SILODOSIN capsule

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

SILODOSIN (UNII: CUZ39LUY82) (SILODOSIN - UNII:CUZ39LUY82)

Disponible desde:

Amneal Pharmaceuticals NY LLC

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Silodosin, a selective alpha-1 adrenergic receptor antagonist, is indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) [see Clinical Studies (14)] . Silodosin capsules are not indicated for the treatment of hypertension. - Severe renal impairment (CCr < 30 mL/min) - Severe hepatic impairment (Child-Pugh score ≥ 10) - Concomitant administration with strong Cytochrome P450 3A4 (CYP3A4) inhibitors (e.g., ketoconazole, clarithromycin, itraconazole, ritonavir) [see Drug Interactions (7.1)] - Patients with a history of hypersensitivity to silodosin or any of the ingredients of silodosin capsules [see Adverse Reactions (6.2) and Description (11)] Risk Summary Silodosin capsules are not indicated for use in females. Silodosin capsules are not indicated for use in females. Infertility Males Possible effects on male fertility could be observed based on findings in rats at exposures that were at least two times higher than at the MRHD (based on AUC). These findings may be reversible, and the clinical relevance is unknown [see Nonclinical Toxicology (13.1)] . Silodosin capsules are not indicated for use in pediatric patients. Safety and effectiveness in pediatric patients have not been established. In double-blind, placebo-controlled, 12-week clinical studies of silodosin, 259 (55.6%) were under 65 years of age, 207 (44.4%) patients were 65 years of age and over, while 60 (12.9%) patients were 75 years of age and over. Orthostatic hypotension was reported in 2.3% of silodosin patients < 65 years of age (1.2% for placebo), 2.9% of silodosin patients ≥ 65 years of age (1.9% for placebo), and 5.0% of patients ≥ 75 years of age (0% for placebo). There were otherwise no significant differences in safety or effectiveness between older and younger patients [see Clinical Pharmacology (12.3)] . The effect of renal impairment on silodosin pharmacokinetics was evaluated in a single dose study of six male patients with moderate renal impairment and seven male subjects with normal renal function. Plasma concentrations of silodosin were approximately three times higher in subjects with moderate renal impairment compared with subjects with normal renal function. Silodosin should be reduced to 4 mg per day in patients with moderate renal impairment. Exercise caution and monitor patients for adverse events. Silodosin has not been studied in patients with severe renal impairment. Silodosin is contraindicated in patients with severe renal impairment [see Contraindications (4) , Warnings and Precautions (5.2) and Clinical Pharmacology (12.3)] . In a study comparing nine male patients with moderate hepatic impairment (Child-Pugh scores 7 to 9), to nine healthy male subjects, the single dose pharmacokinetics of silodosin were not significantly altered in patients with hepatic impairment. No dosing adjustment is required in patients with mild or moderate hepatic impairment. Silodosin has not been studied in patients with severe hepatic impairment. Silodosin is contraindicated in patients with severe hepatic impairment [see Contraindications (4) , Warnings and Precautions (5.3)  and Clinical Pharmacology (12.3)] .

Resumen del producto:

Silodosin Capsules, 4 mg are supplied as white, opaque, hard # 3 gelatin capsules imprinted with “AN” in gold on the cap and “1421” in gold on the body. They are available as follows: Bottles of 30:                          NDC 60219-1421-3 Bottles of 90:                          NDC 60219-1421-9 Silodosin Capsules, 8 mg are supplied as white, opaque, hard # l gelatin capsules imprinted with “AN” in green on the cap and “1420” in green on the body. They are available as follows: Bottles of 30:                          NDC 60219-1420-3 Bottles of 90:                          NDC 60219-1420-9 Storage Store at 20° to 25ºC (68° to 77ºF); excursions permitted between 15º to 30ºC (59° to 86ºF) [see USP Controlled Room Temperature]. Protect from light and moisture. Keep out of reach of children.

Estado de Autorización:

Abbreviated New Drug Application

Ficha técnica

SILODOSIN- SILODOSIN CAPSULE
AMNEAL PHARMACEUTICALS NY LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
SILODOSIN CAPSULES
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR SILODOSIN
CAPSULES.
SILODOSIN CAPSULES, FOR ORAL USE
INITIAL U.S. APPROVAL: 2008
INDICATIONS AND USAGE
Silodosin, an alpha-1 adrenergic receptor antagonist, is indicated for
the treatment of the signs and
symptoms of benign prostatic hyperplasia (BPH).
Silodosin capsules are not indicated for the treatment of
hypertension. (1)
DOSAGE AND ADMINISTRATION
8 mg capsules taken orally once daily with a meal. (2.1)
4 mg capsules taken orally once daily with a meal for those with
moderate renal impairment [Creatinine
Clearance (CCr) 30 mL/min to 50 mL/min]. (2.2)
DOSAGE FORMS AND STRENGTHS
Capsules: 4 mg and 8 mg. (3)
CONTRAINDICATIONS
Patients with severe renal impairment [Creatinine Clearance (CCr < 30
mL/min)]. (4)
Patients with severe hepatic impairment (Child-Pugh score > 10). (4)
Concomitant administration with strong Cytochrome P450 3A4 (CYP3A4)
inhibitors (e.g., ketoconazole,
clarithromycin, itraconazole, ritonavir). (4)
Patients with a history of hypersensitivity to silodosin or any of the
ingredients of silodosin capsules. (4)
WARNINGS AND PRECAUTIONS
Postural hypotension, with or without symptoms (e.g., dizziness), may
develop when beginning silodosin
treatment. (5.1)
In patients with moderate renal impairment, silodosin dose should be
reduced to 4 mg once daily. (5.2)
Silodosin should not be used in combination with other alpha-blockers.
(5.5)
Examine patients thought to have BPH prior to starting therapy with
silodosin to rule out the presence
of carcinoma of the prostate. (5.6)
Inform patients planning cataract surgery to notify their
ophthalmologist that they are taking silodosin
because of the possibility of Intraoperative Floppy Iris Syndrome
(IFIS). (5.7)
ADVERSE REACTIONS
Most common adverse reactions (incidence ≥ 2%) are retrograde
ejaculation, dizzi