silodosin

REMS

Benign prostatic hyperplasia (BPH).

Contraindicated in:

Hypersensitivity;
Severe renal impairment (CrCl <30 mL/min);
Severe hepatic impairment;
Concurrent use of strong CYP3A4 inhibitors.

Use Cautiously in:

Cataract surgery (may cause intraoperative floppy iris syndrome);
Moderate renal impairment (lower dose recommended);
Geri: ↑risk of orthostatic hypotension in older adults;
Pedi: Safety and effectiveness not established in children.

CV: orthostatic hypotension

Derm: pruritus, rash, urticaria

GI: diarrhea

GU: retrograde ejaculation

Neuro: dizziness, headache

Misc: allergic reactions

Drug-drug:

Strong CYP3A4 inhibitors, including ketoconazole, clarithromycin, itraconazole, and ritonavir, significantly ↑ levels and risk of toxicity; concurrent use contraindicated.
Moderate CYP3A4 inhibitors, including diltiazem, erythromycin, and verapamil, may ↑ levels and risk of toxicity; use cautiously.
Concurrent use with antihypertensives (including calcium channel blockers and thiazide diuretics), other alpha blockers, and PDE-5 inhibitors (including sildenafil, tadalafil, and vardenafil) ↑ the risk of dizziness and orthostatic hypotension.
P-glycoprotein inhibitors, including cyclosporine, may ↑ levels and the risk of toxicity; concurrent use not recommended.

(Generic available)

Capsules: 4 mg; 8 mg

PO (Adults ): 8 mg once daily.

Renal Impairment

PO (Adults ): CCr 30–50 mL/min: 4 mg once daily.

Rapaflo

Blocks postsynaptic alpha₁-adrenergic receptors. Decreases contractions in the smooth muscle of the prostatic capsule.

Therapeutic effects:

Decreased signs and symptoms of BPH (urinary urgency, hesitancy, nocturia).

Therapeutic Classification: benign prostatic hyperplasia bph agents

Pharmacologic Classification: alpha adrenergic blockers

Absorption: 32% absorbed following oral administration.

Distribution: Well distributed to tissues.

Protein Binding: 97%.

Metabolism/Excretion: Extensively metabolized by the liver by the CYP3A4 isoenzyme, UGT2B7, and other metabolic pathways; 33.5% excreted in urine and 54.9% in feces.

Half-Life: 13.3 hr.

(effect on BPH symptoms)

ROUTE	ONSET	PEAK	DURATION
PO	rapid	24 hr	24 hr*

*Following discontinuation.

Instruct patient to take medication as directed with the same meal each day.
- May cause dizziness. Caution patient to avoid driving or other activities requiring alertness until response to the medication is known.
- Caution patient to avoid sudden changes in position to decrease orthostatic hypotension, especially patients with low BP or concurrently taking antihypertensives. Assess risk for falls; instruct patient and family in preventing falls at home.
- Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and consult health care professional before taking any new medications, especially cough, cold, or allergy remedies.
- Instruct patient to notify health care professional of medication regimen before any surgery. Patients planning cataract surgery should notify ophthalmologist of silodosin therapy prior to surgery.
- Inform patient that silodosin may cause retrograde ejaculation (orgasm with reduced or no semen). This does not pose a safety concern and is reversible with discontinuation.
- Emphasize the importance of follow-up exams to evaluate effectiveness of medication.

si-LO-do-sin

NDC Code

0023- Allergan, Inc.
- 0023-6142- RAPAFLO
  - 0023-6142-30- 30 CAPSULE in 1 BOTTLE, UNIT-DOSE (0023-6142-30)

0023- Allergan, Inc.
- 0023-6142- RAPAFLO
  - 0023-6142-90- 90 CAPSULE in 1 BOTTLE, UNIT-DOSE (0023-6142-90)

0023- Allergan, Inc.
- 0023-6147- RAPAFLO
  - 0023-6147-30- 30 CAPSULE in 1 BOTTLE, UNIT-DOSE (0023-6147-30)

0781- Sandoz Inc
- 0781-2623- Silodosin
  - 0781-2623-10- 1000 CAPSULE, GELATIN COATED in 1 BOTTLE (0781-2623-10)

0781- Sandoz Inc
- 0781-2623- Silodosin
  - 0781-2623-31- 30 CAPSULE, GELATIN COATED in 1 BOTTLE (0781-2623-31)

0781- Sandoz Inc
- 0781-2623- Silodosin
  - 0781-2623-92- 90 CAPSULE, GELATIN COATED in 1 BOTTLE (0781-2623-92)

0781- Sandoz Inc
- 0781-2624- Silodosin
  - 0781-2624-10- 1000 CAPSULE, GELATIN COATED in 1 BOTTLE (0781-2624-10)

