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 surgery. The product is not intended for use as a routine laxative.
In a randomized, multicentre, blinded study in adults, bowel cleansing before colonoscopy was compared using two different regimens of CitraFleet with the following preparation 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 to Klean-Prep), while significantly higher proportions of patients had good/excellent cleansing with the CitraFleet morning-of-procedure regimen compared to both day-before preparations (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 effects with the CitraFleet day-before regimen. No serious adverse effects occurred.
In a randomized, multicentre, blinded study in adults, bowel cleansing before colonoscopy was compared using two different regimens of CitraFleet: split dosing (1 sachet in the evening before colonoscopy and the second sachet on the morning before colonoscopy, n=159) and a 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). Good/excellent bowel cleansing was achieved in a significantly higher proportion of patients 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 effects in the split-dose group and the morning-before-procedure group, 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 effects 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, a careful assessment of the benefit/risk balance of Citrafleet must be made in this at-risk population before initiating treatment.
Special attention should be paid when prescribing Citrafleet to any patients with regard to known contraindications. Furthermore, special attention should be given to the importance of adequate hydration and, in at-risk patients (as described below), also 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 particular care.
Citrafleet should be used with caution in patients with diagnosed water and/or electrolyte balance disorders or in patients taking medicines 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 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 through abdominal stimuli, e.g. pain, which may 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 should therefore be used with caution. For example, isolated cases of seizures have been reported in patients taking antiepileptic drugs whose epilepsy was previously well controlled (see sections 4.5 and 4.8).
Citrafleet may induce aphthoid ulcers in the colonic mucosa and serious cases of colitis (including ischaemic colitis) requiring hospitalisation have been reported. Consequently, this diagnosis should be considered in cases 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 low-potassium diet.
This medicinal product contains less than 1 mmol (23 mg) sodium per sachet, that is to say essentially sodium-free.
This medicine contains sulfites including disulfites and hydrogen sulfites, which are generated from the maltodextrin present in the lemon flavouring. Rarely, these may cause severe hypersensitivity reactions and bronchospasm.
