. Name Of The Medicinal Product

Norvir 80 mg/ml oral solution

2. Qualitative And Quantitative Composition

Each ml of oral solution contains 80 mg of ritonavir.

Excipients:

Alcohol (43% v/v)

Polyoxyl 35 Castor Oil

Sunset Yellow (E110)

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Oral solution

The solution is a practically clear, orange solution for oral administration.

4. Clinical Particulars

4.1 Therapeutic Indications

Ritonavir is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infected patients (adults and children of 2 years of age and older).

4.2 Posology And Method Of Administration

Ritonavir should be administered by physicians who are experienced in the treatment of HIV infection.

Norvir solution is administered orally and should preferably be ingested with food.

Ritonavir dosed as a pharmacokinetic enhancer

When ritonavir is used as a pharmacokinetic enhancer with other protease inhibitors the Summary of Product Characteristics for the particular protease inhibitor must be consulted.

The following HIV-1 protease inhibitors have been approved for use with ritonavir as a pharmacokinetic enhancer at the noted doses.

Adult use:

Amprenavir 600 mg twice daily with ritonavir 100 mg twice daily

Atazanavir 300 mg once daily with ritonavir 100 mg once daily

Fosamprenavir 700 mg twice daily with ritonavir 100 mg twice daily

Lopinavirco-formulated with ritonavir (lopinavir/ritonavir) 400 mg/100 mg or 800 mg/200mg.

Saquinavir 1000 mg twice daily with ritonavir 100 mg twice daily

Tipranavir 500 mg twice daily with ritonavir 200 mg twice daily

Darunavir 600 mg twice daily with ritonavir 100 mg twice daily in antiretroviral treatment (ART) experienced patients

Darunavir 800mg once daily with ritonavir 100 mg once daily in ART-naïve patients

Paediatric use: Ritonavir is recommended for children 2 years of age and older. For further dosage recommendations, refer to the product information of other Protease Inhibitors approved for co-administration with ritonavir. Norvir is not recommended in children below 2 years of age due to lack of data on safety and efficacy.

Renal impairment: As ritonavir is primarily metabolised by the liver, ritonavir may be appropriate for use with caution as a pharmacokinetic enhancer in patients with renal insufficiency depending on the specific protease inhibitor with which it is co-administered. However, since the renal clearance of ritonavir is negligible, the decrease in the total body clearance is not expected in patients with renal impairment. For specific dosing information in patients with renal impairment, refer to the Summary of Product Characteristics (SPC) of the co-administered protease inhibitor.

Hepatic impairment: Ritonavir should not be given as a pharmacokinetic enhancer to patients with decompensated liver disease (see section 4.3). In the absence of pharmacokinetic studies in patients with stable severe hepatic impairment (Child Pugh Grade C) without decompensation, caution should be exercised when ritonavir is used as a pharmacokinetic enhancer as increased levels of the co-administered PI may occur. Specific recommendations for use of ritonavir as a pharmacokinetic enhancer in patients with hepatic impairment are dependent on the protease inhibitor with which it is co-administered. The SPC of the co-administered PI should be reviewed for specific dosing information in this patient population.

Ritonavir dosed as an antiretroviral agent

Adult use: The recommended dosage of Norvir solution is 600 mg (7.5 ml) twice daily by mouth.

Gradually increasing the dose of ritonavir when initiating therapy may help to improve tolerance. Treatment should be initiated at 300 mg (3.75 ml) twice daily for a period of three days and increased by 100 mg (1.25 ml) twice daily increments up to 600 mg twice daily over a period of no longer than 14 days. Patients should not remain on 300 mg twice daily for more than 3 days.

Paediatric use (2 years of age and above): the recommended dosage of Norvir solution in children is 350 mg/m^² by mouth twice daily and should not exceed 600 mg twice daily. Norvir should be started at 250 mg/m^² and increased at 2 to 3 day intervals by 50 mg/m^² twice daily. The dose should be administered using a calibrated dosing syringe.

Paediatric Dosage Guidelines

Body Surface area* (m²)	Twice daily dose 250 mg/m²	Twice daily dose 300 mg/m²	Twice daily dose 350 mg/m²
0.25	0.8 ml (62.5 mg)	0.9 ml (75 mg)	1.1 ml (87.5 mg)
0.50	1.6 ml (125 mg)	1.9 ml (150 mg)	2.2 ml (175 mg)
1.00	3.1 ml (250 mg)	3.8 ml (300 mg)	4.4 ml (350 mg)
1.25	3.9 ml (312.5 mg)	4.7 ml (375 mg)	5.5 ml (437.5 mg)
1.50	4.7 ml (375 mg)	5.6 ml (450 mg)	6.6 ml (525 mg)

* Body surface area can be calculated with the following equation

BSA (m^²) ⁼√(Height (cm) X Weight (kg) / 3600)

Doses for intermediate body surface areas not included in the above table can be calculated using the following equations:

To calculate the volume to be administered (in ml) the body surface area should be multiplied by a factor of: 3.1 for a dose of 250 mg/m^²; 3.8 for one of 300 mg/m^²; and by 4.4 for 350 mg/m^².

Renal impairment: Currently, there are no data specific to this patient population and therefore specific dosage recommendations cannot be made. The renal clearance of ritonavir is negligible; therefore, a decrease in the total body clearance is not expected in patients with renal impairment. Because ritonavir is highly protein bound it is unlikely that it will be significantly removed by haemodialysis or peritoneal dialysis.

Hepatic impairment: Ritonavir is principally metabolised and eliminated by the liver. Pharmacokinetic data indicate that no dose adjustment is necessary in patients with mild to moderate hepatic impairment (see section 5.2). Ritonavir should not be given to patients with severe hepatic impairment (see section 4.3).

Elderly: Pharmacokinetic data indicated that no dose adjustment is necessary for elderly patients (see section 5.2).

The bitter taste of Norvir solution may be lessened if mixed with chocolate milk.

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients.

When ritonavir is used as a pharmacokinetic enhancer of other PIs, consult the Summary of Product Characteristics of the co-administered protease inhibitor for contraindications.

Ritonavir should not be given as a pharmacokinetic enhancer or as an antiretroviral agent to patients with decompensated liver disease.

In vitro and in vivo studies have demonstrated that ritonavir is a potent inhibitor of CYP3A- and CYP2D6- mediated biotransformations. The following medicines are contraindicated when used with ritonavir and unless otherwise noted, the contraindication is based on the potential for ritonavir to inhibit metabolism of the co-administered medicinal product, resulting in increased exposure to the co-administered medicinal product and risk of clinically significant adverse effects.

