ABRIDGED PRESCRIING INFORMATION – TAVIN-LN KIT

Composition:

Each Combikit contains: Part A: One film coated tablet of Lamivudine IP 300 mg and Tenofovir Disoproxil fumarate IP 300 mg eq to Tenofovir Disoproxil 245 mg Part B: Two tablets of Nevirapine IP200 mg.


Indication:

For the treatment of HIV-1 infection in adults.


Dosage And Administration:

One tablet from Part A should be taken once daily. One tablet from Part B should be taken twice daily.


Contraindications:

Hypersensitivity.


Warnings And Precautions:

Lactic acidosis/severe hepatomegaly with steatosis, new-onset or worsening renal impairment, hepatotoxicity, skin rash, patients with HIV-1 and HBV co-infection require close monitoring emergence of lamivudine-resistant HBV, Use with other lamivudine or nevirapine containing products not recommended, coadministration with interferon alpha with or without ribavirin has resulted into hepatic decompensation, decrease in bone marrow density, fat redistribution, immune reconstitution syndrome.


Adverse Drug Reactions (Common):

Tenofovir: rash, diarrhea, headache, pain, depression, asthenia, nausea, mild to moderate gastrointestinal events and dizziness.


Lamivudine:

Stomatitis, hyperglycemia, anemia, lymphadenopathy, splenomegaly, hepatic steatosis, pancreatitis, post-treatment exacerbation of hepatitis B, anaphylaxis, urticaria, muscle weakness, CPK elevation, rhabdomyolysis, paresthesia, peripheral neuropathy, abnormal breath sounds/wheezing, alopecia, rash, pruritus.


Nevirapine:

Hepatitis/hepatic failure, Stevens-Johnson syndrome, toxic epidermal necrolysis, and hypersensitivity reactions.


Use In Special Popualtion:


Pregnancy and lactation:

Category C. Use if benefits justify the associated risk.


Renal impairment:

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


Hepatic impairment:

Should be used with caution in patients with liver impairment.


Pediatric population:

Not indicated.


Geriatric population:

Dose selection should be cautious keeping in mind the comorbidities and co-therapies.


Storage:

Store in a cool and dry place.


Presentation:

Blister pack containing part A with one tablet and part B with two tablets.


For further information please consult the full prescribing information.

Prepared by Dr. Aditi Apte on 09-03-2011