Buy Viramune Online

Viramune XR (nevirapine)

BOXED WARNING

Severe, life-threatening, and in some cases fatal, hepatotoxicity (particularly in the first 18 weeks) and skin reactions (eg, Stevens-Johnson syndrome, toxic epidermal necrolysis, hypersensitivity reactions) reported. Increased risk of hepatotoxicity reported in women and patients with higher CD4+ cell counts, including pregnant women. Hepatic failure reported in patients without HIV taking nevirapine for postexposure prophylaxis (PEP). Use for occupational and non-occupational PEP is contraindicated. D/C therapy and seek medical evaluation immediately if hepatitis, transaminase elevations combined with rash or other systemic symptoms, severe skin rash, or hypersensitivity reactions develop; do not restart therapy. The 14-day lead-in period with 200mg daily dosing must be followed; may decrease the incidence of rash. Monitor intensively during the first 18 weeks of therapy, especially the first 6 weeks.

OTHER BRAND NAMES

Viramune

THERAPEUTIC CLASS

Non-nucleoside reverse transcriptase inhibitor (NNRTI)

DEA CLASS

RX

INDICATIONS

Treatment of HIV-1 infection in combination with other antiretrovirals.

ADULT DOSAGE

HIV-1 Infection


Combination w/ Other Antiretrovirals:
Tab (Immediate-Release [IR]):
Initial: 200mg qd for the first 14 days
Maint: 200mg bid

Tab, Extended-Release (ER):
Not Currently Taking IR Nevirapine:
Initial: One 200mg IR tab qd for first 14 days
Maint: One 400mg ER tab qd

Switching from IR Tab to ER Tab:
Switch to 400mg ER tab qd w/o 14-day lead-in period

PEDIATRIC DOSAGE

HIV-1 Infection

Combination w/ Other Antiretrovirals:
Tab/Oral Sus:
≥15 Days of Age:
Initial: 150mg/m2 qd for the first 14 days
Maint: 150mg/m2 bid
Max: 400mg/day

Tab, Extended-Release (ER):
6-<18 Years:
Initial:
150mg/m2 IR tab/oral sus qd for first 14 days
Max: 200mg/day
Maint:
BSA 0.58-0.83m2: Two 100mg ER tabs qd
BSA 0.84-1.16m2: Three 100mg ER tabs qd
BSA ≥1.17m2: One 400mg ER tab qd
Max: 400mg/day

DOSING CONSIDERATIONS

Renal Impairment
Requiring Dialysis: Administer additional 200mg IR dose after each dialysis treatment

Hepatic Impairment
Moderate or Severe (Child-Pugh Class B or C): Not recommended for use
Symptomatic Hepatic Event Occurrence: Permanently d/c; do not restart after recovery

Adverse Reactions
Severe Rash/Rash Accompanied by Constitutional Findings: D/C
Mild to Mod Rash w/o Constitutional Symptoms During Lead-In Period: Do not initiate XR therapy until rash has resolved; duration of lead-in period should not exceed 28 days, at which point an alternative regimen should be sought

Other Important Considerations
Dose Interruption for >7 Days: Restart using lead-in dosing

ADMINISTRATION

Oral route

Take w/ or w/o food

Tab, ER
Swallow whole; do not chew, crush, or divide

Oral Sus
Shake gently prior to administration
Administer the entire measured dose by using an oral dosing syringe or dosing cup

HOW SUPPLIED

[IR] Sus: 50mg/5mL [240mL], Tab: 200mg*; Tab, ER: 100mg, 400mg *scored

CONTRAINDICATIONS

Moderate or severe (Child-Pugh Class B or C) hepatic impairment. Use as part of occupational and non-occupational PEP regimens.

WARNINGS/PRECAUTIONS

Not recommended for adult females with CD4+ cell counts >250 cells/mm3 or in adult males with CD4+ cell counts >400 cells/mm3. Coinfection with hepatitis B or C and/or increased transaminase elevations at the start of therapy may increase risk of later symptomatic events (≥6 weeks after starting therapy) and asymptomatic increases in AST/ALT. Caution with hepatic fibrosis/cirrhosis; monitor for drug-induced toxicity. Rhabdomyolysis reported in some patients with skin and/or liver reactions. Monitor closely if isolated rash of any severity occurs; delay in stopping treatment after the onset of rash may result in a more serious reaction. Do not use as single agent to treat HIV-1 or add on as a sole agent to a failing regimen; resistant virus emerges rapidly when administered as monotherapy. Consider potential for cross-resistance in the choice of new antiretroviral agents to be used in combination with therapy. Take into account the half-lives of the combination antiretroviral drugs when discontinuing the regimen; nevirapine has a long half-life and resistance may develop if antiretrovirals with shorter half-lives are stopped concurrently. Immune reconstitution syndrome, autoimmune disorders (eg, Graves' disease, polymyositis, Guillain-Barre syndrome) in the setting of immune reconstitution, and redistribution/accumulation of body fat reported. Caution in elderly.