The enzyme-modulating effect of ritonavir may be dose dependent. For some products, contraindications may be more relevant when ritonavir is used as an antiretroviral agent than when ritonavir is used as a pharmacokinetic enhancer (eg rifabutin and voriconazole):

Medicinal Product Class	Medicinal Products within Class	Rationale
Concomitant medicinal product levels increased
α1 -Adrenoreceptor Antagonist	Alfuzosin	Increased plasma concentrations of alfuzosin which may lead to severe hypotension (see section 4.5).
Analgesics	Pethidine, piroxicam, propoxyphne	Increased plasma concentrations of norpethidine, piroxicam and propoxyphene. Thereby, increasing the risk of serious respiratory depression or haematologic abnormalities, or other serious adverse effects from these agents.
Antiarrthymics	Amiodarone, bepridil, encainide, flecanide, propafenone, quinidine	Increased plasma concentrations of amiodarone, bepridil, encainide, flecanide, propafenone, quinidine. Thereby, increasing the risk of arrhythmias or other serious adverse reactions from these agents.
Antibiotic	Fusidic Acid	Increased plasma concentrations of fusidic acid and ritonavir.
Antifungal	Voriconazole	Concomitant use of ritonavir (400 mg twice daily and more) and voriconazole is contraindicated due to a reduction in voriconazole plasma concentrations and possible loss of effect (see section 4.5)
Antihistamines	Astemizole, terfenadine	Increased plasma concentrations of astemizole and terfenadine. Thereby, increasing the risk of serious arrhythmias from these agents.
Antimycobacterial	Rifabutin	Concomitant use of ritonavir dosed as an antiretroviral agent (600 mg twice daily) and rifabutin due to an increase of rifabutin serum concentrations and risk of adverse events including uveitis (see section 4.4). Recommendations regarding use of ritonavir dosed as a pharmacokinetic enhancer with rifabutin are noted in section 4.5
Antipsychotics/ Neuroleptics	Clozapine, pimozide	Increased plasma concentrations of clozapine and pimozide. Thereby, increasing the risk of serious haematologic abnormalities, or other serious adverse effects from these agents.
Ergot Derivatives	Dihydroergotamine, ergonovine, ergotamine, methylergonovine	Increased plasma concentrations of ergot derivatives leading to acute ergot toxicity, including vasospasm and ischaemia.
GI motility agent	Cisapride	Increased plasma concentrations of cisapride. Thereby, increasing the risk of serious arrhythmias from this agent.
HMG Co-A Reductase Inhibitor	Lovastatin, simvastatin	Increased plasma concentrations of lovastatin and simvastatin; thereby, increasing the risk of myopathy including rhabdomyolysis (see section 4.5).
PDE5 inhibitor	Sildenafil	Contraindicated when used for the treatment of pulmonary arterial hypertension (PAH) only. Increased plasma concentrations of sildenafil. Thereby, increasing the potential for sildenafil-associated adverse events (which include hypotension and syncope). See section 4.4 and section 4.5 for coadministration of sildenafil in patients with erectile dysfunction.
Sedatives/hypnotics	Clorazepate, diazepam, estazolam, flurazepam, oral midazolam and triazolam	Increased plasma concentrations of clorazepate, diazepam, estazolam, flurazepam, oral midazolam and triazolam. Thereby, increasing the risk of extreme sedation and respiratory depression from these agents. (For caution on parenterally administered midazolam, see section 4.5).

Ritonavir medicinal product level decreased
Herbal Preparation	St. John's Wort	Herbal preparations containing St John's wort (Hypericum perforatum) due to the risk of decreased plasma concentrations and reduced clinical effects of ritonavir (see section 4.5).

4.4 Special Warnings And Precautions For Use

Ritonavir is not a cure for HIV-1 infection or AIDS. Patients receiving ritonavir or any other antiretroviral therapy may continue to develop opportunistic infections and other complications of HIV-1 infection.

Patients should be advised that current antiretroviral therapy has not been proven to prevent the risk of transmission of HIV to others through blood or sexual contact. Appropriate precautions should continue to be used.

When ritonavir is used as a pharmacokinetic enhancer with other PIs, full details on the warnings and precautions relevant to that particular PI should be considered, therefore the Summary of Product Characteristics for the particular PI must be consulted.

Ritonavir dosed as an antiretroviral agent or as a pharmacokinetic enhancer

Patients with chronic diarrhoea or malabsorption: Extra monitoring is recommended when diarrhoea occurs. The relatively high frequency of diarrhoea during treatment with ritonavir may compromise the absorption and efficacy (due to decreased compliance) of ritonavir or other concurrent medicinal products. Serious persistent vomiting and/or diarrhoea associated with ritonavir use might also compromise renal function. It is advisable to monitor renal function in patients with renal function impairment.

Haemophilia: there have been reports of increased bleeding, including spontaneous skin haematomas and haemarthroses, in haemophiliac patients type A and B treated with protease inhibitors. In some patients additional factor VIII was given. In more than a half of the reported cases, treatment with protease inhibitors was continued or reintroduced if treatment had been discontinued. A causal relationship has been evoked, although the mechanism of action has not been elucidated. Haemophiliac patients should therefore be made aware of the possibility of increased bleeding.

Diabetes mellitus and hyperglycaemia: New onset diabetes mellitus, hyperglycaemia or exacerbation of existing diabetes mellitus has been reported in patients receiving protease inhibitors. In some of these the hyperglycaemia was severe and in some cases also associated with ketoacidosis. Many patients had confounding medical conditions, some of which required therapy with agents that have been associated with the development of diabetes mellitus or hyperglycaemia.

Lipodystrophy: Combination antiretroviral therapy has been associated with redistribution of body fat (lipodystrophy) in HIV patients. The long-term consequences of these events are currently unknown. Knowledge about the mechanism is incomplete. A connection between visceral lipomatosis and PIs and lipoatrophy and nucleoside reverse transcriptase inhibitors (NRTIs) has been hypothesised. A higher risk of lipodystrophy has been associated with individual factors such as older age, and with medicinal product related factors such as longer duration of antiretroviral treatment and associated metabolic disturbances. Clinical examination should include evaluation for physical signs of fat redistribution. Consideration should be given to measurement of fasting serum lipids and blood glucose. Lipid disorders should be managed as clinically appropriate (see section 4.8).

