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Tenofovir Disoproxil Fumarate
Overview
What is Tenofovir Disoproxil Fumarate?
Tenofovir DF (a prodrug of tenofovir) is a fumaric acid salt of bis-isopropoxycarbonyloxymethyl ester derivative of tenofovir.
tenofovir DF is converted to tenofovir, an acyclic nucleoside phosphonate (nucleotide) analog of adenosine 5'-monophosphate. Tenofovir exhibits activity against HIV-1 reverse transcriptase.
The chemical name of tenofovir disoproxil fumarate is 9-[(
)-2-[[bis[[(isopropoxycarbonyl)oxy]methoxy]phosphinyl]methoxy]propyl]adenine fumarate (1:1). It has a molecular formula of C
H
N
O
P • C
H
O
and a molecular weight of 635.52. It has the following structural formula:
Tenofovir DF is a white to off-white crystalline powder with a solubility of 13.4 mg/mL in distilled water at 25 °C. It has an octanol/phosphate buffer (pH 6.5) partition coefficient (log p) of 1.25 at 25 °C.
Tenofovir disoproxil fumarate tablets is available as tablets.
Tenofovir disoproxil fumarate tablets are for oral administration in strength of 300 mg of tenofovir DF, which is equivalent to 245 mg of tenofovir disoproxil. Each tablet contains the following inactive ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and pregelatinized starch. The 300 mg tablets are coated with Opadry II 32K605004, which contains FD&C blue #2 aluminum lake, hypromellose 2910, lactose monohydrate, titanium dioxide, and triacetin.
In this insert, dosages are expressed in terms of tenofovir DF except where otherwise noted.
What does Tenofovir Disoproxil Fumarate look like?
What are the available doses of Tenofovir Disoproxil Fumarate?
Tablets: 300 mg (
)
What should I talk to my health care provider before I take Tenofovir Disoproxil Fumarate?
Nursing mothers: Women infected with HIV should be instructed not to breastfeed. (
)
How should I use Tenofovir Disoproxil Fumarate?
Tenofovir disoproxil fumarate tablets are indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients 2 years of age and older.
The following points should be considered when initiating therapy with tenofovir disoproxil fumarate tablets for the treatment of HIV-1 infection:
For the treatment of HIV-1 or chronic hepatitis B: The dose is one 300 mg tenofovir disoproxil fumarate tablet once daily taken orally, without regard to food.
In the treatment of chronic hepatitis B, the optimal duration of treatment is unknown. Safety and efficacy in pediatric patients with chronic hepatitis B weighing less than 35 kg have not been established.
What interacts with Tenofovir Disoproxil Fumarate?
Sorry No Records found
What are the warnings of Tenofovir Disoproxil Fumarate?
Sorry No Records found
What are the precautions of Tenofovir Disoproxil Fumarate?
Sorry No Records found
What are the side effects of Tenofovir Disoproxil Fumarate?
Sorry No records found
What should I look out for while using Tenofovir Disoproxil Fumarate?
None.
Severe acute exacerbations of hepatitis have been reported in HBV-infected patients who have discontinued anti-hepatitis B therapy, including tenofovir disoproxil fumarate tablets. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who discontinue anti-hepatitis B therapy, including tenofovir disoproxil fumarate. If appropriate, resumption of anti-hepatitis B therapy may be warranted
.
What might happen if I take too much Tenofovir Disoproxil Fumarate?
Limited clinical experience at doses higher than the therapeutic dose of tenofovir disoproxil fumarate tablets 300 mg is available. In Study 901, 600 mg tenofovir DF was administered to 8 subjects orally for 28 days. No severe adverse reactions were reported. The effects of higher doses are not known.
If overdose occurs the patient must be monitored for evidence of toxicity, and standard supportive treatment applied as necessary.
Tenofovir is efficiently removed by hemodialysis with an extraction coefficient of approximately 54%. Following a single 300 mg dose of tenofovir disoproxil fumarate tablets, a four-hour hemodialysis session removed approximately 10% of the administered tenofovir dose.
How should I store and handle Tenofovir Disoproxil Fumarate?
