Tenofovir Stada 300mg treatment for HIV-1 infection, hepatitis B (3 blisters x 10 tablets)

Dosage form Box of 3 blisters x 10 tablets
Specifications Tenofovir disoproxil fumarat

Ingredient

Composition information	Content
Tenofovir disoproxil fumarat	300mg

Uses

Indications

Tenofovir 300 mg stada is indicated in the following cases:

Tenofovir Disoproxil Fumarat is used in combination with other antiviral drugs (but should not be used individually) in the treatment of HIV-TYP 1 infection (HIV-1) in adults. Occupation) In individuals at risk of viral infection. Like Adefovir, Tenofovir also has the activity against the HBV virus that mutates resistance to lamivudin. ADefovir Dipivoxil.

Tenofovir Disoproxil Fumarat needs to undergo initial hydrolysis of the hydrolyzed to convert to Tenofovir and followed by phosphorylation thanks to HIV-1 reverse copying enzymes by competing with natural substrates Deoxyadenosin-5’-triphosphate and after merging DNA, ending the DNA chain.

Besides, Tenofovir Disoproxil Fumarat also inhibits DNA polymerase of the hepatitis B virus (HBV), an essential enzyme for the virus copied in liver cells.

Tenofovir diphosphate is a weak inhibitor of α and β DNA polymerase of mammals and enzymes γ DNA polymerase in the mitochondria.

pharmacokinetic

absorption

After oral, Tenofovir Disoproxil Fumarat is quickly absorbed and transformed into Tenofovir with peak plasma concentrations after 1 to 2 hours. Born using drugs in patients about 25% but increasing when using Tenofovir Disoproxil Fumarat with a fat -rich meal.

Distribution

Tenofovir is widely distributed in tissues, especially in the kidneys and liver. The cohesion with plasma protein is less than 1% and with serum protein about 7%.

Metabolism

Tenofovir disoproxil fumarat is a water -soluble ester in the rapidly converted in vitro into tenofovir and formaldehyde. Tenofovir is converted in intracellular to Tenofovir Monophosphate and substance with Tenofovir Diphosphate activity.

Elimination

Tenofovir's final waste time is from 12 to 18 hours. Tenofovir is excreted mainly in urine in both ways. Active excretion through renal tubules and glomerular filtration. Tenofovir antiviral drugs are excluded by hemolysis.

Before taking Tenofovir Stada 300mg treatment for HIV-1 infection, hepatitis B (3 blisters x 10 tablets)

How to use

Tenofovir Stada 300 mg is used once orally daily, not affected by meals.

Dosage

HIV infection treatment

Take 1 capsule 1 time/day, combined with other antacids.

Prevention of HIV -infected after contact due to occupational causes

Use 1 tablet 1 time/day in combination with other antiviral drugs (usually combined with lamivudin or emtricitabin). Prevention should start as soon as possible after contact due to career reasons (preferably within a few hours than a few days) and continue for the next 4 weeks if tolerated.

Prevention of HIV infection after contact is not due to occupational reasons

Take 1 capsule 1 time/day in combination with at least 2 other antiviral drugs. Preventive should start as soon as possible after contact without career reasons (preferably within 72 hours) and continue in 28 days.

Treatment of chronic hepatitis B

recommended dose is 1 tablet 1 time/day for 48 weeks.

Patients with renal failure

Should change the dose of Tenofovir Disoproxil Fumarat by adjusting the medication period in patients with renal impairment based on the patient's creatinine clearance (CLCR) of the patient:

CLCR ≥ 50 ml/minute: Use the usual doses 1 time/day. The safety and effectiveness of these doses that have not been evaluated in clinical studies, should closely monitor the clinical response of therapy and kidney function.

Patients with liver failure

There is no need to adjust the dose.

Note: The above dose is for reference only. Specific dosage depends on the condition and level of progression of the disease. For a suitable dose, you need to consult a doctor or medical specialist.

What to do when overdose?

If overdose occurs, patients need to be monitored signs of poisoning, using standard supportive treatments.

Tenofovir is eliminated effectively by hemolysis with a separation coefficient of about 54%. With a single dose of 300 mg, about 10% of Tenofovir dose is excluded in a 4 -hour hemolysis.

What to do when forgetting 1 dose? However, if the time to relax with the next dose is too short, skip the dose and continue the calendar of the drug. Do not use double dose to compensate for missed dose.

Side Effects

When using Tenofovir 300 mg Stada, you may experience unwanted effects (ADR).

Common, ADR> 1/100

digestive: diarrhea, vomiting and nausea, abdominal pain, flatulence, indigestion and anorexia. Calculate.

When experiencing side effects of the drug, it is necessary to stop using and notify the doctor or go to the nearest medical facility for timely treatment.

Warnings

Before using the drug you need to read the instructions carefully and refer to the information below.