Pancreatitis: Pancreatitis should be considered if clinical symptoms (nausea, vomiting, abdominal pain) or abnormalities in laboratory values (such as increased serum lipase or amylase values) suggestive of pancreatitis should occur. Patients who exhibit these signs or symptoms should be evaluated and Norvir therapy should be discontinued if a diagnosis of pancreatitis is made (see section 4.8).

Immune Reactivation Syndrome: in HIV-infected patients with severe immune deficiency at the time of institution of combination antiretroviral therapy (CART), an inflammatory reaction to asymtomatic or residual opportunistic pathogens may arise and cause serious clinical conditions, or aggravation of symptoms. Typically, such reactions have been observed within the first few weeks or months of initiation of CART. Relevant examples are cytomegalovirus retinitis, generalised and/or focal mycobacterial infections, and Pneumocystis jiroveci pneumonia. Any inflammatory symptoms should be evaluated and treatment instituted when necessary.

Liver disease: Ritonavir should not be given to patients with decompensated liver disease. For patients with stable severe hepatic impairment (Child Pugh Grade C) without decompensation see section 4.2. Patients with chronic hepatitis B or C and treated with combination antiretroviral therapy are at an increased risk for severe and potentially fatal hepatic adverse reactions. In case of concomitant antiviral therapy for hepatitis B or C, please refer to the relevant product information for these medicinal products.

Patients with pre-existing liver dysfunction including chronic active hepatitis have an increased frequency of liver function abnormalities during combination antiretroviral therapy and should be monitored according to standard practice. If there is evidence of worsening liver disease in such patients, interruption or discontinuation of treatment must be considered.

Renal disease: Since the renal clearance of ritonavir is negligible, the decrease in the total body clearance is not expected in patients with renal impairment. For specific dosing information in patients with renal impairment, refer to the Summary of Product Characteristics (SPC) of the co-administered protease inhibitor. See also section 4.2.

Ritonavir oral solution contains castor oil polyoxyl which may cause stomach upset and diarrhoea. Ritonavir oral solution also contains the azo-colouring agent sunset yellow (E110) which may cause allergic reactions.

Ritonavir oral solution contains alcohol (43% v/v), ie up to 258 mg per maximum dose of 600 mg, equivalent to 65 ml beer, 27 ml wine per dose. Each 100 mg dose contains up to 43 mg alcohol and each 200 mg dose contains 86 mg alcohol. Therefore concomitant administration of Norvir with disulfiram or medicines with disulfiram-like reactions (eg metronidazole) should be avoided. Also to be taken into account in pregnant or breast-feeding women, children and high-risk groups such as patients with liver disease or epilepsy.

Osteonecrosis: Although the etiology is considered to be multifactorial (including corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index), cases of osteonecrosis have been reported in patients with advanced HIV-disease and/or long-term exposure to combination antiretroviral therapy (CART). Patients should be advised to seek medical advice if they experience joint aches and pain, joint stiffness or difficulty in movement.

PR interval prolongation: ritonavir has been shown to cause modest asymptomatic prolongation of the PR interval in some healthy adult subjects. Rare reports of 2^nd or 3^rd degree atrioventricular block in patients with underlying structural heart disease and pre-existing conduction system abnormalities or in patients receiving medicinal products known to prolong the PR interval (such as verapamil or atazanavir) have been reported in patients receiving ritonavir. Norvir should be used with caution in such patients (see section 5.1).

Interactions with other medicinal products

Ritonavir dosed as an antiretroviral agent

The following Warnings and Precautions should be considered when ritonavir is used as an antiretroviral agent. When ritonavir is used as a pharmacokinetic enhancer at the 100 mg and 200 mg level it cannot be assumed that the following warnings and precautions will also apply. When ritonavir is used as a pharmacokinetic enhancer, full details on the warnings and precautions relevant to that particular PI must be considered, therefore the Summary of Product Characteristics, section 4.4, for the particular PI must be consulted to determine if the information below is applicable.

PDE5 inhibitors: Particular caution should be used when prescribing sildenafil, tadalafil or vardenafil for the treatment of erectile dysfunction in patients receiving ritonavir. Co-administration of ritonavir with these medicinal products is expected to substantially increase their concentrations and may result in associated adverse reactions such as hypotension and prolonged erection (see section 4.5). Concomitant use of sildenafil with ritonavir is contraindicated in pulmonary arterial hypertension patients (see section 4.3).

HMG-CoA reductase inhibitors: The HMG-CoA reductase inhibitors simvastatin and lovastatin are highly dependent on CYP3A for metabolism, thus concomitant use of ritonavir with simvastatin or lovastatin is not recommended due to an increased risk of myopathy including rhabdomyolysis. Caution must also be exercised and reduced doses should be considered if ritonavir is used concurrently with atorvastatin, which is metabolised to a lesser extent by CYP3A. While rosuvastatin elimination is not dependent on CYP3A, an elevation of rosuvastatin exposure has been reported with ritonavir co-administration. The mechanism of this interaction is not clear, but may be the result of transporter inhibition. When used with ritonavir dosed as a pharmacokinetic enhancer or as an antiretroviral agent, the lowest doses of atorvastatin or rosuvastatin should be administered. The metabolism of pravastatin and fluvastatin is not dependent of CYP3A, and interactions are not expected with ritonavir. If treatment with an HMG-CoA reductase inhibitor is indicated, pravastatin or fluvastatin is recommended (see section 4.5).

Digoxin: Particular caution should be used when prescribing ritonavir in patients taking digoxin since co-administration of ritonavir with digoxin is expected to increase digoxin levels. The increased digoxin levels may lessen over time (see section 4.5).

In patients who are already taking digoxin when ritonavir is introduced, the digoxin dose should be reduced to one-half of the patients' normal dose and patient need to be followed more closely than usual for several weeks after initiating co-administration of ritonavir and digoxin.

In patients who are already taking ritonavir when digoxin is introduced, digoxin should be introduced more gradually than usual. Digoxin levels should be monitored more intensively than usual during this period, with dose adjustments made, as necessary, based on clinical, electrocardiographic and digoxin level findings.

Ethinyl estradiol: Barrier or other non-hormonal methods of contraception should be considered when administering ritonavir at therapeutic or low doses as ritonavir is likely to reduce the effect and change the uterine bleeding profile when co-administered with estradiol-containing contraceptives.

