Getino-B 300mg Getz drug controls HIV infection, treatment of chronic hepatitis B (30 tablets)

Dosage form Box of 30 tablets
Specifications Tenofovir disoproxil fumarate

Ingredient

Composition information	Content
Tenofovir disoproxil fumarate	300mg

Uses

indications

Getino-300 medicine is indicated in the following cases:

Combined with at least 2 other antiviral drugs in HIV -infected control in adults.

Treatment of chronic hepatitis B in adults in patients with compensation hepatitis, with evidence of viral activity copy, prolonged alanine aminotransferase concentration in plasma (ALT) and histological evidence of anti -inflammatory and fibrosis activity.

Pharmacy

Tenofovir Disoproxil Fumarate is the Fumarate salt of the pre -substance of Tenofovir Disoproxil. Tenofovir Disoproxil is absorbed and transformed into a tenofovir activity, which is similar to nucleoside monophosphate (nucleotide). Tenofovir is transformed into metabolites with Tenofovir Diphosphate activity, the final substance of the metabolic chain thanks to the enzymes in the cell.

Tenofovir diphosphate has half an intracellular life for about 10 hours in activated form and 50 hours in the form of resting in a single nucleus cell in peripheral blood. Tenofovir Diphosphate inhibits the activity of HIV-1 reverse copy enzymes by competing with natural substrate Deoxyribonucleotide, after cohesion to DNA, finishing the DNA chain.

Tenofovir diphosphate inhibits weak polymerase cells A, B and G. At a concentration of up to 300 μmol/l, Tenofovir also shows no effect on the synthesis of mitochondrial DNA or the production of experimental lactic acid on in vitro.

pharmacokinetic

tenofovir disoproxil fumarate quickly absorbed and converted into tenofovir after drinking, the peak concentration of plasma is achieved after 1-2 hours.

The drug uses about 25% but increases when using Tenofovir Disoproxil Fumarate with a fat -rich meal.

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

Tenofovir's ending semi -waste time is from 12 to 18 hours.

Tenofovir is excreted mainly through urine by both excretion through the renal tubules and glomerular filtration. Tenofovir is eliminated by hemolysis.

Special case

renal failure: Tenofovir pharmacokinetics change in patients with renal failure. In case of non -HIV and non -HBV infection in patients with creatinine clearance ratio

Before taking Getino-B 300mg Getz drug controls HIV infection, treatment of chronic hepatitis B (30 tablets)

How to use

Getino-300 pills with food.

Dosage

Getino-300 dose for adults

The recommended dose for HIV or chronic hepatitis B is 300mg (1 tablet) per day, drinking with food.

Getino-300 dose for patients with chronic hepatitis B

So far has not found the optimal treatment. Stop treatment must consider the following factors:

HBeAg positive patients without cirrhosis, so treatment for at least 6-12 months after HBE serum metabolism (HBeAg negative and HBV DNA with HBE resistance detection) are determined or until HBS serum metabolism or loss of effect. The concentration of ALT and HBV DMA in serum should be monitored regularly after stopping treatment to detect any virus recurrence.

HBeAg negative patients without cirrhosis, so treatment should be at least until HBS serum metabolism or show signs of loss. With more than 2 years of treatment, it is recommended to evaluate regularly to determine the appropriate maintenance therapy for patients.

Getino-300 dose for patients with renal failure

No need to adjust the dose in patients with mild renal impairment (clearine clearine 50 - 80ml/ minute clearance). Regular monitoring of creatinine and phosphor clearance in serum should be conducted in patients with mild renal impairment. The table below the recommended dose instructions:

Creatinine Clearance (ml/min) A

≥ 50

30 - 49

10 - 29

Every 24 hours

Every 48 hours

Each 72 - 96 hours

Every 7 days after the appraisal or after 12 hours of division

Calculated on weight.

b. About 3 times a week of hemolysis, about 4 hours. Getino-B (Tenofovir Disoproxil Hibernate) should be used after finishing.

There is no recommended dose in patients with creatinine clearance

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?

Tenofovir is excluded by hemolysis, the average blood separation clearance is about 134 ml/min. There is no study of the elimination of tenofovir by abdominal separation.

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 Getino-B 300, you may experience unwanted effects (ADR).

Side effects often occur when using Tenofovir Disoproxil Fumarate is an effect on the mild gastrointestinal tract, especially diarrhea, vomiting and anorexia. Amylase concentration in serum may increase and pancreatitis may occur. Often occurs hypoglycemia. The skin rash may occur.

Unusual side effects such as peripheral neuropathy, headache, dizziness, insomnia, depression, weakness, sweating and muscle pain. There is a report on liver enzyme, increased blood triglyceride levels, hyperglycemia and neutrophils.

There are also reports on renal failure, acute renal failure and the effects on the nearby tube, including fanconi syndrome. Lactic acid contamination, often combined with serious liver and fatty liver, is common when treated with enamel inhibitors copying 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

Getino-B 300 drug contraindicated in the following cases:

Tenofovir Disoproxil Fumarate is contraindicated in patients with hypersensitivity to Tenofovir or any ingredient of the drug.

should not be used simultaneously drugs containing other tenofovir or adefovir dipivoxil.

