Tenofovir Disoproxil Fumarate Tablets ip 300 mg TELAVINCE 300
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Composition Tenofovir Disoproxil Fumarate Tablets ip 300 mg
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Description:
Tenofovir Disoproxil Fumarate Tablets IP 300 mg is a clinically established nucleotide reverse transcriptase inhibitor (NRTI) antiviral medicine used in the treatment of HIV-1 infection and chronic Hepatitis B virus (HBV) infection in adult patients. It works by blocking the reverse transcriptase enzyme that both the HIV and HBV viruses depend on to replicate inside human cells — effectively suppressing viral load, slowing disease progression, and improving the patient's immune system response over time. The standard adult dose is one 300mg tablet taken orally once daily, with or without food, strictly under the prescription and supervision of a qualified infectious disease specialist or physician. It is not a cure for HIV or Hepatitis B but is a cornerstone of long-term antiviral management in both conditions.
What Is Tenofovir Disoproxil Fumarate Tablets IP 300 mg?
Tenofovir Disoproxil Fumarate Tablets IP 300 mg — commonly abbreviated as TDF 300mg — is a prescription-only antiviral medication belonging to the nucleotide analogue reverse transcriptase inhibitor (NtRTI) class of drugs. It is formulated as a film-coated oral tablet containing 300 mg of tenofovir disoproxil fumarate, which is equivalent to 245 mg of tenofovir disoproxil as the active pharmaceutical ingredient.
Tenofovir Disoproxil Fumarate is the prodrug form of tenofovir — meaning it is converted into its pharmacologically active form inside the body after oral absorption. Once absorbed through the gastrointestinal tract and converted intracellularly, it acts as a potent inhibitor of viral reverse transcriptase — the enzyme that both HIV and Hepatitis B viruses use to convert their RNA genetic material into DNA and replicate within human immune cells.
TDF 300mg is one of the most widely prescribed and globally trusted antiretroviral medicines, forming the backbone of several combination antiretroviral therapy (cART) regimens recommended by the World Health Organization (WHO) and the National AIDS Control Organisation (NACO) of India for first-line HIV treatment.
How Does Tenofovir Disoproxil Fumarate 300 mg Work?
Understanding how TDF 300mg works at a cellular level helps explain why it is such a critical medicine in the management of both HIV and chronic Hepatitis B.
Step 1 — Absorption and Conversion After oral administration, Tenofovir Disoproxil Fumarate is rapidly absorbed from the gastrointestinal tract and enters the bloodstream. Once inside cells — particularly CD4+ T-lymphocytes (the immune cells targeted by HIV) and hepatocytes (liver cells targeted by HBV) — it is converted by cellular enzymes into its pharmacologically active form: tenofovir diphosphate.
Step 2 — Reverse Transcriptase Inhibition Tenofovir diphosphate acts as a faulty building block that competes with the natural nucleotide deoxyadenosine triphosphate (dATP) for incorporation into the viral DNA chain being built by the reverse transcriptase enzyme. When tenofovir diphosphate gets incorporated into the growing viral DNA chain, it terminates the chain — meaning the virus can no longer complete the replication process and produce new copies of itself.
Step 3 — Viral Suppression By consistently blocking reverse transcriptase activity with daily dosing, Tenofovir Disoproxil Fumarate 300mg significantly reduces the viral load — the measurable amount of virus circulating in the patient's blood — often to levels that are undetectable by standard clinical tests. In HIV patients, this allows the CD4+ T-cell count to recover, restoring immune function. In Hepatitis B patients, it prevents liver damage progression and reduces the risk of cirrhosis and hepatocellular carcinoma.
Therapeutic Uses of Tenofovir Disoproxil Fumarate Tablets IP 300 mg
Tenofovir Disoproxil Fumarate 300mg is prescribed for the following clinically approved indications:
HIV-1 Infection Treatment TDF 300mg is a cornerstone component of combination antiretroviral therapy (cART) for HIV-1 infection in adults and adolescents above 12 years of age weighing at least 35 kg. It is almost always prescribed as part of a fixed-dose combination regimen — commonly alongside emtricitabine (FTC) and efavirenz or dolutegravir — to maximise viral suppression while minimising the risk of drug resistance. The WHO and NACO both recommend TDF-based regimens as preferred first-line HIV treatment. TDF 300mg cannot cure HIV but when taken daily without interruption, it suppresses the virus effectively enough to allow patients to live long, healthy, and near-normal lives.
Chronic Hepatitis B Virus (HBV) Infection TDF 300mg is also a first-line treatment for chronic Hepatitis B infection in adult patients, particularly those who have failed or shown resistance to older antiviral therapies like lamivudine or adefovir. It suppresses HBV DNA replication in liver cells, reduces liver inflammation, prevents progression to cirrhosis, and significantly lowers the long-term risk of developing hepatocellular carcinoma (liver cancer) in patients with chronic HBV. Clinical trials involving thousands of patients have confirmed TDF's superiority over adefovir dipivoxil in achieving undetectable HBV DNA levels at 48 weeks and beyond.
Pre-Exposure Prophylaxis (PrEP) for HIV In combination with emtricitabine (as Truvada), TDF 300mg is used as pre-exposure prophylaxis (PrEP) — a preventive strategy for HIV-negative individuals at high risk of HIV exposure. When taken daily as prescribed, PrEP with TDF reduces the risk of HIV transmission by up to 99%, making it one of the most effective HIV prevention tools available today.