Glucocorticoids: Concomitant use of ritonavir and fluticasone or other glucocorticoids that are metabolised by CYP3A4 is not recommended unless the potential benefit of treatment outweighs the risk of systemic corticosteroid effects, including Cushing's syndrome and adrenal suppression (see section 4.5).

Trazodone: Particular caution should be used when prescribing ritonavir in patients using trazodone. Trazodone is a CYP3A4 substrate and co-administration of ritonavir is expected to increase trazodone levels. Adverse reactions of nausea, dizziness, hypotension and syncope have been observed in single dose interaction studies in healthy volunteers (see section 4.5)

Ritonavir dosed as a pharmacokinetic enhancer

The interaction profiles of HIV-protease inhibitors, co-administered with low dose ritonavir, are dependant on the specific co-administered protease inhibitor.

For a description of the mechanisms and potential mechanisms contributing to the interaction profile of the PIs, see section 4.5. Please also review the Summary of Product Characteristics for the particular boosted PI.

Saquinavir: Doses of ritonavir higher than 100 mg twice daily should not be used. Higher doses of ritonavir have been shown to be associated with an increased incidence of adverse reactions. Co-administration of saquinavir and ritonavir has led to severe adverse reactions, mainly diabetic ketoacidosis and liver disorders, especially in patients with pre-existing liver disease.

Saquinavir/ritonavir should not be given together with rifampicin, due to the risk of severe hepatotoxicity (presenting as increased hepatic transaminases) if the three medicines are given together (see section 4.5).

Tipranavir: co-administered with 200 mg of ritonavir has been associated with reports of clinical hepatitis and hepatic decompensation including some fatalities. Extra vigilance is warranted in patients with chronic hepatitis B or hepatitis C co-infection, as these patients have an increased risk of hepatotoxicity.

Doses of ritonavir lower than 200 mg twice daily should not be used as they might alter the efficacy profile of the combination.

Fosamprenavir: Co-administration of fosamprenavir with ritonavir in doses greater than 100 mg twice daily has not been clinically evaluated. The use of higher ritonavir doses might alter the safety profile of the combination and therefore is not recommended.

Atazanavir: Co-administration of atazanavir with ritonavir at doses greater than 100 mg once daily has not been clinically evaluated. The use of higher ritonavir doses may alter the safety profile of atazanavir (cardiac effects, hyperbilirubinemia) and therefore is not recommended. Only when atazanavir with ritonavir is co-administered with efavirenz, a dose increase of ritonavir to 200mg once daily could be considered. In this instance, close clinical monitoring is warranted. Refer to the Reyataz Summary of Product Characteristics for further details.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Ritonavir dosed as a pharmacokinetic enhancer or as an antiretroviral agent

Ritonavir has a high affinity for several cytochrome P450 (CYP) isoforms and may inhibit oxidation with the following ranked order: CYP3A4 > CYP2D6. Co-administration of Norvir and medicinal products primarily metabolised by CYP3A may result in increased plasma concentrations of the other medicinal product, which could increase or prolong its therapeutic and adverse effects. For select medicinal products (eg alprazolam) the inhibitory effects of ritonavir on CYP3A4 may decrease over time. Ritonavir also has a high affinity for P-glycoprotein and may inhibit this transporter. The inhibitory effect of ritonavir (with or without other protease inhibitors) on P-gp activity may decrease over time (eg digoxin and fexofenadine-see table “Ritonavir effects on non-antiretroviral medicinal products” below). Ritonavir may induce glucuronidation and oxidation by CYP1A2, CYP2C8, CYP2C9 and CYP2C19 thereby increasing the biotransformation of some medicinal products metabolised by these pathways, and may result in decreased systemic exposure to such medicinal products, which could decease or shorten their therapeutic effect.

Important information regarding medicinal product interactions when ritonavir is used as a pharmacokinetic enhancer is also contained in the Summary of Product Characteristics of the co-administered protease inhibitor.

Medicinal products that affect ritonavir levels

Serum levels of ritonavir can be reduced by concomitant use of herbal preparations containing St John's wort (Hypericum perforatum). This is due to the induction of medicinal product metabolising enzymes by St John's wort. Herbal preparations containing St John's wort must not be used in combination with ritonavir. If a patient is already taking St John's wort, stop St John's wort and if possible check viral levels. Ritonavir levels may increase on stopping St John's wort. The dose of ritonavir may need adjusting. The inducing effect may persist for at least 2 weeks after cessation of treatment with St John's wort (see section 4.3).

Serum levels of ritonavir may be affected by select co-administered medicinal products (eg delavirdine, efavirenz, phenytoin and rifampicin). These interactions are noted in the medicinal product interaction tables below.

Medicinal product that are affected by the use of ritonavir

Interactions between ritonavir and protease inhibitors, antiretroviral agents other than protease inhibitors and other non-antiretroviral medicinal products are listed in the tables below.

