Nchi: Marekani
Lugha: Kiingereza
Chanzo: NLM (National Library of Medicine)
TENOFOVIR DISOPROXIL FUMARATE (UNII: OTT9J7900I) (TENOFOVIR ANHYDROUS - UNII:W4HFE001U5)
REMEDYREPACK INC.
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 ® , 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
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
Abbreviated New Drug Application
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 Soma hati kamili