Krajina: Spojené štáty
Jazyk: angličtina
Zdroj: NLM (National Library of Medicine)
DUTASTERIDE (UNII: O0J6XJN02I) (DUTASTERIDE - UNII:O0J6XJN02I)
GlaxoSmithKline LLC
DUTASTERIDE
DUTASTERIDE 0.5 mg
ORAL
PRESCRIPTION DRUG
AVODART (dutasteride) soft gelatin capsules are indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to: AVODART in combination with the alpha-adrenergic antagonist, tamsulosin, is indicated for the treatment of symptomatic BPH in men with an enlarged prostate. AVODART is not approved for the prevention of prostate cancer. AVODART is contraindicated for use in: Risk Summary AVODART is contraindicated for use in pregnancy because it may cause harm to the male fetus [see Contraindications (4)] . AVODART is not indicated for use in women. AVODART is a 5 alpha‑reductase inhibitor that prevents conversion of testosterone to dihydrotestosterone (DHT), a hormone necessary for normal development of male genitalia. Abnormalities in the genitalia of male fetuses is an expected physiological consequence of inhibition of this conversion. These results are similar to observations in male infants with genetic 5 alpha‑reductase deficiency. In the U.S. general populat
AVODART soft gelatin capsules 0.5 mg are oblong, opaque, dull yellow, gelatin capsules imprinted with “GX CE2” with red edible ink on one side, packaged in bottles of 30 (NDC 0173-0712-15) and 90 (NDC 0173-0712-04) with child-resistant closures. Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Dutasteride is absorbed through the skin. AVODART capsules should not be handled by women who are pregnant or who could become pregnant because of the potential for absorption of dutasteride and the subsequent potential risk to a developing male fetus [see Warnings and Precautions (5.4)] .
New Drug Application
AVODART- DUTASTERIDE CAPSULE, LIQUID FILLED GLAXOSMITHKLINE LLC ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE AVODART SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR AVODART. AVODART (DUTASTERIDE) SOFT GELATIN CAPSULES INITIAL U.S. APPROVAL: 2001 INDICATIONS AND USAGE AVODART is a 5 alpha-reductase inhibitor indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to: (1.1) • • • AVODART in combination with the alpha-adrenergic antagonist, tamsulosin, is indicated for the treatment of symptomatic BPH in men with an enlarged prostate. (1.2) Limitations of Use: AVODART is not approved for the prevention of prostate cancer. (1.3) DOSAGE AND ADMINISTRATION • • • DOSAGE FORMS AND STRENGTHS 0.5-mg soft gelatin capsules (3) CONTRAINDICATIONS • • WARNINGS AND PRECAUTIONS • • • • • ADVERSE REACTIONS The most common adverse reactions, reported in ≥1% of subjects treated with AVODART and more commonly than in subjects treated with placebo, are impotence, decreased libido, ejaculation disorders, and breast disorders. (6.1) TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT GLAXOSMITHKLINE AT 1-888-825-5249 OR FDA AT 1-800- FDA-1088 OR WWW.FDA.GOV/MEDWATCH. DRUG INTERACTIONS Use with caution in patients taking potent, chronic cytochrome P450 (CYP)3A4 enzyme inhibitors (e.g., ritonavir). (7) SEE 17 FOR PATIENT COUNSELING INFORMATION AND FDA-APPROVED PATIENT LABELING. REVISED: 1/2020 improve symptoms, reduce the risk of acute urinary retention, and reduce the risk of the need for BPH-related surgery. Monotherapy: 0.5 mg once daily. (2.1) Combination with tamsulosin: 0.5 mg once daily and tamsulosin 0.4 mg once daily. (2.2) Dosing considerations: Swallow whole. May take with or without food. (2) Pregnancy. Dutasteride use is contraindicated in women who are pregnant. (4, 5.4, 8.1) Patients with previously demonstrated, clinically significant hypersensitivity (e.g., seriou Prečítajte si celý dokument