Efavirenz STELLA 600 mg

Rx

Indications

Treatment of human immunodeficiency virus HIV-1 infected adult, adolescents and children 3 years of age and older. Post-exposure prophylaxis following occupational or non-occupational exposure to HIV.

Dosage

Treatment of HIV infection

• Adults, adolescents and children ≥ 40 kg: 600 mg once daily; combined efavirenz with 2 other nucleoside (stavudine (d4T), lamivudine (3TC), efavirenz (EFV) or zidovudine (ZDV) + 3TC + EFV).

Post-exposure prophylaxis

• Following occupational exposure to HIV: 600 mg once daily at bedtime in conjunction with 2 nucleoside reverse transcriptase inhibitors, started as soon as possible following occupational exposure (preferably within hours) and continued for 4 weeks.
• Following non-occupational exposure to HIV: 600 mg once daily at bedtime in conjunction with 2 other antiretrovirals, started as soon as possible following non-occupational exposure (preferably within 72 hours) and continued for 28 days.
• If efavirenz is coadministered with voriconazole, the voriconazole maintenance dose must be 400 mg every 12 hours and the efavirenz dose must be 300 mg once daily; when treatment with voriconazole is stopped, the initial dose of efavirenz should be restored.
• If efavirenz is coadministered with rifampicin to patients weighing 50 kg or more, the dose of efavirenz 800 mg/day may be considered.

Usage

• Efavirenz STELLA 600 mg is administered orally on an empty stomach. Avoid taking in a high fat meal (lipid). Dosing at bedtime is recommended during the first 2 to 4 weeks of therapy to improve tolerability and minimize the adverse events on central nervous system. If there are no adverse effects on the central nervous system, efavirenz can be taken at a convenient time of the day.
• The tablet should not be broken.
• Must take this drug on time, if you forget to take this drug on time, take it as soon as you remember. If the administration time is close to the next dose, skip the missed dose. Do not take a double dose at once.

• Know hypersensitivity to any of the ingredients.
• Patients with severe hepatic impairment.
• Efavirenz must not be administered concurrently with terfenadine, astemizole, cisapride, midazolam, triazolam, pimozide, bepridil or ergot alkaloids (e.g. ergotamine, dihydroergotamine, ergonovine and methylergonovine); herbal preparations containing Hypericum perforatum.

Very common

• Rash.

Common

• Hypertriglyceridaemia;
• Abnormal dreams, anxiety, depression, insomnia;
• Cerebellar coordination and balance disturbances, disturbance in attention dizziness, headache, somnolence;
• Abdominal pain, diarrhea, nausea, vomiting;
• Increase AST, ALT, GGT;
• Pruritus;
• Fatigue.

• Efavirenz STELLA 600 mg should be used with caution in patients with mild to moderate liver disease; patients with a history of seizures or psychiatric disorders including depression.
• Efavirenz STELLA 600 mg should be stopped if a severe skin rash, associated with blistering, desquamation, mucosal involvement, or fever, develops.
• Monitoring of serum lipids and blood-glucose may be considered during Efavirenz STELLA 600 mg
• In HIV infected patients with severe immune deficiency at the time of institution of combination antiretroviral therapy (CART), an inflammatory reaction to asymptomatic or residual opportunistic pathagen may arise and cause serious clinical conditions, or aggravation of symptoms.
• Autoimmune disorders may occur.
• Risk of osteonecrosis, particularly in patients with advanced HIV-disease and/or long-term exposure to combination antiretroviral therapy.
• Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose – galactose malabsorption should not take Efavirenz STELLA 600 mg.
• Efavirenz may cause fetal harm if administered during the first trimester of pregnancy. Women of childbearing potential should not receive efavirenz until pregnancy is excluded. It is recommended that HIV infected women do not breast-feed their infants under any circumstances in order to avoid transmission of HIV.
• Efavirenz STELLA 600 mg may cause dizziness, impaired concentration and/or somnolence. Patients should be instructed that if they experience these symptoms they should avoid potentially hazardous tasks such as driving or operating machinery.