国: アメリカ合衆国
言語: 英語
ソース: NLM (National Library of Medicine)
TENOFOVIR DISOPROXIL FUMARATE (UNII: OTT9J7900I) (TENOFOVIR ANHYDROUS - UNII:W4HFE001U5)
Teva Pharmaceuticals USA, Inc.
TENOFOVIR DISOPROXIL FUMARATE
TENOFOVIR DISOPROXIL FUMARATE 300 mg
ORAL
PRESCRIPTION DRUG
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® , 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 HBV infection: - The indication in adults is based on safety and efficacy data from treatment of subjects who were nucleoside-treatment-naïve and subjects who were treatment-experienced w
Tenofovir disoproxil fumarate tablets are available as follows: 300 mg – light-blue to blue, modified capsule-shaped, film-coated tablets, debossed with “TV” on one side of the tablet and “7104” on the other side, in unit of use bottles of 30 (containing a desiccant and closed with a child-resistant closure) (NDC 0093-7104-56). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Keep this and all medications out of the reach of children. Keep the bottle tightly closed. Dispense only in original container. Do not use if seal over bottle opening is broken or missing.
Abbreviated New Drug Application
TENOFOVIR DISOPROXIL FUMARATE- TENOFOVIR DISOPROXIL FUMARATE TABLET, FILM COATED TEVA PHARMACEUTICALS USA, INC. ---------- 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. 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) 04/2017 Boxed Warning, Lactic Acidosis/Severe Hepatomegaly With Steatosis Removed 04/2017 Warnings and Precautions, Lactic Acidosis/Severe Hepatomegaly With Steatosis (5.3) 04/2017 Warnings and Precautions, Coadministration With Other Products (5.4) 04/2017 Warnings and Precautions, Fat Redistribution Removed 04/2017 INDICATIONS AND USAGE Tenofovir disoproxil fumarate tablets are a nucleotide analog HIV-1 reverse transcriptase inhibitor and an HBV reverse transcriptase inhibitor. (1) 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 ped 完全なドキュメントを読む