"Metoclopramide" meets these 6 special groups, how to adjust the dose?

*For medical professionals only

Clinical decision-making can be simpler

1. Adults (impaired renal function)

▌Domestic usage:

In patients with severe renal insufficiency, the dose should be reduced by at least 60 percent, as these patients are susceptible to extrapyramidal symptoms[1].

▌ U.S. Drug Administration (FDA) Usage:

Metoclopramide is excreted mainly through the kidneys, and in patients with creatinine clearance below 40 mL / min, treatment should be started after reducing the recommended dose by about 50%. Depending on clinical efficacy and safety considerations, doses may be increased or decreased as appropriate [2,4,5].

Patients with moderate to severe renal impairment have reduced metoclopramide clearance and increased systemic exposure compared with patients with normal renal function, possibly increasing the risk of adverse effects, and dose adjustments are shown in Tables 1 and 2 [3,6].

Table 1 Dose adjustment for the treatment of gastroesophageal reflux (GERD) in patients with renal impairment

Table 2 Dose adjustment for acute and recurrent diabetic gastroparesis (gastric retention) in patients with renal impairment

2. Adults (impaired liver function)

Patients with severe hepatic impairment (Child-Pugh C) have a decreased systemic metoclopramide clearance (about 50%), increasing the risk of adverse reactions compared with patients with normal liver function.

There are no pharmacokinetic data in patients with moderate liver impairment (Child-Pugh B).

Patients with mild liver impairment (Child-Pugh A) do not need to adjust the dose.

Patients with moderate or severe (Child-Pugh B or C) liver damage reduce the dose of this product. Dose adjustments are shown in Tables 3 and 4 [3,6].

Table 3 Dose adjustment for use of GERD in patients with liver impairment

Table 4 Dose adjustment in patients with liver damage for acute and recurrent diabetic gastroparesis (gastric retention).

Except for simple binding, metoclopramide is metabolized very little in the liver. Its safe use has been described in patients with advanced liver disease with normal renal function [4-5].

3. Children's Usage

▌Domestic usage

5-14 years old take 2.5 mg (0.5-1 tablet) 3 times a day, 30 minutes before meals, preferably for short-term use. The total dose for children should not exceed 0.1 mg/kg per day. Children should not take it for a long time [1].

0.1 mg/kg each time for children under 6 years old and 2.5-5 mg once for 6-14 years old. It should not be taken for a long time in children [2].

▌ FDA usage

This product is not recommended for pediatric patients because of the risk of tardive dyskinesia (TD) and other extrapyramidal symptoms and the risk of neonatal methemoglobinemia. The safety and efficacy of this product in pediatric patients has not been established [3-7].

4. Usage for the elderly

Elderly people should not be used in large quantities for a long time, and are prone to extrapyramidal symptoms [1-2].

Table 5 Dose adjustments for GERD

Table 6 Dose adjustment for acute and recurrent diabetic gastroparesis (gastric retention).

Dose selection should be cautious in older patients, who may be more sensitive to adverse effects of metoclopramide, metoclopramide hydrochloride is not recommended as initial therapy, and if needed, it should be started with a lower starting dose and avoid treatment with metoclopramide (all dosage forms and routes of administration) for more than 12 weeks [4,5,7].

5. Medication during pregnancy

Published studies, including retrospective cohort studies, national registry studies and meta-analyses, did not report consistent patterns or continued increased risk of adverse pregnancy-related outcomes with oral metoclopramide during pregnancy. Available data are insufficient to assess the drug-related risks of major birth defects, miscarriage, and adverse maternal or fetal outcomes.

Metoclopramide passes through the placental barrier, and intrauterine exposure to metoclopramide during childbirth is a potential risk to newborns. Maternal administration during childbirth may cause extrapyramidal signs and methemoglobinemia in newborns. If exposed, newborns should be monitored for extrapyramidal signs [3,6,7].

6. Medication during lactation

Published data indicate that after oral administration, different amounts of metoclopramide are present in human breast milk. Breastfed infants exposed to metoclopramide have experienced gastrointestinal adverse reactions, including intestinal discomfort and increased intestinal gas.

The developmental and health benefits of breastfeeding, as well as any potential adverse effects of the mother's clinical need for this product, or the underlying maternal disease, on the breastfeeding infant should be considered.

Breastfed neonates should be monitored because metoclopramide may cause extrapyramidal symptoms (dystonia) and methemoglobinemia [3,6,7].

bibliography:

[3] Product Information: METOCLOPRAMIDE HYDROCHLORIDE tablet, orally disintegrating, Lupin Pharmaceuticals,Inc, Updated December 2， 2020.

[4] Product Information: METOCLOPRAMIDE solution, Bryant Ranch Prepack, Updated February 4, 2021.

[5] Product Information: METOCLOPRAMIDE injection, solution, Hospira, Inc，Updated January 15, 2021.

[6] Product Information: METOCLOPRAMIDE tablet, Par Pharmaceutical, Inc, Updated May 18, 2021.

[7] Product Information: metoclopramide-metoclopramide hydrochloride spray， Evoke Pharma，Inc, Updated January 7, 2021.

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