APO-METOCLOPRAMIDE

What it is

APO-METOCLOPRAMIDE contains metoclopramide hydrochloride anhydrous. The medicine is available as 5 mg and 10 mg film-coated tablets.

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. APO-METOCLOPRAMIDE has been found useful in the management of gastric retention after gastric surgery. APO-METOCLOPRAMIDE may be useful in the treatment of diabetic gastroparesis of mild to moderate severity. For young adults aged 15–19 years, use 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, with use only as second line therapy.

Dosing overview

For medical indications in adults aged 20 years and over, the oral dose is 10 mg three times daily. For young adults aged 15–20 years, the dose is 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; young adults aged 15–19 years receive 10 mg. Maximum recommended treatment duration is 5 days in all age groups.

Key safety warnings

Persistent 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, and symptoms are persistent and can oftentimes appear to be irreversible. 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 APO-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, 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, which is potentially fatal and comprises hyperpyrexia, altered consciousness, muscle rigidity, autonomic instability and elevated levels of CPK. APO-METOCLOPRAMIDE elevates prolactin levels, and approximately one-third of human breast cancers are prolactin dependent in vitro, a factor of potential importance if the prescription of APO-METOCLOPRAMIDE is contemplated in a patient with previously detected breast cancer. Metoclopramide-induced depression has been reported in patients without a prior history of depression; APO-METOCLOPRAMIDE should be given to patients with a prior history of depression only if the expected benefits outweigh the potential risks.

Contraindications

APO-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. APO-METOCLOPRAMIDE should not be used in phaeochromocytoma because the drug may cause a hypertensive crisis, probably due to release of catecholamines from the tumour. Known hypersensitivity or intolerance to the drug is a contraindication. Porphyria is a contraindication. APO-METOCLOPRAMIDE should not be used in epilepsy as it may increase the frequency and severity of seizures. APO-METOCLOPRAMIDE tablets should not be used in children below 15 years of age.

PBS listing

The 10 mg tablet is listed on the PBS with 3 items, unrestricted access, at an ex-manufacturer price of A$2.50.

Regulatory history

APO-METOCLOPRAMIDE (10 mg film coated tablets) was first listed on the ARTG on 3 June 2013.