PRAMIN

What it is

PRAMIN 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

**Adults (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:** — Severe intractable vomiting of known cause as second line therapy only. — Vomiting associated with radiotherapy and intolerance to cytotoxic drugs. — As an aid to gastrointestinal intubation.

Dosing overview

**Medical indications:** Adults aged 20 years and over: 10 mg three times daily. Elderly patients receive the same dose as adults. Young adults aged 15–20 years: 5 to 10 mg three times daily, commencing at the lower dosage and used as second line therapy only. **Diagnostic indications:** A single dose may be given 5 to 10 minutes before examination. Adults aged 20 years and over: 10 to 20 mg. Young adults aged 15–19 years: 10 mg. Total daily dosage should not normally exceed 0.5 mg per kilogram 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 discontinuation. The risk appears greater in elderly patients on high dose therapy, especially females, and the symptoms can appear 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 duration of treatment and 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 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. 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. It is contraindicated in known hypersensitivity or intolerance to the drug. Metoclopramide should not be used in porphyria. It is contraindicated in epilepsy as metoclopramide may increase the frequency and severity of seizures. Metoclopramide tablets should not be used in children below 15 years of age.

Regulatory history

PRAMIN metoclopramide hydrochloride 10 mg tablets in bottle form were first listed on the ARTG on 20 September 1991 under licence category RE. A blister pack variant was subsequently registered on 31 August 2021.