Medicinal Product Interactions – Ritonavir with Protease Inhibitors
Co-administered Medicinal Product	Dose of Co-administered Medicinal Product (mg)	Dose of NORVIR (mg)	Medicinal Product Assessed	AUC	Cmin
Amprenavir	600 q12h	100 q12h	Amprenavir2	↑ 64%	↑ 5 fold
	Ritonavir increases the serum levels of amprenavir as a result of CYP3A4 inhibition. Clinical trials confirmed the safety and efficacy of 600 mg amprenavir twice daily with ritonavir 100 mg twice daily. Norvir oral solution should not be co-administered with amprenavir oral solution to children due to the risk of toxicity from excipients in the two formulations. For further information, physicians should refer to the Agenerase Summary of Product Characteristics.
Atazanavir	300 q24h	100 q24h	Atazanavir	↑ 86%	↑ 11 fold
			Atazanavir1	↑ 2 fold	↑ 3-7 fold
	Ritonavir increases the serum levels of atazanavir as a result of CYP3A4 inhibition. Clinical trials confirmed the safety and efficacy of 300 mg atazanavir once daily with ritonavir 100 mg once daily in treatment experienced patients. For further information, physicians should refer to the Reyataz Summary of Product Characteristics.
Darunavir	600, single	100 q12h	Darunavir	↑ 14 fold
	Ritonavir increases the serum levels of darunavir as a result of CYP3A inhibition. Darunavir must be given with ritonavir to ensure its therapeutic effect. Ritonavir doses higher than 100 mg twice daily have not been studied with darunavir. For further information, refer to the Summary of Product Characteristics for Prezista.
Fosamprenavir	700 q12h	100 q12h	Amprenavir	↑ 2.4 fold	↑ 11 fold
	Ritonavir increases the serum levels of amprenavir (from fosamprenavir) as a result of CYP3A4 inhibition. Fosamprenavir must be given with ritonavir to ensure its therapeutic effect. Clinical trials confirmed the safety and efficacy of fosamprenavir 700 mg twice daily with ritonavir 100 mg twice daily. Ritonavir doses higher than 100 mg twice daily have not been studied with fosamprenavir. For further information, physicians should refer to the Telzir Summary of Product Characteristics.
Indinavir	800 q12h	100 q12h	Indinavir3	↑ 178%	ND
			Ritonavir	↑ 72%	ND
	400 q12h	400 q12h	Indinavir3	↔	↑ 4 fold
			Ritonavir	↔	↔
	Ritonavir increases the serum levels of indinavir as a result of CYP3A4 inhibition. Appropriate doses for this combination, with respect to efficacy and safety, have not been established. Minimal benefit of ritonavir-mediated pharmacokinetic enhancement is achieved with doses higher than 100 mg twice daily. In cases of co-administration of ritonavir (100 mg twice daily) and indinavir (800 mg twice daily) caution is warranted as the risk of nephrolithiasis may be increased.
Nelfinavir	1250 q12h	100 q12h	Nelfinavir	↑ 20to39%	ND
	750, single	500 q12h	Nelfinavir	↑ 152%	ND
			Ritonavir	↔	↔
	Ritonavir increases the serum levels of nelfinavir as a result of CYP3A4 inhibition. Appropriate doses for this combination, with respect to efficacy and safety, have not been established. Minimal benefit of ritonavir-mediated pharmacokinetic enhancement is achieved with doses higher than 100 mg twice daily.
Saquinavir	1000 q12h	100 q12h	Saquinavir4	↑ 15-fold	↑ 5-fold
			Ritonavir	↔	↔
	400 q12h	400 q12h	Saquinavir4	↑ 17-fold	ND
			Ritonavir	↔	↔
	Ritonavir increases the serum levels of saquinavir as a result of CYP3A4 inhibition. Saquinavir should only be given in combination with ritonavir. Ritonavir 100 mg twice daily with saquinavir 1000 mg twice daily provides saquinavir systemic exposure over 24 hours similar to or greater than those achieved with saquinavir 1200 mg three times daily without ritonavir. In a clinical study investigating the interaction of rifampicin 600 mg once daily and saquinavir 1000 mg with ritonavir 100 mg twice daily in healthy volunteers, severe hepatocellular toxicity with transaminase elevations up to > 20-fold the upper limit of normal after 1 to 5

Cortatrigen Modified

Generic Name: hydrocortisone, neomycin, and polymyxin B otic (HYE droe KOR ti sone, NEE oh MYE sin, POL ee MIX in B)

Brand Names: Cort-Biotic, Cortatrigen, Cortatrigen Modified, Cortisporin Otic, Cortomycin, Oti-Sone, Pediotic

What is Cortatrigen Modified (hydrocortisone, neomycin, and polymyxin B otic)?

Hydrocortisone is a steroid. It reduces the actions of chemicals in the body that cause inflammation, redness, and swelling.

Neomycin and polymyxin B are antibiotics that fight bacteria.

The combination of hydrocortisone, neomycin, and polymyxin B otic (for the ears) is used to treat ear infections caused by bacteria.

This medication will not treat a viral infection such as herpes or shingles.

Hydrocortisone, neomycin, and polymyxin B otic may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Cortatrigen Modified (hydrocortisone, neomycin, and polymyxin B otic)?

You should not use this medication if you are allergic to hydrocortisone, neomycin, or polymyxin B, or if you have a ruptured ear drum, or an ear infection caused by chickenpox, or herpes infection (simplex or zoster).

Before using this medication, tell your doctor if you have herpes (simplex or zoster), chickenpox or small pox, any ear infection that causes blistering, asthma or sulfite allergy, or if you are allergic to an antibiotic similar to neomycin, such as amikacin (Amikin), gentamicin (Garamycin), kanamycin (Kantrex), netilmicin (Netromycin), paromomycin (Humatin, Paromycin), streptomycin, or tobramycin (Nebcin, Tobi).

Use this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Talk with your doctor if your symptoms do not improve after 1 week of using this medication.

Do not use this medication for longer than 10 days in a row unless your doctor tells you to. Long-term use of neomycin may cause damage to your hearing. Stop using this medication and call your doctor at once if you have skin rash, redness, swelling, itching, dryness, scaling, severe burning or stinging, or other irritation in or around the ear. Other serious side effects include new signs of infection, hearing loss, or urinating less than usual or not at all.

What should I discuss with my health care provider before using Cortatrigen Modified (hydrocortisone, neomycin, and polymyxin B otic)?

You should not use this medication if you are allergic to hydrocortisone, neomycin, or polymyxin B, or if you have:

• 
  

  a ruptured ear drum; or

  
  


• 
  

  an ear infection caused by chickenpox, or herpes infection (simplex or zoster).

  
  

If you have any of these other conditions, you may need a dose adjustment or special tests to safely use this medication:

• 
  

  herpes (simplex or zoster);

  
  


• 
  

  chickenpox or small pox;

  
  


• 
  

  any ear infection that causes blistering;

  
  


• 
  

  asthma or sulfite allergy; or

  
  


• 
  

  if you are allergic to an antibiotic similar to neomycin, such as amikacin (Amikin), gentamicin (Garamycin), kanamycin (Kantrex), netilmicin (Netromycin), paromomycin (Humatin, Paromycin), streptomycin, or tobramycin (Nebcin, Tobi).

  
  

FDA pregnancy category C. It is not known whether hydrocortisone, neomycin, and polymyxin B otic ear drops are harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Hydrocortisone and colistin 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 use this medication in a child younger than 2 years old.

How should I use Cortatrigen Modified (hydrocortisone, neomycin, and polymyxin B otic)?

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

Before using this medication, clean and dry your ear canal with sterile cotton.

Shake the ear drops well just before you measure a dose.

This medication is usually given as 4 to 5 drops into the affected ear every 6 to 8 hours. Children may need to use fewer drops. Follow your doctor's instructions about how much medication you should use and how often.

Do not use this medication for longer than 10 days in a row unless your doctor tells you to. Long-term use of neomycin may cause damage to your hearing.

