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Tenolam

PRODUCT DETAILS

Trade name : Tenolam
Active ingredient : Tenofovir disoproxil fumarate + lamivudine
Strength availability : 300mg + 300mg
Manufactured by : Mylan
Package : 30 tablets in a container

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A Tenolam 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 Tenolam is used to reduce the HIV viral production.

DOSAGE

Before begin the therapy with Tenolam, patient should be examined for presence of HBV infection or not. Follow Renal function & liver function test before the treatment. The Tenolam recommended dose for adult suffering from HIV infection The administrated one tablet orally given onace a day with combination of other antiretroviral agents. Tenolam 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.

NOT PRESCRIBED FOR

Patients who have creatinine clearance less than 50ml/min With severe renal impairment Hemodialysis patient Tenolam should not be used for; Moderate & severe liver impairment patients In pediatric patients dose: The patients should weighing atleast 35kg administrated one tablet given once a day via orally with combination of other antiretroviral agents.

PHARMACOLOGY

MECHANISM OF ACTION :
The major mechanism of Tenolam 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

PHARMACOKINETIC

Absorption: 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: 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 :
The metabolism of Tenolam is occurs hepatically. Lamivudine get metabolized by undergoing biotransformation. Tenofovir metabolism is not induced by cytochrome isoenzymes.
Elimination: Lamivudine eliminated by urine. The elimination of tenofovir DF is occurs via glomerular filteration & active tubular secretion. The half lives of Tenolam; Tenofovir: 17 hours Lamivudine: 5 to 7 hours

WARNING & PRECAUTION

Embryo fetal damage : Tenolam is contraindicated to pregnancy condition
Skin problems : Severe hypersensitivity reactions are produced during Tenolam 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 : Tenolam 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 Tenolam treatment.
Nervous problem : Reduce the problem by giving Tenolam 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 Tenolam tablets. Fat redistribution, discontinue the Tenolam tablets QT prolongation reduced by avoiding the concomitant use of Tenolam with drugs which may extends the QT intervals.

DRUG INTERACTION

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 Tenolam with drugs affecting the renal functions causes increased concentration of tenofovir and leads to increase the adverse effects. Tenolam should not be combined with cannabinoids receptors Tenolam with CYP3A inducers causes increased clearance of Tenolam & leads to reduce the plasma concentration. Interaction of Tenolam with warfarin causes fluctuation in prothrombin time & INR values. Tenolam combination with anti-fungals, anti-depressants, or anti-infective causes reduced effect of concentration of these drugs. Interaction of Tenolam with anti-malarial, anti-mycobacterials, calcium channel blockers, or lipid lowering drugs causes decreased effect of concentration of these drugs. Tenolam should not be combined with other anti-retroviral drugs. Tenolam should not be combined with QT prolonged drugs

CONTRAINDICATION

Hypersensitivity reactions are produced due to patients is contraindicated to the component of Tenolam.

MISSED DOSE

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 Tenolam tablets.

STORAGE

Tenolam container should be kept at temperature below 30℃ Protect away from heat, moisture & light

SIDE EFFECTS

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.

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