Tefostad T300 Stella medicine and HIV-1 prevention and treatment (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

Tefostad T300 is indicated in the following cases:

Tenofovir Disoproxil Fumarate is used in conjunction with other Retrovirus anti-Retrovirus (but should not be used individually) in the treatment of HIV-1 infection (HIV-1) in adults.

Pharmacology

Tenofovir disoproxil fumarate is a nucleoside phosphonate diester with a similar spiral structure of adenosin monophosphate and has a molecular structure close to Adefovir Dipivoxil. Tenofovir Disoproxil Fumarate needs to undergo initial hydrolysis to convert to Tenofovir and followed by phosphorylation by enzymes in cells to form Tenofovir Diphosphate.

Tenofovir Diphosphate inhibits the activity of the enzyme to copy HIV-1 by competing with the natural substrate Deoxyadenosin 5'-triphosphate and after merging into DNA. End of DNA string. In addition, Tenofovir Disoproxil Fumarate also inhibits DNA polymerase of the hepatitis B virus (HBV), an essential enzyme for the virus in liver cells.

Tenofovir Diphosphate is a weak inhibitor and DNA polymerase of mammal and DNA polymerase enzyme CD Dev DNA polymerase in the mitochondria.

Pharmacokinetics

absorption

After drinking, Tenofovir Disoproxil Fumarate is quickly absorbed and converted into Tenofovir, with peaks in plasma after 1 to 2 hours.

Birth of drugs in patients with hunger is about 25% but increases when using Tenofovir Disoproxil Fumarate with a fat -rich meal.

Distribution

Tenofovir is widely distributed in tissues, especially in the kidneys and liver.

The cohesion with plasma proteins is less than 1% and with serum protein about 7%.

Metabolism

Tenofovir disoproxil fumarate is a water -soluble ester in the water that is rapidly transformed in vivo into tenofovir and formaldehyde.

Tenofovir is converted in intracellular into tenofovir monophosphate and substance with tenofovir diphosphate.

Elimination

Tenofovir's final waste time is from 12 to 18 hours.

Tenofovir is excreted mainly through urine in both ways: active excretion through the renal tubules and glomerular filtration, Tenofovir is excluded by hemolysis.

Before taking Tefostad T300 Stella medicine and HIV-1 prevention and treatment (3 blisters x 10 tablets)

How to use

Tefostad T300 tablets tablets used by oral once a day, not affected by meals.

Dosage

Adults

HIV infection treatment: 1 tablet x 1 time/day, combined with other antiviral drugs.

Prevention of HIV -contaminated after contact due to occupational causes: 1 tablet x 1 time/day in combination with other antiviral drugs (usually combined with lamivudin or emtricitabine). 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.

HIV infection prevention is not due to occupational reasons: 1 tablet x 1 time/day in combination with at least 2 other antiviral drugs. Prevention should start as soon as possible after contact without career reasons (preferably within 72 hours) and contact within 28 days.

Treatment of chronic hepatitis B: The recommended dose is 1 tablet 1 time/day for 48 weeks.

Patients with renal failure

Should change the dose of Tenofovir Disoproxil Fumarate by adjusting the duration of the drug time in patients with renal impairment based on the patient's clearance (CLCR) of patient:

CLCR> 50 ml/minute: Using normal doses 1 time/day.

CLCR 30 to 49 ml/minute: use each 48 hours.

CLCR 10 to 29 ml/minute: Use each 72 to 96 hours.

Patients with hemolysis: take a dose every 7 days or after adding 12 hours.

Due to the safety and effectiveness of these doses that have not been evaluated with clinical research, it is closer to closely monitor the clinical response of therapy and kidney function.

Patients with liver failure

For patients with impaired liver function, the dose is not required.

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 the overdose occurs, patients need to be monitored signs of poisoning, necessary to use 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 you forget a dose? However, if close to the next dose, skip the forgotten dose and take the next dose at the time as planned. Do not use double the prescribed dose.

Side Effects

When using Tefostad T300, you may experience unwanted effects (ADR).

The most unwanted effect (1/100

Serum amylase concentration may increase and pancreatitis.

Hemorrhage reduction also occurs.

You can also meet.

Peripheral neuropathy, headache, dizziness, insomnia, depression, weakness, sweating and muscle pain.

Increased liver enzyme, increased blood triglycerides, hyperlem of blood glucose and neutropenia.

Renal failure, acute renal failure and the effects on the close tube, including fanconi syndrome.

Lactic acid infection, often combined with serious liver and fatty liver, is common when treated with enzyme inhibitors that copy 2 nucleosides.

Instructions on how to handle ADR

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

Tefostad T300 is contraindicated in the following cases:

Patients with hypersensitivity to Tenofovir Disoproxil Fumarate or any ingredients of the drug.

Be cautious when using

When using Tenofovir, as well as reverse, solitary or coordinated copy inhibitors, there are patients with lactic acid -contaminated patients, serious liver and fatty (can die).

Adiperatoma: The re-distribution or accumulation of fat in the body includes abdominal fat, the front-and-neck hypertrophy (buffalo hunchback), peripheral nerves, face, mammary hypertrophy, Cushing syndrome has been reported when using Retrovirus anti-Retrovirus drugs.

Effects on bone: When using Tenofovir simultaneously with lamivudin and in HIV -infected patients, there is a decrease in the mineral density of lumbar spine, increasing the concentration of 4 bone metabolic factors, increasing serum parathyroid hormone levels.

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 liver disease worse than 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 whether the treatment in patients with HIV-1 and HBV is simultaneously leads to HBV's resistance progression for Tenofovir Disoproxil Fumarate 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 cause serious clinical or severe clinical diseases. 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.

The ability to drive and operate machinery

No research shows that the effect of the drug affects the ability to drive and operate machinery. However, patients need to be notified of the ability to cause dizziness when treated with Tenofovir Disoproxil Fumarate.

Pregnancy

There is no clinical information about the use of Tenofovir Disoproxil Fumarate during pregnancy.

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

Breastfeeding period

It is unknown whether Tenofovir Disoproxil Fumarate is excreted in tamarind milk. It is recommended that women are being treated with Tenofovir disoproxil fumarate should not be breastfeeding. According to the general rule, it is recommended that women with HIV -infected women are not breastfeeding to avoid HIV transmission to babies.

Interactive drug

drugs affected or metabolized by enzymes in the liver:

Tenofovir's pharmacokinetic interaction with inhibitors or substrates of microscopic enzymes in the liver is unknown.

Tenofovir and its precursor not 50 are the substrate of CYP450 isoenzym, not inhibiting the isomers 3A4, 2D6, 2C9, or 2E1 but slightly inhibited over 1A.

Medications are influenced or eliminated through the kidneys:

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: combined or co -operational 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

Store in closed packaging, dry place. The temperature does not exceed 30 ° C.

Other drugs

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