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APO-NEVIRAPINE is a brand name for Nevirapine, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE ....................................................................................... 3 CONTRAINDICATIONS .......................................................................................................... 4 WARNINGS AND PRECAUTIONS…
Verbatim from this product's HC label. Tap a section to expand.
” - Intensive clinical and laboratory monitoring, including liver function tests, is essential at baseline and during the first 18 weeks of treatment with APO-NEVIRAPINE or APO- NEVIRAPINE XR (see WARNINGS AND PRECAUTIONS, Monitoring and Laboratory Tests).
- APO-NEVIRAPINE or APO-NEVIRAPINE XR administration should be interrupted in patients experiencing moderate or severe liver function test abnormalities (> 5x ULN) (excluding GGT), until the liver function test elevations have returned to baseline (see WARNINGS AND PRECAUTIONS, Monitoring and Laboratory Tests).
Recommended Dose and Dosage Adjustment Immediate-Release Tablets The recommended dose for APO-NEVIRAPINE (nevirapine) is one 200 mg tablet daily for the first 14 days (this lead-in period should be used because it has been found to lessen the frequency of rash), followed by one 200 mg tablet twice daily, as part of a multi-drug antiretroviral treatment regimen.
APO-NEVIRAPINE or APO-NEVIRAPINE XR can be taken with or without food. The manufacturer’s recommended dosage and monitoring for the concomitantly administered antiretroviral therapy should be used. Extended-Release Tablets Patients should initiate therapy with one 200 mg tablet of nevirapine immediate-release once daily for the first 14 days (this lead-in period should be used because it has been found to lessen the frequency of rash), followed by one 400 mg tablet of nevirapine extended-release once daily.
The nevirapine extended-release tablets should not be broken or chewed. Nevirapine extended- release tablets can be taken with or without food. Nevirapine immediate-release tablets and nevirapine extended-release tablets should be combined with at least two additional antiretroviral agents.
For concomitantly administered therapy, the manufacturers recommended dosage should be followed. Patients currently on a nevirapine immediate-release twice daily regimen Patients already on a regimen of nevirapine immediate-release 200 mg twice daily in combination with other antiretroviral agents can be switched to nevirapine extended-release 400 mg once daily in combination with other antiretroviral agents without a lead-in period of nevirapine immediate-release.
Monitoring of Patients APO-NEVIRAPINE or APO-NEVIRAPINE XR should be discontinued if patients experience severe rash or a rash accompanied by constitutional findings (see WARNINGS AND PRECAUTIONS, Skin). Patients experiencing rash during the 14-day lead-in period of 200 mg/day of immediate-release tablets should not have their nevirapine dose increased to APO-NEVIRAPINE and APO-NEVIRAPINEXR Product Monograph Page 37 of 65 400 mg/day until the rash has resolved (see WARNINGS AND PRECAUTIONS, Hepatic/Biliary/Pancreatic and Skin).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Nevirapine in Canada.
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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
The risk of development of resistance to nevirapine is unknown when the 200 mg once daily dosing regimen is continued beyond 14 days. Patients with Renal Impairment In End Stage Renal Disease (ESRD) appropriate doses of nevirapine immediate release or nevirapine extended release tablets with respect to safety and efficacy have not been established.
5% reduction in nevirapine AUC over a one week exposure period with an accumulation of nevirapine hydroxy-metabolites in plasma. An additional 200 mg dose of nevirapine immediate-release tablets following each dialysis treatment is recommended in patients requiring dialysis.
In renal dysfunction, a single dose study suggested that patients with a creatinine clearance ≥ 20 mL/min do not require an adjustment in nevirapine dosing. Nevirapine extended-release tablets have not been studied in patients with renal dysfunction.
Patients with Hepatic Impairment Patients with mild hepatic impairment do not require an adjustment in nevirapine dosing; however, caution should be exercised when nevirapine immediate release or nevirapine extended release tablets is administered to patients with moderate hepatic impairment.
Nevirapine immediate release or nevirapine extended release tablets should not be administered to patients with severe hepatic dysfunction. Patients with Lactose Intolerance Nevirapine immediate-release tablets contain 482 mg of lactose per maximum recommended daily dose.
g. galactosaemia, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine. Missed Dose Patients who miss a dose should take it as soon as they remember and then continue as before. Do not double the next dosage.
Patients who interrupt APO-NEVIRAPINE or APO-NEVIRAPINE XR dosing for more than 7 days should restart the recommended dosing, using one 200 mg tablet daily for the first 14 days (lead-in) followed by one 200 mg tablet twice daily or one 400 mg tablet once daily.
OVERDOSAGE For management of a suspected overdose, contact your regional Poison Control Centre immediately. There is no known antidote for APO-NEVIRAPINE or APO-NEVIRAPINE XR overdosage. The use of activated charcoal may be helpful. APO-NEVIRAPINE and APO-NEVIRAPINEXR Product Monograph Page 38 of 65 Cases of nevirapine overdose with nevirapine immediate-release at doses ranging from 800 to 6000 mg per day for up to 15 days have been reported.
Patients have experienced edema, erythema nodosum, fatigue, fever, headache, insomnia, nausea, pulmonary infiltrates, rash, vertigo, vomiting, increase in transaminases, and weight decrease. All subsided following discontinuation of nevirapine.
In one case, a patient accidentally ingested nevirapine 1200 mg daily for three days, and then 1800 mg for a fourth day. The patient suffered fever, generalized rash, nausea, vomiting, headache, chills, and facial swelling, and was admitted to […]