ABRIDGED PRESCRIBING INFORMATION - EFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE TABLETS

Composition:

Each film-coated tablet contains: Tenofovir disoproxil fumarate IP 300 mg equivalent to Tenofovir disoproxil 245 mg, Lamivudine IP 300 mg, Efavirenz IP 600mg.


Indication:

Indicated for the treatment of HIV-1 infection in adults.


Dosage:

One tablet once daily on empty stomach preferably at bedtime. Contraindications: Hypersensitivity. Should not be administered concurrently with astemizole, bepridil, cisapride, midazolam, pimozide, triazolam or ergot derivatives, or with voriconazole.


Warnings and precautions:

Lactic acidosis, severe splenomegaly with steatosis, new onset or worsening of renal failure, patients with HIV or HBV coinfection, emergence of lamivudine resistant HBV, Hepatic decompensation (some fatal) has occurred in HIV-1/HCV co-infected patients receiving combination antiretroviral therapy for HIV-1 and interferon alfa with or without ribavirin, psychiatric and central nervous system effects, rise in liver enzymes, convulsions, lipid elevation, decrease in bone marrow density, fat redistribution, immune reconstitution syndrome.


Use in special population:


Pregnancy:

Contraindicated.


Lactation:

Not to breastfeed children.


Pediatric:

Not recommended.


Geriatric:

Caution while administration and monitoring required.


Renal impairment:

Not suitable for patients with baseline creatinine clearance < 50mL/min.


Hepatic dysfunction:

should be used with caution.


Adverse drug reactions:

headache, pain, fever, abdominal pain, back pain, asthenia, diarrhea, nausea, dyspepsia, vomiting, lipodystrophy, arthralgia, myalgia, depression, insomnia, dizziness, peripheral neuropathy, anxiety, pneumonia, rash.


Storage:

Store in a dry place at a temperature not exceeding 25 °C.


Presentation:

HDPE bottle containing 30 tablets. For further information, please consult full prescribing information.


Updated by Dr. Aditi Apte on 20-07-2011