Concise Prescribing Info
HIV-1 infection in combination w/ other antiretrovirals.
Dosage/Direction for Use
Adult 1 tab (600 mg) once daily.
Should be taken on an empty stomach: Take preferably at bedtime.
Hypersensitivity. Concurrent administration w/ astemizole, cisapride, midazolam, triazolam or ergot derivatives due to CYP3A4 competition resulting in potential serious adverse reactions (eg, cardiac arrhythmias, prolonged sedation or resp depression).
Special Precautions
Psychiatric symptoms eg, severe depression, suicidal ideation, nonfatal suicide attempts, aggressive behavior, paranoid & manic reactions. CNS symptoms eg, dizziness, insomnia, impaired conc, somnolence, abnormal dreams, hallucinations. Skin rash; fat redistribution/accumulation; convulsions, history of seizures. Impaired hepatic function. Pregnancy & lactation. Childn <3 yr & weighing <13 kg. Elderly.
Adverse Reactions
MI, palpitations, prolonged QT interval; rash, pruritus; fat maldistribution, hyperlipidemia, increased glucose level, raised serum triglycerides, vit D deficiency; abdominal pain, diarrhea, indigestion, nausea, vomiting, raised serum amylase; neutropenia; raised ALT (SGPT), AST/SGOT & γ-glutamyl transferase, hepatitis; immune hypersensitivity reaction, immune reconstitution syndrome; osteomalacia; dizziness, headache, insomnia, seizure; toxic maculopathy; aggressive & manic behaviors, anxiety, delusion of persecution, depression, dream, psychotic & sleep disorders, suicidal risks & thoughts; pulmonary hypersensitivity, cough; fatigue, fever & pain.
Drug Interactions
Increased clearance w/ drugs that induce CYP3A4 activity eg, phenobarb, rifampin, rifabutin. Decreased plasma levels w/ phenytoin, carbamazepine. Higher frequency of adverse effects & lab abnormalities w/ ritonavir; monitor liver enzymes. Decreased serum conc of amprenavir. Decreased plasma conc of clarithromycin. Increased AUC of ethinyl estradiol. Decreased AUC & Cmax of indinavir, methadone. Increased AUC & Cmax of saquinavir. Increased or decreased plasma conc of warfarin. Concomitant use w/ alcohol or psychoactive drugs may cause potential additive CNS effects.
MIMS Class
ATC Classification
J05AG03 - efavirenz ; Belongs to the class of non-nucleoside reverse transcriptase inhibitors. Used in the systemic treatment of viral infections.
Estiva-600 FC tab 600 mg
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