TENOFOVIR DISOPROXIL FUMARATE tablet, film coated

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

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

Disponible desde:

NorthStar RxLLC

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

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: • Tenofovir disoproxil fumarate tablets should not be used in combination with ATRIPLA® , BIKTARVY® , COMPLERA® , DESCOVY® , GENVOYA® , ODEFSEY® , STRIBILD® , TRUVADA® , or VEMLIDY® [See Warnings and Precautions (5.4)]. Tenofovir disoproxil fumarate tablets are indicated for the treatment of chronic hepatitis B in adults and pediatric patients 12 years of age and older. The following points should be considered when initiating therapy with tenofovir disoproxil fumarate tablets for the treatment of chronic hepatitis B infection: • The indication in adults is based on safety and efficacy data from treatment of subjects who were nucleoside-treatment-naïve and subjects

Resumen del producto:

Tablets Tenofovir disoproxil fumarate tablets, 300 mg,  are white colored, almond shaped, film coated tablets contain 300 mg of tenofovir DF, which is equivalent to 245 mg of tenofovir disoproxil, are debossed with .H. on one side and .123. on other side. They are packaged as follows: Bottle of 30 tablets       (NDC 16714-820-01) Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Keep the bottle tightly closed. Do not use if seal over bottle opening is broken or missing.

Estado de Autorización:

Abbreviated New Drug Application

Ficha técnica

TENOFOVIR DISOPROXIL FUMARATE - TENOFOVIR DISOPROXIL FUMARATE TABLET,
FILM COATED
NORTHSTAR RXLLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
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: 2001
WARNING: POSTTREATMENT EXACERBATION OF HEPATITIS _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
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 IN THESE PATIENTS. IF APPROPRIATE,
RESUMPTION OF ANTI-HEPATITIS B THERAPY MAY
BE WARRANTED. (5.1)
RECENT MAJOR CHANGES
Indications and Usage (1.1) 07/2018
Warnings and Precautions, Coadministration with
Other Products (5.4) 07/2018
INDICATIONS AND USAGE
Tenofovir disoproxil fumarate tablets are a nucleotide analog HIV-1
reverse transcriptase inhibitor and an HBV reverse
transcriptase inhibitor.
• 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. (1)
• Tenofovir disoproxil fumarate tablets are indicated for the
treatment of chronic hepatitis B in adults and pediatric patients
12 years of age and older. (1)
DOSAGE AND ADMINISTRATION
• Recommended dose for the treatment of HIV-1 or chronic hepatitis B
in adults and pediatric patients 12 years of age and
older (35 kg or more): 300 mg once daily taken orally without regard
to food. (2.1)
• Recommended dose for the treatment of HIV-1 in pediatric patients
(2 to less than 12 years of age):
o Tablets: For pediatric patients weighing greater than or equal to 17
kg who can swallow an intact tablet, one tenofovir
disoproxil fumarat