RAPAFLO silodosin capsule

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

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

Prieinama:

Avera McKennan Hospital

INN (Tarptautinis Pavadinimas):

SILODOSIN

Sudėtis:

SILODOSIN 4 mg

Recepto tipas:

PRESCRIPTION DRUG

Autorizacija statusas:

New Drug Application

Prekės savybės

RAPAFLO- SILODOSIN CAPSULE
AVERA MCKENNAN HOSPITAL
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HIGHLIGHTS OF PRESCRIBING INFORMATION
_RAPAFLO (SILODOSIN) CAPSULES_
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
RAPAFLO SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR RAPAFLO.
RAPAFLO (SILODOSIN) CAPSULE FOR ORAL USE
INITIAL U.S. APPROVAL: 2008
INDICATIONS AND USAGE
RAPAFLO, an alpha-1 adrenergic receptor antagonist, is indicated for
the treatment of the signs and symptoms of benign
prostatic hyperplasia (BPH). RAPAFLO is 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) 30-50 mL/min]. (2.2)
DOSAGE FORMS AND STRENGTHS
Capsules: 8 mg and 4 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 RAPAFLO. (4)
WARNINGS AND PRECAUTIONS
Postural hypotension, with or without symptoms (e.g., dizziness), may
develop when beginning RAPAFLO treatment.
(5.1)
In patients with moderate renal impairment, RAPAFLO dose should be
reduced to 4 mg once daily. (5.2)
RAPAFLO should not be used in combination with other alpha-blockers.
(5.5)
Examine patients thought to have BPH prior to starting therapy with
RAPAFLO 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 RAPAFLO because of the
possibility of Intraoperative Floppy Iris Syndrome (IFIS). (5.7)
ADVERSE REACTIONS
Most common adverse reactions (incidence > 2%) are retrograde
ejaculation, dizziness, diarrhea, orthostatic hypotensio