Product Overview
[Drug Name]
Generic Name: Tenofovir Disoproxil Fumarate Tablets
Trade Name: NaXinDe Tenofovir Disoproxil Fumarate Tablets 0.3g*30 Tablets
Pinyin Code: NaXinDe FuMaSuanTiNuoFuWeiErZuoZuoZuoPian 0.3g*30 Tablets
[Main Ingredient]
Tenofovir Disoproxil Fumarate.
[Indications/Main Functions]
Indicated for use in combination with other antiretroviral drugs for the treatment of HIV-1 infection in adults. Indicated for the treatment of chronic hepatitis B in adults and pediatric patients 12 years and older.
[Specifications]
0.3g*30 tablets
[Dosage and Administration]
Recommended dose for adults and pediatric patients 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 food. The optimal duration of treatment for chronic hepatitis B has not been established. Safety and efficacy in children with chronic hepatitis B weighing less than 35 kg have not been studied.
[Contraindications]
This drug is contraindicated in patients with a prior allergy to any of the components of this drug.
[Drug Interactions]
1. This drug may interfere with the blood concentration of didanosine. Tenofovir should be taken 2 hours before or 1 hour after didanosine.
2. Coadministration of didanosine with tenofovir disoproxil fumarate tablets may increase didanosine blood concentrations, increasing the risk of pancreatitis.
3. This drug is excreted through the kidneys via glomerular filtration and tubular secretion. Coadministration with other drugs excreted via tubular secretion may increase their plasma concentrations. Drugs that reduce renal function may also increase this drug's blood concentration.
4. Coadministration of this drug with lamivudine, indinavir, lopinavir, and ritonavir may decrease the blood concentrations of these drugs.
[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 infection are advised to avoid breastfeeding.
3. Obesity may increase the risk of drug use.
4. Other pediatric and geriatric uses and dosage adjustments are under investigation.
5. In the event of an overdose of tenofovir disoproxil fumarate tablets, monitor for toxic reactions and provide supportive care. It is unknown whether this product can be eliminated by dialysis.
6. Store at 15-30°C.
[Pharmacology and Toxicology]
This product is a nucleotide reverse transcriptase inhibitor that inhibits reverse transcriptase in a manner similar to nucleoside reverse transcriptase inhibitors, thus possessing potential anti-HIV-1 activity. The active ingredient, tenofovir bisphosphonate, inhibits viral polymerase by directly competing with the natural deoxyribose substrate and terminates the DNA chain by intercalating into DNA. In vitro, tenofovir disoproxil fumarate tablets are effective against a variety of viruses, including those resistant to nucleoside reverse transcriptase inhibitors. In vitro, the IC50 for this product is 1.6 micromolar against wild-type HIV-1, 4.9 micromolar against HIV-2, and 1.1 micromolar against HBV.
