Metoclopramide
Dosing in kidney impairment
Renal Impairment The clearance of metoclopramide is decreased and the systemic exposure is increased in patients with moderate to severe renal impairment compared to patients with normal renal function, which may increase the risk of adverse reactions. Reduce the metoclopramide dosage in patients with moderate and severe renal impairment (creatinine clearance less than or equal to 60 mL/minute), including those receiving hemodialysis and continuous ambulatory peritoneal dialysis [see Dosage and Administration ( 2.1 , 2.2 ), Clinical Pharmacology].
| 1Elderly 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 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 1four 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 |
| 1Elderly patients may be more sensitive to the therapeutic or adverse effects of metoclopramide; 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. | ||
| 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 1four 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, 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 twice daily | 10 mg |
Dosing in liver impairment
Hepatic Impairment Patients with severe hepatic impairment (Child-Pugh C) have reduced systemic metoclopramide clearance (by approximately 50%) compared to patients with normal hepatic function. The resulting increase in metoclopramide blood concentrations increases the risk of adverse reactions. There is no pharmacokinetic data in patients with moderate hepatic impairment (Child-Pugh B).
Reduce metoclopramide dosage in patients with moderate or severe (Child-Pugh B or C) hepatic impairment [see Dosage and Administration ( 2.1 , 2.2 )] . There is no dosage adjustment required for patients with mild hepatic impairment (Child-Pugh A). In addition, metoclopramide, by producing a transient increase in plasma aldosterone, may increase the risk of fluid retention in patients with hepatic impairment [see Warnings and Precautions] .
Monitor patients with hepatic impairment for the occurrence of fluid retention and volume overload.
| 1Elderly 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 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 1four 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 |
| 1Elderly patients may be more sensitive to the therapeutic or adverse effects of metoclopramide; 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. | ||
| 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 1four 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, 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 twice daily | 10 mg |