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Rapaflo Capsules

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Rapaflo Capsules

Rapaflo Capsules

INDICATIONS

RAPAFLO, 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]. RAPAFLO is not indicated for the treatment of hypertension.

DOSAGE AND ADMINISTRATION

Dosing Information

The recommended dose is 8 mg orally once daily with a meal.

Patients who have difficulty swallowing pills and capsules may carefully open the RAPAFLO capsule and sprinkle the powder inside on a tablespoonful of applesauce. The applesauce should be swallowed immediately (within 5 minutes) without chewing and followed with an 8 oz glass of cool water to ensure complete swallowing of the powder. The applesauce used should not be hot, and it should be soft enough to be swallowed without chewing. Any powder/applesauce mixture should be used immediately (within 5 minutes) and not stored for future use. Subdividing the contents of a RAPAFLO capsule is not recommended [see CLINICAL PHARMACOLOGY].

Dosage Adjustment in Special Populations

Renal impairment

RAPAFLO is contraindicated in patients with severe renal impairment (CCr < 30 mL/min). In patients with moderate renal impairment (CCr 30-50 mL/min), the dose should be reduced to 4 mg once daily taken with a meal. No dosage adjustment is needed in patients with mild renal impairment (CCr 50-80 mL/min) [see CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS, Use In Specific Populations, and CLINICAL PHARMACOLOGY].

Hepatic impairment

RAPAFLO has not been studied in patients with severe hepatic impairment (Child-Pugh score ≥ 10) and is therefore contraindicated in these patients. No dosage adjustment is needed in patients with mild or moderate hepatic impairment [see CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS, Use In Specific Populations, and CLINICAL PHARMACOLOGY].

HOW SUPPLIED

Dosage Forms And Strengths

The 8 mg capsules are white, opaque, hard #1 gelatin capsules imprinted with “WATSON 152” in green on the cap and “8 mg” in green on the body.

The 4 mg capsules are white, opaque, hard #3 gelatin capsules imprinted with “WATSON 151” in gold on the cap and “4 mg” in gold on the body.

Storage And Handling

White, opaque, hard gelatin 8 mg capsules. Cap is imprinted with “WATSON 152” in green. Body is imprinted with “8 mg” in green. 8 mg capsules are supplied in unit of use HDPE bottles of:

30 capsules (NDC 52544-152-30)
90 capsules (NDC 52544-152-19)

Bottles of 30 and 90 capsules are supplied with child-resistant closures.

White, opaque, hard gelatin 4 mg capsules. Cap is imprinted with “WATSON 151” in gold. Body is imprinted with “4 mg” in gold. 4 mg capsules are supplied in unit of use HDPE bottles of:

30 capsules (NDC 52544-151-30)
90 capsules (NDC 52544-151-19)

Bottles of 30 and 90 capsules are supplied with child-resistant closures.

Storage

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F). [See USP controlled room temperature.] Protect from light and moisture.

Keep out of reach of children.

Manufactured By: Watson Laboratories, Inc. Corona, CA 92880 USA. Distributed By: Watson Pharma, Inc. Parsippany, NJ 07054 USA. Revised: January 2013

Last reviewed on RxList: 7/30/2013
This monograph has been modified to include the generic and brand name in many instances.

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