Metoclopramide Hydrochloride 1mg/1ml
Usage and indications:
Dosage and administration:
Dosage recommendations given should be strictly followed to avoid dystonic side effect.
For adults & children, the maximum dose in 24 hours is 0.5mg/Kg of body weight.
Dosage should be at reduced levels in patients with significant renal or hepatic impairment.
Adults of 20 years and older:
The usual dose is 10mg up to three times daily. [If weigh below 60Kg see later]
Young adults and children:
Only use Metoclopramide Hydrochloride Oral Solution after examination to avoid masking an underlying disorder, such as cerebral irritation. Primary consideration must be given to body weight and treatment should be initiated at the lower dosage indicated.
The recommended dose is 0.1 to 0.15mg /Kg of body weight, up to 3 times daily.
Blood and lymphatic system disorders:
Extremely rarely cases of red cell disorders such as methaemoglobinaemia and sulphaemoglobinaemia have been reported, particularly at high doses of metoclopramide.
If this occurs the drug should be withdrawn. Methaemoglobinaemia may be treated using methylene blue. Methaemoglobinaemia could be related to NADH cytochrome b5 reductase deficiency particularly in neonates.
Immune system disorders:
Allergic reactions may also occur. Very rarely hypersensitivity, including anaphylaxis has been reported.
Raised serum prolactin levels have been observed during metoclopramide therapy this may result in galactorrhoea, irregular periods and gynaecomastia.
Restlessness (about 5%)
Rare: Trouble sleeping, unusual irritability and confusion
Depression has been reported extremely rarely.
Nervous system disorders:
Various extrapyramidal reactions to metoclopramide, usually of the dystonic kind, have been reported. Incidence of dystonic reactions, particularly in children and young adults, is increased if daily doses in excess of 0.5mg/kg body weight are used. Examples of dystonic reactions include: facial muscle spasm, trismus, bulbar type speech, rhythmic tongue protrusion, spasm of extraocular muscles (including oculogyric crises), unnatural positioning of head and shoulders and opisthotonos. There may also be a generalized increase in muscle tone. In most cases, the majority of these reactions occur within 36 hours of initiating treatment, they usually reverse within 24 hours of drug withdrawal. If necessary, dystonic reactions may be treated by use of an anticholinergic anti-parkinsonian drug, or a benzodiazepine.
Tardive dyskinesia, occurring during prolonged treatment, has been reported, mainly in elderly patients; such patients should be regularly reviewed. The likelihood of the occurrence of this serious side effect is increased when neuroleptic agents are used concurrently.
Very rare occurrences of neuroleptic malignant syndrome have been reported.
This syndrome is potentially fatal and comprises of hyperpyrexia, altered consciousness, muscle rigidity, autonomic instability and elevated levels of creatinine phosphokinase (CPK) and must be treated urgently (recognised treatments include dantrolene and bromocriptine). Metoclopramide should be stopped immediately if this syndrome occurs.
Extrapyramidal symptoms: Acute dystonia and dyskinesia, parkinsonian syndrome, akathisia, even following administration of a single dose of the drug, particularly in children and young adults
Drowsiness (about 10%)
Rare: Dizziness (less than 1%), headache
Visual disturbances have been reported.
Very rare reports of abnormalities of cardiac conduction (bradycardia, asystole, heart block, sinus arrest and cardiac arrest) have been reported following intravenous administration.
Acute hypertension may occur in patients with phaeochromocytoma. hypotension has also been reported.
Respiratory, thoracic and mediastinal disorders:
Dyspnoea may occur.
Rare: Constipation (less than 1%), diarrhea, nausea, unusual dryness of mouth.
Skin and subcutaneous tissue disorders:
Rare: Skin rash, a small number of skin reactions such as urticaria and pruritus.
Reproductive system and breast disorders:
Rare: Breast tenderness and swelling, changes in menstruation.
General disorders and administration site conditions:
Unusual tiredness or weakness (about 10%)
Rare: Edema (including face edema)
Warnings and precautions:
Excipient Warnings: This product contains sorbitol. Patients with rare hereditary problems of fructose intolerance should not take this medicine. Methyl and propyl hydroxybenzoates are contained in this product which may cause allergic reactions (possibly delayed).
Pack: Carton box containing a glass bottle of 120ml.