Reglan

2 DOSAGE AND ADMINISTRATION Symptomatic, Documented Gastroesophageal Reflux in Adults Who Fail Conventional Therapy ( 2.1 ) • Administer Reglan continuously or intermittently: ○ Continuous: The recommended dosage is 10 to 15 mg orally, 30 minutes before each meal and at bedtime (maximum of 60 mg per day) for 4 to 12 weeks, as determined by endoscopic response. ○ Intermittent: Single doses up to 20 mg prior to provoking situation. Acute and Recurrent Diabetic Gastroparesis in Adults ( 2.2 ) • The recommended dosage is 10 mg orally, 30 minutes before each meal and at bedtime (maximum of 40 mg per day). Dosage Adjustment in Specific Populations ( 2.1 , 2.2 ) • For symptomatic, documented gastroesophageal reflux and acute and recurrent diabetic gastroparesis, see Full Prescribing Information for recommended dosage reductions for elderly patients, in patients with moderate or severe hepatic or renal impairment, and cytochrome P450 2D6 (CYP2D6) poor metabolizers. 2.1 Recommended Dosage for Symptomatic, Documented Gastroesophageal Reflux in Adults Who Fail Conventional Therapy Reglan tablets may be administered continuously or intermittently in patients with symptomatic, documented gastroesophageal reflux who fail to respond to conventional therapy: Continuous Dosing • The recommended dosage of Reglan tablets is 10 to 15 mg orally four times daily. The maximum recommended daily oral dosage is 60 mg. • Administer each dose thirty minutes before a meal and at bedtime. • The recommended treatment duration is 4 to 12 weeks, as determined by endoscopic response. Use Reglan for the shortest duration of treatment and periodically reassess the need for continued treatment. • The maximum recommended duration of treatment is 12 weeks [see Warnings and Precautions ( 5.1 )] . Table 1 displays the recommended daily dosage and maximum daily dosage for adults and dosage adjustments for patients with moderate or severe hepatic impairment (Child-Pugh B or 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. Intermittent Dosing If symptoms only occur intermittently or at specific times of the day, administer Reglan as a single dose up to 20 mg prior to the provoking situation. Consider dosage reductions for the populations and situations in Table 1. Table 1. Recommended Dosage of Reglan Tablets for Symptomatic, Documented Gastroesophageal Reflux in Adults Who Fail Conventional Therapy Recommended Dosage Maximum Recommended Daily Dosage Adult patients 10 to 15 mg four times daily (thirty minutes before each meal and at bedtime) 60 mg Mild hepatic impairment (Child-Pugh A) Elderly patients [see Use in Specific Populations ( 8.5 )] 5 mg 1 four times daily (thirty minutes before each meal and at bedtime) Moderate or severe hepatic impairment (Child-Pugh B or C) [see Use in Specific Populations ( 8.7 )] 5 mg four times daily (thirty minutes before each meal and at bedtime), or 10 mg taken three times daily 30 mg CYP2D6 poor metabolizers [see Use in Specific Populations ( 8.9 )] Concomitant use with strong CYP2D6 inhibitors (e.g., quinidine, bupropion, fluoxetine, and paroxetine) [see Drug Interactions ( 7.1 )] Moderate or severe renal impairment (creatinine clearance less than or equal to 60 mL/minute) [see Use in Specific Populations ( 8.6 )] Patients with End-Stage Renal Disease (ESRD ) including those treated with hemodialysis and continuous ambulatory peritoneal dialysis [see Use in Specific Populations ( 8.6 )] 5 mg four times daily (thirty minutes before each meal and at bedtime) or 10 mg twice daily 20 mg 1 Elderly patients may be more sensitive to the therapeutic or adverse effects of Reglan; therefore, consider a lower starting dosage of 5 mg four times daily with titration to the recommended adult dosage of 10 to 15 mg four times daily based upon response and tolerability. 2.2 Recommended Dosage for Acute and Recurrent Diabetic Gastroparesis in Adults • The recommended oral dosage of Reglan tablets for the relief of symptoms in adults with acute and recurrent diabetic gastroparesis is 10 mg four times daily. The maximum recommended daily dosage is 40 mg. • Administer each dose thirty minutes before each meal and at bedtime. • Use Reglan for the shortest duration of treatment and periodically reassess the need for continued treatment. • Avoid treatment with metoclopramide, including Reglan tablets, for longer than 12 weeks. If longer-term use is unavoidable, routinely monitor for signs and symptoms of TD [see Warnings and Precautions ( 5.1 )]. Table 2 displays the recommended daily dosage and maximum daily dosage for adults and dosage adjustments for patients with moderate or severe hepatic impairment (Child-Pugh B or 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. If patients with diabetic gastroparesis have severe nausea or vomiting and are unable to take oral Reglan tablets, consider starting therapy with metoclopramide injection given intramuscularly or intravenously for up to 10 days (see the prescribing information for metoclopramide injection). After patients are able to take oral therapy, switch to Reglan tablets. Table 2. Recommended Reglan Tablet Dosage in Adult Patients with Acute and Recurrent Diabetic Gastroparesis Recommended Dosage Maximum Recommended Daily Dosage Adult Patients 10 mg four times daily (30 minutes before each meal and at bedtime) 40 mg Mild hepatic impairment (Child-Pugh A) Elderly patients [see Use in Specific Populations ( 8.5 )] 5 mg 1 four times daily (30 minutes before each meal and at bedtime) Moderate or severe hepatic impairment (Child-Pugh B or C) [see Use in Specific Populations ( 8.7 )] 5 mg four times daily (30 minutes before each meal and at bedtime) 20 mg CYP2D6 poor metabolizers [see Use in Specific Populations ( 8.9 )] Concomitant use with strong CYP2D6 inhibitors (e.g., quinidine). Avoid use with bupropion, fluoxetine, and paroxetine [see Drug Interactions ( 7.1 )] Moderate or severe renal impairment (creatinine clearance less than 60 mL/minute) [see Use in Specific Populations ( 8.6 )] Patients with End-Stage Renal Disease (ESRD ) including those treated with hemodialysis and continuous ambulatory peritoneal dialysis [see Use in Specific Populations ( 8.6 )] 5 mg twice daily 10 mg 1 Elderly patients may be more sensitive to the therapeutic or adverse effects of Reglan; therefore, consider a lower dosage of 5 mg four times daily with titration to the recommended adult dosage of 10 mg four times daily based upon response and tolerability.

See official label

1 INDICATIONS AND USAGE Reglan tablets are indicated for the: • Treatment for 4 to 12 weeks of symptomatic, documented gastroesophageal reflux in adults who fail to respond to conventional therapy.