Country of origin: Germany, Boehringer Ingelheim International GmbH, produced by Roxane Laboratories Inc. United States of America
Pharm-Group: Antiviral-anti-HIV drugs
Manufacturers: Boehringer Ingelheim (Germany), Boehringer Ingelheim International GmbH, produced by Roxane Laboratories Inc (United States of America)
International name: Nevirapine
Dosage forms: tablets 200 mg, oral suspension 50 mg/5 ml, oral suspension 50 mg/5 ml
Composition: Active substance - Nevirapine.
Indications for use: Treatment and prevention of HIV-1 infection. When the drug is prescribed as monotherapy, viral resistance quickly and almost always develops, so it should always be prescribed in combination with at least two other antiretroviral drugs.
Contraindications: Hypersensitivity, breastfeeding.
Side effects: Skin reactions (including those caused by Stevens-Johnson syndrome and toxic epidermal necrolysis), changes in liver function indicators (increased activity of ALT, AST, gamma-glutamine transferase, total bilirubin and alkaline phosphatase), jaundice, hepatitis, nausea, fatigue, fever, headache, drowsiness, vomiting, diarrhea, abdominal pain, myalgia, granulocytopenia (more often in children), allergic and other hypersensitivity reactions (anaphylaxis, angioedema, urticaria, lymphadenopathy, eosinophilia, etc.).
Interaction: May reduce plasma concentrations of drugs actively metabolized by cytochrome P450 enzymes (dose adjustment may be required). No change in dosage regimen is required when using nevirapine in combination with nucleoside analogues (zidovudine, didanosine, zalcitabine); does not interact with protease inhibitors (saquinavir, ritonavir, indinavir). Should not be administered simultaneously with ketoconazole. Rifampicin and rifabutin reduce the maximum concentration of nevirapine. St. John's wort preparations reduce the concentration of nevirapine and other NNRTIs in the blood (even to a level below therapeutic), so their simultaneous use is not recommended (loss of effectiveness and development of viral resistance are possible). Inhibitors of the cytochrome P450 CYP isoenzyme increase (mutually) AUC and maximum concentration. When used simultaneously with cimetidine, the minimum stable concentration of nevirapine in plasma increases. It changes the pharmacokinetic parameters of oral contraceptives (reduces the concentration in the blood and accelerates elimination), so there is a risk of reducing their effectiveness (if contraception is necessary, it is recommended to switch to other methods, for example, barrier, and if When using oral contraceptives for other indications, therapeutic efficacy should be constantly monitored). Ketoconazole and erythromycin inhibit the formation of hydroxylated metabolites of nevirapine. It may reduce the concentration of methadone in plasma by increasing its metabolism in the liver, which leads to the development of drug withdrawal syndrome (treatment monitoring and, if necessary, dose adjustment are required).
Overdose: Symptoms: angioedema, erythema nodosum, fatigue, fever, headache, insomnia, nausea, formation of infiltrate in the lungs, rash, dizziness, vomiting, weight loss. Treatment: there is no specific antidote. After a single oral dose of 2.6 g, only mild and rapidly passing symptoms were noted. Gastric lavage and symptomatic therapy are necessary.
Special instructions: Use during pregnancy is possible only if the expected effect of therapy exceeds the potential risk to the fetus. Use should be stopped immediately if the patient develops severe rashes, incl. with signs