Generic Medicine Info
Should be taken on an empty stomach. Take on an empty stomach, preferably at bedtime.
Hypersensitivity. History of severe cutaneous reaction (e.g. Stevens-Johnson syndrome, erythema multiforme, toxic skin eruptions); family history of sudden death, or of congenital QTc interval prolongation, or with any other clinical condition known to prolong the QTc interval; history of symptomatic cardiac arrhythmias, or with clinically relevant bradycardia, or with CHF accompanied by reduced LVEF; severe electrolyte balance disturbances (e.g. hypokalaemia, hypomagnesaemia). Severe hepatic impairment (Child Pugh Class C). Pregnancy (1st trimester) and lactation. Concomitant use with terfenadine, astemizole, cisapride, flecainide, methadone, midazolam, triazolam, pimozide, bepridil, ergot alkaloids, elbasvir, grazoprevir, St. John's wort, classes IA and III antiarrhythmics, neuroleptics, antidepressants, certain antibiotics (e.g. some macrolides, fluoroquinolones, imidazole and triazole antifungals), certain antimalarials.
Special Precautions
Patients with history of seizure, psychiatric disorders (including depression), or drug abuse; HIV-associated dementia, chronic hepatitis B or C infection. Not intended to be used as a single agent to treat HIV or add on as a sole agent to a failing regimen. Not recommended in moderate hepatic impairment. Severe renal and mild hepatic impairment. Children. Pregnancy (2nd-3rd trimester). CYP2D6 ultrarapid, rapid, intermediate, and poor metabolisers. Patient Counselling This drug may cause dizziness, somnolence or impaired concentration, if affected, do not drive or operate machinery. Efavirenz does not reduce your risk of passing HIV infection through sexual contact. Avoid sexual intercourse and follow your doctor's advise on ways to prevent passing the disease to others. Use an effective barrier contraception in addition to hormonal contraceptives during and for 12 weeks after treatment. Monitoring Parameters Monitor viral load, CD4 count, serum transaminases, blood glucose, serum cholesterol and triglycerides at baseline and periodically during treatment. Assess for signs and symptoms of infection and psychiatric effects.
Adverse Reactions
Significant: QTc prolongation, CNS effects (e.g. dizziness, insomnia, somnolence, impaired concentration, abnormal dreams), psychiatric effects (e.g. aggression, delusions, severe depression, paranoia, psychosis-like behaviour, mania), fat redistribution or accumulation (e.g. central obesity, buffalo hump, peripheral and facial wasting, breast enlargement, cushingoid appearance), hypercholesterolaemia, immune reconstitution syndrome (e.g. activation of Graves' disease, polymyositis, Guillain-Barré syndrome), osteonecrosis, seizures. Blood and lymphatic system disorders: Neutropenia. Ear and labyrinth disorders: Tinnitus. Eye disorders: Blurred vision. Gastrointestinal disorders: Abdominal pain, diarrhoea, nausea, vomiting, pancreatitis. General disorders and administration site conditions: Fatigue, ataxia. Investigations: Increased ALT and AST, elevated gamma-glutamyl transferase. Metabolism and nutrition disorders: Hypertriglyceridaemia, hyperglycaemia. Nervous system disorders: Abnormal coordination, balance and attention disturbances, headache, vertigo, amnesia, abnormal thinking, tremor. Psychiatric disorders: Anxiety, affect lability, confusion, euphoria, hallucination, catatonia. Reproductive system and breast disorders: Gynaecomastia. Respiratory, thoracic and mediastinal disorders: Dyspnoea. Skin and subcutaneous tissue disorders: Rash, pruritus. Rarely, photoallergic dermatitis. Vascular disorders: Flushing.
Potentially Fatal: Stevens-Johnson syndrome, fulminant hepatitis progressing to hepatic failure, fatal suicide attempts.
Drug Interactions
May reduce plasma concentrations of voriconazole, rifampicin, HIV non-nucleoside reverse transcriptase inhibitors (NNRTIs), HIV integrase inhibitors, Ca channel blockers, HMG-CoA reductase inhibitors (e.g. atorvastatin, pravastatin, simvastatin), immunosuppressants (e.g. ciclosporin, tacrolimus, sirolimus). May increase CNS effects with psychoactive drugs. May alter plasma warfarin concentrations resulting to increased or decreased anticoagulant effect.
CIMS Class
ATC Classification
J05AG03 - efavirenz ; Belongs to the class of non-nucleoside reverse transcriptase inhibitors. Used in the systemic treatment of viral infections.
Disclaimer: This information is independently developed by CIMS based on efavirenz from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to CIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, CIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2021 CIMS. All rights reserved. Powered by CIMSAsia.com
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