ABRIDGED PRESCRIBING INFORMATION: TAVIN-L TABLET

Therapeutic Category:

Antiretroviral.


Composition:

Each film-coated tablet contains Tenofovir Disoproxil Fumarate 300 mg and Lamivudine 300 mg.


Indication:

For the treatment of HIV infection in combination with other antiretroviral agents (such as non-nucleoside reverse transcriptase inhibitors or protease inhibitors).


Dosage and Administration:

One tablet to be taken orally once daily.


Contraindications:

Patients hypersensitive to any of the components of the formulation.


Warnings & Precautions:

This product should not be administered to patients with creatinine clearance < 50 ml/min. Lactic acidosis and severe hepatomegaly with steatosis, Immune reconstitution syndrome have been reported with nucleoside analogues. Redistribution of body fat have been reported. Severe acute exacerbations of hepatitis B have been reported in patients who are co-infected with Hepatitis B virus and HIV and have discontinued Lamivudine or Tenofovir DF. Combination of Didanosine and Tenofovir DF is not recommended for initial therapy, early virologic failure, rapid selection of resistant mutations, and potential for non-response. Concurrent use of nephrotoxic drug therapy may increase risk of renal impairment. Decrease in bone mineral density and osteomalacia have been reported with Tenofovir therapy. Patients with HIV/HCV co-infection receiving combination antiretroviral therapy, Interferon Alfa and Ribavirin are at risk of hepatic decompensation.


Drug Interactions:

Use of Lamivudine in combination with Zalcitabine is not recommended. Concurrent administration of Lamivudine with drugs associated with pancreatitis (e.g., Alcohol, Didanosine, IV Pentamidine, Sulfonamides) or with drugs associated with peripheral neuropathy (e.g., Dapsone, Didanosine, Isoniazid, Stavudine, Zalcitabine) should be avoided or use with caution. Coadministration of Tenofovir DF and Didanosine should be undertaken with caution, and patients receiving this combination should be monitored closely for Didanosine associated adverse events. Patients receiving Atazanavir or Lopinavir / Ritonavir and Tenofovir DF should be monitored for Tenofovir associated adverse events. Tenofovir DF should be discontinued in patients who develop Tenofovir associated adverse events. Atazanavir without Ritonavir should not be co-administered with this product.


Pregnancy:

Category C.


Nursing Mothers:

Mothers should be instructed not to breast feed if they are receiving this product.


Adverse Reactions:

Adverse reactions of Lamivudine include headache, malaise, fatigue, nausea, vomiting, diarrhea, anorexia, abdominal pain, abdominal cramps and dyspepsia, peripheral neuropathy, dizziness, insomnia, arthralgia, myalgia, depressive disorders. Common Adverse reactions associated with Tenofovir DF include asthenia, nausea, vomiting, and diarrhea. Less common Adverse reactions are hepatotoxicity including lactic acidosis, abdominal pain, anorexia, flatulence, allergic reaction, dyspnoea, Fanconi’s syndrome, hypophosphatemia, pancreatitis, proximal tubulopathy, renal insufficiency or renal failure and acute tubular necrosis.


Overdosage:

Treatment of overdose should consist of general supportive measures, including monitoring of vital signs and observation of the patient's clinical status. Administration of activated charcoal may be used. There is no specific antidote for overdose with this product.


Storage:

Store at a temperature not exceeding 30?C, protect from moisture.


Presentation:

30 tablets in a HDPE bottle. For further information, please consult the full prescribing information.