Names and pronunciation
(ne-veer′a-peen) Viramune, Viramune XR
Source page 944
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Individual generic drug information
Extracted information for nevirapine only.
(ne-veer′a-peen) Viramune, Viramune XR
Source page 944
Func. class.: Antiretroviral Func. class.: Vit B3, antihyperlipidemic
Source pages 944, 946
Chem. class.: Nonnucleoside reverse transcriptase inhibitor (NNRTI) Chem. class.: Water-soluble vitamin
Source pages 944, 946
Do not confuse: nevirapine/nelfinavir Viramune/Viracept
Source page 944
ACTION: Binds directly to reverse transcriptase and blocks RNA, DNA, thus causing a disruption of the enzyme’s site
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USES: HIV-1 in combination with other highly active antiretroviral therapy (HAART) USES: Pellagra, hyperlipidemias (types 4, 5), peripheral vascular disease that presents a risk for pancreatitis
Source pages 944, 946
Extracted information for nevirapine only.
CONTRAINDICATIONS: Hyper- sensitivity Precautions: Pregnancy, breastfeeding, children, renal disease, Hispanic patients, hepatitis CONTRAINDICATIONS: Breast- feeding, hypersensitivity, peptic ulcer, hepatic disease, hemorrhage, severe hypotension, history of gouty arthritis, uncontrolled hyperglycemia
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Black Box Warning: serious rash, hepa- totoxicity Black Box Warning: Hepatotoxic- ity: may be fatal; usually occurs within the first 18 wk of treatment, may have rash, fever; assess for anorexia, jaun- dice, clay-colored stools, nausea, fatigue, hepatic pain; higher risk in females with higher CD4+ counts • Do not start therapy in females, includ- ing pregnant women, with CD4+ cell counts >250 cell/mm3 or adult males with CD4+ >400 cells/mm3 • Rhabdomyolysis: pain, tenderness, weakness, edema; product should be dis- continued • Bowel pattern before, during treatment; if severe abdominal pain with bleeding occurs, product should be discontinued; monitor hydration Black Box Warning: Stevens-Johnson syndrome, toxic epidermal necrolysis: allergies before treatment, reaction to each medication; assess for skin erup- tions; rash, urticaria, itching; if rash is severe or systemic symptoms occur, dis- continue immediately, usually within first 6 wk of treatment • Hypersensitivity reaction: usually within first 18 wk of treatment; rash, fe- ver, fatigue, muscle/joint pain, oral lesions N • Pregnancy/breastfeeding: use only if benefits outweigh fetal risk, those who are pregnant should enroll in the Antiret- roviral Pregnancy Registry (1-800-258- 4263), may cause infertility, do not breastfeed if HIV is present Black Box Warning: To stop drug and report immediately any right quadrant pain, yellowing of eyes or skin, dark urine, nausea, anorexia, muscle pain or tender- ness, rash • That follow-up exams and blood work will be needed • That product may be taken with food, antacids • To take as prescribed; if dose is missed, to take as soon as remembered up to 1 hr before next dose; not to dou- ble dose • That product is not a cure, does not prevent transmission; controls symptoms of HIV • To avoid all agents unless approved by prescriber • That body fat redistribution may occur • To use a nonhormonal form of contra- ception during treatment in those using contraceptives (nye′a-sin) Equaline Niacin, Niaspan, Niodan , Slo-Niacin
Source pages 944, 945, 946
SIDE EFFECTS CNS: Paresthesia, headache, fever, peripheral neuropathy GI: Diarrhea, abdominal pain, nausea, stomatitis, hepatotoxicity, hepatic failure HEMA: Neutropenia INTEG: Rash, toxic epidermal necrolysis MISC: Stevens-Johnson syndrome, ana phylaxis MS: Pain, myalgia
Source page 944
INTERACTIONS Increase: nevirapine levels—cimetidine, macrolide antiinfectives, fluconazole, voriconazole Increase: effect of warfarin Decrease: effects of protease inhibitors, oral contraceptives, ketoconazole, metha- done, itraconazole, boceprevir, telaprevir, clarithromycin, efavirenz, fosamprenavir, saquinavir rifamycins, anticonvulsants, clonazePAM, diazepam Drug/Herb Decrease: action of antiretroviral—St. John’s wort; do not use concurrently Drug/Lab Test Increase: ALT, AST, GGT, bilirubin, HB Decrease: neutrophil count
Source page 945
Extracted information for nevirapine only.