To use the ear drops, first remove the cap from the dropper bottle. Lie down or tilt your head with your ear facing upward. Pull back on your ear gently to open up the ear canal. If giving this medicine to a child, pull down on the earlobe to open the ear canal. Hold the dropper upside down over the ear canal and drop the correct number of drops into the ear.

Do not place the dropper tip into your ear or allow the tip to touch any surface. It may become contaminated.

After using the ear drops, stay lying down or with your head tilted for at least 5 minutes.

As an alternative to dropping the medicine into your ear, you may insert a small piece of cotton into the ear canal and then drop the medicine directly onto the cotton to soak it. Leave the cotton in the ear and keep it moist by adding more of the medication every 4 to 8 hours. Replace the cotton at least every 24 hours. Follow your doctor's instructions about the use of cotton with this medication.

Wipe the ear dropper tip with a clean tissue. Do not wash the tip with water or soap.

Use this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Talk with your doctor if your symptoms do not improve after 1 week of using this medication.

Store this medication at room temperature away from moisture and heat.

What happens if I miss a dose?

Use the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not use 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 hearing problems, or urinating less than usual.

What should I avoid while using Cortatrigen Modified (hydrocortisone, neomycin, and polymyxin B otic)?

Avoid getting this medication in your eyes. If this does happen, rinse with water.

Cortatrigen Modified (hydrocortisone, neomycin, and polymyxin B otic) 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 a serious side effect such as:

• 
  

  skin rash, redness, swelling, itching, dryness, scaling, or other irritation in or around the ear;

  
  


• 
  

  severe burning, stinging, or other irritation when using the medication;

  
  


• 
  

  new signs of infection;

  
  


• 
  

  hearing loss; or

  
  


• 
  

  urinating less than usual or not at all.

  
  

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 Cortatrigen Modified (hydrocortisone, neomycin, and polymyxin B otic)?

It is not likely that other drugs you take orally or inject will have an effect on hydrocortisone, neomycin, and polymyxin B used in the ears. But many drugs can interact with each other. 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 Cortatrigen Modified resources

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

• Cort-Biotic Advanced Consumer (Micromedex) - Includes Dosage Information


• Cortomycin Solution MedFacts Consumer Leaflet (Wolters Kluwer)


• Cortomycin Prescribing Information (FDA)


• Pediotic Prescribing Information (FDA)

Compare Cortatrigen Modified with other medications

• Otitis Externa
• Otitis Media

Where can I get more information?

• Your pharmacist can provide more information about hydrocortisone, neomycin, and polymyxin B otic.

See also: Cortatrigen Modified side effects (in more detail)

Lidex-E

Generic Name: fluocinonide topical (floo oh SIN oh nide)

Brand Names: Fluocinonide-E, Lidex, Lidex-E, Vanos

What is Lidex-E (fluocinonide topical)?

Fluocinonide is a topical (for the skin) steroid. It reduces the actions of chemicals in the body that cause inflammation, redness, and swelling.

Fluocinonide topical is used to treat the inflammation and itching caused by a number of skin conditions such as allergic reactions, eczema, and psoriasis.

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

What is the most important information I should know about Lidex-E (fluocinonide topical)?

Use this medication exactly as directed on the label, or as it has been prescribed by your doctor. Do not use the medication in larger amounts or for longer than recommended. Topical steroid medicine can be absorbed through the skin, which may cause steroid side effects throughout the body.

Do not cover treated skin areas with a bandage or other covering unless your doctor has told you to. Plastic film covering (such as plastic wrap) is sometimes used when treating psoriasis. Follow your doctor's instructions.

If you are treating the diaper area of a baby, do not use plastic pants or tight-fitting diapers. Covering the skin that is treated with fluocinonide topical can increase the amount of medicine your skin absorbs, which may lead to unwanted side effects.

Do not use this medication on a child without a doctor's advice. Children are more likely to absorb large amounts of a topical steroid through the skin. Steroid absorption in children may cause unwanted side effects, or a delay in growth with long-term use. Talk with your doctor if you think your child is not growing at a normal rate while using this medication over a long treatment period. Contact your doctor if your condition does not improve after 2 weeks of using this medicine, or if you develop signs of a bacterial, fungal, or viral skin infection.

What should I discuss with my healthcare provider before using Lidex-E (fluocinonide topical)?

Do not use this medication if you are allergic to fluocinonide.

Before using fluocinonide topical, tell your doctor if you are allergic to any drugs, or if you have any type of skin infection.

Also tell your doctor if you have diabetes. Topical steroid medicines absorbed through the skin may increase the glucose (sugar) levels in your blood or urine.

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 fluocinonide topical 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. Do not use this medication on a child without a doctor's advice. Children are more likely to absorb large amounts of a topical steroid through the skin. Steroid absorption in children may cause unwanted side effects, or a delay in growth with long-term use. Talk with your doctor if you think your child is not growing at a normal rate while using this medication over a long treatment period.

How should I use Lidex-E (fluocinonide topical)?

Use this medication exactly as directed on the label, or as it has been prescribed by your doctor. Do not use the medication in larger amounts or for longer than recommended. Topical steroid medicine can be absorbed through the skin, which may cause steroid side effects throughout the body.

Wash your hands before and after using fluocinonide topical, unless you are using the medication to treat the skin on your hands.

Apply a small amount to the affected area and rub it gently into the skin. Do not use this medication over a large area of skin.

If you are treating your scalp, part the hair and apply the medicine directly to the scalp, rubbing in gently. Avoid washing or rubbing the treated scalp area right away. Wait until the medicine has dried thoroughly.

Do not cover treated skin areas with a bandage or other covering unless your doctor has told you to. If you are treating the diaper area of a baby, do not use plastic pants or tight-fitting diapers. Covering the skin that is treated with fluocinonide topical can increase the amount of medicine your skin absorbs, which may lead to unwanted side effects. Follow your doctor's instructions. Contact your doctor if your condition does not improve after 2 weeks of using this medicine, or if you develop signs of a bacterial, fungal, or viral skin infection. It is important to use fluocinonide topical regularly to get the most benefit.

To be sure this medication is not causing harmful effects with long-term use, you may need blood tests. Do not miss any scheduled appointments.

If you need to have any type of surgery, tell the surgeon ahead of time that you are using fluocinonide topical. Store fluocinonide topical at room temperature away from moisture and heat. Keep from freezing.

