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:

REMEDYREPACK INC.

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 tab

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: NDC: 70518-2151-00 NDC: 70518-2151-01 PACKAGING: 30 in 1 BLISTER PACK PACKAGING: 4 in 1 BLISTER PACK 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. Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

Estado de Autorización:

Abbreviated New Drug Application

Ficha técnica

TENOFOVIR DISOPROXIL FUMARATE- TENOFOVIR DISOPROXIL FUMARATE TABLET,
FILM
COATED
REMEDYREPACK INC.
----------
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 fumara