Viread - Instructions For Use, Indications, Doses, Analogues

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

Viread

Instructions for use:

1. 1. Release form and composition
2. 2. Indications for use
3. 3. Contraindications
4. 4. Method of application and dosage
5. 5. Side effects
6. 6. Special instructions
7. 7. Drug interactions
8. 8. Analogs
9. 9. Terms and conditions of storage
10. 10. Terms of dispensing from pharmacies

Prices in online pharmacies:

from 8700 rub.

Buy

Viread is an antiviral drug that is active against HIV.

Release form and composition

Vireada dosage form - film-coated tablets: almond-shaped, core color - white, shell - light blue; engraving on one side - GILEAD and "4331", on the other - "300" (30 pcs. in high density polyethylene bottles, 1 bottle in a cardboard box).

Composition of 1 tablet:

• active substance: tenofovir - 300 mg;
• auxiliary components: pregelatinized starch - 33.33 mg; microcrystalline cellulose - 133.33 mg; croscarmellose sodium - 40 mg; lactose monohydrate - 153.33 mg; magnesium stearate - 6.67 mg;
• shell: Opadry 11 Y-30-10671-A (triacetin - 2.136 mg; aluminum varnish based on indigo carmine - 0.398 mg; hypromellose - 7.476 mg; lactose monohydrate - 10.68 mg; titanium dioxide - 6.01 mg) - 26, 7 mg.

Indications for use

• HIV-1 infection (in combination with other antiretroviral drugs);
• chronic viral hepatitis B in patients against the background of the following diseases / conditions: compensated hepatic failure, persistent increased activity of alanine aminotransferase in the blood serum, signs of active viral replication, histological evidence of fibrosis and / or an active inflammatory process.

Contraindications

Absolute:

• renal failure with creatinine clearance <30 ml / min (also not used in patients for whom hemodialysis is indicated);
• lactose intolerance, lactase deficiency, glucose-galactose malabsorption;
• lactation period;
• age up to 18 years;
• individual intolerance to the components of the drug.

Relative (diseases / conditions in which the appointment of Viread requires caution):

• renal failure with creatinine clearance of 30-50 ml / min;
• combined use with didanosine;
• age from 65 years;
• pregnancy (use is possible only in cases where the expected benefit is higher than the possible harm).

Method of administration and dosage

Viread is taken orally, preferably on an empty stomach or with food.

The daily dose is 1 tablet in 1 reception.

Recommendations for correcting the regimen of drug use in patients with functional impairments of the kidneys (depending on creatinine clearance):

• 50–80 ml / min: standard dosage regimen, therapy is carried out under constant monitoring of creatinine clearance and serum phosphate levels;
• 30–49 ml / min: 1 tablet every 2 days;
• <30 ml / min (including patients requiring hemodialysis): the drug is not prescribed.

Antiretroviral therapy is usually indicated throughout life.

The recommended duration of Viread's use in chronic hepatitis B:

• HBeAg-positive patients without liver cirrhosis: within 6-12 months after confirmation of HBe seroconversion (disappearance of HBeAg and hepatitis B virus DNA with anti-HBe detection), or until HBs seroconversion, or until the drug is no longer effective. In order to detect any delayed virological relapses after the end of the course, it is necessary to regularly measure the levels of alanine aminotransferase and hepatitis B virus DNA in the blood serum;
• HBeAg negative patients without cirrhosis: at least until HBs seroconversion or until efficacy is lost. If a long course is carried out (from 2 years), to confirm the adequacy of the appointment of Viread, it is recommended to regularly examine the patient.

Side effects

• immune system: allergic reactions, including angioedema;
• digestive system: abdominal pain, diarrhea, pancreatitis, vomiting, flatulence, nausea, bloating, increased amylase activity;
• musculoskeletal system: myopathy, muscle weakness, rhabdomyolysis, osteomalacia (in most cases manifests itself as bone pain, occasionally leads to fractures);
• nervous system: depression, headache, dizziness;
• respiratory system: shortness of breath;
• metabolism: lactic acidosis, hypophosphatemia, hypokalemia;
• liver and biliary tract: fatty degeneration of the liver, hepatitis, increased activity of liver enzymes;
• kidney and urinary tract: impaired renal function (including acute), acute necrosis of renal tubules, nephrogenic diabetes insipidus, renal failure, increased creatinine concentration, Fanconi syndrome, renal tubulopathy of the proximal type, interstitial nephritis (including cases of acute nephritis), polyuria, proteinuria;
• skin and subcutaneous fat: rash;
• others: asthenia, fatigue.

special instructions

It should be borne in mind that Viread therapy does not prevent the risk of HIV and hepatitis B transmission to other people. Appropriate precautions should be taken during sexual intercourse.

