Transcription of Reference ID: 4145755 - accessdata.fda.gov
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Reference ID: 4145755 - accessdata.fda.gov
HIGHLIGHTS OF PRESCRIBING INFORMATION Acute and Recurrent Diabetic Gastroparesis ( ). These highlights do not include all the information needed to use REGLAN Administer 10 mg, 30 minutes before each meal and at bedtime (maximum TABLETS safely and effectively. See full prescribing information for of 40 mg per day) for 2 to 8 weeks REGLAN TABLETS. Dosage Adjustment in Specific Populations ( , ). For gastroesophageal reflux and acute and recurrent diabetic gastroparesis, REGLAN (metoclopramide) tablets, for oral use see Full Prescribing Information for recommended dosage reductions for Initial Approval: 1979 elderly patients, in patients with moderate or severe hepatic or renal impairment, and cytochrome p450 2D6 (CYP2D6) poor metabolizers. WARNING: TARDIVE DYSKINESIA. See full prescribing information for complete boxed warning. ---------------------DOSAGE FORMS AND STRENGTHS.
C), in patients with creatinine clearance less than 60 mL/minute, in cytochrome P450 2D6 (CYP2D6) poor metabolizers, and with concomitant use with strong CYP2D6 inhibitors.
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