Boruza

Registration number: QLDB-504-15
Packaging: Box: 3 blisters x 10 tablets
Standard: TCCS Lifespan: 36 months
Manufacturing company: Pharmaceutical and biological medical one member limited liability company
Dosage form: Film-coated tablets.
Ingredients: Tenofovir disoproxil fumarate 300 mg
Point:
- The drug is used in combination with other antiretroviral drugs (not used alone) in the treatment of HIV - type 1 infection (in adults).
- Used in combination with other antiretroviral drugs to prevent HIV infection after exposure in individuals at risk of viral infection.
- Used in the treatment of chronic hepatitis B in adults, tenofovir is active against mutant HBV viruses resistant to lamivudine.
Contraindications: Patients with hypersensitivity to tenofovir disoproxil fumarate or any ingredient of the drug.

Side effects:

- The most common effects when using tenofovir disoproxil fumarate are mild effects on the digestive tract, especially diarrhea, vomiting and nausea, abdominal pain, flatulence, indigestion, and loss of appetite.

- Serum amylase levels may be elevated and pancreatitis may occur.

- Hypophosphatemia also commonly occurs.

- Skin rash may also occur.

- Some other common side effects include peripheral neuropathy, headache, dizziness, insomnia, depression, asthenia, sweating and muscle pain.

- Increased liver enzymes, increased blood triglyceride levels, hyperglycemia and neutrophil deficiency.

- Renal failure, acute renal failure and proximal tubular effects, including Fanconi syndrome

- Lactic acidosis, often associated with severe hepatomegaly and steatosis, is common when treated with nucleoside reverse transcriptase inhibitors.

Pregnant and lactating women:

Pregnant:

-There is no information on the use of tenofovir disoproxil fumarate during pregnancy. Tenofovir disoproxil fumarate should only be used when the demonstrated benefit outweighs the risk to the fetus.

-However, due to the unknown risk of increased fertility, use of tenofovir disoproxil fumarate in women of reproductive age should be accompanied by effective contraception.

Women who are breastfeeding:

-There is no information on the excretion of tenofovir disoproxil fumarate in breast milk.

-Therefore, do not use tenofovir in breast-feeding women. As a general recommendation, women infected with HIV should not breastfeed to avoid transmitting HIV to the child.

Effects on people operating machinery and driving vehicles:

There are no studies showing that the drug's effects affect the ability to drive and operate machinery. However, patients should be informed of the potential for dizziness during treatment with tenofovir disoproxil fumarate.

Dosage:

Tenofovir 300 mg is administered orally once daily, regardless of meals.

Adult:

Treatment of HIV infection:

-1 tablet x 1 time/day, combined with other antiretroviral drugs.

-Prophylaxis of HIV infection after exposure due to occupational causes: 1 tablet x 1 time/day combined with other antiretroviral drugs (usually combined with lamivudine or emtricitabine).

-Prophylaxis should begin as soon as possible after occupational exposure (preferably within hours rather than days) and continue for the next 4 weeks as tolerated.

-Prophylaxis of HIV infection due to non-occupational causes: 1 tablet x 1 time/day combined with at least 2 other antiretroviral drugs.

-Prophylaxis should begin as soon as possible after non-occupational exposure (preferably within 72 hours) and continue for 28 days.

Treatment of chronic hepatitis B:

The recommended dose is 1 tablet once daily for over 48 weeks.

Patients with kidney failure:

– The dose of tenofovir disoproxil fumarate should be reduced by adjusting the dosing interval in patients with renal impairment based on the patient's creatinine clearance (CC):

* CC 50 ml/min or greater: usual dose once daily.

* CC 30 to 49 ml/min: administered every 48 hours.

* CC 10 to 29 ml/minute: administered every 72 to 96 hours.

* Hemodialysis patients: use each dose 7 days apart or 12 hours after dialysis.

– Because the safety and effectiveness of the above doses have not been clinically evaluated, clinical response to therapy and renal function should be closely monitored.

Patients with liver failure:

For patients with impaired liver function, no dose adjustment is necessary.

Exclusive Distributor:
Tung Linh Pharmaceutical Joint Stock Company
Address: House B-TT8-4, Him Lam Van Phuc Residential Area, Van Phuc Ward, Ha Dong District, Hanoi City, Vietnam
Tel: 024 6297 7875

Dosage:

Tenofovir 300 mg is administered orally once daily, regardless of meals.

Adult:

Treatment of HIV infection:

-1 tablet x 1 time/day, combined with other antiretroviral drugs.

-Prophylaxis of HIV infection after exposure due to occupational causes: 1 tablet x 1 time/day combined with other antiretroviral drugs (usually combined with lamivudine or emtricitabine).

-Prophylaxis should begin as soon as possible after occupational exposure (preferably within hours rather than days) and continue for the next 4 weeks as tolerated.

-Prophylaxis of HIV infection due to non-occupational causes: 1 tablet x 1 time/day combined with at least 2 other antiretroviral drugs.

-Prophylaxis should begin as soon as possible after non-occupational exposure (preferably within 72 hours) and continue for 28 days.

Treatment of chronic hepatitis B:

The recommended dose is 1 tablet once daily for over 48 weeks.

Patients with kidney failure:

– The dose of tenofovir disoproxil fumarate should be reduced by adjusting the dosing interval in patients with renal impairment based on the patient's creatinine clearance (CC):

* CC 50 ml/min or greater: usual dose once daily.

* CC 30 to 49 ml/min: administered every 48 hours.

* CC 10 to 29 ml/minute: administered every 72 to 96 hours.

* Hemodialysis patients: use each dose 7 days apart or 12 hours after dialysis.

– Because the safety and effectiveness of the above doses have not been clinically evaluated, clinical response to therapy and renal function should be closely monitored.

Patients with liver failure:

For patients with impaired liver function, no dose adjustment is necessary.

Packaging: Box: 3 blisters x 10 tablets