TENOFOVIR DISOPROXIL FUMARATE- tenofovir disoproxil fumarate tablet, film coated

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

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

Mevcut itibaren:

Camber Pharmaceuticals, Inc.

INN (International Adı):

TENOFOVIR DISOPROXIL FUMARATE

Kompozisyon:

TENOFOVIR DISOPROXIL FUMARATE 300 mg

Uygulama yolu:

ORAL

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

Tenofovir disoproxil fumarate tablets are 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 tablets are 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.

Ürün özeti:

Tenofovir Disoproxil Fumarate Tablets, 300 mg, are white colored, almond shaped, film coated tablets contain 300 mg of tenofovir disoproxil fumarate, 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 31722-535-30) Bottle of 60 tablets                  (NDC 31722-535-60) Bottle of 100 tablets                (NDC 31722-535-01) Bottle of 500 tablets                (NDC 31722-535-05) Bottle of 1000 tablets               (NDC 31722-535-10) Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. • Keep container tightly closed. • Do not use if seal over bottle opening is broken or missing.

Yetkilendirme durumu:

Abbreviated New Drug Application

Ürün özellikleri

TENOFOVIR DISOPROXIL FUMARATE - TENOFOVIR DISOPROXIL FUMARATE TABLET,
FILM COATED
CAMBER PHARMACEUTICALS, 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 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 tablets are a nucleotide analog HIV-1
reverse transcriptase inhibitor and an
HBV reverse transcriptase inhibitor and is 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 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 fumarate
tablets 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 kid