WelCome to HepBest 25mg

Tenofovir Alafenamide Fumarate

HepBest 25mg Mechanism of Action

Hepbest 25 mg (Tenofovir Alafenamide Fumarate (TAF)) is a Nucleotide Reverse Transcriptase Inhibitor (NRTI) and a novel ester prodrug of the antiretroviral,tenofovir. TAF is converted in vivo to tenofovir, an acyclic nucleoside phosphonate (nucleotide) analog of adenosine monophosphate. Tenofovir mimics normal DNA building blocks but is lacking OH molecule required for phosphodiester bond linkage. By competing with regular nucleotides for incorporation into proviral DNA and prevention of the formation of phosphodiester linkage required for DNA elongation, tenofovir causes early chain termination and prevents proviral DNA transcription .

HepBest 25mg Pharmacokinetics Action

The Pharmacokinetic (PK) properties of Hepbest 25 mg (Tenofovir Alafenamide Fumarate (TAF)) are given below. The multiple dose PK parameters of TAF and its metabolite, tenofovir are given below.

HepBest 25mg Bioavailability

Following oral administration, peak plasma concentrations occur approximately 0.48 hours after the dose.

Food

Administration of a high-fat meal increases Area Under Curve (AUC) by 1.65 folds compared with administration in the fasting state.

Distribution

Plasma protein binding is 80%.

HepBest 25mg Metabolism

  • Tenofovir Alafenamide requires initial hydrolysis for intracellular conversion to tenofovir and subsequent phosphorylation by cellular enzymes to form the active metabolite, tenofovir diphosphate.

  • Principally hydrolyzed intracellularly by Carboxylesterase 1 (CES1) in hepatocytes and cathepsin A in peripheral Blood Mononuclear Cells (PBMCs) and macrophages
  • Only minimally metabolized by CYP3A

Elimination Route

  • Eliminated by kidneys using a combination of glomerular filtration and active tubular secretion
  • 31.7% of dose excreted in feces; <1% excreted in urine

HepBest 25mg Half-life

Median Terminnal Plasma Half-life: 0.5 hours.

Contraindications

• There are no contraindications reported with Tenofovir Alafenamide Fumarate (TAF).

HepBest 25mg Precautions

Lactic Acidosis and Severe Hepatomegaly with Steatosis

Treatment with Hepbest 25 mg (Tenofovir Alafenamide Fumarate (TAF)) should be suspended in any patient who develops clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity.

Post-Treatment Exacerbation of Hepatitis B

Discontinuation of Hepbest 25 mg (Tenofovir Alafenamide Fumarate (TAF)) may result in severe acute exacerbations of hepatitis B.
Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least s everal months in patients who discontinue Hepbest 25 mg treatment.

Risk of Development of HIV-1 Resistance in Patients Coinfected with HBV and HIV-1

Tenofovir Alafenamide Fumarate (TAF) alone is not recommended for the t reatment of HIV-1 infection, as there is a risk of development of HIV-1 resistance.
In patients co-infected with HBV and HIV-1, efficacy of Hepbest 25 mg (Tenofovir Alafenamide Fumarate (TAF)) has not been established.

New Onset or Worsening Renal Impairment

Renal impairment, including cases of acute renal failure and Fanconi syndrome (renal tubular injury with severe hypophosphatemia), has been reported with the use of tenofovir prodrugs in both animal toxicology studies and human trials.

Patients taking tenofovir prodrugs who have impaired renal function and those taking nephrotoxic agents, including non-steroidal anti-inflammatory drugs, are at increased risk of developing renal-related adverse reactions.

It is recommended that serum creatinine, serum phosphorous, estimated creatinine clearance, urine glucose and urine protein be assessed before initiating TAF and during therapy in all patients as clinically appropriate.

HepBest 25mg Drug Interactions

Coadministration of Hepbest 25 mg with drugs that reduce renal function or compete for active tubular secretion may increase concentrations of tenofovir and other renally eliminated drugs and this may increase the risk of adverse reactions.

