Nevirapine Tablets

Nevirapine is a non-nucleoside reverse transcriptase inhibitor (NNRTI) of human immunodeficiency virus (HIV-1). Nevirapine directly binds to the reverse transcriptase (RT) of HIV-1 and blocks both RNA-dependent and DNA-dependent DNA polymerase activity by cleaving the catalytic end of the enzyme. Nevirapine does not compete with substrates or nucleoside triphosphates.

The main ingredient of this product is nevirapine, whose chemical name is 11-cyclopropyl-5,11-dihydro-4-methyl-6H-dipyrido[3,2-b:2#39;,3#39;-e][1,4]diazepine-6-one

This product is off-white tablets.

This product is suitable for the treatment of HIV-1 infection and should be used in combination with other anti-HIV-1 drugs. It can be used alone to prevent mother-to-child transmission.

Adults: Oral, 200 mg once a day for 14 consecutive days (this introduction period can reduce the incidence of rash); then change to 200 mg twice a day, and use at least two other anti-HIV-1 drugs at the same time. Children: The recommended oral dose for children aged 2 months to 8 years (excluding 8 years) is 4 mg/kg once a day for the first 14 days; then change to 7 mg/kg twice a day. The recommended dose for children aged 8 years and above is 4 mg/kg once a day for the first 14 days; then change to 4 mg/kg twice a day. The total daily dose for any patient should not exceed 400 mg. Patients should be informed of the necessity of taking nevirapine daily according to the prescribed dose. If a dose is missed, the patient should take the next dose as soon as possible, but do not double it. If the patient stops taking nevirapine for more than seven days, it should be restarted according to the principle of dosing, that is, 200 mg of the drug, once a day, and then 200 mg twice a day.

Rash, abnormal liver function, fatigue, fever, headache, lethargy, gastrointestinal adverse reactions and myalgia. Severe hepatitis/liver failure and allergic reactions.

Patients who are allergic to nevirapine or any of the ingredients in the tablets are contraindicated.

Precautions for children: The clearance rate of children is faster than that of adults, and the clearance rate decreases with age. Side effects are similar to those of adults. Precautions for pregnancy and lactation: Pregnant women: No obvious teratogenic effects were found in reproductive studies of pregnant rats and rabbits. When the systemic exposure (measured in AUC) produced by the dose of rats administered was 50% higher than the systemic exposure of humans at the clinically recommended dose, a significant decrease in fetal weight was observed, but there was no effect on maternal and fetal development. There is a lack of appropriate, controlled studies on the treatment of HIV-1 infection in pregnant women. The use of this product in pregnant women should only be considered when the potential benefits of the drug outweigh the possible fetal harm caused by the drug. Breastfeeding: From the preliminary results of an ongoing pharmacokinetic study (ACT grams 250), for 10 HIV-1 infected pregnant women who took a single dose of 100 mg or 200 mg of this product an average of 5.8 hours before delivery, nevirapine was able to cross the placenta and exist in breast milk. HIV-infected mothers are advised not to breastfeed their infants to avoid postpartum transmission of HIV to their infants. Elderly precautions: The pharmacokinetics of nevirapine have not been evaluated in HIV patients older than 55 years.

Nevirapine is an inducer of hepatic cytochrome P450 metabolizing enzymes and can reduce the plasma concentrations of drugs that are mainly metabolized by CYP3A and CYP2B. Therefore, if a patient is receiving a stable dose of a drug metabolized by CYP3A or CYP2B, the dose of the former needs to be adjusted if this product is co-administered.

Sealed storage

0.2g

Tentative 18 months

Beijing Sunho Pharmaceutical Co., Ltd.

• Founded in:

  2000-10-27

• Address:

  No. 18, Zhonghe Street, Beijing Economic and Technological Development Zone, Beijing

• Tax NO.:

  91110302722616050J

• Registered Funds:

  122.2882 million yuan

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