CALOTRANS

What it is

CALOTRANS contains prucalopride as the succinate salt, available as 1 mg or 2 mg film-coated tablets. Prucalopride is a drug acting on serotonin receptors (ATC code A03AE04).

Approved indications

— Treatment of chronic functional constipation in adults in whom laxatives fail to provide adequate relief.

Dosing overview

The standard adult dose is 2 mg once daily. CALOTRANS film-coated tablets are for oral use and can be taken with or without food. For elderly patients (over 65 years), treatment should start with one 1 mg tablet once daily; if needed the dose can be increased to 2 mg once daily. For patients with severe hepatic impairment (Child-Pugh class C), the dose is 1 mg once daily. For patients with severe renal impairment not requiring dialysis (GFR < 30 mL/min/1.73m²), the dose is 1 mg once daily. CALOTRANS is not recommended in children and adolescents younger than 18 years. If treatment with CALOTRANS is not effective within four weeks, the benefit of continuing treatment should be reconsidered. Efficacy and safety of prucalopride has been established in double-blind placebo controlled studies for up to 12 weeks, and patients should be reassessed after 12 weeks prior to continuation of treatment.

Key safety warnings

Suicides, suicide attempts, and suicidal ideation have been reported in clinical trials and post-market experience, although a causal association between treatment with CALOTRANS and suicidal ideation and behaviour has not been established. Patients should be monitored for persistent worsening of depression or the emergence of suicidal thoughts and behaviours. CALOTRANS should be used with caution in patients with a history of arrhythmias or ischaemic cardiovascular disease. CALOTRANS should be used with caution in patients receiving concomitant drugs known to cause QTc prolongation. Efficacy and safety of prucalopride in patients with secondary causes of constipation including endocrine disorders, metabolic disorders and neurologic disorders have not been assessed and use in these patients is not recommended. Use in patients with medication-related constipation, including constipation due to opioid use, is not recommended. The most frequently reported adverse reactions are headache and gastrointestinal symptoms (abdominal pain, nausea or diarrhoea) occurring in approximately 20% of patients each, predominantly at the start of therapy and usually disappearing within a few days with continued treatment.

Contraindications

CALOTRANS is contraindicated in patients with hypersensitivity to the active substance or to any of the excipients; renal impairment requiring dialysis; intestinal perforation or obstruction due to structural or functional disorder of the gut wall, obstructive ileus and active severe inflammatory conditions of the intestinal tract, such as Crohn's disease, and ulcerative colitis and toxic megacolon/megarectum; or recent bowel surgery.

PBS listing

Information about PBS listing for CALOTRANS is not available in the provided sources.

Regulatory history

CALOTRANS prucalopride (as succinate) 1 mg and 2 mg tablets were first listed on the Australian Register of Therapeutic Goods on 17 October 2025 under licence category RE (Pharmacor sponsor).