Dosage and Administration
Tenofovir Disoproxil Fumarate Tablets IP 300 mg is intended for once-daily oral administration. The tablet should be swallowed whole with a full glass of water. It can be taken with or without food, as food does not significantly affect the bioavailability of tenofovir disoproxil fumarate.
Standard Adult Dosage: One tablet (300mg) taken orally once daily — at the same time every day to maintain consistent plasma drug levels and reduce the risk of developing viral resistance.
Paediatric Dosage: For paediatric patients above 2 years of age, the dose is calculated as 8mg per kg of body weight per day, up to a maximum of 300mg per day, as determined by the treating paediatrician or infectious disease specialist.
Renal Impairment: Tenofovir is primarily excreted through the kidneys. Dose adjustment and extended dosing intervals are required in patients with reduced creatinine clearance (below 50 mL/min). This tablet is not recommended in patients with severe renal impairment (creatinine clearance below 10 mL/min) who are not on haemodialysis, without specialist guidance.
Never miss a dose — Consistent daily dosing is critical for maintaining adequate drug levels in the blood to suppress the virus effectively. Missing doses, even occasionally, can allow viral replication to resume and increase the risk of drug resistance developing.
Common Side Effects of Tenofovir Disoproxil Fumarate 300 mg
TDF 300mg is generally well tolerated when used as prescribed. However, like all antiretroviral medicines, some patients may experience side effects — most of which are mild and resolve over time with continued therapy.
Commonly Reported Side Effects:
- Nausea and vomiting — particularly in the first few weeks of starting therapy
- Diarrhoea and loose stools
- Headache and dizziness
- Fatigue and general weakness
- Skin rash — usually mild and transient
- Flatulence and abdominal discomfort
- Loss of appetite
Clinically Significant Side Effects (Consult Doctor Promptly):
- Kidney toxicity (nephrotoxicity) — TDF can reduce kidney function with long-term use; regular monitoring of serum creatinine and urine protein is essential
- Decreased bone mineral density — long-term TDF use has been associated with reduced bone density; calcium and vitamin D supplementation may be recommended
- Lactic acidosis — a rare but serious buildup of lactic acid in the blood; symptoms include rapid breathing, muscle pain, and extreme weakness
- Hepatomegaly with steatosis — rare liver enlargement with fat accumulation
- Fanconi syndrome — rare proximal renal tubular dysfunction affecting phosphate, glucose, and amino acid reabsorption in the kidneys
Important Precautions and Contraindications
Tenofovir Disoproxil Fumarate 300mg is contraindicated in patients with known hypersensitivity to tenofovir disoproxil fumarate or any excipient present in the tablet formulation.
Special caution is required in patients with pre-existing kidney disease, liver disease, osteoporosis, or a history of bone fractures. Regular monitoring of renal function, serum phosphate, complete blood count, and liver enzymes is required throughout the course of therapy.
This medicine is not recommended as monotherapy for HIV treatment, as using a single antiretroviral agent dramatically increases the risk of drug resistance developing. It must always be used as part of a combination antiretroviral regimen as prescribed by a specialist.
Patients with chronic Hepatitis B who discontinue TDF 300mg must be closely monitored for several months after stopping, as severe acute exacerbation of hepatitis B has been reported following abrupt discontinuation.
Pregnancy — TDF 300mg may be used during pregnancy under specialist supervision when the clinical benefit clearly outweighs any potential risk. It is commonly used in pregnant women living with HIV as part of prevention of mother-to-child transmission (PMTCT) programmes.
Choose Steris Healthcare for Tenofovir Disoproxil Fumarate Tablets IP 300 mg
When it comes to clinically reliable, GMP-certified antiviral therapy, Steris Healthcare is a name that healthcare professionals and patients can trust. Steris Healthcare's Tenofovir Disoproxil Fumarate Tablets IP 300 mg are manufactured under stringent quality standards — with every batch tested for API purity, consistent bioavailability, and patient safety before release. With affordable pricing, a transparent ingredient profile, and a growing distribution network across India, Steris Healthcare is committed to making high-quality HIV and Hepatitis B antiviral therapy accessible to every patient who needs it — because no one should have to compromise on the quality of life-saving medicine.
Frequently Asked Questions (FAQ)
Q1. What is Tenofovir Disoproxil Fumarate 300mg tablet used for?
A: Tenofovir 300mg — a proven antiviral — treats HIV-1 infection and chronic Hepatitis B in adults.
Q2. How should Tenofovir Disoproxil Fumarate 300mg be taken?
A: One 300mg tablet once daily, swallowed whole with water, with or without food.
Q3. Can Tenofovir Disoproxil Fumarate cure HIV completely?
A: No — it suppresses HIV effectively but does not cure the infection permanently.
Q4. Does TDF 300mg affect the kidneys?
A: Yes — long-term use may reduce kidney function; regular renal monitoring is essential.
Q5. Can Tenofovir 300mg be taken during pregnancy?
A: Yes — it is commonly used in pregnancy for HIV management under specialist supervision.
Q6. What happens if I miss a dose of Tenofovir 300mg?
A: Take it as soon as remembered — but never double the dose to make up for a missed one.