0781- Sandoz Inc
- 0781-2624- Silodosin
  - 0781-2624-31- 30 CAPSULE, GELATIN COATED in 1 BOTTLE (0781-2624-31)

0781- Sandoz Inc
- 0781-2624- Silodosin
  - 0781-2624-92- 90 CAPSULE, GELATIN COATED in 1 BOTTLE (0781-2624-92)

27241- Ajanta Pharma Limited
- 27241-144- Silodosin
  - 27241-144-01- 30 CAPSULE in 1 BOTTLE (27241-144-01)

27241- Ajanta Pharma Limited
- 27241-145- Silodosin
  - 27241-145-01- 30 CAPSULE in 1 BOTTLE (27241-145-01)

27241- Ajanta Pharma Limited
- 27241-145- Silodosin
  - 27241-145-03- 90 CAPSULE in 1 BOTTLE (27241-145-03)

33342- Macleods Pharmaceuticals Limited
- 33342-384- Silodosin
  - 33342-384-07- 30 CAPSULE in 1 BOTTLE (33342-384-07)

33342- Macleods Pharmaceuticals Limited
- 33342-384- Silodosin
  - 33342-384-10- 90 CAPSULE in 1 BOTTLE (33342-384-10)

33342- Macleods Pharmaceuticals Limited
- 33342-384- Silodosin
  - 33342-384-12- 100 BLISTER PACK in 1 CARTON (33342-384-12) > 10 CAPSULE in 1 BLISTER PACK

33342- Macleods Pharmaceuticals Limited
- 33342-385- Silodosin
  - 33342-385-07- 30 CAPSULE in 1 BOTTLE (33342-385-07)

33342- Macleods Pharmaceuticals Limited
- 33342-385- Silodosin
  - 33342-385-10- 90 CAPSULE in 1 BOTTLE (33342-385-10)

33342- Macleods Pharmaceuticals Limited
- 33342-385- Silodosin
  - 33342-385-12- 100 BLISTER PACK in 1 CARTON (33342-385-12) > 10 CAPSULE in 1 BLISTER PACK

46708- Alembic Pharmaceuticals Limited
- 46708-405- Silodosin
  - 46708-405-30- 30 CAPSULE in 1 BOTTLE (46708-405-30)

46708- Alembic Pharmaceuticals Limited
- 46708-405- Silodosin
  - 46708-405-90- 90 CAPSULE in 1 BOTTLE (46708-405-90)

46708- Alembic Pharmaceuticals Limited
- 46708-405- Silodosin
  - 46708-405-91- 1000 CAPSULE in 1 BOTTLE (46708-405-91)

46708- Alembic Pharmaceuticals Limited
- 46708-406- Silodosin
  - 46708-406-30- 30 CAPSULE in 1 BOTTLE (46708-406-30)

46708- Alembic Pharmaceuticals Limited
- 46708-406- Silodosin
  - 46708-406-90- 90 CAPSULE in 1 BOTTLE (46708-406-90)

46708- Alembic Pharmaceuticals Limited
- 46708-406- Silodosin
  - 46708-406-91- 1000 CAPSULE in 1 BOTTLE (46708-406-91)

52544- Actavis Pharma, Inc.
- 52544-151- RAPAFLO
  - 52544-151-19- 90 CAPSULE in 1 BOTTLE, UNIT-DOSE (52544-151-19)

52544- Actavis Pharma, Inc.
- 52544-151- RAPAFLO
  - 52544-151-30- 30 CAPSULE in 1 BOTTLE, UNIT-DOSE (52544-151-30)

52544- Actavis Pharma, Inc.
- 52544-152- RAPAFLO
  - 52544-152-19- 90 CAPSULE in 1 BOTTLE, UNIT-DOSE (52544-152-19)

52544- Actavis Pharma, Inc.
- 52544-152- RAPAFLO
  - 52544-152-30- 30 CAPSULE in 1 BOTTLE, UNIT-DOSE (52544-152-30)

59651- Aurobindo Pharma Limited
- 59651-095- SILODOSIN
  - 59651-095-30- 30 CAPSULE in 1 BOTTLE (59651-095-30)

59651- Aurobindo Pharma Limited
- 59651-095- SILODOSIN
  - 59651-095-90- 90 CAPSULE in 1 BOTTLE (59651-095-90)

59651- Aurobindo Pharma Limited
- 59651-096- SILODOSIN
  - 59651-096-30- 30 CAPSULE in 1 BOTTLE (59651-096-30)

59651- Aurobindo Pharma Limited
- 59651-096- SILODOSIN
  - 59651-096-90- 90 CAPSULE in 1 BOTTLE (59651-096-90)

