Efavir 600mg

Efavir 600mg Tablet (Efavirenz 600mg)

Active Ingredient: Efavirenz 600mg
Therapeutic Class: Antiretroviral – Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI)

Description

Efavir 600mg contains Efavirenz, an antiretroviral drug used in combination with other medications to treat HIV infection.

• It suppresses viral replication, helping to maintain immune function and delay AIDS-related complications.

• Efavirenz does not cure HIV/AIDS, and therapy must be under medical supervision.

Indications

• Treatment of HIV infection in adults and children ≥3 months old or weighing ≥3.5 kg.

• Must be used in combination with other antiretroviral agents.

Mechanism of Action

• Efavirenz inhibits viral reverse transcriptase, an enzyme necessary for converting viral RNA into DNA.

• It undergoes intracellular conversion to an active form that blocks viral DNA synthesis, preventing the production of new viral particles.

Side Effects

Common:

• Psychiatric symptoms: anxiety, depression, abnormal dreams

• CNS effects: dizziness, headache, insomnia

• GI symptoms: nausea, vomiting, diarrhea, dyspepsia, abdominal pain

• Rash, fatigue

Laboratory Abnormalities:

• Elevated AST, ALT, amylase

• Increased blood glucose, neutropenia

Post-Marketing / Rare:

• Allergic reactions, fat redistribution

• Ataxia, convulsions, neuropathy, tremor, vertigo

• Gynecomastia, palpitations

• Hepatic failure, hypercholesterolemia, dyspnea, vision changes

Precautions

• Monitor cholesterol, triglycerides, liver function in patients with hepatitis B/C.

• Be cautious with CNS or psychiatric disorders; rare reports of severe psychiatric events including suicide.

• Fat redistribution (central obesity, dorsocervical fat, peripheral wasting) may occur.

• Immune reconstitution syndrome may develop.

• Avoid monotherapy; resistance emerges rapidly.

• Use caution in patients with history of seizures.

Drug Interactions

• May increase CNS effects with psychoactive drugs.

• Alters plasma levels of warfarin, HIV integrase inhibitors (e.g., dolutegravir), NNRTIs (e.g., etravirine), and statins (simvastatin).

• Serious interactions with terfenadine, astemizole, cisapride, midazolam, triazolam, pimozide, ergot derivatives, potentially causing cardiac arrhythmias or respiratory depression.

• Dose adjustments required when co-administered with voriconazole or rifampin.

Pregnancy & Lactation

• Pregnancy Category D: Positive evidence of fetal risk in humans; use only if benefits outweigh risks.

• Breastfeeding: Avoid to prevent HIV transmission.

Dosage

Adults:

• 600mg orally once daily, preferably at bedtime, with other antiretrovirals.

• Avoid taking with food to reduce CNS side effects.

• Dose adjustments:

  • With voriconazole: Efavirenz 300mg once daily

  • With rifampin: Efavirenz 800mg once daily

Pediatric (≥3 months): Weight-based dosing:

• 10–<15 kg: 200mg

• 15–<20 kg: 250mg

• 20–<25 kg: 300mg

• 25–<32.5 kg: 350mg

• 32.5–<40 kg: 400mg

• ≥40 kg: 600mg

Administration: Tablets should not be broken, chewed, or crushed.

Storage

• Store at room temperature (25°C) in a closed container.

• Protect from heat, moisture, and direct light.

• Keep out of reach of children and do not use after expiry date.

Missed Dose

• Take as soon as remembered, unless near the next scheduled dose.

• Do not double doses to make up for missed doses.

• Follow doctor’s instructions.