Tenoxil Heterero Treatment of chronic 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

Tenoxil 300 mg is indicated in the following cases:

HIV-1 infection in adults over 18 years of age: Must coordinate with other antiviral drugs. The alt lasts long, the hepatitis is active and/or has cirrhosis proved by the organization.

The drug is used by oral in the form of Disoproxil Fumarat ester. 300 mg Tenofovir disoproxil fumarat is equivalent to about 245 mg of tenofovir disoproxil or about 136 mg of tenofovir.

Tenofovir Disoproxil Fumarat is a salt of the Tenofovir Disoproxil, which is quickly absorbed and converted into Tenofovir and then Tenofovir Diphosphate due to the phosphorylation in cells. This substance inhibits the reverse code enzyme of the HIV-1 virus and inhibits the polymerase enzyme of the hepatitis B DNA virus, due to disputes with natural substrates, Deoxyadenosin 5’-Triphosphate and after attaching it to DNA will terminate the DNA sequence.

For HIV In vitro, the Tenofovir concentration is needed to inhibit 50% (CE50) wild strains in HIV -1 laboratory is from 1 - 6 micromol/liter in lymphocytes. Tenofovir also works for HIV-2 In vitro, with a 50% inhibitor of 4.9 micromol/liter in MT4 cells. Sensitive HIV-1 strains for Tenofovir Disoproxil Fumarat can produce in vitro, and also found in clinical treatment when treated with this drug. These strains have a mutant K65R. Tenofovir can be resistant to other reverse transcription enzyme inhibitors.

For hepatitis B virus, Tenofovir's In vitro antivirus activity has been assessed in HEPG cells 222.15. Tenofovir concentration needed to inhibit 50% is 0.14 - 1.5 micromol/liter, 50% cellular toxicity is> 100 micrograms/liter.

There has been no hepatitis B virus resistant to Tenofovir Disoproxil Fumarat.

In Tenofovir Diphosphate animals are weak inhibitors and polymerase alpha, beta and mitochondrial DNA.

Pharmacokinetics

absorption

After giving HIV taken Tenofovir disoproxil fumarat, the drug is quickly absorbed and converted into Tenofovir. Tenofovir peak concentration in plasma is 296 ± 90 nanogam/ml after taking 300 mg for 1-2 hours. Born in hungry people is about 25%, but increases if taking Tenofovir Disoproxil Fumarat with a lot of fat meals.

Distribution

Tenofovir is distributed throughout the tissues, especially in the liver and the kidneys. The percentage of drugs attached to plasma proteins is less than 1%, attached to serum protein is about 7%. Half lifetime elimination is 12 - 18 hours.

Elimination

Tenofovir is mainly eliminated in the urine thanks to the filtration process in the glomerular and positive excretion in the renal tubules. Hematoparoa ceases to remove drugs from the blood.

Before taking Tenoxil Heterero Treatment of chronic hepatitis B (3 blisters x 10 tablets)

How to use

Take oral use.

Dosage

Tenofovir disoproxil fumarat dose is calculated according to Tenofovir Dinatri Fumarat.

HIV infection treatment:

Tenofovir disoproxil fumarat dose for adults is 300 mg, once a day. In combination with other antacids.

HIV infection for adults exposed to HIV-1:

Tenofovir must be used in combination with other antiviral drugs. Must use early, within a few hours after being exposed.

Tenofovir disoproxil fumarat dose is 300 mg/day and for 4 weeks if tolerated well.

Note: See HIV infection treatment regimens. There is no data on dosage, safety and effectiveness of drugs in children under 18 years old and in the elderly over 65 years old.

Chronic hepatitis B:

Recommended dose: Take Tenofovir Disoproxil Fumarat 300 mg, 1 tablet daily. The current optimal drug stop time is unknown. Can stop:

In patients with AGHBE (+), no cirrhosis: Treatment for at least 6-12 months after determining the serum conversion of HBE (AGHBE (-), no DNA DNA of hepatitis B virus and HBE resistance) or until serum converts HBS or when the drug is inactive. The ratio of serum and DNA of the hepatitis B virus must be checked regularly after stopping treatment to detect any late recurrence.

In patients with AGHBE (-), no cirrhosis: Treatment must last until the serum converts HBS or until the drug is no longer effective. In the case of treatment that lasts for more than 2 years, it should be re -evaluated regularly to determine whether such a pursuit is suitable for patients.

If the Tenofovir Disoproxil Fumarat stops in patients with chronic hepatitis B and have HIV infection, closely monitor patients to detect all the severe signs of hepatitis.

