Agifovir 300mg Agimexpharm supports HIV-1 treatment, chronic hepatitis B (3 blisters x 10 tablets)

Dosage form Box of 3 blisters x 10 tablets
Specifications Tenofovir disoproxil fumarat
Ingredient HIV/AIDS, hepatitis B

Ingredient

Composition information	Content
Tenofovir disoproxil fumarat	300mg

Uses

indications

Agifovir drugs are indicated in the following cases:

Treatment HIV -1

Tenofovir disoproxil fumarat combined with other antacids-viruses in the treatment of coach-type 1 infection (HIV-1) in adults and children aged 12 and older. This indication is based on the analysis of plasma HIV-1 RNA and the number of CD4 cells in patients who have not been treated with anti-Retrovirus anti-Retrovirus drugs and patients who have been treated with anti-Retrovirus drugs first.

Tenofovir disoproxil fumarat is indicated in combination with other antiviral drugs in the treatment of coach-1 (HIV-1) infection in patients over 18 years old.

Before starting HIV-1 treatment with Tenofovir should pay attention to the following points:

Do not specify tenofovir with formulas combined in the formula containing tenofovir.

Tenofovir must not be used in combination with adefovir dipivoxil.

Chronic hepatitis B treatment

Tenofovir is indicated for chronic hepatitis B treatment in adult patients.

Indications based on data collected from the treatment of untreated patients with nucleoside and a less than before being treated with lavumidin or adefovir . Patients who are adults with chronic hepatitis B have HBeAg+ and HBeAg- with compensated liver disease. Tenofovir has not been evaluated in patients with liver disease.

The choice of Tenofovir in treating patients treated with Retro-Virus anti-Retro-Virus drugs should be based on the antiviral test of each individual and/or the patient's history of treatment.

Pharmacokic

Tenofovir is an antiviral drug Retrovirus (ARV). The drug inhibits the reverse transcription that makes the virus DNA not formed to attack the host cell nucleus.

Tenofovir disoproxil Fumarat has a structure of a nucleotid diester similar to adenosin monophosphate. Tenofovir Disoproxil Fumarat undergoing the initial hydrolysis of Tenofovir and followed by phosphorylation by the enzymes in the cell to form Tenofovir Diphosphate.

Tenofovir Diphosphate inhibits the activity of HIV-1 copying enzymes in two mechanisms: by competing with the natural substrate Deoxyadenosin-5 'Triphosphate and after cohesion to DNA, finish the DNA chain.

Tenofovir diphosphate is a weak inhibitor of enamel alpha, beta and gamma - DNA polymerase mitochondria of mammals.

Dynamic pharmacokinetics

After taken, Tenofovir Disoproxil Fumarat is quickly absorbed and converted into Tenofovir, with peak plasma concentrations after 1 to 2 hours. Born is about 25% but increases when using Tenofovir Disoproxil Fumarat with a fat -rich meal.

Tenofovir is widely distributed in tissues, especially in the kidneys and liver. The cohesion with serum protein is very low below 10%.

After taking the single dose, Tenofovir's ending time is about 17 hours. With a dose of 300 mg/day/day, after many doses of oral 32 ± 10% of the dose is found in urine after 24 hours. Tenofovir is excreted mainly through urine by both excretion through the renal tubules and glomerular filtration. Tenofovir is eliminated by hemolysis.

There may be compatibility with other compounds that also excreted through the kidneys.

Before taking Agifovir 300mg Agimexpharm supports HIV-1 treatment, chronic hepatitis B (3 blisters x 10 tablets)

How to use

oral medication, should be taken during meals.

Note:

The body absorbs the best drugs when taking the medicine at full.

When taking Tenofovir should use high -fat food to increase the ability to absorb the drug.

Dosage

Adults:

HIV-1 treatment and chronic hepatitis B: Tenofovir 300 mg 1 time/day.

Optimal treatment time for chronic hepatitis B is not known.

Children:

HIV-1 treatment on children 12 years and older weighs> 35 kg: Take 300mg/1 time/day.

Adjustable dose for patients with renal failure:

For patients with medium or severe kidney failure, Tenofovir, the concentration of blood in the drug increases significantly. Therefore, Tenofovir dose should be adjusted in patients with CLCR

If ClCR 30 - 49 ml/ minute: The recommended dose is 300 mg every 48 hours.

If CLCR 10 - 29 ml/minute: The recommended dose is 300 mg x 2 times/week.

For patients with hemolysis: Tenofovir should be used with a dose of 300 mg x 1 time/week or 300 mg after the appraisal with a total time of about 12 hours, the dose should be used after the fertilizer is completed.

No dose adjustment for patients with mild renal impairment (CLCR 50 - 80 ml/ minute), it is necessary to regularly check the clearinine clearance and serum phosphorus for patients of this group.