Advice not to use Tenofovir Disoproxil Fumarate for children under 18 years old.

Caution when used

Lactic acid infection, serious liver with fatty and after treatment of severe hepatitis.

Lactic acid infection and serious liver with fatty liver, including deadly cases, have been reported when using nucleoside similar substances including tenofovir disoproxil fumarate, when combined with other antiviral drugs.

The severe acute hepatitis has been reported in patients with HBV when stopping the treatment of anti -hepatitis B drugs, including Tenofovir disoproxil fumarate. Regular monitoring of clinical liver function and on tests for at least a few months in patients who stop using hepatitis B anti -hepatitis, including Tenofovir Disoproxil Fumarate. If appropriate, hepatitis B anti -hepatitis may be allowed to continue.

Should temporarily stop the treatment of Tenofovir Disoproxil Fumarate in clinical or tested patients with lactic acid infection or toxicity on the liver.

Patients using Tenofovir Disoproxil Fumarate or any other antiviral drugs, the opportunity infection can continue to grow and other complications of HIV infection, so it should be carefully monitored by clinical monitoring by experienced doctors in the treatment of HIV -related diseases.

recommend patients that Retrovirus resistance therapy, including Getino-B, does not prevent HIV transmission or HBV transferred by sex or via blood. Should continue to apply appropriate caution measures.

Do not take this drug in patients with genetic problems such as galactose intolerance, lactase lactase deficiency or poor absorption of glucose-galactose.

Older people: Tenofovir disoproxil fumarate can reduce the proportion of bone and patients should be monitored abnormal signs of bone.

Patients with renal impairment: Creatinine clearance should be calculated in patients before taking Tenofovir Disoproxil Fumarate, the first dose at the appropriate appropriate target. Patients with risk or history of kidney dysfunction should be monitored regularly to detect changes in creatinine and serum phosphate.

Patients with hepatic failure: Patients with cirrhosis may have a high risk of liver loss in severe hepatitis and thus should monitor carefully during treatment.

Patients with HIV and hepatitis B: Previous patients with liver dysfunction including acute and chronic hepatitis have regular increase in liver function abnormalities while combining Retrovirus resistance therapy and should be monitored for conventional standards. If the patient shows signs of deteriorating liver, consider stopping the drug.

Patients with fat metabolic disorders (fat loss/fat tumor): Lipid tests should be tested in fast serum and blood glucose. Lipid disorders should be controlled according to appropriate clinical indicators.

Immunous regeneration syndrome: When necessary, it should be started to evaluate and treat anti -inflammatory symptoms.

Bone necrosis: Patients should find a doctor's advice, if they have experienced joint pain and stiffness or difficulty movement.

The ability to drive and operate machinery

No research shows 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

Tenofovir disoproxil fumarate is only for pregnant women when the benefits are proven to be more important than the risk to the fetus.

Due to the risk of increased conception, the use of Tenofovir Disoproxil Fumarate in reproductive age women should be accompanied by effective contraception.

Breastfeeding period

There is no information on the excretion of Tenofovir Disoproxil Fumarate through breast milk. Therefore, it is recommended that women are being treated with Tenofovir Disoproxil Fumarate should not breastfeed.

According to general recommendations, women with HIV and HBV should not breastfeed to avoid HIV and HBV transmission to children.

Drug interaction

Didanosine

Be cautious when using Tenofovir Disoproxil Fumarate and Didanosine and patients with combination should be carefully monitored side effects related to Didanosine. Didanosine should be discontinued in patients who increase side effects related to Didanosine.

Atazanavir

Tenofovir disoproxil fumarate affected on Atazanavir pharmacokinetics. Tenofovir disoproxil fumarate should only be used with enhanced Atazanavir (ATZ 300mg or RTV 100mg) Ba Therapy with nucleoside or nucleotide: The rate of failure with high viruses and the appearance of resistance in the early HIV patients occurs when using Tenofovir Disoproxil Fumarate daily combined with Lamivudine and Abacabudine and Lamivudine Didanosine. Patients using Ba therapy, only nucleoside should be carefully monitored and considered to reduce in treatment.

tacrolimus and other drugs affect kidney function

Because Tacrolimus can affect kidney function, carefully monitoring when used simultaneously with Tenofovir disoproxil fumarate. Simultaneous use of Tenofovir Disoproxil Fumarate, which reduces or competes, excretes through the kidneys that can increase the concentration of tenofovir disoproxil fumarate in serum.

HIV and HBV co -infected

Due to the risk of increased HIV resistance, in patients with HIV/HBV co -infected patients should only use Tenofovir Disoproxil Fumarate combined with Retrovirus resistance and appropriate diet.

Storage

Leave a cool place, avoid light, temperature below 30⁰C.

To be out of reach of children.

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