Efavirenz is a human immunodeficiency virus 1 non-nucleoside analog reverse transcriptase inhibitor sold in the U.S. under 2 brand and generic names, for acquired immunodeficiency syndrome. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
From the FDA label for Sustiva (application NDA021360). Other efavirenz products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
2 DOSAGE & ADMINISTRATION • Efavirenz should be taken orally once daily on an empty stomach, preferably at bedtime. ( 2 ) • Recommended adult dose: 600 mg. ( 2.2 ) • With rifampin, increase efavirenz dose to 800 mg once daily for patients weighing 50 kg or more. ( 2.2 ) • Pediatric dosing is based on weight. ( 2.3 ) 2.1 Hepatic Function Monitor hepatic function prior to and during treatment with efavirenz [ see Warnings and Precautions ( 5.9 ) ]. Efavirenz is not recommended in patients with moderate or severe hepatic impairment (Child Pugh B or C) [ see Warnings and Precautions ( 5.9 ) and Use in Specific Populations ( 8.6 ) ]. 2.2 Adults The recommended dosage of efavirenz is 600 mg orally, once daily, in combination with a protease inhibitor and/or nucleoside analogue reverse transcriptase inhibitors (NRTIs). It is recommended that efavirenz be taken on an empty stomach, preferably at bedtime. The increased efavirenz concentrations observed following administration of efavirenz with food may lead to an increase in frequency of adverse reactions [see Clinical Pharmacology ( 12.3 )]. Dosing at bedtime may improve the tolerability of nervous system symptoms [see Warnings and Precautions ( 5.6 ), Adverse Reactions ( 6.1 ), and Patient Counseling Information ( 17 )]. Efavirenz capsules or tablets should be swallowed intact with liquid. Concomitant Antiretroviral Therapy…
The most significant adverse reactions observed in patients treated with efavirenz are: •psychiatric symptoms [see Warnings and Precautions ( 5.5 )], •nervous system symptoms [see Warnings and Precautions ( 5.6 )], •rash [see Warnings and Precautions ( 5.8 )]. •hepatotoxicity [see Warnings and Precautions ( 5.9 )] Most common adverse reactions (>5%, moderate-severe) are impaired concentration, abnormal dreams, rash, dizziness, nausea, headache, fatigue, insomnia, and vomiting.( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Macleods Pharmaceutical Ltd at 1-888-943-3210 or 1-855-926-3384 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, the adverse reaction rates reported cannot be directly compared to rates in other clinical studies and may not reflect the rates observed in clinical practice. Adverse Reactions in Adults. The most common (>5% in either efavirenz treatment group) adverse reactions of at least moderate severity among patients in Study 006 treated with efavirenz in combination with zidovudine/lamivudine or indinavir were rash, dizziness, nausea, headache, fatigue, insomnia, and vomiting Selected clinical adverse reactions of moderate or severe intensity observed in ≥2% of efavirenz-treated patients in two controlled clinical trials are presented in Table 2…
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
| # | Drug | Rating | Type | Form | Generic? | Typical price | |
|---|---|---|---|---|---|---|---|
| 1 | 72/100 | Prescription | Capsule | Generic | $42 | View → | |
| 2 | Not yet rated | Prescription | Capsule | Generic | $42 |
Imprint codes, colour and shape from the FDA’s labelling data. Match the imprint on your pill — or search any imprint.
| Imprint | Strength | Colour | Shape | Maker |
|---|---|---|---|---|
| I48 | 600 mg / 200 mg / 300 mg | white | oval | — |
| H;128 | 600 mg / 200 mg / 300 mg | white | capsule | — |
| LA36 | 600 mg / 200 mg / 300 mg | pink | capsule | — |
| TV;C72 | 600 mg / 200 mg / 300 mg | pink | oval | — |
| CL301 | 600 mg | yellow | capsule | — |
| I48 |
A combination is a different drug — different dosing, different warnings. It is listed here so you can find it, not so you can substitute it.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Efavirenz is contraindicated in patients with previously demonstrated clinically significant hypersensitivity (e.g., Stevens-Johnson syndrome, erythema multiforme, or toxic skin eruptions) to any of the components of this product. • Coadministration of efavirenz with elbasvir and grazoprevir is contraindicated [ see Warnings and Precautions ( 5.1 ) and Drug Interactions ( 7.1 ) ]. •Patients with previously demonstrated hypersensitivity (e.g., Stevens-Johnson syndrome, erythema multiforme, or toxic skin eruptions to any of the components of this product. ( 4 ) •Coadministration of efavirenz with elbasvir/grazoprevir
Coadministration of efavirenz can alter the concentrations of other drugs and other drugs may alter the concentrations of efavirenz. The potential for drug-drug interactions should be considered before and during therapy. ( 7 ) 7.1 Potential for efavirenz to Affect other Drugs Efavirenz has been shown in vivo to induce CYP3A and CYP2B6. Other compounds that are substrates of CYP3A or CYP2B6 may have decreased plasma concentrations when coadministered with efavirenz 7.2 Potential for Other Drugs to Affect efavirenz Drugs that induce CYP3A activity (e.g., phenobarbital, rifampin, rifabutin) would be expected to increase the clearance of efavirenz resulting in lowered plasma concentrations [see Dosage and Administration ( 2.2 )]. 7.3 QT Prolonging Drugs There is limited information available on the potential for a pharmacodynamic interaction between efavirenz and drugs that prolong the QTc interval. QTc prolongation has been observed with the use of efavirenz [see Clinical Pharmacology ( 12.2 )]. Consider alternatives to efavirenz when coadministered with a drug with a known risk of Torsade de Pointes. 7.4 Established and Other Potentially Significant Drug Interactions Drug interactions with efavirenz are summarized in Table 5. For pharmacokinetics data, [see Clinical Pharmacology ( 12.3 )] Tables 7 and 8. This table includes potentially significant interactions, but is not all…
| 600 mg / 200 mg / 300 mg |
| white |
| oval |
| — |
| L40 | 400 mg / 300 mg / 300 mg | white | oval | — |
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| M;152 | 600 mg / 300 mg / 300 mg | white | oval | — |
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| L65 | 600 mg / 300 mg / 300 mg | white | capsule | — |
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