Pharmacotherapeutic group: sodium picosulfate, combinations, ATC code: A06AB58. The active ingredients of Citrafleet are sodium picosulfate, a stimulant laxative acting locally in the colon, and magnesium citrate, which acts as an osmotic laxative by retaining moisture in the colon. These substances produce a powerful "washout" effect combined with stimulation of peristalsis, aimed at bowel cleansing before radiological examination, colonoscopy, or surgical procedures. The product is not intended for use as a routine laxative.
In a randomised, multicentre, blinded study in adults, bowel cleansing before colonoscopy was compared using two different regimens with CitraFleet versus Klean-Prep (one sachet contains 59 g polyethylene glycol 3350, 5.685 g sodium sulfate, 1.685 g sodium bicarbonate, 1.465 g sodium chloride and 0.7425 g potassium chloride; to be dissolved in 1 litre of water). The treatment groups were: CitraFleet administered the day before the procedure (2 sachets 5 hours apart during the afternoon and evening the day before colonoscopy, n=229); Klean-Prep administered the day before the procedure (4 sachets administered during the afternoon and evening the day before colonoscopy, n=227); and CitraFleet administered on the morning of the procedure (2 sachets 3 hours apart on the morning before colonoscopy, n=56). Bowel cleansing was assessed using a categorical scale (excellent, good, acceptable and poor). Good/excellent cleansing was recorded in 68.1% of patients with the CitraFleet day-before regimen (statistically non-significant difference versus Klean-Prep), whereas significantly higher proportions of patients had good/excellent cleansing with the CitraFleet morning-of-procedure regimen compared with both day-before regimens (p<0.05). Both CitraFleet regimens were rated by patients as significantly easier to complete than Klean-Prep (p<0.001). All regimens were well tolerated, with only 2.2% of patients reporting adverse events with the CitraFleet day-before regimen. No serious adverse events occurred.
In a randomised, multicentre, blinded study in adults, bowel cleansing before colonoscopy was compared using two different regimens with CitraFleet: split dosing (1 sachet the evening before colonoscopy and the second sachet on the morning before colonoscopy, n=159) and day-before morning regimen (1 sachet before 8:00 AM the day before colonoscopy and the second sachet 6–8 hours later, n=156). Bowel cleansing was assessed using a categorical scale (excellent, good, acceptable and poor). A significantly higher proportion of patients achieved good/excellent bowel cleansing with the split-dose regimen (79.9% vs. 30.8% with the day-before morning regimen, p<0.0001). Over 93% of patients in both groups rated the regimens as "easy" or "very easy" to take. Both regimens were well tolerated, with 1.9% and 2.5% of patients experiencing adverse events in the split-dose group and day-before morning group, respectively. More patients in the split-dose group than in the day-before morning group experienced nausea (23.3% vs. 13.5%) and overall physical discomfort (29.6% vs. 17.3%), whereas more patients in the day-before morning group experienced hunger (46.2% vs. 32.1% with the split-dose regimen). No serious adverse events occurred. Overall, mean changes in electrolyte values and other laboratory parameters were small in both groups.
⚠️ Warnings
Citrafleet should not be used as a routine laxative.
Citrafleet could in rare cases lead to serious and potentially fatal electrolyte imbalances or renal impairment in frail or debilitated patients. Therefore, in this at-risk population, the benefit/risk ratio of Citrafleet must be carefully evaluated before initiating treatment.
Special attention is required when prescribing Citrafleet to any patients with regard to the known contraindications. Furthermore, particular attention should be given to the importance of adequate hydration and, in at-risk patients (as identified below), to the importance of determining electrolyte levels at the start and after completion of treatment.
Elderly and debilitated patients, as well as patients at risk of developing hypokalaemia or hyponatraemia, may require special care.
Citrafleet should be used with caution in patients with diagnosed water and/or electrolyte balance disorders or in patients taking medicinal products that may affect water and/or electrolyte balance, such as diuretics, corticosteroids, lithium (see section 4.5).
Caution should also be exercised in patients who have recently undergone gastrointestinal surgery or who suffer from renal impairment, mild to moderate dehydration, hypotension, or cardiac disease.
The duration of bowel cleansing should not exceed 24 hours, as prolonged preparation may increase the risk of water and electrolyte imbalance.
Diarrhoea caused by the evacuant action of Citrafleet may result in fluid and electrolyte loss, hypovolaemia and hypotension. In addition, vasovagal reflexes may be triggered by abdominal stimuli, e.g. pain, which may lead to low blood pressure and loss of consciousness. Adequate intake of clear fluids is essential, see section 4.2.
Citrafleet may alter the absorption of regularly prescribed oral medications and therefore should be used with caution. For example, isolated cases of seizures have been reported in patients taking antiepileptic drugs whose epilepsy had previously been under control (see sections 4.5 and 4.8).
Citrafleet may induce aphthoid ulcers on the colonic mucosa, and serious cases of colitis (including ischaemic colitis) requiring hospitalisation have been reported. Consequently, this diagnosis should be considered in the event of severe and/or persistent abdominal pain, with or without rectal bleeding, following administration of Citrafleet.
This product contains 5 mmol (or 195 mg) of potassium per sachet. This should be taken into consideration in patients with reduced renal function and in patients on a controlled potassium diet.
This medicinal product contains less than 1 mmol (23 mg) sodium per sachet, that is to say essentially sodium-free.
This medicinal product contains sulfites including disulfites and hydrogen sulfites, which arise from the maltodextrin present in the lemon flavouring. Rarely, these may cause severe hypersensitivity reactions and bronchospasm.
