Metoclopramide

METOCLOPRAMIDE- metoclopramide hydrochloride tablet
Mylan Institutional Inc.

WARNING: TARDIVE DYSKINESIA

  • Metoclopramide can cause tardive dyskinesia (TD), a serious movement disorder that is often irreversible. There is no known treatment for TD. The risk of developing TD increases with duration of treatment and total cumulative dosage [ see Warnings and Precautions ( 5.1) ].
  • Discontinue metoclopramide in patients who develop signs or symptoms of TD. In some patients, symptoms may lessen or resolve after metoclopramide is stopped [ see Warnings and Precautions ( 5.1) ].
  • Avoid treatment with metoclopramide for longer than 12 weeks because of the increased risk of developing TD with longer-term use [ see Warnings and Precautions ( 5.1) and Dosage and Administration ( 2.2, 2.3) ].

1 INDICATIONS AND USAGE

Metoclopramide tablets are indicated for the:Metoclopramide 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.
  • Relief of symptoms in adults with acute and recurrent diabetic gastroparesis.

Limitations of Use:

Metoclopramide tablets are not recommended for use in pediatric patients due to the risk of developing tardive dyskinesia (TD) and other extrapyramidal symptoms as well as the risk of methemoglobinemia in neonates [ see Use in Specific Populations ( 8.4) ].

2 DOSAGE AND ADMINISTRATION

2.1 Important Administration Instructions

Avoid treatment with metoclopramide for longer than 12 weeks because of the increased risk of developing TD with longer-term use [ see Dosage and Administration ( 2.2, 2.3), Warnings and Precautions ( 5.1) ].

2.2 Dosage for Gastroesophageal Reflux

Metoclopramide tablets may be administered continuously or intermittently in patients with symptomatic gastroesophageal reflux who fail to respond to conventional therapy:Metoclopramide tablets may be administered continuously or intermittently in patients with symptomatic gastroesophageal reflux who fail to respond to conventional therapy:

Continuous Dosing

The recommended adult dosage of metoclopramide is 10 to 15 mg four times daily for 4 to 12 weeks. The treatment duration is determined by endoscopic response. Administer the dosage thirty minutes before each meal and at bedtime. The maximum recommended daily dosage is 60 mg.The recommended adult dosage of metoclopramide is 10 to 15 mg four times daily for 4 to 12 weeks. The treatment duration is determined by endoscopic response. Administer the dosage thirty minutes before each meal and at bedtime. The maximum recommended daily dosage is 60 mg.

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 metoclopramide in single dose up to 20 mg prior to the provoking situation. Consider dosage reductions for the populations and situations in Table 1.If symptoms only occur intermittently or at specific times of the day, administer metoclopramide in 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 Metoclopramide Tablet Dosage in Patients with Gastroesophageal Reflux
*
Elderly patients may be more sensitive to the therapeutic or adverse effects of metoclopramide; 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.

Recommended Dosage

Maximum Recommended Daily Dosage

Adult patientsAdult patients

10 to 15 mg four times daily (thirty minutes before each meal and at bedtime)10 to 15 mg four times daily (thirty minutes before each meal and at bedtime)

60 mg60 mg

Mild hepatic impairment (Child-Pugh A)Mild hepatic impairment (Child-Pugh A)

Elderly patients [ ] Elderly patients [ see Use in Specific Populations ( 8.5) ]

5 mg four times daily (thirty minutes before each meal and at bedtime) 5 mg * four times daily (thirty minutes before each meal and at bedtime)

Moderate or severe hepatic impairment (Child-Pugh B or C) [ ] 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), or5 mg four times daily (thirty minutes before each meal and at bedtime), or

10 mg taken three times daily10 mg taken three times daily

30 mg30 mg

CYP2D6 poor metabolizers [ ] CYP2D6 poor metabolizers [ see Use in Specific Populations ( 8.9) ]

Concomitant use with strong CYP2D6 inhibitors (e.g., quinidine, bupropion, fluoxetine, and paroxetine) [ ] 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) [ ] 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 [ ] 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 daily5 mg four times daily (thirty minutes before each meal and at bedtime) or 10 mg twice daily

20 mg20 mg

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