DOSAGE AND ROUTES HIV infection • Adult/adolescent: PO 200 mg/day × 2 wk, then 200 mg bid in combination; EXT REL 200 mg/day × 14 days with other antiretrovirals; if no consistent rash present, then 400 mg/day ER tab with other antiretrovirals • Child/adolescent ≥6 yr and BSA ≥1.17 m2 PO 150 mg/m2 daily (max 200 mg/day) × 14 days, then ext rel 400 mg/day, max 400 mg/day • Child/infant/neonate ≥15 days old: PO 150 mg/m2/dose × 14 days, then 150 mg/m2 bid, max 200 mg/dose Hepatic dose • Adult: PO do not use with Child-Pugh grade B or C DOSAGE AND ROUTES Niacin deficiency • Adult: PO 100-500 mg/day in divided doses; • Child: PO ≤300 mg/day in divided doses Adjunct in hyperlipidemia • Adult: PO 250 mg after evening meal; may increase dose at 1-4 wk intervals to 1-2 g tid, max 6 g/day; EXT REL 500 mg at bedtime × 4 wk, then 1000 mg at bedtime for wk 5-8; do not increase by >500 mg q4wk, max 2000 mg/day Pellagra • Adult: PO 300-500 mg/day in divided doses • Child: PO 100-300 mg/day in divided doses Peripheral vascular disease • Adult: PO 250-800 mg/day in 3-5 di- vided doses
Source pages 944, 946
Available forms: Tabs 200 mg; oral susp 50 mg/5 mL; ext rel 100, 400 mg Available forms: Extended-release cap- sule 250 mg; tablet 50,100, 250, 500; extended-release tablet 250, 500, 750, 1000 mg
Source pages 944, 946
Administer: • Do not initiate treatment in females when CD4 counts >250 cells/mm3 or in males when >400 cells/mm3 unless ben- efits outweigh risks • Without regard to meals • Use in combination with at least 1 other antiretroviral • Ext rel: swallow whole; do not crush, chew • Oral susp should be shaken before giving, use oral syringe if possible
Source page 944
Extracted information for nevirapine only.
Assess: • HIV: blood studies during treatment: ALT, AST, viral load, CD4, plasma HIV RNA, renal studies; if LFTs elevated sig- nificantly, product should be withheld; glucose levels in patients with diabetes; if treatment is interrupted by >1 wk, restart at initial dose • Resistance testing before therapy and when therapy fails • Signs of infection, anemia, hepatotox- icity, immune reconstitution syndrome; hepatitis B or C, liver toxicity may occur
Source page 945
Evaluate: • Therapeutic response: absence of AIDS-defining symptoms, improvement in quality of life; decreased viral load, increase in CD4 count
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CLINICAL CONSIDERATIONS
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Patient and caregiver information:
Source page 945
Extracted information for nevirapine only.
PHARMACOKINETICS Rapidly absorbed, peak 4 hr, 60% bound to plasma proteins, metabolized by liver; metabolized by hepatic P450 enzyme system, excreted 91% in urine, terminal half-life 25-30 hr, 50% removed by peritoneal dialysis; with hepatic disease and in Hispanic patients, African-American patients, slower rate of clearance
Source page 945
Filter the extracted dose blocks for this individual drug.
HIV infection
• Adult/adolescent: PO 200 mg/day × 2 wk, then 200 mg bid in combination; EXT REL 200 mg/day × 14 days with other antiretrovirals; if no consistent rash present, then 400 mg/day ER tab with other antiretrovirals
Candidate age grouping · source pages 944, 946
HIV infection
• Adult: PO do not use with Child-Pugh grade B or C DOSAGE AND ROUTES Niacin deficiency
Candidate age grouping · source pages 944, 946
HIV infection
• Adult: PO 100-500 mg/day in divided doses;
Candidate age grouping · source pages 944, 946
HIV infection
• Adult: PO 250 mg after evening meal; may increase dose at 1-4 wk intervals to 1-2 g tid, max 6 g/day; EXT REL 500 mg at bedtime × 4 wk, then 1000 mg at bedtime for wk 5-8; do not increase by >500 mg q4wk, max 2000 mg/day Pellagra
Candidate age grouping · source pages 944, 946
HIV infection
• Adult: PO 300-500 mg/day in divided doses
Candidate age grouping · source pages 944, 946
HIV infection
• Adult: PO 250-800 mg/day in 3-5 di- vided doses
Candidate age grouping · source pages 944, 946