TENOFOVIR DISOPROXIL FUMARATE tablet, film coated

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

Aurobindo Pharma Limited

INN (Διεθνής Όνομα):

TENOFOVIR DISOPROXIL FUMARATE

Σύνθεση:

TENOFOVIR DISOPROXIL FUMARATE 150 mg

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

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 2 years of age and older weighing at least 10 kg. 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. Risk Summary Available data from the APR show no increase in the overall risk of major birth defects with first trimester exposure for tenofovir disoproxil fumarate (TDF) (2.1%) compared with the background rate for major birth defects of 2.7% in a U.S. reference popul

Περίληψη προϊόντος:

Tenofovir Disoproxil Fumarate Tablets, 150 mg are white to off-white, capsule shaped, biconvex, film-coated tablets debossed with ‘35’ on one side and ‘J’ on the other side.      Bottles of 30                                        NDC 65862-818-30      3 x 10 Unit-dose Tablets                     NDC 65862-818-03 Tenofovir Disoproxil Fumarate Tablets, 200 mg are white to off-white, round shaped, biconvex, film-coated tablets debossed with ‘K’ on one side and ‘25’ on the other side.      Bottles of 30                                        NDC 65862-819-30           3 x 10 Unit-dose Tablets                     NDC 65862-819-03 Tenofovir Disoproxil Fumarate Tablets, 250 mg are white to off-white, capsule shaped, biconvex, film-coated tablets debossed with ‘69 Y’ on one side and plain on the other side.      Bottles of 30                                        NDC 65862-820-30      3 x 10 Unit-dose Tablets                     NDC 65862-820-03 Tenofovir Disoproxil Fumarate Tablets, 300 mg are white to off-white, oval shaped, biconvex, film-coated tablets debossed with ‘I’ on one side and ‘36’ on the other side.      Bottles of 30                                         NDC 65862-421-30 Store at 20º to 25ºC (68º to 77ºF); excursions permitted to 15º to 30ºC (59° to 86°F) [see USP Controlled Room Temperature]. • Keep container tightly closed. • Dispense only in original container. • Do not use if seal over bottle opening is broken or missing.

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Αρχείο Π.Χ.Π.

TENOFOVIR DISOPROXIL FUMARATE - TENOFOVIR DISOPROXIL FUMARATE TABLET,
FILM COATED
AUROBINDO PHARMA LIMITED
----------
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)
INDICATIONS AND USAGE
Tenofovir disoproxil fumarate is 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 2 years and older weighing at
least 10 kg. (1.2)
DOSAGE AND ADMINISTRATION
Testing: Prior to or when initiating tenofovir disoproxil fumarate
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 kidney
disease, also assess serum phosphorous.
(2.1)
Recommended tablet dosage in adults and pediatric patients weighing at
least 35 kg: One tenofovir
disoproxil fumarate 300 mg tablet once daily taken orally without
regard to food. (2.2)
Reco