62332- Alembic Pharmaceuticals Inc.
- 62332-405- Silodosin
  - 62332-405-30- 30 CAPSULE in 1 BOTTLE (62332-405-30)

62332- Alembic Pharmaceuticals Inc.
- 62332-405- Silodosin
  - 62332-405-90- 90 CAPSULE in 1 BOTTLE (62332-405-90)

62332- Alembic Pharmaceuticals Inc.
- 62332-405- Silodosin
  - 62332-405-91- 1000 CAPSULE in 1 BOTTLE (62332-405-91)

62332- Alembic Pharmaceuticals Inc.
- 62332-406- Silodosin
  - 62332-406-30- 30 CAPSULE in 1 BOTTLE (62332-406-30)

62332- Alembic Pharmaceuticals Inc.
- 62332-406- Silodosin
  - 62332-406-90- 90 CAPSULE in 1 BOTTLE (62332-406-90)

62332- Alembic Pharmaceuticals Inc.
- 62332-406- Silodosin
  - 62332-406-91- 1000 CAPSULE in 1 BOTTLE (62332-406-91)

68180- Lupin Pharmaceuticals, Inc.
- 68180-740- Silodosin
  - 68180-740-02- 500 CAPSULE in 1 BOTTLE (68180-740-02)

68180- Lupin Pharmaceuticals, Inc.
- 68180-740- Silodosin
  - 68180-740-06- 30 CAPSULE in 1 BOTTLE (68180-740-06)

68180- Lupin Pharmaceuticals, Inc.
- 68180-740- Silodosin
  - 68180-740-09- 90 CAPSULE in 1 BOTTLE (68180-740-09)

68180- Lupin Pharmaceuticals, Inc.
- 68180-741- Silodosin
  - 68180-741-02- 500 CAPSULE in 1 BOTTLE (68180-741-02)

68180- Lupin Pharmaceuticals, Inc.
- 68180-741- Silodosin
  - 68180-741-06- 30 CAPSULE in 1 BOTTLE (68180-741-06)

68180- Lupin Pharmaceuticals, Inc.
- 68180-741- Silodosin
  - 68180-741-09- 90 CAPSULE in 1 BOTTLE (68180-741-09)

69238- Amneal Pharmaceuticals NY LLC
- 69238-1420- Silodosin
  - 69238-1420-3- 30 CAPSULE in 1 BOTTLE (69238-1420-3)

69238- Amneal Pharmaceuticals NY LLC
- 69238-1420- Silodosin
  - 69238-1420-9- 90 CAPSULE in 1 BOTTLE (69238-1420-9)

69238- Amneal Pharmaceuticals NY LLC
- 69238-1421- Silodosin
  - 69238-1421-3- 30 CAPSULE in 1 BOTTLE (69238-1421-3)

69238- Amneal Pharmaceuticals NY LLC
- 69238-1421- Silodosin
  - 69238-1421-9- 90 CAPSULE in 1 BOTTLE (69238-1421-9)

69539- MSN LABORATORIES PRIVATE LIMITED
- 69539-052- SILODOSIN
  - 69539-052-30- 30 CAPSULE in 1 BOTTLE (69539-052-30)

69539- MSN LABORATORIES PRIVATE LIMITED
- 69539-052- SILODOSIN
  - 69539-052-90- 90 CAPSULE in 1 BOTTLE (69539-052-90)

69539- MSN LABORATORIES PRIVATE LIMITED
- 69539-052- SILODOSIN
  - 69539-052-99- 1000 CAPSULE in 1 BOTTLE (69539-052-99)

69539- MSN LABORATORIES PRIVATE LIMITED
- 69539-053- SILODOSIN
  - 69539-053-30- 30 CAPSULE in 1 BOTTLE (69539-053-30)

69539- MSN LABORATORIES PRIVATE LIMITED
- 69539-053- SILODOSIN
  - 69539-053-90- 90 CAPSULE in 1 BOTTLE (69539-053-90)

69539- MSN LABORATORIES PRIVATE LIMITED
- 69539-053- SILODOSIN
  - 69539-053-99- 1000 CAPSULE in 1 BOTTLE (69539-053-99)

72205- Novadoz Pharmaceuticals LLC
- 72205-009- SILODOSIN
  - 72205-009-30- 30 CAPSULE in 1 BOTTLE (72205-009-30)

72205- Novadoz Pharmaceuticals LLC
- 72205-010- SILODOSIN
  - 72205-010-30- 30 CAPSULE in 1 BOTTLE (72205-010-30)

72205- Novadoz Pharmaceuticals LLC
- 72205-010- SILODOSIN
  - 72205-010-90- 90 CAPSULE in 1 BOTTLE (72205-010-90)

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