Therapeutic Action
Antiretroviral, HIV-1 non nucleoside reverse transcriptase inhibitor
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Individual generic drug information
Extracted information for NEVIRAPINE only.
Antiretroviral, HIV-1 non nucleoside reverse transcriptase inhibitor
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Prevention of mother-to-child transmission (PMTCT) of HIV in neonates, alone or in combination with other antiretrovirals
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Extracted information for NEVIRAPINE only.
Do not administer to neonates: with severe hepatic impairment; born to mothers with resistance to NVP or HIV-2 mono-infection. May cause: rash and hepatic disorders, especially in the first 6 weeks of treatment; gastrointestinal disturbances; less frequently, hypersensitivity reactions (including severe cutaneous reactions such as Stevens-Johnson, Lyell and DRESS syndromes) and life-threatening hepatotoxicity. Any isolated rash requires immediate medical attention and surveillance. Stop NVP immediately and permanently in the event of: severe rash or rash associated with signs and symptoms of hypersensitivity reaction (e.g. fever, mouth ulcer, cutaneous blister, conjunctivitis, facial oedema); signs and symptoms of hepatic disorders (e.g. anorexia, nausea, general malaise, dark urine, pale stools, hepatomegaly, jaundice). NVP is a hepatic enzyme inducer. It may interact with many drugs and concomitant use requires monitoring (e.g. azole derivates, phenobarbital, phenytoin, carbamazepine, clarithromycin). Avoid combination with rifampicin (decreased NVP plasma concentrations).
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Extracted information for NEVIRAPINE only.
50 mg/5 ml oral suspension 50 mg scored dispersible tablet
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Full term neonate: Follow national recommendations. For information (WHO simplified age-based dosage): From birth to 6 weeks of age (from 0 to 42 days): 15 mg (1.5 ml) oral suspension or 25 mg (1/2 tab) dispersible tablet once daily. From birth to 4 weeks of age, preferably use the oral suspension. Then, when indicated, After 6 weeks and up to 12 weeks of age (from 43 to 84 days): 20 mg (2 ml) oral suspension or 25 mg (1/2 tab) dispersible tablet once daily Preterm or low-birth weight neonate: seek specialist advice.
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Depending on the risk of acquiring HIV infection (for information): High risk: 6 weeks (NVP combined with zidovudine). For breastfed children, treatment is extended for an additional 6 weeks (NVP alone or combined with zidovudine). Low risk (NVP alone): 4 to 6 weeks for non-breastfed children; 6 weeks for breastfed children.
Source page 228
Extracted information for NEVIRAPINE only.
Shake the oral suspension well before use. The 50 mg tablet should be dispersed in 10 ml of water immediately before administration. NVP is also used for the treatment of HIV-1 infection in children and adults, in combination with other antiretrovirals. Check national recommendations. Also comes in fixed-dose combinations with other antiretrovirals. For PMTCT, NVP is sometimes given as a fixed-dose combination of zidovudine/lamivudine/nevirapine.
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– Below 25 °C Once opened, oral suspension keeps for 2 months maximum.
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