Contraindicated

Tenofovir 300 mg stada contraindicated in cases of hypersensitivity to Tenofovir Disoproxil Fumarat or any ingredients of the drug.

Caution when using

When using Tenofovir (as well as reverse copy inhibitors (single or coordinated)), there has been a patient with lactic acid infected, serious liver and fatty (can die).

Adipplication of fat tissue

The re-distribution or accumulation of fat in the body, including abdominal fat, the front-and-tanged fertility ("buffalo hunchback"), devastating peripheral nerves, face, mammary hypertrophy, often appeared Cushing syndrome when taking antacids of Retrovirus.

Effects on bone

When using Tenofovir simultaneously with lamivudin and efavirenz in HIV -infected patients, there is a decrease in the mineral density of lumbar spine, increasing the concentration of 4 bone metabolism and increased serum parathyroid hormones.

Need to closely monitor bone in HIV -infected patients with a history of pathological fractures, or at high risk of bone deficiency. Although there is no research on the effectiveness of calcium and vitamin D supplementation, the addition may be useful for these patients. When bone abnormalities need to consult a physician.

Patients who have had previous liver dysfunction including chronic progressive hepatitis regularly increased liver function abnormalities during the combination of antiviral drugs and should be monitored by standard methods. If there is evidence of more severe liver disease in these patients, temporary stop or stop treatment.The severe HBV infection has been reported in HIV -infected patients after stopping the treatment of Tenofovir. Clinical and experimental liver function should be monitored for at least a few months after stopping Tenofovir in infected patients at the same time HBV and HIV. If appropriate, should start treating HBV.

The clinical activity of Tenofovir Disoproxil has not been determined against hepatitis B (HBV) virus in humans. It is unknown that the treatment in patients with HIV-1 and HBV contaminated at the same time leads to HBV's resistance progression for Tenofovir Disoproxil Fumarat and other drugs.

Immune activation syndrome

In patients with HIV infected with severe immunodeficiency at the beginning of the combination of anti -Retrovirus (Cart) drugs, there may be asymptomatic inflammatory reactions or opportunistic infections and causing serious or serious clinical diseases or severe symptoms.

Typically, these reactions are seen within a few weeks or the first few months when starting cart. For example, cytomegalovirus retinitis, bodybacterium infection with body and/or local or local and pneumonia caused by Pneumocystis Carinii. Any symptoms of inflammation should be evaluated and started treatment when necessary.

The ability to drive and operate machinery

drugs that affect the ability to drive and operate machinery. However, patients need to be notified of the ability to cause dizziness when treated with Tenofovir Disoproxil Fumarat.

Pregnancy

should only use Tenofovir Disoproxll Fumarat when the benefits are higher than the risk to the fetus. However, due to the unknown risk of the development of the fetus, the use of Tenofovir Disoproxil Fumarat in women of reproductive age should be accompanied by effective contraception.

Breastfeeding period

It is unknown whether Tenofovir Disoproxil Fumarat is excreted in breast milk or not. It is recommended that women are being treated with Tenofovir disoproxil fumarat should not be breastfeeding. According to the general rule, it is recommended that women who are HIV -infected with no breastfeeding to avoid HIV transmission to children.

Drug interaction

drugs affected or metabolized by mitochondrial enzymes in the liver

Tenofovir's pharmacokinetic interaction with inhibited drugs or substrates of microscopic enzymes in the liver is unknown. Tenofovir and its precursor are not the substrate of CYP450 isoenzyme, not inhibiting the isomers 3A4, 2D6, 2C9, or 2E1 but slightly inhibited over 1A.

Tenofovir interacts with drugs that reduce kidney function or compete with Tenofovir active excretion through the renal tubules (for example: Acyclovir, Cidofovir, Ganciclovir, Valacyclovir, Valganciclovir), increasing the Tenofovir concentration in plasma or shared drugs.

HIV Protease inhibitors: Collective or co -operations between Tenofovir and HIV Protease inhibitors such as Amprenavir, Atazanavir, Indinavir, Nelfinavir, Ritonavir, Saquinavir.

Nucleosid -free copy -copy enzyme inhibitors: Collective or co -operations between tenofovir and nucleosid -free copy enzyme inhibitors such as Delavirdin, Efavirenz, Nevirapin.

Nucleosid reverse copy enzyme inhibitors: A combination or co -operating interaction between Tenofovir and nucleosid copy enzyme inhibitors such as Abacavir, Didanosin, Emtricitabin, Lamivudin, Stavudin, Zalcitabin, Zidovudin.

adefovir: Do not share tenofovir with adefovir.

Didanosin: Tenofovir increases the concentration of didanosin in plasma, so do not combine these two drugs.

Oral contraceptives: Unknown pharmacological interaction with oral contraceptives containing ethinyl estradiol and norgestimat.

Storage

In closed packaging. The temperature does not exceed 30 ° C.

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