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 prior to radiological examination, colonoscopy, or surgical procedure. 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 of CitraFleet with the comparator 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 before colonoscopy, n=229); Klean-Prep administered the day before the procedure (4 sachets administered during the afternoon and evening 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 compared with Klean-Prep), while 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 substantially easier to complete than Klean-Prep (p<0.001). All regimens were well tolerated, with only 2.2% of patients experiencing 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 of CitraFleet: split dosing (1 sachet on the evening before colonoscopy and the second sachet on the morning before colonoscopy, n=159) and morning-before-procedure regimen (1 sachet before 8:00 on 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 morning-before-procedure 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 and morning-before-procedure groups, respectively. More patients in the split-dose group than in the morning-before-procedure group experienced nausea (23.3% vs. 13.5%) and overall physical discomfort (29.6% vs. 17.3%), while more patients in the morning-before-procedure 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 disturbances or renal impairment in frail or debilitated patients. Therefore, a careful assessment of the benefit/risk balance of Citrafleet is necessary in this at-risk population before initiating treatment.
Special attention should be paid 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 described below), to the importance of measuring electrolyte levels at baseline and after treatment completion.
Elderly and debilitated patients, as well as patients at risk of developing hypokalaemia or hyponatraemia, may require extra care.
Citrafleet should be used with caution in patients with diagnosed disorders of water and/or electrolyte balance, or in patients taking medicines that may affect water and/or electrolyte balance, such as diuretics, corticosteroids, or lithium (see section 4.5).
Caution should also be exercised in patients who have recently undergone gastrointestinal surgery, or who have renal impairment, mild to moderate dehydration, hypotension, or cardiac disease.
The duration of bowel preparation should not exceed 24 hours, as longer preparation may increase the risk of water and electrolyte imbalance.
Diarrhoea caused by the evacuant effect of Citrafleet may result in fluid and electrolyte loss, hypovolaemia, and hypotension. In addition, vasovagal reflexes may be triggered by abdominal stimuli such as pain, which can lead to low blood pressure and loss of consciousness. Adequate intake of clear fluids is necessary, 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 well controlled (see sections 4.5 and 4.8).
Citrafleet may induce aphthoid ulcers of 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) of sodium per sachet, i.e. it is essentially sodium-free.
This medicine contains sulfites including disulfites and hydrogen sulfites formed from maltodextrin present in the lemon flavour. Rarely, it may cause severe hypersensitivity reactions and bronchospasm.
