EMEXLON

What it is

EMEXLON contains metoclopramide hydrochloride anhydrous. The medicine is available as 5 mg and 10 mg film-coated tablets. Metoclopramide hydrochloride stimulates motility of the upper gastrointestinal tract without stimulating gastric, biliary, or pancreatic secretions.

Approved indications

Adults aged 20 years and over: — As an adjunct to X-ray examination of the stomach and duodenum — To assist in intestinal intubation — To control nausea and vomiting associated with intolerance to essential drugs possessing emetic properties, uraemia, radiation sickness, malignant disease, postoperative vomiting, labour, and infectious diseases — Management of gastric retention after gastric surgery — Treatment of diabetic gastroparesis of mild to moderate severity Young adults aged 15–19 years (second line therapy only): — Severe intractable vomiting of known cause — Vomiting associated with radiotherapy and intolerance to cytotoxic drugs — Aid to gastrointestinal intubation

Dosing overview

For medical indications in adults aged 20 years and over, the oral dose is 10 mg three times daily. Young adults aged 15–20 years take 5 to 10 mg three times daily, commencing at the lower dosage. For diagnostic indications, a single dose of 10 to 20 mg may be given 5 to 10 minutes before examination in adults aged 20 years and over, or 10 mg in young adults aged 15–19 years. Total daily dosage should not normally exceed 0.5 mg per kg bodyweight with a maximum of 30 mg daily. Maximum recommended treatment duration is 5 days in all age groups. In patients with clinically significant renal or hepatic impairment, therapy should be initiated at half the recommended dose, with subsequent dosage depending on individual clinical response.

Key safety warnings

Tardive dyskinesia may appear in some patients on long-term therapy or after drug therapy has been discontinued. The risk appears to be greater in elderly patients on high-dose therapy, especially females. The symptoms are persistent and can often appear to be irreversible. One published study reported a tardive dyskinesia prevalence of 20% among patients treated for at least 3 months. The risk of developing the syndrome and the likelihood that it will become irreversible are believed to increase with the duration of treatment and the total cumulative dose. Prolonged treatment greater than 12 weeks with metoclopramide should be avoided in all but rare cases where therapeutic benefit is thought to outweigh the risks to the patient of developing tardive dyskinesia. Dystonic reactions occur in approximately 1% of patients given metoclopramide hydrochloride. These occur more frequently in children and young adults and may occur after a single dose. Very rare occurrences of neuroleptic malignant syndrome have been reported. This syndrome is potentially fatal and comprises hyperpyrexia, altered consciousness, muscle rigidity, autonomic instability and elevated levels of CPK and must be treated urgently. Metoclopramide-induced depression has been reported in patients without a prior history of depression. Metoclopramide should be given to patients with a prior history of depression only if the expected benefits outweigh the potential risks. The most frequent adverse reactions are restlessness, drowsiness, fatigue, and lassitude, which occur in approximately 10% of patients. Less frequently, insomnia, headache, dizziness, nausea, or bowel disturbances may occur.

Contraindications

Metoclopramide should not be used whenever stimulation of gastrointestinal motility might be dangerous, such as in the presence of gastrointestinal haemorrhage, mechanical obstruction, or perforation. It should not be used in phaeochromocytoma because the drug may cause a hypertensive crisis, probably due to release of catecholamines from the tumour. Metoclopramide is contraindicated in patients with known hypersensitivity or intolerance to the drug. Porphyria is a contraindication. Metoclopramide is contraindicated in epilepsy as it may increase the frequency and severity of seizures. Metoclopramide should not be administered to patients receiving other drugs which are likely to cause extrapyramidal reactions, since the frequency and severity of extrapyramidal reactions may be increased. Metoclopramide tablets should not be used in children below 15 years of age.

Regulatory history

EMEXLON metoclopramide hydrochloride 5 mg and 10 mg film-coated tablets (blister pack) were first listed on the Australian Register of Therapeutic Goods on 17 December 2015. The 10 mg film-coated tablets in bottle pack were first listed on 4 May 2016.