Product Overview
[Drug Name]
Generic Name: Tenofovir Disoproxil Fumarate Tablets (Beixin)
English Name: FuMaSuanTiNuoFuWeiErBiFuZhiPian (BeiXin)
Chinese Pinyin: Tenofovir Disoproxil Fumarate Tablets
[Ingredients]
The main ingredient of this product is tenofovir disoproxil fumarate, whose chemical name is: 9-((R)-2-((Bis(((isopropoxycarbonyl)oxy(methoxy)phosphinyl)-propyl)adenine fumarate (1:1). Chemical Structure: Molecular Formula: C19H30N5O10.C4H4O4 Molecular Weight: 635.52
[Properties]
This product is a white, almond-shaped, film-coated tablet engraved with "GILEAD" on one side and "4331" on the bottom. It appears white after removal of the coating.
[Indications]
Indicated for use in combination with other antiretroviral drugs for the treatment of HIV-1 infection in adults.
[Dosage and Administration]
Recommended dose for adults and children 12 years and older (35 kg or more): For the treatment of HIV-1 or chronic hepatitis B: 300 mg (one tablet) once daily, orally, on an empty stomach or with other medications. For the treatment of chronic hepatitis B, the optimal duration of treatment has not been established. Safety and efficacy in children with chronic hepatitis B weighing less than 35 kg have not been studied. [See package insert for details]
[Adverse Reactions]
In two studies, nearly one-third of the patients in the treatment group received this product had Patients experienced adverse reactions, but the incidence was similar to that in the control group. Common adverse reactions to this drug include mild to moderate gastrointestinal discomfort (commonly diarrhea, nausea, vomiting, and flatulence); metabolic system hypophosphatasia (1% incidence); and mild to moderate decreases in serum phosphate (12% in the dapoxetine group vs. 7% in the control group at 24 weeks and 15% in the dapoxetine group at 58 weeks). There is a risk of lactic acidosis.
[Contraindications]
This drug is contraindicated in patients with a prior hypersensitivity to any of the ingredients.
[Precautions]
1. Use with caution in patients with hepatic insufficiency. Reproductive toxicity is classified as B; use with caution in pregnant women. 2. It is unknown whether this drug is present in breast milk; all women with HIV are advised to avoid breastfeeding. 3. Obesity may increase the risk of drug use. 4. Other pediatric and geriatric medications The potential for adverse reactions and dose adjustments is still under study. 5. In the event of an overdose, monitor for toxic reactions and implement supportive care. It is unknown whether this product can be eliminated by dialysis. 6. Store between 15°C and 30°C. [See package insert for details] Please read the package insert carefully and use as directed by your doctor.
[Use in Special Populations]
Precautions for Children:
Not yet available.
Precautions for Pregnancy and Lactation:
Not yet available.
Precautions for Elderly:
Clinical trials of tenofovir disoproxil fumarate did not include sufficient numbers of subjects aged 65 years and older to determine whether their responses differ from those of younger subjects. In general, elderly patients should be dosed with caution, bearing in mind their increased risk of decreased liver, kidney, and heart function, concurrent illnesses, or ongoing medications.
[Drug Interactions]
1. This 1. This product may interfere with the blood concentration of didanosine. Tenofovir should be taken 2 hours before or 1 hour after didanosine. 2. Combination use of didanosine and this product may increase didanosine blood concentrations, increasing the risk of pancreatitis. 3. This product is excreted through the kidneys via glomerular filtration and tubular secretion. Combination use with other drugs excreted via tubular secretion may increase the plasma concentration of both drugs. Drugs that reduce renal function may also increase the blood concentration of this product. 4. Combination use of this product with lamivudine, indinavir, lopinavir, and ritonavir may decrease the blood concentrations of these drugs.
[Storage] Sealed.
[Specification] 300mg * 30 tablets (Baixin)
[Packaging Specification] 300mg * 30 tablets/box.
[Expiration Date] 36 months
[Approval Number] National Medicine Standard H20163436