ADVERSE REACTIONS

Hepatotoxicity, skin reactions, diarrhea, nausea, headache, fatigue, abdominal pain.

DRUG INTERACTIONS

Avoid with atazanavir, boceprevir, telaprevir, ketoconazole, itraconazole, and rifampin. Not recommended with fosamprenavir (without ritonavir), efavirenz, and St. John's wort or St. John's wort-containing products. May alter levels of other non-nucleoside reverse transcriptase inhibitor (NNRTI) (eg, delavirdine, etravirine, rilpivirine); avoid coadministration. Increased incidence and severity of rash with prednisone during the first 6 weeks of therapy; not recommended to prevent nevirapine-associated rash. May increase levels of 14-OH clarithromycin and rifabutin. May increase levels of antithrombotics (eg, warfarin); monitor anticoagulation levels. May decrease levels of CYP3A/2B6 substrates, clarithromycin, ethinyl estradiol, norethindrone, efavirenz, atazanavir, amprenavir, indinavir, lopinavir, methadone, nelfinavir, boceprevir, telaprevir, antiarrhythmics, anticonvulsants, ketoconazole, itraconazole, calcium channel blockers, cancer chemotherapy, ergot alkaloids, immunosuppressants, motility agents, and opiate agonists. Fluconazole may increase levels and rifampin may decrease levels. Refer to PI for further information when used with certain concomitant therapies.

PREGNANCY AND LACTATION

Category B, not for use in nursing.

MECHANISM OF ACTION

NNRTI; binds directly to reverse transcriptase and blocks RNA-dependent and DNA-dependent DNA polymerase activities by causing a disruption of the enzyme's catalytic site.

PHARMACOKINETICS

Absorption: Readily absorbed. IR: Absolute bioavailability (93%, tab), (91%, sus); Cmax=2mcg/mL; Tmax=4 hrs. ER (single dose): AUC=161,000ng•hr/mL; Cmax=2060ng/mL; Tmax=24 hrs (median). Distribution: Vd=1.21L/kg (IV, healthy); plasma protein binding (60%). Crosses placenta; found in breast milk. Metabolism: Liver (extensive); glucuronide conjugation, oxidative metabolism via CYP3A and CYP2B6. Elimination: T1/2=45 hrs (single dose), 25-30 hrs (multiple dosing). IR: Urine (81.3%; <3%, parent drug), feces (10.1%).

ASSESSMENT

Assess for hepatic fibrosis/cirrhosis, hepatitis B or C coinfection, pregnancy/nursing status, and possible drug interactions. Obtain baseline LFTs. (ER) Assess the ability to swallow tabs in pediatric patients.

MONITORING

Monitor for hepatotoxicity, skin or hypersensitivity reactions, immune reconstitution syndrome, autoimmune disorders, fat redistribution/accumulation, rhabdomyolysis, and other adverse reactions. Perform intensive clinical and lab monitoring, including LFTs, during the first 18 weeks of therapy and frequently throughout treatment. Measure serum transaminases immediately if signs/symptoms of hepatitis, hypersensitivity reactions, and rash develop. Monitor anticoagulation levels with antithrombotics (eg, warfarin).

PATIENT COUNSELING

Inform about the risks and benefits of therapy. Inform that severe liver disease/skin reactions may occur. Counsel about signs/symptoms of hepatotoxicity, skin reactions, and other adverse reactions, and advise to d/c and seek medical evaluation immediately if any occur. Inform to take drug as prescribed. Instruct not to alter the dose without consulting physician. Inform that therapy is not a cure for HIV-1 infection and that illnesses associated with HIV-1 infection, including opportunistic infections, may still occur. Advise to avoid doing things that can spread HIV-1 infection to others (eg, sharing needles or other inj equipment, sharing personal items that can have blood or body fluids on them [toothbrush, razor blades], breastfeeding). Instruct not to have any kind of sex without protection; inform to always practice safe sex by using a latex or polyurethane condom to lower the chance of sexual contact with semen, vaginal secretions, or blood. Advise to notify physician of the use of any other prescription/OTC medication, or herbal products, particularly St. John's wort. Inform women taking therapy that hormonal methods of birth control should not be used as the sole method of contraception. Inform that fat redistribution may occur. Instruct not to take IR tabs/sus and ER tabs at the same time. (ER) Advise that soft remnants of the drug may be seen in stool.

STORAGE

25°C (77°F); excursions permitted to 15-30°C (59-86°F).

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