The combined treatment of HIV-infected persons can lead to the occurrence of lactic acidosis and a pronounced increase in the size of the liver with its fatty degeneration, in some cases with a fatal outcome. Symptoms and laboratory signs indicating the development of these disorders: general malaise, loss of weight / appetite, vomiting, nausea, abdominal pain, respiratory failure, muscle weakness, impaired motor functions, serum lactic acid content of more than 5 mmol / l. When they appear, the use of Viread is suspended.

It is recommended to calculate creatinine clearance in all patients before starting therapy, as well as while taking the drug (if clinically indicated).

In patients who are at risk of developing renal impairment, including patients with previously identified renal impairment during therapy with adefovir, it is necessary to regularly monitor the calculated creatinine clearance and serum phosphorus concentration in the blood. Viread should not be used in combination with nephrotoxic drugs or in cases of recent use of drugs of this kind.

The efficacy / safety of therapy in patients with creatinine clearance of 30–49 ml / min has not been studied, therefore, for this group of patients, before prescribing the drug, it is necessary to correlate the expected benefit with the possible risk of toxic effects on the kidneys. In cases of need for treatment, the interval between doses of the drug is adjusted, and the functional state of the kidneys is closely monitored.

In patients infected with HIV and the hepatitis B virus, after discontinuation of Viread, an exacerbation of hepatitis in a severe course may be observed. In this regard, for several months after the end of the course, it is necessary to conduct careful clinical / laboratory observation of the condition of the patients. In severe functional disorders of the liver, drug withdrawal is not indicated, since this can lead to exacerbation of hepatitis and decompensation of hepatic function.

Before starting therapy, all patients with hepatitis B virus infection should be tested for HIV antibodies.

Because of the risk of resistance, Viread should be used as part of a comprehensive antiretroviral treatment in people infected with HIV and hepatitis B simultaneously.

In cases of suspicion of a violation of the skeletal system, you should consult a specialist.

The condition of patients whose therapy regimen involves the use of only three nucleoside inhibitors should be closely monitored, and in these cases it is also recommended to consider the possibility of correcting the therapeutic regimen.

Immune reconstitution syndrome has been observed in HIV-infected patients receiving combination antiretroviral therapy.

At the beginning of the course, with a severe degree of immunodeficiency in response to asymptomatic or residual opportunistic infections, inflammatory reactions may develop, as a result of which serious clinical conditions appear or the severity of symptoms increases. Most often, such reactions (cytomegalovirus retinitis, Pneumocystis jirovecii pneumonia, generalized / focal mycobacterial infection) are observed in the first few weeks / months of antiretroviral therapy. If any symptoms of an inflammatory nature appear, it is necessary to give it an appropriate assessment, if necessary, appropriate treatment should be prescribed. All patients should be closely monitored by specialists with experience in treating patients with HIV disease.

Given the profile of adverse reactions, including the likelihood of developing dizziness, care must be taken while taking Viread when driving.

Drug interactions

Combination use with drugs such as Atripla (efavirenz / emtricitabine / tenofovir), Truvada (tenofovir / emtricitabine), and Hepsera (adefovir) is not recommended.

With the combined use of Viread with some drugs / substances, the following effects may develop:

• didanosine (in a daily dose of 400 mg): an increase in its content in the body (during the period of using a combination of drugs, it is necessary to monitor the condition of patients for the development of undesirable phenomena, such as lactic acidosis and pancreatitis); decrease in the number of CD4 + lymphocytes; if the patient weighs more than 60 kg, the daily dose of didanosine should be reduced to 250 mg; for patients with lower body weight, there are no recommendations for correcting the dosage regimen;
• atazanavir: a change in its pharmacokinetics; therapy can only be carried out simultaneously with ritonavir (100 mg ritonavir + 300 mg atazanavir);
• drugs that affect renal function or reduce / stop active tubular secretion: an increase in serum concentrations of tenofovir and / or these drugs.

Analogs

Viread's analogues are: Tenofovir, Tenofovir-TL.

Terms and conditions of storage

Store in a place protected from light and moisture at temperatures up to 30 ° C. Keep out of the reach of children.

The shelf life is 3 years.

Terms of dispensing from pharmacies

Dispensed by prescription.

Viread: prices in online pharmacies

Drug name Price Pharmacy

Viread 300 mg film-coated tablets 30 pcs. RUB 8700 Buy

Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!