EFAVIR 600 MG 30 TAB

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Description

EFAVIR 600 MG 30 TAB

Efavirenz | Antivirals | Antiretrovirals | AIDS | HIV

efavir 600 mg tab

Active Ingrdiant

Each film-coated tablet contains 600 mg of efavirenz.

indications

Efavirenz is indicated in antiviral combination treatment of human immunodeficiency virus-1 (HIV-1) infected adults, adolescents, and children 3 months of age and older and weighing at least 3.5 kg.

Efavirenz has not been adequately studied in patients with advanced HIV disease, in patients with CD4 counts < 50 cells/mm3, or after the failure of protease inhibitor (PI) containing regimens. Although cross-resistance of efavirenz with PIs has not been documented, there is currently insufficient data on the efficacy of subsequent use of PI-based combination therapy after failure of regimens containing efavirenz.

Contraindications

Hypersensitivity to the active substance or to any of the excipients

Patients with severe hepatic impairment (Child-Pugh Class C)

Co-administration with terfenadine, astemizole, cisapride, midazolam, triazolam, pimozide, bepridil, or ergot alkaloids (for example, ergotamine, dihydroergotamine, ergonovine, and methylergonovine) because competition for CYP3A4 by efavirenz could result in inhibition of metabolism and create the potential for serious and/or life-threatening adverse reactions [for example, cardiac arrhythmias, prolonged sedation or respiratory depression] (see section 4.5).

Co-administration with elbasvir (EBR) and grazoprevir (GZR) due to the potential for significant decreases in plasma concentrations of EBR and GZR (see section 4.5).

Herbal preparations containing St. John’s wort (Hypericum perforatum) due to the risk of decreased plasma concentrations and reduced clinical effects of efavirenz (see section 4.5).

Patients with:

– a family history of sudden death or of congenital prolongation of the QTc interval on electrocardiograms, or with any other clinical condition known to prolong the QTc interval.

– a history of symptomatic cardiac arrythmias or with clinically relevant bradycardia or with congestive cardiac failure accompanied by reduced left ventricle ejection fraction

– severe disturbances of electrolyte balance e.g. hypokalemia or hypomagnesemia.

Patients taking drugs that are known to prolong the QTc interval (proarrythmic).

These drugs include:

– antiarrhythmics of classes IA and III,

– neuroleptics, antidepressive agents,

– certain antibiotics including some agents of the following classes: macrolides, fluoroquinolones, imidazole and triazole antifungal agents,

– certain non-sedating antihistamines (terfenadine, astemizole),

– cisapride,

– flecainide,

– certain antimalarials,

– methadone.

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