Adult Dosing
Gastroesophageal reflux
- 10-15 mg PO qid at least 30 minutes before each meal and at bedtime
- Elderly: Use lowest effective dose
- Max duration: 12 wks
- If symptoms occur intermittently or at specific times of the day, administer single doses up to 20 mg PO prior to the provoking situation
Diabetic gastroparesis
- 10 mg PO qid, 30 minutes before each meal and at bedtime x2-8 wks
- Elderly: Use lowest effective dose
- Max duration: 12 wks
Nausea and vomiting [Non-FDA Approved]
- 10 mg PO q4 hours as needed
Pediatric Dosing
- Safety and effectiveness in pediatric patients have not been established
Nausea and vomiting [Non-FDA Approved]
- 0.15 mg/kg (maximum 10 mg) PO q4 hours as needed
- Be aware of extrapyramidal symptoms, more common in children
[Outline]
Renal Dose Adjustment (Based on CrCl)
- <40 mL/min: Start therapy at approximately 50% of the usual recommended dose; titrate subsequently based upon the patient’s clinical response and tolerance
Hepatic Dose Adjustment
- Hepatic impairment: No dose adjustments
See Supplemental Patient Information
- The risk of developing irreversible tardive dyskinesia (TD) increases with the duration of treatment and the total cumulative dose of metoclopramide. The elderly, women, and diabetics are at an increased risk of developing TD. Discontinue therapy if signs/symptoms of TD appear [US Black Box Warning]
- Therapy with metoclopramide should not exceed 12 wks in duration [US Black Box Warning]
- Extrapyramidal symptoms, manifested as acute dystonic reactions, are usually seen during the first 24-48 hrs of therapy and occur more frequently in children and young adults (<30 yrs) and are even more frequent at higher doses
- Drug-induced parkinsonism may occur more commonly within the first 6 months of starting metoclopramide treatment, but can also occur after longer periods. Parkinsonian symptoms generally subside within 2-3 months after discontinuation of therapy. Caution should be exercised in patients with a history of Parkinson’s disease
- Potentially fatal symptom complex, sometimes referred to as neuroleptic malignant syndrome (NMS), manifested as hyperpyrexia, muscle rigidity, altered mental status, and evidence of autonomic instability, may occur in association with metoclopramide
- Management of NMS includes immediate discontinuation of the drug and other drugs not essential for concurrent therapy, intensive symptomatic treatment and medical monitoring, specific treatment of any concomitant serious medical problems
- Mild to severe symptoms of depression, including suicidal ideation and suicide, may occur in patients with and without a history of depression
- Patients with cirrhosis or congestive heart failure may be at risk of developing fluid retention and volume overload during metoclopramide therapy; discontinue the drug if such events occur
- Withdrawal symptoms such as dizziness, nervousness, and/or headaches may occur after stopping metoclopramide
Cautions: Use cautiously in
- Diabetes mellitus
- Hypertension
- Renal impairment
- NADH methemoglobin reductase deficiency
- Neonates
Supplemental Patient Information
- Advise patients to refrain from performing hazardous tasks such as operating machinery or driving a motor vehicle during therapy as it may impair mental and/or physical abilities required to perform for such activities
Pregnancy Category:B
Breastfeeding: Safety unknown; excreted in variable amounts in breast milk. Most infants would receive <10% of the maternal weight-adjusted dosage, but some receive higher doses that achieve pharmacologically active serum levels, elevated serum prolactin, and possible GI side effects. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 21 April 2011). Manufacturer advices caution because metoclopramide is excreted in breast milk and may cause serious adverse reactions in breastfed infants.
