Fovirpoxil 300mg OPV treatment HIV-1, hepatitis B in adults (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

Fovirpoxil is indicated in the following cases:

HIV infection treatment - 1 in adults over 18 years old: Must coordinate with other antiviral drugs. Learning

Tenofovir Disoproxil Fumarat is a nucleosid phosphonate diester with a similar twisted structure of adenosin monophosphate and has a molecular structure close to Adefovir Dipivoxil. Tenofovir Disoproxil Fumarat 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, finishing the DNA chain. In addition, 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 dnapolymerase in mitochondria.

Pharmacokinetics

absorption

After drinking, Tenofovir Disoproxil Fumarat is quickly absorbed and converted into Tenofovir, with peaks in plasma 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 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 in urine in both ways: active excretion through the renal tubules and glomerular filtration. Tenofovir is excluded by fertilizer.

Before taking Fovirpoxil 300mg OPV treatment HIV-1, hepatitis B in adults (3 blisters x 10 tablets)

How to use

Take it once a day, at full or hungry.

Dosage

Adult dose is 300 mg, once a day.

Patients with renal failure

CLCR> = 50 ml/minute: Use the usual doses 1 time/day.

Take a dose every 7 days or after 12 hours of division.

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 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 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. Note that it should not be used double the prescribed dose.

Side Effects

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

Common, ADR> 1/100

Body: muscle fatigue, headache.

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

Hematology: neutral leukopenia, hypogonfalls.

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

Uncommon, 1/1 000

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

Rare, ADR

Liver is poisoned, lactic acidosis (abdominal pain, anorexia, diarrhea, weak breathing, body discomfort, 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

Fovirpoxil drug is contraindicated in the following cases:

Hypersensitivity to Tenofovir Disoproxil Fumarat or any ingredient of the drug.

Be cautious when used

When using Tenofovir (as well as reverse copy inhibitors (solo or coordination)), there has been a patient infected with lactic acid, serious liver and fatty (possible death).

Adipplication of fat tissue

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

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. Clinically and experimental liver function should be closely 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 treatment in patients with HIV - 1 and HBV infected and HBV leads to HBV's resistance progression for Tenofovir Disoproxil Fumarat and other drugs.

Immunously activated syndrome: In patients with HIV infected with severe immunodeficiency at the time of starting treatment for combination of antiviral drugs (Cart), there may be asymptomatic inflammatory reactions or opportunistic infections and cause serious or serious 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. Any symptoms of inflammation should be evaluated and started treatment when necessary.

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 Fumarat.

Pregnancy

There is no clinical information about the use of Tenofovir Disoproxil Fumarat during pregnancy. Tenofovir disoproxll fumarat should be used 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 the microscopy enzyme in the liver: Tenofovir's pharmacokinetic interaction with inhibited drugs or substrates of unknown liver microscopic enzymes. 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.

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

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

Nucleosid -free reverse copy enzyme inhibitors: Collective or co -operations between tenofovir and nucleosid -free copy 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 a dry place, avoid light, temperature below 30 ° C.

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