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AURO-EFAVIRENZ-EMTRICITABINE-TENOFOVIR is a brand name for Efavirenz, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE…………………………………………………..
Verbatim from this product's HC label. Tap a section to expand.
43 PART II. 63 Page 3 of 67 PART I. HEALTH PROFESSIONAL INFORMATION SUMMARY PRODUCT INFORMATION Route of Administration Dosage Form/Strength All Nonmedicinal Ingredients Oral Tablet efavirenz 600 mg/ emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg Croscarmellose Sodium, Low- substituted Hydroxypropyl Cellulose, Microcrystalline Cellulose, Hydroxypropyl Cellulose, Sodium Lauryl Sulfate, Hypromellose, Magnesium stearate and Opadry II Pink 85F94172.
INDICATIONS AND CLINICAL USE Auro-Efavirenz-Emtricitabine-Tenofovir (efavirenz [EFV]/emtricitabine [FTC]/tenofovir disoproxil fumarate [TDF]) is indicated for use alone as a complete regimen or in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults.
(see CLINICAL TRIALS, Description of Clinical Studies and ADVERSE REACTIONS).
Geriatrics (>65 years of age):
Clinical studies of the components of efavirenz/emtricitabine/tenofovir disoproxil fumarate did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.
Pediatrics (<18 years of age):
Safety and effectiveness in pediatric patients have not been established. Auro-Efavirenz- Emtricitabine-Tenofovir is not recommended for pediatric administration. CONTRAINDICATIONS Auro-Efavirenz-Emtricitabine-Tenofovir is contraindicated in patients with previously demonstrated hypersensitivity to any of the components of the product.
For a complete listing, see the DOSAGE FORMS, COMPOSITION AND PACKAGING section of the Product Monograph. Competition for CYP3A4 by EFV could result in inhibition of metabolism of some drugs and create the potential for serious and/or life-threatening adverse events.
Drugs that are contraindicated with Auro-Efavirenz-Emtricitabine-Tenofovir are listed in Table 1. See also DRUG INTERACTIONS, Drug-Drug Interactions. Page 4 of 67 Table 1. Drugs That Are Contraindicated with Auro-Efavirenz-Emtricitabine-Tenofovir Drug Class: Drug Name Clinical Comment Antiarrhythmics: bepridil* CONTRAINDICATED due to potential for serious and/or life- threatening reactions such as cardiac arrhythmias.
HCV antiviral agents: elbazvir/grazoprevir CONTRAINDICATED due to the expected significant decreases in plasma concentrations of elbasvir and grazoprevir. This effect is due to induction of CYP3A4 by efavirenz, and may result in loss of therapeutic effect.
Antifungal: voriconazole CONTRAINDICATED because EFV significantly decreases voriconazole plasma concentrations, and coadministration may decrease the therapeutic effectiveness of voriconazole. Also, voriconazole significantly increases EFV plasma concentrations, which may increase the risk of EFV- associated side effects.
Because Auro-Efavirenz-Emtricitabine-Tenofovir is a fixed dose combination product, the dose of EFV cannot be altered; therefore, voriconazole and Auro-Efavirenz-Emtricitabine- Tenofovir cannot be coadministered. Antihistamines: astemizole*, terfenadine* CONTRAINDICATED due to potential for serious and/or life- threatening reactions such as cardiac arrhythmias.
Antimigraine: ergot derivatives (dihydroergotamine, ergonovine, ergotamine, methylergonovine) CONTRAINDICATED due to potential for serious and/or life- threatening reactions such as acute ergot toxicity characterized by peripheral vasospasm and ischemia of the extremities and other tissues.
Benzodiazepines: midazolam, triazolam CONTRAINDICATED due to potential for serious and/or life- threatening reactions such as prolonged or increased sedation or respiratory depression. Neuroleptic: pimozide CONTRAINDICATED due to potential for serious and/or life- threatening reactions such as cardiac arrhythmias.
GI motility agent: cisapride* CONTRAINDICATED due to potential for serious and/or life- threatening reactions such as cardiac arrhythmias.
Herbal products:
St. John’s wort (Hypericum perforatum) CONTRAINDICATED due to risk of reduced plasma concentrations of EFV. This effect is due to an induction of CYP3A4 and may result in loss of virologic response and possible resistance to EFV or to the class of non-nucleoside reverse transcriptase inhibitors (NNRTIs).
*Not marketed in Canada. WARNINGS AND PRECAUTIONS Lactic […]
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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