HepBest 25mg Indications and Usage

Hepbest 25mg tablet is indicated for the treatment of chronic HBV infection in adults with compensated liver disease.

HepBest 25mg Administration and Dosage

The recommended dosage of HepBest 25mg tablets in for adults is once a day.
Take this medicine orally once daily with food.

HepBest 25mg Use in Specific Population

For Pediatric : Efficacy and safety of Hepbest (Tenofovir Alafenamide Fumarate (TAF)) in pediatric patients (<18 years of age) has not been established.
For Geriatric Use: Clinical trials of Hepbest (Tenofovir Alafenamide Fumarate (TAF)) have not included sufficient number of subjects aged 65 and over to determine whether they respond differently from younger subjects.
Pregnancy: Data not available regarding use in pregnant women.
Renal Impairment: No dosage adjustment of Hepbest (Tenofovir Alafenamide Fumarate (TAF)) is required in patients with mild, moderate or severe renal impairment. TAF is not recommended in patients with end-stage renal disease (creatinine clearance < 15 mL/min).
Hepatic Impairment: No dosage adjustment of Hepbest medicine is required in patients with mild hepatic impairment (Child-Pugh A). Hepbest is not recommended in patients with decompensated (Child-Pugh B or C) hepatic impairment.
Lactation: Not known, whether Hepbest 25 mg (Tenofovir Alafenamide Fumarate (TAF)) and metabolites distribute into human milk, affect human milk production or have effects on breast-fed infant.

HepBest 25mg Dosage Forms and Composition

Dosage Forms: Film-coated tablet.
Composition: Each tablet contains 25 mg of tenofovir alafenamide (equivalent to 28 mg of tenofovir alafenamide fumarate).
The tablet includes the following inactive ingredients: Croscarmellose sodium, lactose monohydrate, magnesium stearate and microcrystalline cellulose.
The Hepbest 25mg tablet is film coated with a coating material containing: Iron oxide yellow, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide.

HepBest 25mg Storage and Handling

Store below 30°C (86°F).

• Keep container tightly closed
• Dispense only in original container



HepBest 25mg

Hepbest 25mg(Tenofovir Alafenamide Fumarate (TAF)) is a Nucleotide Reverse Transcriptase Inhibitor (NRTI) and a novel ester prodrug of the antiretroviral,tenofovir. TAF is converted in vivo to tenofovir, an acyclic nucleoside phosphonate (nucleotide) analog of adenosine monophosphate.

Brand Name : HepBest 25mg
Compositio : Tenofovir Alafenamide Fumarate (TAF)
Packing: 30 tablets in a Pack



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DISCLAIMER


This information should not be used to decide whether or not to take this Product or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this Product . It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this product. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this product.


Metabolism

• Tenofovir Alafenamide requires initial hydrolysis for intracellular conversion to tenofovir and subsequent phosphorylation by cellular enzymes to form the active metabolite, tenofovir diphosphate.

• Principally hydrolyzed intracellularly by Carboxylesterase 1 (CES1) in hepatocytes and cathepsin A in peripheral Blood Mononuclear Cells (PBMCs) and macrophages

• Only minimally metabolized by CYP3A

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What we do

HepBest 25mg (Tenofovir Alafenamide Fumarate (TAF))

Pharmacokinetics

The Pharmacokinetic (PK) properties of Hepbest (Tenofovir Alafenamide Fumarate (TAF)) are given below.

Bioavailability

Following oral administration, peak plasma concentrations occur approximately 0.48 hours after the dose.

Food

Administration of a high-fat meal increases Area Under Curve (AUC) by 1.65 folds compared with administration in the fasting state.

Distribution

Plasma protein binding is 80%.

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HepBest 25mg

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Maharashtra.

Phone : +91- 99877 11567
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