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Telura

PRODUCT DETAILS

Trade name : Telura
Active ingredient : Tenofovir disoproxil fumarate + lamivudine + efavirenz
Strength availability : 300mg + 300mg + 600mg
Manufactured by : Mylan
Package : 30 tablets

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A Telura tablets consist of three anti-retroviral agents like tenofovir DF, lamivudine & efavirenz. Telura tablets are not used for curing the infection, but it is elaborated in decline of advancement of HIV-1 into AIDS. Telura is used to decrease the HIV viral multiplication. Telura is prescription drug sold under guidance of medical practioners

INDICATION

Telura tablets are indicated for the adults & pediatric patients with weight of at least 40kg for the treatment of HIV-1 infection which is applicable

DOSAGE

Before starting the therapy with Telura, patient should be investigate for presence of HBV infection or not. kidney function & hepatic function test should be performed. The usual dose of Telura is one tablet of Tenofovir DF 300mg+Lamivudine 300mg+ Efavirenz 600mg should be administered as once daily. Telura 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. Telura should not be recommended for; Patients who have creatinine clearance less than 50ml/min With severe renal impairment Hemodialysis patient Telura should not be used for; Moderate & severe liver impairment patients

PHARMACOLOGY

The primary mechanism of Telura which includes in inhibition of reverse transcriptase enzyme. The enzyme is required for HIV viral production.
Tenofovir DF :
This prodrug converted into tenofovir by diester hydrolysis and gets phosphorylated to from triphosphate form (nucleoside analogue), infused into viral cells by HIV RT enzyme causes chain termination.
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.
Efavirenz :
The anti-viral activity of Efavirenz is due to formation of active triphosphate form of efavirenz by undergoing intracellular conversion. This formed active metabolite gets inserted into viral cells by RT causes inhibition of newly formed virions by obstruct the DNA copies.

PHARMACOKINETICS

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% The apparent volume of distribution is 1.3 plus or minus 0.4L/kg. Tenofovir has low protein binding capacity by 0.7% to human plasma protein or <7.2% to serum proteins. The binding nature of efavirenz is nearly 99.5 to 99.75%.
Metabolism :
The metabolism of Telura is occurs hepatically. Efavirenz get metabolized by using cytochrome P450 isoenzymes to form metabolites. Lamivudine get metabolized by undergoing biotransformation. Tenofovir metabolism is not induced by cytochrome isoenzymes.
Elimination :
The elimination of tenofovir DF is occurs via glomerular filteration & active tubular secretion. Efavirenz get eliminated via urine Lamivudine eliminated by urine. The half lives of Telura; Tenofovir: 17 hours Efavirenz: 40 to 55 hours Lamivudine: 5 to 7 hours

SAFETY MEASURES

Loss of virological effects : Telura 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 Telura treatment.
Aggravation of HBV : After discontinuing the anti-HBV agents, reactivation of HBV infection occurs. Prevent the problem by investigating the patient’s history whether suspected with HBV infection or not.
Embryo fetal damage : Telura is contraindicated to pregnancy condition
Liver toxicity : Monitor the liver function test Maintain the hepatic enzymes In severe condition, stop the treatment
Skin problems : Severe hypersensitivity reactions are produced during Telura therapy. Prevent the problem by providing general supportive measures.
Bone defects : During the treatment, loss of calcium levels occur causes osteomalacia Prevent the problem by providing vitamin D supplements.
Nervous problem : Reduce the problem by giving Telura at bed time on an empty stomach. QT prolongation reduced by avoiding the concomitant use of Telura with drugs which may extends the QT intervals.
Immune reconstitution syndrome : This fatal case is frequently occurred in anti-retroviral therapy. In serious condition stop the Telura tablets. Fat redistribution, discontinue the Telura tablets

DRUG INTERACTION

Interaction of Telura should not be combined with other anti-retroviral drugs. Combination with QT prolonged drugs should not occurs with Telura Telura co administrated with anti-fungals, anti-depressants, or anti-infective causes reduced effect of concentration of these drugs Telura interaction with drugs affecting the kidney functions causes increased concentration of tenofovir and cause to increase the adverse effects. Interaction of Telura with CYP3A inducers causes increased clearance of Telura & leads to reduce the plasma concentration. Co administration of Telura with anti-malarial, anti-mycobacterials, calcium channel blockers, or lipid lowering drugs causes decreased effect of concentration of these drugs. Concomitant use of Telura with warfarin causes fluctuation in prothrombin time & INR values. Combination of Telura with anti-convulsants causes reduced effect of concentration of these drugs.

CONTRAINDICATION

Telura is contraindicated to patients who are concomitantly received elbasvir & grazoprevir. Hypersensitivity reactions are produced due to patients is contraindicated to the component of Telura.

OVER DOSAGE

Telura is contraindicated to patients who are concomitantly received elbasvir & grazoprevir. Hypersensitivity reactions are produced due to patients is contraindicated to the component of Telura.

SIDE EFFECTS

Liver toxicity, Hepatic decompensated cirrhosis, Pancreatitis, Bone defects, Immune reconstitution syndrome, Redistribution of fat, Lactic acidosis, Aggravation of HBV, Renal damage, Psychiatric problems, Nervous problems, Skin related problems.
The most common side effects :
Pain in head, lipodystrophy, pain, fever, abdominal pain, back pain, asthenia, diarrhea, nausea, dyspepsia, vomiting, , arthralgia, insomnia Lab abnormalities :
Increased cholesterol, elevation of creatine kinase, increased AST & ALT, Hematuria, neutropenia, increased serum amylase

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