Tavin L (Tenofovir disoproxil fumarate + lamivudine)

Tenofovir disoproxil fumarate + lamivudine
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Emcure Pharmaceuticals Ltd

Tavin L (Tenofovir disoproxil fumarate + lamivudine)

ManufacturerEmcure Pharmaceuticals LtdBrand nameTavin L Active substanceTenofovir disoproxil fumarate + lamivudineStrength300mg + 300mgCategoryHIVManufacturerEmcure Pharmaceuticals Ltd

Description  of  Tavin L (Tenofovir disoproxil fumarate 300mg + Lamivudine 300mg) 

Tavin L (Tenofovir disoproxil fumarate 300mg + Lamivudine 300mg) tablets belongs to type of three anti-retroviral agents which includes of two components i.e Tenofovir DF, Lamivudine Tenofovir DF: adenine analogue of reverse transcriptase inhibitor & acyclic nucleoside phosphonate analogue of adenosine 5’ monophosphate Lamivudine: reverse transcriptase inhibitor, Zalcitabine analogue, nucleoside analogue Tavin L (Tenofovir disoproxil fumarate 300mg + Lamivudine 300mg) is used to reduce the HIV viral production.

INDICATIONS   of  Tavin L (Tenofovir disoproxil fumarate 300mg + Lamivudine 300mg) 

Tavin L (Tenofovir disoproxil fumarate 300mg + Lamivudine 300mg) tablets are used for the treatment of HIV-1 infection which is applicable for the adults & pediatric patients with weight of at least 40kg.

MECHANISM OF ACTION  of  Tavin L (Tenofovir disoproxil fumarate 300mg + Lamivudine 300mg) 

The major mechanism of Tavin L (Tenofovir disoproxil fumarate 300mg + Lamivudine 300mg) is involved in prohibition of reverse transcriptase enzyme. The enzyme is responsible for HIV viral production. Lamivudine: Lamivudine after absorption, undergoes phosphorylation intracellularly leads to form an active moiety known as lamivudine 5’ triphosphate (nucleoside analogue). This metabolite gets inserted into DNA of HIV virus which is aided by HIV RT & HBV polymerase. Tenofovir DF; This prodrug converted into tenofovir by diester hydrolysis and gets phosphorylated to from triphosphate form (nucleoside analogue), inserted into viral cells by HIV RT enzyme causes chain termination. Tenofovir DF: chain terminator Lamivudine: chain terminator

 

Absorption of  Tavin L (Tenofovir disoproxil fumarate 300mg + Lamivudine 300mg) 

Tenofovir bioavailability is 25% & increases up to 40% by administering with food. Peak plasma concentration time of Tenofovir is 1.0 plus or minus 0.4 hour The absolute bioavailability of Lamivudine is occurs by 86% plus or minus 16%. Lamivudine get absorbed very quickly.

 

Distribution of Tavin L (Tenofovir disoproxil fumarate 300mg + Lamivudine 300mg) 

Lamivudine get binds to human plasma protein by <36% Tenofovir has low protein binding capacity by 0.7% to human plasma protein or <7.2% to serum proteins.

Metabolism  of  Tavin L (Tenofovir disoproxil fumarate 300mg + Lamivudine 300mg) 
The metabolism of Tavin L (Tenofovir disoproxil fumarate 300mg + Lamivudine 300mg) is occurs hepatically. Lamivudine get metabolized by undergoing biotransformation. Tenofovir metabolism is not induced by cytochrome isoenzymes.

Excretion  of  Tavin L (Tenofovir disoproxil fumarate 300mg + Lamivudine 300mg) 
Lamivudine eliminated by urine. The elimination of tenofovir DF is occurs via glomerular filteration & active tubular secretion. The half lives of Tavin L (Tenofovir disoproxil fumarate 300mg + Lamivudine 300mg); Tenofovir: 17 hours Lamivudine: 5 to 7 hours

 


SIDE EFFECTS of  Tavin L (Tenofovir disoproxil fumarate 300mg + Lamivudine 300mg) 

Common side effects :
Headache, Pain, Diarrhea, Rash , depression.
Serious side effects:
Lactic acidosis, Aggravation of HBV, Renal damage, Psychiatric problems, Nervous problems, Skin related problems, Liver toxicity, Hepatic decompensated cirrhosis, Pancreatitis, Bone defects, Immune reconstitution syndrome, Redistribution of fat.
Lab abnormalities :
Increased cholesterol, elevation of creatine kinase, increased AST & ALT, Hematuria, neutropenia, increased serum amylase.

PRECAUTIONS of  Tavin L (Tenofovir disoproxil fumarate 300mg + Lamivudine 300mg) 

