silodosin 8 MG Oral Capsule

1 INDICATIONS 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) [see Clinical Studies (14 ) ] . Silodosin capsules are not indicated for the treatment of hypertension. 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 )

Amneal Pharmaceuticals NY LLC

FDA Reported Adverse Reactions
`[1] fatigue` `[2] drug ineffective` `[3] off label use` `[4] nausea` `[5] pain` `[6] headache` `[7] dyspnoea` `[8] toxicity to various agents` `[9] diarrhoea` `[10] arthralgia`

4 years ago

CAPSULE WHITE AN 1420

16 HOW SUPPLIED/STORAGE AND HANDLING

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 69238-1421-3 Bottles of 90: NDC 69238-1421-9

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 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.

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Amneal Pharmaceuticals NY LLC

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