Brand Name
Silodosin
View Brand InformationFDA approval date: December 03, 2018
Classification: alpha-Adrenergic Blocker
Form: Capsule
What is Silodosin?
Silodosin, a selective alpha‑1 adrenergic receptor antagonist, is indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia . Silodosin capsules is not indicated for the treatment of hypertension. Silodosin capsules, an alpha‑1 adrenergic receptor antagonist, is indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia . Silodosin capsules are not indicated for the treatment of hypertension.
Approved To Treat
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Brand Information
Silodosin (Silodosin)
1INDICATIONS AND USAGE
Silodosin, a selective alpha-1 adrenergic receptor antagonist, is indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH)
2DOSAGE FORMS AND STRENGTHS
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.
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.
3CONTRAINDICATIONS
- 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)
- Patients with a history of hypersensitivity to silodosin or any of the ingredients of silodosin capsules
4OVERDOSAGE
Silodosin was evaluated at doses of up to 48 mg/day in healthy male subjects. The dose-limiting adverse event was postural hypotension.
Should overdose of silodosin lead to hypotension, support of the cardiovascular system is of first importance. Restoration of blood pressure and normalization of heart rate may be accomplished by maintaining the patient in the supine position. If this measure is inadequate, administration of intravenous fluid should be considered. If necessary, vasopressors could be used, and renal function should be monitored and supported as needed. Dialysis is unlikely to be of significant benefit since silodosin is highly (97%) protein bound.
5DESCRIPTION
Silodosin is a selective antagonist of alpha-1 adrenoreceptors. The chemical name of silodosin is 1-(3-Hydroxypropyl)-5-[(2
Silodosin is a white to pale yellowish white powder that melts at approximately 105° to 109°C. It is very soluble in acetic acid, freely soluble in alcohol, and very slightly soluble in water.
Each silodosin capsules, 4 mg and 8 mg for oral administration contains 4 mg or 8 mg silodosin respectively and inactive ingredients: gelatin, mannitol, pregelatinized starch [Botanical source: corn (maize)], sodium lauryl sulphate, sodium stearyl fumarate and titanium dioxide.
Each capsule of 4 mg and 8 mg are imprinted with gold pharmaceutical ink or green pharmaceutical ink respectively and contains: FD & C blue #2 aluminum lake (green pharmaceutical ink), butyl alcohol, dehydrated alcohol, isopropyl alcohol, propylene glycol, shellac, strong ammonia solution, titanium dioxide (green pharmaceutical ink), and yellow iron oxide.
6HOW SUPPLIED/STORAGEAND HANDLING
Silodosin Capsules,
Bottles of 30: NDC 69238-1421-3
Bottles of 90: NDC 69238-1421-9
Silodosin Capsules,
Bottles of 30: NDC 69238-1420-3
Bottles of 90: NDC 69238-1420-9
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.
7PATIENT COUNSELING INFORMATION
Advise patients to take silodosin capsules once daily with a meal
Advise patients about the possible occurrence of symptoms related to postural hypotension (such as dizziness), and should be cautioned about driving, operating machinery, or performing hazardous tasks until they know how silodosin will affect them. This is especially important for those with low blood pressure or who are taking antihypertensive medications
Counsel patients on that the most common side effect seen with silodosin is an orgasm with reduced or no semen. This side effect does not pose a safety concern and is reversible with discontinuation of the product
Counsel patients to tell their ophthalmologist about the use of silodosin before cataract surgery or other procedures involving the eyes, even if the patient is no longer taking silodosin
For additional information see: www.amneal.com or call 1-877-835-5472.
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Rev. 03-2021-01
8PRINCIPAL DISPLAY PANEL
NDC 69238-1421-3
Silodosin Capsules, 4 mg
Rx only
30 Capsules
Amneal Pharmaceuticals LLC
NDC 69238-1420-3
Silodosin Capsules, 8 mg
Rx only
30 Capsules
Amneal Pharmaceuticals LLC