CLOVOMET

What it is

CLOVOMET contains metoclopramide hydrochloride anhydrous. It 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 For 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 CLOVOMET has been found useful in the management of gastric retention after gastric surgery. CLOVOMET may be useful in the treatment of diabetic gastroparesis of mild to moderate severity. For young adults aged 15–19 years, CLOVOMET should be restricted to severe intractable vomiting of known cause, vomiting associated with radiotherapy and intolerance to cytotoxic drugs, and as an aid to gastrointestinal intubation, and only used as second line therapy.

Dosing overview

For adults aged 20 years and over, the recommended dose is 10 mg three times daily. For young adults aged 15–20 years, the recommended dose is 5 to 10 mg three times daily, commencing at the lower dosage and used as second line therapy only. For diagnostic indications, a single dose may be given 5 to 10 minutes before the examination; for adults aged 20 years and over the recommended dose is 10 to 20 mg, and for young adults aged 15–19 years the recommended dose is 10 mg. Total daily dosage should not normally exceed 0.5 mg/kg bodyweight with a maximum of 30 mg daily. Maximum recommended treatment duration is 5 days in all age groups.

Key safety warnings

Tardive dyskinesia may appear in some patients on long-term therapy or may appear 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 oftentimes appear to be irreversible. One published study reported a tardive dyskinesia prevalence of 20% among patients treated for at least 3 months. Both 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 the 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. CLOVOMET should be given to patients with a prior history of depression only if the expected benefits outweigh the potential risks.

Contraindications

CLOVOMET should not be used whenever stimulation of gastrointestinal motility might be dangerous, such as in the presence of gastrointestinal haemorrhage, mechanical obstruction, or perforation. CLOVOMET should not be used in phaeochromocytoma because the drug may cause a hypertensive crisis, probably due to release of catecholamines from the tumour. CLOVOMET should not be used in patients with known hypersensitivity or intolerance to the drug. CLOVOMET should not be used in porphyria. CLOVOMET should not be used in epilepsy as it may increase the frequency and severity of seizures. CLOVOMET tablets should not be used in children below 15 years of age.

Regulatory history

CLOVOMET metoclopramide hydrochloride 5 mg and 10 mg film-coated tablets in blister packs were first listed on the ARTG on 17 December 2015. CLOVOMET metoclopramide hydrochloride 10 mg film-coated tablets in bottle format were first listed on the ARTG on 4 May 2016.