Tenofovir TL, pills 300mg, 30pcs

Composition

Active ingredients:

Tenofovir disoproxil fumarate 300.0 mg

Indications

Treatment of HIV-1 infection as part of combined antiretroviral therapy in adults.

Contraindications

Tenofovir is contraindicated in patients with hypersensitivity to any component of the drug.

With caution

Renal insufficiency with creatinine clearance less than 50 ml / min, including patients undergoing hemodialysis. If the creatinine clearance is less than 30 ml / min, the drug should be avoided; in the event that other drugs are used. If treatment is not available, renal function should be carefully monitored and the interval between drug use should be adjusted.

Side effects

Below are the adverse reactions with an estimated (possible) connection with the product, are listed by system-organ classes in descending order of severity, with the following frequency: very often (>1/10) and often (> 1/100, < 1/10), rarely (> 1/10000, < 1/1000), very rare

Metabolic and nutritionaldisorders: hypophosphatemia is very common.

Nervous systemdisorders: very common-dizziness.

From the gastrointestinal tract: very often – diarrhea, vomiting, nausea; often-flatulence.

Combined retroviral therapy was associated with such metabolic disorders as hypertriglyceridemia, hypercholesterolemia, insulin resistance, hyperglycemia and hyperlactatemia; redistribution of subcutaneous tissue (lipodystrophy).

Cases of osteonecrosis have been reported, especially in patients with risk factors or with long-term combined antiviral therapy. The frequency is unknown.

Post-marketing experience

Metabolic and nutritionaldisorders: rare-lactate acidosis, frequency unknown-hypokalemia

Respiratory, thoracic and mediastinal disorders: very rare – dyspnoea.

From the gastrointestinal tract: rarely-pancreatitis.

From the side of the hepatobiliary system: rarely-increased transaminase activity; very rarely-hepatitis, frequency unknown-liver steatosis.

Skin and subcutaneous tissuedisorders: rarely-rash.

From the musculoskeletal system: frequency unknown – rhabdomyolysis, osteomalacia, muscle weakness, myopathy.

From the urinary system: rarely-acute renal failure, proximal renal tubulopathy (including Fanconi syndrome), hypercreatininemia; very rarely – acute tubular necrosis; frequency unknown – nephritis (including acute interstitial), nephrogenic diabetes insipidus.

General disorders and changes at the injectionsite: very rarely – asthenia.

Interaction

of Didanosine: increased concentrations of didanosine when used together; it is necessary to use them with caution and monitor the manifestations of didanosine toxicity (for example, pancreatitis, neuropathy). The combination of tenofovir with didanosine is not recommended; if justified, consideration should be given to reducing the dose or discontinuing didanosine therapy. Tenofovir is combined with reduced doses of didanosine (for example, patients with a body weight > 60 kg are prescribed didanosine 250 mg once a day; > On the other hand, such a low-dose combination may be characterized by low antiviral activity and insufficient increase in the number of Cd4 lymphocytes, as indicated by the high frequency of ineffectiveness of therapy when using this combination with the addition of efavirenz or nevirapine. Atazanavir: reduced concomitant concentrations of atazanavir and increased concentrations of tenofovir. It is necessary to use tenofovir with atazanavir only with an additional increase in the effect of the latter ritonavir. Lopinavir/ritonavir: increased concomitant concentrations of tenofovir. Darunavir: increases the concentration of tenofovir by 20-25%. Drugs should be used in standard doses, and the nephrotoxic effect of tenofovir should be carefully monitored. Tenofovir is mainly eliminated from the body through the kidneys, and concomitant use of tenofovir with drugs that reduce renal function or reduce / stop active tubular secretion may increase the serum concentration of tenofovir and/or increase the concentrations of other drugs excreted through the kidneys.

Ganciclovir, valganciclovir and cidofovir compete with tenofovir for active renal tubular secretion, resulting in increased levels of tenofovir or the concomitant drug; caution is required regarding possible side effects. Nephrotoxic drugs may also increase the concentration of tenofovir in the blood serum.

How to take, course of use and dosage

Inside, regardless of food intake. Recommended dose for the treatment of HIV-1 infection: 300 mg once a day.

The recommended dosage regimen of Tenofovir in patients with renal insufficiency: Creatinine clearance 30-49 ml / min: 300 mg every 48 h. Creatinine clearance 10-29 ml / min: 300 mg every 72-96 h. Hemodialysis: 300 mg every 7 days after dialysis.

There are no recommendations for the dosage regimen in patients with creatinine clearance less than 10 ml/min (without hemodialysis).

Overdose

In case of overdose, the patient should be examined for possible signs of intoxication. If necessary, standard maintenance therapy is used.

Tenofovir is effectively removed by hemodialysis with an extraction rate of approximately 54%. After taking 300 mg of tenofovir, a 4-hour hemodialysis procedure removes approximately 10% of the tenofovir dose taken.

Active ingredient

Tenofovir

Conditions of release from pharmacies

By prescription

Dosage form

Tablets

Description

For adults as prescribed by a doctor, for children as prescribed by a doctor

Indications

HIV Infection, Hepatitis