Store tenofovir disoproxil fumarate tablets at 25 °C (77 °F), excursions permitted to 15°C to 30°C (59°F to 86°F) (see USP Controlled Room Temperature).Keep the bottle tightly closed. Do not use if seal over bottle opening is broken or missing.Store tenofovir disoproxil fumarate tablets at 25 °C (77 °F), excursions permitted to 15°C to 30°C (59°F to 86°F) (see USP Controlled Room Temperature).Keep the bottle tightly closed. Do not use if seal over bottle opening is broken or missing.ULTRAVIST Injection is a sterile, clear, colorless to slightly yellow, odorless, pyrogen-free aqueous solution available in three strengths. ULTRAVIST Injection 240 mg Iodine per mL Pharmacy Bulk PackageULTRAVIST Injection 300 mg Iodine per mL Pharmacy Bulk PackageULTRAVIST Injection 370 mg Iodine per mL Pharmacy Bulk PackageStore ULTRAVIST at 25°C (77°F); excursions permitted to 15–30°C (59–86°F) and protected from light. Directions for Proper Use of ULTRAVIST Injection PHARMACY BULK PACKAGEULTRAVIST Injection is a sterile, clear, colorless to slightly yellow, odorless, pyrogen-free aqueous solution available in three strengths. ULTRAVIST Injection 240 mg Iodine per mL Pharmacy Bulk PackageULTRAVIST Injection 300 mg Iodine per mL Pharmacy Bulk PackageULTRAVIST Injection 370 mg Iodine per mL Pharmacy Bulk PackageStore ULTRAVIST at 25°C (77°F); excursions permitted to 15–30°C (59–86°F) and protected from light. Directions for Proper Use of ULTRAVIST Injection PHARMACY BULK PACKAGEULTRAVIST Injection is a sterile, clear, colorless to slightly yellow, odorless, pyrogen-free aqueous solution available in three strengths. ULTRAVIST Injection 240 mg Iodine per mL Pharmacy Bulk PackageULTRAVIST Injection 300 mg Iodine per mL Pharmacy Bulk PackageULTRAVIST Injection 370 mg Iodine per mL Pharmacy Bulk PackageStore ULTRAVIST at 25°C (77°F); excursions permitted to 15–30°C (59–86°F) and protected from light. Directions for Proper Use of ULTRAVIST Injection PHARMACY BULK PACKAGEULTRAVIST Injection is a sterile, clear, colorless to slightly yellow, odorless, pyrogen-free aqueous solution available in three strengths. ULTRAVIST Injection 240 mg Iodine per mL Pharmacy Bulk PackageULTRAVIST Injection 300 mg Iodine per mL Pharmacy Bulk PackageULTRAVIST Injection 370 mg Iodine per mL Pharmacy Bulk PackageStore ULTRAVIST at 25°C (77°F); excursions permitted to 15–30°C (59–86°F) and protected from light. Directions for Proper Use of ULTRAVIST Injection PHARMACY BULK PACKAGEULTRAVIST Injection is a sterile, clear, colorless to slightly yellow, odorless, pyrogen-free aqueous solution available in three strengths. ULTRAVIST Injection 240 mg Iodine per mL Pharmacy Bulk PackageULTRAVIST Injection 300 mg Iodine per mL Pharmacy Bulk PackageULTRAVIST Injection 370 mg Iodine per mL Pharmacy Bulk PackageStore ULTRAVIST at 25°C (77°F); excursions permitted to 15–30°C (59–86°F) and protected from light. Directions for Proper Use of ULTRAVIST Injection PHARMACY BULK PACKAGEULTRAVIST Injection is a sterile, clear, colorless to slightly yellow, odorless, pyrogen-free aqueous solution available in three strengths. ULTRAVIST Injection 240 mg Iodine per mL Pharmacy Bulk PackageULTRAVIST Injection 300 mg Iodine per mL Pharmacy Bulk PackageULTRAVIST Injection 370 mg Iodine per mL Pharmacy Bulk PackageStore ULTRAVIST at 25°C (77°F); excursions permitted to 15–30°C (59–86°F) and protected from light. Directions for Proper Use of ULTRAVIST Injection PHARMACY BULK PACKAGE
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Tenofovir DF is an antiviral drug
Non-Clinical Toxicology
None.Severe acute exacerbations of hepatitis have been reported in HBV-infected patients who have discontinued anti-hepatitis B therapy, including tenofovir disoproxil fumarate tablets. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who discontinue anti-hepatitis B therapy, including tenofovir disoproxil fumarate. If appropriate, resumption of anti-hepatitis B therapy may be warranted .
See Table 2 for clinically significant drug interactions with diclofenac.
Discontinuation of anti-HBV therapy, including tenofovir disoproxil fumarate tablets, may be associated with severe acute exacerbations of hepatitis. Patients infected with HBV who discontinue tenofovir disoproxil fumarate tablets should be closely monitored with both clinical and laboratory follow-up for at least several months after stopping treatment. If appropriate, resumption of anti-hepatitis B therapy may be warranted.
The following adverse reactions are discussed in other sections of the labeling:
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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