What happens if I miss a dose?

Use the medication as soon as you remember. If it is almost time for the next dose, skip the missed dose and use the medicine at the next regularly scheduled time. Do not use 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 fluocinonide is not expected to produce life-threatening symptoms. However, long-term use of high steroid doses can lead to symptoms such as thinning skin, easy bruising, changes in the shape or location of body fat (especially in your face, neck, back, and waist), increased acne or facial hair, menstrual problems, impotence, or loss of interest in sex.

What should I avoid while using Lidex-E (fluocinonide topical)?

Fluocinonide topical should not be used to treat any skin condition your doctor has not prescribed it for.

Avoid getting this medication in your eyes. If contact does occur, rinse with water. Do not use fluocinonide topical on broken or infected skin. Also avoid using this medication in open wounds.

Lidex-E (fluocinonide topical) 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 severe irritation of any treated skin, or if you show signs of absorbing fluocinolone topical through your skin, such as:

• 
  

  blurred vision, or seeing halos around lights;

  
  


• 
  

  mood changes;

  
  


• 
  

  sleep problems (insomnia);

  
  


• 
  

  weight gain, puffiness in your face; or

  
  


• 
  

  muscle weakness, feeling tired.

  
  

Less serious side effects may include:

• 
  

  mild skin itching, burning, peeling, or dryness;

  
  


• 
  

  headache;

  
  


• 
  

  stuffy nose, sore throat;

  
  


• 
  

  thinning or softening of your skin;

  
  


• 
  

  skin rash or irritation around your mouth;

  
  


• 
  

  swollen hair follicles;

  
  


• 
  

  changes in color of treated skin;

  
  


• 
  

  blisters, pimples, or crusting of treated skin; or

  
  


• 
  

  stretch marks.

  
  

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.

What other drugs will affect Lidex-E (fluocinonide topical)?

It is not likely that other drugs you take orally or inject will have an effect on topically applied fluocinonide topical. But many drugs can interact with each other. 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 Lidex-E resources

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

• Lidex-E Advanced Consumer (Micromedex) - Includes Dosage Information


• Lidex-E Prescribing Information (FDA)


• Lidex-E Cream MedFacts Consumer Leaflet (Wolters Kluwer)


• Lidex Prescribing Information (FDA)


• Lidex Topical Solution Prescribing Information (FDA)


• Vanos Prescribing Information (FDA)


• Vanos Cream MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Lidex-E with other medications

• Atopic Dermatitis
• Dermatitis
• Psoriasis

Where can I get more information?

• Your pharmacist can provide more information about fluocinonide topical.

See also: Lidex-E side effects (in more detail)

gentian violet Topical

JEN-shun VYE-oh-let

Available Dosage Forms:

• Solution

Therapeutic Class: Antifungal

Uses For gentian violet

Gentian violet belongs to the group of medicines called antifungals. Topical gentian violet is used to treat some types of fungus infections inside the mouth (thrush) and of the skin.

Gentian violet is available without a prescription.

Before Using gentian violet

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 gentian violet, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to gentian violet 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

Although there is no specific information comparing use of gentian violet in children with use in other age groups, gentian violet is not expected to cause different side effects or problems in children than it does in adults.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults. Although there is no specific information comparing use of gentian violet in the elderly with use in other age groups, gentian violet is not expected to cause different side effects or problems in older people than it does in younger adults.

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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

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.

Other Medical Problems

The presence of other medical problems may affect the use of gentian violet. Make sure you tell your doctor if you have any other medical problems, especially:

• Ulcerative skin condition on the face—Use of gentian violet may cause tattooing of the area

Proper Use of gentian violet

Using a cotton swab, apply enough gentian violet to cover only the affected area.

If you are applying gentian violet to affected areas in the mouth, avoid swallowing any of the medicine.

If you are using gentian violet in a child's mouth, make sure you understand exactly how to apply it so that it is not swallowed. If you have any questions about this, check with your health care professional.

Do not apply an occlusive dressing (airtight covering, such as kitchen plastic wrap) over gentian violet. It may cause irritation of the skin.

To help clear up your infection completely, keep using gentian violet for the full time of treatment, even if your condition has improved. Do not miss any doses.

Dosing

The dose of gentian violet 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 gentian violet. 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 topical solution dosage form:
  
  • For fungus infections:
    
    • Adults and children—Apply to the affected area(s) of the skin two or three times a day for three days.
    
    
  
  

Missed Dose

If you miss a dose of gentian violet, apply 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.

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 gentian violet

Gentian violet will stain the skin and clothing. Avoid getting the medicine on your clothes.

gentian violet 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:

• Skin irritation not present before use of gentian violet

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.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More gentian violet Topical resources

• Gentian violet Topical Support Group
• 0 Reviews for Gentian violet Topical - Add your own review/rating

Compare gentian violet Topical with other medications

• Fungal Infection Prophylaxis
• Oral Thrush

Fungi-Guard Topical

Generic Name: tolnaftate (Topical route)

tol-NAF-tate

Commonly used brand name(s)

In the U.S.

• Absorbine Jr. Antifungal


• Aftate


• Blis-To-Sol


• Dermasept Antifungal


• Fungi-Guard


• Podactin


• Q-Naftate


• Tinactin


• Tinaderm


• Ting

In Canada

• Athlete's Foot Gel


• Dr. Scholl's Athlete's Foot


• Pitrex


• Scholl's Athlete's Foot Spray


• Scholl Tritin Antifungal Powder


• Scholl Tritin Antifungal Spray Powder


• Tinactin Aerosol Liquid


• Tinactin Aerosol Powder


• Tinactin Jock Itch


• Tinactin Plus


• Tinactin Plus Aerosol Powder

Available Dosage Forms:

• Ointment


• Spray


• Cream


• Lotion


• Gel/Jelly


• Powder


• Solution

Therapeutic Class: Antifungal

Uses For Fungi-Guard

Tolnaftate belongs to the group of medicines called antifungals. It is used to treat some types of fungus infections. It may also be used together with medicines taken by mouth for fungus infections.

Tolnaftate is available without a prescription.

Before Using Fungi-Guard

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

Tolnaftate should not be used on children up to 2 years of age, unless otherwise directed by your doctor. Although there is no specific information comparing use of tolnaftate in children 2 years of age and older with use in other age groups, this medicine is not expected to cause different side effects or problems in children 2 years of age and older than it does in adults.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of tolnaftate in the elderly with use in other age groups.

