TENOFOVIR DISOPROXIL FUMARATE tablet

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

TENOFOVIR DISOPROXIL FUMARATE (UNII: OTT9J7900I) (TENOFOVIR ANHYDROUS - UNII:W4HFE001U5)

Διαθέσιμο από:

Strides Pharma Science Limited

INN (Διεθνής Όνομα):

TENOFOVIR DISOPROXIL FUMARATE

Σύνθεση:

TENOFOVIR DISOPROXIL FUMARATE 300 mg

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

Tenofovir disoproxil fumarate is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and pediatric patients 2 years of age and older weighing at least 10 kg. Tenofovir disoproxil fumarate is indicated for the treatment of chronic hepatitis B virus (HBV) in adults and pediatric patients 12 years of age and older Pediatric use information is approved for Gilead Sciences, Inc.'s VIREAD® (tenofovir disoproxil fumarate) tablets. However, due to Gilead Sciences, Inc.'s marketing exclusivity rights, this drug product is not labeled with that pediatric information. None. Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to tenofovir disoproxil fumarate during pregnancy. Healthcare providers are encouraged to register patients by calling the Antiretroviral Pregnancy Registry (APR) at 1-800-258-4263. Risk Summary Available data from the APR show no increase in the

Περίληψη προϊόντος:

Tablets Tenofovir Disoproxil Fumarate Tablets 300 mg are white circular film-coated convex tablets containing 300 mg of tenofovir disoproxil fumarate, which is equivalent to 245 mg of tenofovir disoproxil, engraved TDF on one side and plain on other side and are available in a 40 cc/ 50 cc HDPE container containing a desiccant (silica gel sachet) and closed with child-resistant screw cap. Store tenofovir disoproxil fumarate tablets at 25°C (77°F), excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Keep the bottle tightly closed. Dispense only in original container. Do not use if seal over bottle opening is broken or missing.

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Αρχείο Π.Χ.Π.

TENOFOVIR DISOPROXIL FUMARATE- TENOFOVIR DISOPROXIL FUMARATE TABLET
STRIDES PHARMA SCIENCE LIMITED
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
TENOFOVIR DISOPROXIL FUMARATE
TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
TENOFOVIR DISOPROXIL FUMARATE
TABLETS.
TENOFOVIR DISOPROXIL FUMARATE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL DATE: 2001
WARNINGS: POSTTREATMENT ACUTE EXACERBATION OF HEPATITIS B
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
SEVERE ACUTE EXACERBATIONS OF HEPATITIS B VIRUS (HBV) HAVE BEEN
REPORTED IN HBV-INFECTED PATIENTS WHO
HAVE DISCONTINUED ANTI-HEPATITIS B THERAPY, INCLUDING TENOFOVIR
DISOPROXIL FUMARATE. HEPATIC FUNCTION
SHOULD BE MONITORED CLOSELY IN HBV-INFECTED PATIENTS WHO DISCONTINUE
TENOFOVIR DISOPROXIL FUMARATE. IF
APPROPRIATE, RESUMPTION OF ANTI-HEPATITIS B THERAPY MAY BE WARRANTED.
(5.1)
RECENT MAJOR CHANGES
Indications and Usage, Chronic Hepatitis B (1.2) 12/2018
Dosage and Administration (2.1, 2.2, 2.4) 12/2018
Warnings and Precautions (5.1, 5.2, 5.5, 5.7) 12/2018
Early Virologic Failure Removed 12/2018
INDICATIONS AND USAGE
Tenofovir disoproxil fumarate is a nucleotide analog HIV-1 reverse
transcriptase inhibitor and an HBV reverse
transcriptase inhibitor and is indicated: (1)
in combination with other antiretroviral agents for the treatment of
HIV-1 infection in adults and pediatric patients 2
years of age and older weighing at least 10 kg. (1.1)
for the treatment of chronic hepatitis B in adults and pediatric
patients 12 years and older. (1.2)
DOSAGE AND ADMINISTRATION
Testing: Prior to or when initiating Tenofovir disoproxil fumarates
test for hepatitis B virus infection and HIV-1
infection. Prior to initiation and during use of Tenofovir disoproxil
fumarate, on a clinically appropriate schedule, assess
serum creatinine, estimated creatinine clearance, urine glucose, and
urine protein in all patients. In patients with chronic
kidney disease, also assess serum phosphor