Treatment must be due to experienced physicians. A test to detect anti -HIV antibodies for patients infected with hepatitis B virus before starting treatment with Tenofovir Disoproxil Fumarat.

The drug has not been studied for children under 18 years old and the elderly over 65 years old.

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 using overdose? If the overdose is suspected, it is necessary to go to the anti -toxic center. Considering the pharmacokinetic properties of the drug, the peritoneal diagnosis or hemolysis may increase the speed of Tenofovir elimination. It is unclear whether this method will change the clinical disease of the drug overdose.

Treatment of poisoning, overdose Tenofovir is symptomatic treatment and supportive treatment. Tenofovir can be removed by hemorrhage. Pay attention to psychological assistance for patients with suicide.

What to do when you forget 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 Tenoxil 300 mg, you may experience unwanted effects (ADR).

Common, ADR> 1/100

Body: muscle fatigue, headache.

digestive: diarrhea, bloating, loss of appetite, nausea, vomiting, abdominal pain, indigestion.

Hematology: neutral leukopenia, hypogonfalls.

Biochemistry: Increases the results of ALT, AST, Urinary Glucose.

Uncommon, 1/1000

Abdominal pain, toxic liver, kidneys are poisoned (especially when taking high doses).

Rare, 1/10000

Liver is poisoned, lactic acidosis (abdominal pain, anorexia, diarrhea, fast breathing, uncomfortable body, muscle pain or cramps, nausea, drowsiness).

Acute renal failure, proteinuria, fanconi syndrome, kidney necrosis. pancreatitis.

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

Tenoxil 300 mg is contraindicated in cases of sensitivity to Tenofovir disoproxil fumarat or any ingredient of the drug.

Be cautious when using

Tenofovir disoproxil fumarat must be stopped when the aminotransferase level increases rapidly, liver gradually or fatty liver, or metabolic acidosis or lactic acid for unknown causes. It must be very cautious when using tenofovir for people with large liver disease, or other risks of liver disease. Especially, it is very careful for patients with an additional hepatitis C using interferon alpha and ribavirin. If the patient has more hepatitis B, when the tenofovir stops, there may be a risk of severe hepatitis. Must monitor liver function at least a few months in this patient.

Tenofovir must be used with care in people with kidney damage and dose reduction. Kidney function and serum phosphate must be monitored before starting treatment, every 4 weeks of testing in the first year of treatment, and then every 3 months for people with stones with kidney damage. If the serum phosphate concentration decreases or clears the creatinine below 50 ml/min, the renal function must be assessed within 1 week, and must adjust the distance for the doses, or stop the drug.

Must monitor bone abnormalities, because tenofovir can reduce bone density, bone monitoring in people with fractured stones, or risk of osteoporosis (reduced bone mass).

When using preparations containing tenofovir and emtricitabin must pay attention to the side effects of each separate ingredient.

When using preparations containing tenofovir, emtricitabin and efavirenz must pay attention to the side effects of each separate ingredient.

The ability to drive and operate machinery

No research on the impact of the drug on the ability to operate machinery and train drivers. However, patients need to be notified of dizziness during treatment with Tenofovir Disoproxil Fumarat.

Pregnancy

Research data on the use of Tenofovir Disoproxil Fumarat on pregnant women (over 1,000 pregnant women) shows that there is no defect or toxicity on the fetus or newborn. Animal studies also show no signs of reproductive toxicity. The use of Tenofovir Disoproxil Fumarat may be considered during pregnancy, if necessary.

The period of breastfeeding

is unknown whether the tenofovir will be in milk. However, the mother uses Tenofovir to treat HIV not to breastfeed to prevent infection.

Drug interaction

tenofovir is not used with adefovir dipivoxil.

Tenofovir reduces the concentration of acanavir sulfate in plasma.

Tenofovir increases the concentration of didanosin in plasma. If simultaneously used with Didanosin, you must take Tenofovir before taking Didanosin for 2 hours or after 1 hour of Didanosin.

Tenofovir reduces lamivudine levels in plasma.

indinavir simultaneously used with tenofovir: increases the level of tenofovir and reduces indinavir levels in plasma.

Tenofovir simultaneously used with Lopinavir and Ritonavir: Increasing the level of Tenofovir in plasma, reducing Lopinavir concentration and ritonavir peak concentration in plasma.

Tenofovir simultaneously used with drugs is mainly discharged through the kidneys (Aciclovir, Cidofovir, Ganciclovir, ValacyClovir, Valganciclovir): can increase the serum concentration of Tenofovir or Kia drug due to the excreted road dispute.

Medications that reduce the kidney function may increase the serum tenofovir level.

Storage

In a dry place, temperatures below 30 ° C, avoid light.

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