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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

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 tolnaftate

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

Before applying tolnaftate, wash the affected area and dry thoroughly. Then apply enough medicine to cover the affected area.

Keep this medicine away from the eyes.

For patients using the powder form of this medicine:

• If the powder is used on the feet, sprinkle it between toes, on feet, and in socks and shoes.

For patients using the aerosol powder form of this medicine:

• Shake well before using.


• From a distance of 6 to 10 inches, spray the powder on the affected areas. If it is used on the feet, spray it between toes, on feet, and in socks and shoes.


• Do not inhale the powder.


• Do not use near heat, near open flame, or while smoking.

For patients using the solution form of this medicine:

• If tolnaftate solution becomes a solid, it may be dissolved by warming the closed container of medicine in warm water.

For patients using the aerosol solution form of this medicine:

• Shake well before using.


• From a distance of 6 inches, spray the solution on the affected areas. If it is used on the feet, spray between toes and on feet.


• Do not inhale the vapors from the spray.


• Do not use near heat, near open flame, or while smoking.

To help clear up your infection completely, keep using this medicine for 2 weeks after burning, itching, or other symptoms have disappeared , unless otherwise directed by your doctor. Do not miss any doses.

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.

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 topical dosage forms (aerosol powder, aerosol solution, cream, gel, powder, or topical solution):
  
  • For fungus infections:
    
    • Adults and children 2 years of age and over—Apply to the affected area(s) of the skin two times a day.
    
    
    • Children up to 2 years of age—Use is not recommended except under the advice and supervision of your doctor.
    
    
  
  

Missed Dose

If you miss a dose of this medicine, apply 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.

Storage

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

Store the canister at room temperature, away from heat and direct light. Do not freeze. Do not keep this medicine inside a car where it could be exposed to extreme heat or cold. Do not poke holes in the canister or throw it into a fire, even if the canister is empty.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using Fungi-Guard

If your skin problem does not improve within 4 weeks, or if it becomes worse, check with your health care professional.

To help prevent reinfection after the period of treatment with this medicine, the powder or spray powder form of this medicine may be used each day after bathing and carefully drying the affected area.

Fungi-Guard 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:

• Skin irritation not present before use of this medicine

When you apply the aerosol solution form of this medicine, a mild temporary stinging may be expected.

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: Fungi-Guard Topical side effects (in more detail)

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.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More Fungi-Guard Topical resources

• Fungi-Guard Topical Side Effects (in more detail)
• Fungi-Guard Topical Use in Pregnancy & Breastfeeding
• Fungi-Guard Topical Support Group
• 0 Reviews for Fungi-Guard Topical - Add your own review/rating

Compare Fungi-Guard Topical with other medications

• Tinea Corporis
• Tinea Cruris
• Tinea Pedis
• Tinea Versicolor

Nebupent

Generic Name: pentamidine (Inhalation route)

pen-TAM-i-deen

Commonly used brand name(s)

In the U.S.

• Nebupent

Available Dosage Forms:

• Powder for Solution

Therapeutic Class: Antiprotozoal

Uses For Nebupent

Pentamidine is used to try to prevent Pneumocystis carinii pneumonia (PCP), a very serious type of pneumonia. This type of pneumonia occurs commonly in patients whose immune systems are not working normally, such as patients with acquired immune deficiency syndrome (AIDS). Inhaled pentamidine does not prevent illness in parts of the body outside the lungs. This medicine may also be used for other conditions as determined by your doctor.

Pentamidine is available only with your doctor's prescription.

Before Using Nebupent

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

Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of pentamidine inhalation in children with use in other age groups. However, pentamidine inhalation is recommended in children 5 years of age and older who cannot tolerate other medicines.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of pentamidine inhalation in the elderly with use in other age groups.

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

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 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.

• Bepridil


• Cisapride


• Grepafloxacin


• Levomethadyl


• Mesoridazine


• Pimozide


• Sparfloxacin


• Terfenadine


• Thioridazine


• Ziprasidone

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.

• Acecainide


• Acetophenazine


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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.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Asthma—Patients with asthma may have an increase in coughing or difficulty in breathing while receiving pentamidine inhalation

Proper Use of Nebupent

To help prevent the development or return of pneumocystis pneumonia, you must receive pentamidine inhalation on a regular basis, even if you are feeling well.

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.

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 the inhalation dosage form:
  
  • For the prevention of Pneumocystis carinii pneumonia (PCP):
    
    • Adults and children 5 years of age and older—300 milligrams (mg) by oral inhalation once every four weeks.
    
    
    • Children younger than 5 years of age—Use and dose must be determined by your doctor.
    
    
  
  

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.

Precautions While Using Nebupent

If you are also using the inhalation form of a bronchodilator (medicine used to help relieve breathing problems), use the pentamidine inhalation at least 5 to 10 minutes after the bronchodilator, unless otherwise directed by your doctor. This will help to reduce the possibility of side effects. Do not use the bronchodilator or any medicine other than pentamidine in the nebulizer.

A bitter or metallic taste may occur during use of this medicine. Sucking on a hard candy after each treatment can help reduce this problem.

Cigarette smoking can increase the chance of coughing and difficulty in breathing during pentamidine inhalation therapy.

Nebupent Side Effects

On rare occasions, pneumocystis infections have occurred in parts of the body outside the lungs in patients receiving pentamidine inhalation therapy. You should discuss this possible problem with your doctor.

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:

More common

• Burning pain, dryness, or sensation of lump in throat


• chest pain or congestion


• coughing


• difficulty in breathing


• difficulty in swallowing


• skin rash


• wheezing

Rare

• Nausea and vomiting


• pain in upper abdomen, possibly radiating to the back


• pain in side of chest (severe)


• shortness of breath (sudden and severe)

Rare - with daily treatment doses only

• Anxiety


• chills


• cold sweats


• cool, pale skin


• decreased urination


• headache


• increased hunger


• loss of appetite


• nausea and vomiting


• nervousness


• shakiness


• stomach pain


• unusual tiredness

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: Nebupent side effects (in more detail)

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More Nebupent resources

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

• Nebupent Concise Consumer Information (Cerner Multum)


• Nebupent Solution MedFacts Consumer Leaflet (Wolters Kluwer)


• Pentamidine MedFacts Consumer Leaflet (Wolters Kluwer)


• NebuPent Prescribing Information (FDA)


• Pentamidine Isethionate Monograph (AHFS DI)

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