Monograph Details
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Infections & Infestations
> Viral infections
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ATRIPLA |
| Manufacturer |
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Bristol-Myers Squibb and Gilead |
| Legal Classification |
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Rx
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| Pharmacological Class |
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Non-nucleoside reverse transcriptase inhibitor + nucleoside analogue + nucleotide analogue. |
| Generic Name |
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Efavirenz 600mg, emtricitabine 200mg, tenofovir DF 300mg; tabs. |
| Indications |
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HIV-1 infection. |
| Children |
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<18yrs: not recommended. |
| Adults |
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Take on empty stomach. ≥18yrs: 1 tablet once daily (preferably at bedtime). |
| Contraindications |
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Concomitant cisapride, ergots, midazolam, triazolam, St. John's wort, voriconazole, lamivudine, atazanavir, other forms of emtricitabine, efavirenz, or tenofovir. Moderate to severe renal impairment (CrCl<50mL/min). |
| Precautions |
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Suspend therapy if lactic acidosis or hepatotoxicity (eg, hepatomegaly, steatosis) occurs. Not for treating chronic hepatitis B; test for HBV before starting therapy and closely monitor patients co-infected with HBV and HIV during and for several months after stopping treatment (discontinuing therapy may exacerbate HBV infection). Women, obesity, or prolonged nucleoside exposure: increased risk of toxicity (eg, lactic acidosis). History of seizures. Hepatic impairment. Osteopenia (consider supplemental calcium and Vit.D). Elderly. Pregnancy (Cat.D). Nursing mothers: not recommended. |
| Interactions |
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See Contraindications. Avoid alcohol, other psychoactive and/or hepatotoxic drugs. Potentiates didanosine toxicity (>60kg; reduce dose of didanosine); discontinue didanosine if toxicity develops. Potentiates, and is potentiated by ritonavir (monitor liver function and for adverse events). Tenofovir levels increased by lopinavir; discontinue if toxicity occurs. Efavirenz levels decreased by phenobarbital, rifampin, rifabutin. May decrease levels of indinavir (may be ineffective, even with increased dose), amprenavir, clarithromycin, methadone, rifabutin (increase dose: see literature), sertraline, statins. Efavirenz increases nelfinavir, ethinyl estradiol levels (use non-hormonal contraception. Antagonizes, and is antagonized by, saquinavir (do not use as sole protease inhibitor). Caution with drugs metabolized by, or that affect activity of, CYP2C9, CYP2C19, CYP3A4. Closely monitor warfarin, anticonvulsants (esp. phenytoin, phenobarbital, carbamazepine), rifabutin, others. Monitor drugs that decrease renal function or compete for renal tubular secretion (eg, adefovir, dipivoxil, cidofovir, acyclovir, valacyclovir, ganciclovir, valganciclovir). May cause false (+) cannabis screening test (CEDIA DAU multi-level THC assay). Others. |
| Adverse Reactions |
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Rash, dizziness, insomnia, drowsiness, hallucinations, other CNS and psychiatric effects, GI upset, skin discoloration, fat redistribution, immune reconstitution syndrome; lactic acidosis, severe hepatomegaly with steatosis, false (+) urine test for cannabinoid, others. |
| Extra Text |
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Note: Register pregnant patients exposed to Atripla by calling (800) 258-4263. |
| How Supplied |
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Tabs—30 |
| Additional Resources |
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• Related Prescribing Note |
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