SILODOSIN capsule, gelatin coated

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

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

Saatavilla:

Sandoz Inc

Antoreitti:

ORAL

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

Silodosin capsules, a selective alpha-1 adrenergic receptor antagonist, are 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. Risk Summary Silodosin is not indicated for use in females. Silodosin is 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 is 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. Or

Tuoteyhteenveto:

Silodosin Capsules, for oral administration, are available as: 8 mg: White, opaque, hard gelatin capsules. Cap is imprinted with “SANDOZ” in black. Body is imprinted with “808” in black and supplied as: 4 mg: White, opaque, hard gelatin capsules. Cap is imprinted with “SANDOZ” in black. Body is imprinted with “804” in black and supplied as: Storage Store at 20° to 25°C (68° to 77°F) [see USP controlled room temperature.] Keep container tightly closed and protect from moisture and humidity. KEEP OUT OF THE REACH OF CHILDREN.

Valtuutuksen tilan:

Abbreviated New Drug Application

Valmisteyhteenveto

SILODOSIN- SILODOSIN CAPSULE, GELATIN COATED
SANDOZ INC
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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 capsules, 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
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DOSAGE FORMS AND STRENGTHS
Capsules: 8 mg and 4 mg. (3)
CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
Most common adverse reactions (incidence > 2%) are retrograde
ejaculation, dizziness, diarrhea,
orthostatic hypotension, headache, nasopharyngitis, and nasal
congestion. (6)
To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at
1-800-525-8747 or FDA at 1-800-FDA-
1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
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USE IN SPECIFIC POPULATIONS
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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 to 50 mL/min]. (2.2)
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. (4)
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)
Exam