Embryo fetal damage : Tavin L (Tenofovir disoproxil fumarate 300mg + Lamivudine 300mg) is contraindicated to pregnancy condition
Skin problems : Severe hypersensitivity reactions are produced during Tavin L (Tenofovir disoproxil fumarate 300mg + Lamivudine 300mg) therapy. Prevent the problem by providing general supportive measures.
Aggravation of HBV : After stopping the anti-HBV drug, reactivation of HBV infection occurs. Prevent the problem by investigating the patient’s history whether suspected with HBV infection or not.
Loss of virological effects : Tavin L (Tenofovir disoproxil fumarate 300mg + Lamivudine 300mg) is a three drug fixed dose combination; there is a chance of occurring resistance. Monitor the patient’s condition frequently.
Lactic acidosis : Prevent the problem by measuring the hepatic enzymes level In severe condition stop the Tavin L (Tenofovir disoproxil fumarate 300mg + Lamivudine 300mg) treatment.
Nervous problem : Reduce the problem by giving Tavin L (Tenofovir disoproxil fumarate 300mg + Lamivudine 300mg) at bed time on an empty stomach.
Liver toxicity : Monitor the liver function test Maintain the hepatic enzymes In severe condition, stop the treatment
Bone defects : During the treatment, loss of calcium levels occur causes osteomalacia Prevent the problem by providing vitamin D supplements.
Immune reconstitution syndrome : This fatal case is frequently occurred in anti-retroviral therapy. In serious condition stop the Tavin L (Tenofovir disoproxil fumarate 300mg + Lamivudine 300mg) tablets. Fat redistribution, discontinue the Tavin L (Tenofovir disoproxil fumarate 300mg + Lamivudine 300mg) tablets QT prolongation reduced by avoiding the concomitant use of Tavin L (Tenofovir disoproxil fumarate 300mg + Lamivudine 300mg) with drugs which may extends the QT intervals.

DRUG INTERACTION  of  Tavin L (Tenofovir disoproxil fumarate 300mg + Lamivudine 300mg) 

Interaction with HIV-1 protease inhibitors may decrease Tenofovir AUC. Hence avoid CIMDUO should be discontinued Interaction with hepatitis C drugs may shown to increase Tenofovir exposure Tavin L (Tenofovir disoproxil fumarate 300mg + Lamivudine 300mg) with drugs affecting the renal functions causes increased concentration of tenofovir and leads to increase the adverse effects. Tavin L (Tenofovir disoproxil fumarate 300mg + Lamivudine 300mg) should not be combined with cannabinoids receptors Tavin L (Tenofovir disoproxil fumarate 300mg + Lamivudine 300mg) with CYP3A inducers causes increased clearance of Tavin L (Tenofovir disoproxil fumarate 300mg + Lamivudine 300mg) & leads to reduce the plasma concentration. Interaction of  Tavin L (Tenofovir disoproxil fumarate 300mg + Lamivudine 300mg) with warfarin causes fluctuation in prothrombin time & INR values. Tavin L (Tenofovir disoproxil fumarate 300mg + Lamivudine 300mg) combination with anti-fungals, anti-depressants, or anti-infective causes reduced effect of concentration of these drugs. Interaction of Tavin L (Tenofovir disoproxil fumarate 300mg + Lamivudine 300mg) with anti-malarial, anti-mycobacterials, calcium channel blockers, or lipid lowering drugs causes decreased effect of concentration of these drugs. Tavin L (Tenofovir disoproxil fumarate 300mg + Lamivudine 300mg) should not be combined with other anti-retroviral drugs. Tavin L (Tenofovir disoproxil fumarate 300mg + Lamivudine 300mg) should not be combined with QT prolonged drugs

CONTRAINDICATION  of  Tavin L (Tenofovir disoproxil fumarate 300mg + Lamivudine 300mg) 

Hypersensitivity reactions are produced due to patients is contraindicated to the component of  Tavin L (Tenofovir disoproxil fumarate 300mg + Lamivudine 300mg).

Tavin L (Tenofovir disoproxil fumarate 300mg + Lamivudine 300mg)  in PREGNANCY & LACTATION

Pregnancy category of lamivudine: C

Pregnancy category of tenofovir: B

Tavin L (Tenofovir disoproxil fumarate 300mg + Lamivudine 300mg) should not be used during pregnancy condition; it may leads to embryo fetal damage

Breast feeding should not be allowed.

DOSAGE  of  Tavin L (Tenofovir disoproxil fumarate 300mg + Lamivudine 300mg) 

Before begin the therapy with Tavin L (Tenofovir disoproxil fumarate 300mg + Lamivudine 300mg), patient should be examined for presence of HBV infection or not. Follow Renal function & liver function test before the treatment. The Tavin L (Tenofovir disoproxil fumarate 300mg + Lamivudine 300mg) recommended dose for adult suffering from HIV infection The administrated one tablet orally given onace a day with combination of other antiretroviral agents. Tavin L (Tenofovir disoproxil fumarate 300mg + Lamivudine 300mg) is a three drug fixed dose combination; it should be administered on an empty stomach. This tablet should be consumed at bed time due to reducing the neurological problems.

STORAGE  of  Tavin L (Tenofovir disoproxil fumarate 300mg + Lamivudine 300mg) 

Tavin L (Tenofovir disoproxil fumarate 300mg + Lamivudine 300mg) container should be kept at temperature below 30℃ Protect away from heat, moisture & light

MISSED DOSE  of  Tavin L (Tenofovir disoproxil fumarate 300mg + Lamivudine 300mg) 

In case of missed dose, patients must consult with medical practitioner & follow their instructions. Maintain the regular dosing schedule Avoid the missed dose if possible Do not self medicate the Tavin L (Tenofovir disoproxil fumarate 300mg + Lamivudine 300mg) tablets.

 

Brand name:
Tavin L
Active substance:
Tenofovir disoproxil fumarate + lamivudine
Strength:
300mg + 300mg
Category:
HIV
Manufacturer:
Emcure Pharmaceuticals Ltd
Packaging:
30 Tablets
Product form:
Tablet

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