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 do

do when overdose? If the overdose occurs, patients need to be monitored by signs of poisoning, it is necessary to use basic supportive treatments.

Tenofovir is eliminated effectively by hemolysis with a separation coefficient of about 54%. With a single dose of 300mg, 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 drink twice as prescribed.

Side Effects

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

Common, ADR> 1/100

Metabolism: reduces blood phosphate.

Central nerve: Dizziness. digestive: diarrhea , nausea, vomiting, abdominal pain, bloating, flatulence. liver: Increase transaminase.

DA: rash.

Other: weakness, fatigue.

Uncommon, 1/1,000

Metabolism: hypotension.

digestive: pancreatitis .

Mechanical - Small: Pepper pattern, weak muscle.

kidney: increased creatinine, near renal tubular disease (including fanconi syndrome).

Rare, 1/10,000

Metabolism: Lactic acid infection.

liver: Fatty liver, hepatitis.

Skin and subcutaneous tissue: Evaluation.

muscle - bone: bone puree (manifestation is bone pain and does not often lead to fractures), muscle disease.

kidney: acute renal failure , renal failure, acute renal necrosis, nephritis (including interstitial nephritis), diabetes due to kidneys.

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.

Contraindications:

Agififivir drugs contraindicated in the following cases:

Patients with hypersensitivity to Tenofovir and other ingredients of the drug.

Severe kidney disease.

Patients with abnormal neutrophils (

Be cautious when using

should stop treating with tenofovir disoproxil fumarat if there is an increase in aminotransferase level, fatty liver or progressive liver, metabolic acidosis or lactic acid unknown, need to be cautious when indicating tenofovir for patients with liver disease or other risk factors.

In particular, it is very careful for patients and hepatitis C is being treated with Interferon Alfa and Ribavirin. There is a serious risk of hepatitis when stopping Tenofovir in patients with hepatitis B -infected with hepatitis B and should closely monitor the liver function of these patients at least a few months.

Tenofovir should be used carefully and adjust the dose appropriately for patients with renal impairment, need to monitor kidney function and serum phosphate before starting treatment, every 4 weeks of the first year of the course and then every 3 months.

Patients with a history of kidney failure, and especially risks need to be monitored more often. If serum phosphate concentration is significantly reduced or creatinine clearance below 50ml/min, must monitor kidney function within 1 week and the dose distance may need to be adjusted or stopped treatment.

Tenofovir disoproxil fumarat can be associated with reducing bone density and patients should be monitored with abnormalities of bone abnormalities, bone monitoring should be considered for patients with a history of fractures or people at risk of reducing bone density.

The ability to drive and operate machinery

No research shows that 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 Fumarat.

Pregnancy

There is no information on the use of Tenofovir Disoproxil Fumarat during pregnancy. Tenofovir disoproxil fumarat should only be used when the benefits are proven more than the risk to the fetus.

However, due to the risk of increased conception of unknown pregnancy, the use of Tenofovir disoproxil fumarat in reproductive age women should be accompanied by effective contraception.

Breastfeeding period

There is no information on the excretion of Tenofovir Disoproxil Fumarat through breast milk.

Therefore, do not use Tenofovir in nursing women. According to general recommendations, HIV -infected women should not breastfeed to avoid spreading coaches to children.

Drug interaction

Didanosine : Be careful when using Tenofovir and Didanosine and patients who are using this combination must be closely monitored with adverse reactions related to Didanosine. Stop use if the patient manifests adverse reactions related to Didanosine.

Atazanivir: Increases Tenofovir concentration. The mechanism of interaction is not known. Patients using Tenofovir and Atazanivir must be monitored with adverse reactions related to Tenofovir. Stop using Tenofovir if these reactions occur. Tenofovir reduces AUC and CMIN of Atazanivir. When used with Tenofovir, should use Atazanivir 300mg with Ritonavir 100 mg. Atazanivir is not combined with Ritonavir not to be used simultaneously with Tenofovir.

lopinavir /ritonavir: Increases tenofovir levels. The mechanism of this interaction is not known. Patients using Lopinavir/Ritonavir and Tenofovir must be monitored with adverse reactions related to Tenofovir. Stop using Tenofovir if these reactions occur.

Medicines affecting kidney function: Because Tenofovir is mainly eliminated through the kidney, the use of drugs at the same time reduces the kidney function or competes eliminating in the renal tubules can increase the concentration of tenofovir in serum and /or increase the concentration of other renal elimination drugs. Some drugs in this group are Cidofovir, Acyclovir, Valacyclovir, Ganiclovir, Valganciclovir.

In the treatment of chronic hepatitis B, Tenofovir is not used in combination with Adetovir Dipivoxil.

Storage

temperature below 30 ° C, avoid moisture and light.

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