Země: Spojené státy
Jazyk: angličtina
Zdroj: NLM (National Library of Medicine)
TRETINOIN (UNII: 5688UTC01R) (TRETINOIN - UNII:5688UTC01R)
Teva Pharmaceuticals USA, Inc.
TRETINOIN
TRETINOIN 10 mg
ORAL
PRESCRIPTION DRUG
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
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.
Abbreviated New Drug Application
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) Přečtěte si celý dokument