DOSAGE AND ADMINISTRATION
Dosing Information
The recommended dose is 8 mg orally once daily with a meal.
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 (4)
,
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 (4)
,
Warnings and Precautions
,
Use in Specific Populations
, and
Clinical Pharmacology
].
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.
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