TRETINOIN capsule, liquid filled

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

TRETINOIN (UNII: 5688UTC01R) (TRETINOIN - UNII:5688UTC01R)

Prieinama:

Teva Pharmaceuticals USA, Inc.

INN (Tarptautinis Pavadinimas):

TRETINOIN

Sudėtis:

TRETINOIN 10 mg

Vartojimo būdas:

ORAL

Recepto tipas:

PRESCRIPTION DRUG

Terapinės indikacijos:

Tretinoin capsules are indicated for the induction of remission in adults and pediatric patients 1 year of age and older with acute promyelocytic leukemia (APL) characterized by the presence of the t(15;17) translocation or PML/RARα gene expression, and who are refractory to or who have relapsed from anthracycline chemotherapy or for whom anthracycline-based chemotherapy is contraindicated. Tretinoin capsules are contraindicated in patients with a known hypersensitivity to tretinoin, any of its components, or other retinoids. Reactions have included rash, pruritus, face edema, and dyspnea. [see Adverse Reactions (6.1)] . Risk Summary Based on findings in animals and its mechanism of action [see Clinical Pharmacology (12.1)] , tretinoin can cause embryo-fetal loss and malformations when administered to a pregnant woman. Tretinoin is a retinoid and there is an increased risk of major congenital malformations, spontaneous abortions and premature births following exposure to retinoids during pregnancy in human

Produkto santrauka:

Tretinoin Capsules, 10 mg are available as two-piece hard gelatin capsule with brown opaque cap and dark yellow opaque body, filled with yellow viscous oily suspension. Imprinted in black ink with stylized barr 808. Available in bottles of 100 capsules (NDC 0555-0808-02). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). Keep this and all medications out of the reach of children. Protect from light.

Autorizacija statusas:

Abbreviated New Drug Application

Prekės savybės

TRETINOIN- TRETINOIN CAPSULE, LIQUID FILLED
TEVA PHARMACEUTICALS USA, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
TRETINOIN CAPSULES
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR TRETINOIN
CAPSULES.
TRETINOIN CAPSULES, FOR ORAL USE
INITIAL U.S. APPROVAL: 1995
WARNING: EMBRYO-FETAL TOXICITY AND DIFFERENTIATION SYNDROME
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_.
EMBRYO-FETAL TOXICITY: TRETINOIN CAN CAUSE EMBRYO-FETAL LOSS AND
MALFORMATIONS
WHEN ADMINISTERED TO A PREGNANT WOMAN. ADVISE PREGNANT WOMEN OF THE
POTENTIAL
RISK TO A FETUS. FEMALES OF REPRODUCTIVE POTENTIAL MUST HAVE A
NEGATIVE PREGNANCY
TEST BEFORE INITIATING TRETINOIN. ADVISE FEMALES OF REPRODUCTIVE
POTENTIAL TO USE TWO
EFFECTIVE METHODS OF CONTRACEPTION DURING TREATMENT WITH TRETINOIN AND
FOR 1 MONTH
AFTER THE LAST DOSE. ADVISE MALES WITH FEMALE PARTNERS OF REPRODUCTIVE
POTENTIAL TO
USE EFFECTIVE CONTRACEPTION DURING TREATMENT WITH TRETINOIN AND FOR 1
WEEK AFTER THE
LAST DOSE. (5.1, 8.1, 8.3) DIFFERENTIATION SYNDROME, WHICH CAN BE LIFE-THREATENING OR FATAL,
OCCURRED IN ABOUT
26% OF PATIENTS WITH APL WHO RECEIVED TRETINOIN. AT FIRST SIGNS OR
SYMPTOMS OF THIS
SYNDROME, IMMEDIATELY INITIATE HIGH-DOSE CORTICOSTEROID THERAPY AND
HEMODYNAMIC
MONITORING UNTIL RESOLUTION OF SIGNS AND SYMPTOMS. CONSIDER
WITHHOLDING TRETINOIN
FOR MODERATE AND SEVERE DIFFERENTIATION SYNDROME UNTIL RESOLUTION.
(5.2)
INDICATIONS AND USAGE
Tretinoin capsules are a retinoid indicated for induction of remission
in adults and pediatric patients 1 year
of age and older with acute promyelocytic leukemia (APL),
characterized by presence of t(15;17)
translocation or presence of PML/RARα gene expression, and who are
refractory to or who have relapsed
from anthracycline chemotherapy or for whom anthracycline-based
chemotherapy is contraindicated. (1)
DOSAGE AND ADMINISTRATION
The recommended dosage of tretinoin capsules is 22.5 mg/m orally twice
daily until complete
remission. (2.2)