ROSPRID

What it is

ROSPRID 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 recommended adult dose is 2 mg once daily. Elderly patients (over 65 years) should start with 1 mg 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 (GFR < 30 mL/min/1.73m²), the dose is 1 mg once daily. ROSPRID film-coated tablets are for oral use and can be taken with or without food.

Key safety warnings

Suicides, suicide attempts, and suicidal ideation have been reported in clinical trials and post-market experience. A causal association between treatment with ROSPRID 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. ROSPRID should be used with caution in patients with a history of arrhythmias or ischaemic cardiovascular disease. ROSPRID should be used with caution in patients receiving concomitant drugs known to cause QTc prolongation. The most frequently reported adverse reactions are headache and gastrointestinal symptoms (abdominal pain, nausea or diarrhoea) occurring in approximately 20% of patients each. These adverse reactions occur predominantly at the start of therapy and usually disappear within a few days with continued treatment. In case of severe diarrhoea, the efficacy of oral contraceptives may be reduced and the use of an additional contraceptive method is recommended to prevent possible failure of oral contraception.

Contraindications

ROSPRID 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, and recent bowel surgery.

PBS listing

No information regarding PBS listing is provided in the source documents.

Regulatory history

ROSPRID prucalopride 1 mg tablets (ARTG 358078) and 2 mg tablets (ARTG 358079) were first listed on the Australian Register of Therapeutic Goods on 4 February 2022.