DULCOLAX SP
Sodium picosulfate DULCOLAX SP Drops contains 7.5 mg sodium picosulfate per mL. It also contains sodium benzoate as the preservative, sodium citrate, citric acid monohydrate, sorbitol solution (70%) (non-crystallising) and purified water.
Sodium picosulfate is a locally acting laxative from the triarylmethane group, which after bacterial cleavage in the colon, stimulates the mucosa of the large intestine, causing colonic peristalsis and promotes accumulation of water, and consequently electrolytes, in the colonic lumen. This results in a stimulation of defecation, reduction of transit time and softening of the stool.
After oral ingestion, sodium picosulfate reaches the colon without any appreciable absorption. Therefore enterohepatic circulation is avoided. The active laxative compound, bis-(p- hydroxyphenyl)-pyridyl-2-methane (BHPM), is formed by bacterial cleavage in the intestine. Consequently, the onset of action of the preparation is usually between 6 to 12 hours, which is determined by the release of the active substance. After oral administration, only small amounts of the drug are systemically available. There is no relationship between the laxative effect and plasma levels of the active moiety.
For the treatment of constipation.
DULCOLAX SP is contraindicated in patients with ileus, intestinal obstruction, acute abdominal conditions like acute appendicitis, acute inflammatory bowel diseases, and severe abdominal pain associated with nausea and vomiting which may be indicative of the aforementioned severe conditions. DULCOLAX SP is contraindicated in severe dehydration and when symptoms of water and electrolyte disturbances such as fatigue, weakness, muscle cramps, thirst, dizziness and fainting, are present. DULCOLAX SP is also contraindicated in patients with known hypersensitivity to sodium picosulfate (or substances of the triarylmethane group), or any of the excipients present in DULCOLAX SP. In case of a rare hereditary condition that may be incompatible with the excipients of this medicine (see Precautions), the use of this medicine is contraindicated.
Patients with renal or cardiac impairment, or dehydration, should consult a physician before taking DULCOLAX SP. As with all laxatives, DULCOLAX SP should not be taken on a continuous daily basis or for extended periods, without investigating the cause of constipation. Prolonged or excessive use may lead to excessive water loss, electrolyte imbalance and hypokalaemia. Dizziness and/or syncope have been reported in patients who have taken DULCOLAX SP. The details available for these cases suggest that the events would be consistent with defecation syncope (or syncope attributable to straining at stool), or with a vasovagal response to abdominal pain related to the constipation, and not necessarily to the administration of sodium picosulfate itself. DULCOLAX SP, as with other laxatives, when taken in chronic overdose may cause diarrhoea, abdominal pain, hypokalaemia, secondary hyperaldosteronism and renal calculi. Renal tubular damage, metabolic alkalosis and muscle weakness secondary to hypokalaemia have also been described in association with chronic laxative abuse. Children should not take DULCOLAX SP without medical advice. Patients with the rare hereditary condition of fructose intolerance should not take this medicine. 1 mL (approximately 15 drops) of this medicine contains 450 mg of sorbitol, resulting in 600 mg of sorbitol per maximum recommended daily dose for treatment of adults and children over 10 years.
There are no adequate or well-controlled studies in pregnant women. Long experience has shown no evidence of undesirable or damaging effects during pregnancy. Nevertheless, as with all drugs, DULCOLAX SP should only be taken during pregnancy on medical advice.
Clinical data show that neither the active moiety of sodium picosulfate BHPM (bis-(p- hydroxyphenyl)-pyridyl-2-methane) nor its glucuronides are excreted into the milk of healthy lactating human females. Thus, DULCOLAX SP can be safely used during breast-feeding.
No studies on the effect on human fertility have been conducted. Non-clinical studies did not reveal any effects on fertility.
The concomitant use of diuretics or adreno-corticosteroids may increase the risk of electrolyte imbalance if excessive doses of DULCOLAX SP are taken. Electrolyte imbalance may lead to increased sensitivity to cardiac glycosides. Concurrent administration of antibiotics may reduce the laxative action of DULCOLAX SP.
There have been no studies performed, to date, on the effects on the ability to drive and operate machinery. However, patients should be advised that due to a vasovagal response (e.g., to abdominal spasm they may experience dizziness and/ or syncope. If patients experience abdominal spasm they should avoid potentially hazardous tasks such as driving or operating machinery.
Immune system disorders
Hypersensitivity including angioneurotic oedema and skin reactions.
Nervous system disorders
Dizziness, syncope. Dizziness and syncope ocurring after taking sodium picosulfate appear to be consistent with a vasovagal response (e.g., to abdominal spasm, defecation.)
Gastrointestinal disorders
Abdominal cramps, abdominal pain, diarrhoea, vomiting, nausea, abdominal discomfort.
15 drops from the dropper is equivalent to approximately 7.5 mg sodium picosulfate. Each 1 mL contains 7.5 mg sodium picosulfate.
Adults and children over 10 years:
Initially 10 drops (5 mg) at night.
Increase up to 20 drops (10 mg) only if required.
Children 4 to 10 years:
5 to 10 drops (2.5 - 5 mg) at night
DULCOLAX SP should be taken at night to produce a bowel motion the following morning. DULCOLAX SP Drops can be dripped onto a spoon and then should be taken immediately. DULCOLAX SP Drops can also be added to a glass of water. The entire contents of the glass should be taken immediately after the addition of DULCOLAX SP Drops.
Remove protective cap.
Do not shake the bottle. To make the dropper function, hold the bottle with the dropper facing downwards. Gently and carefully squeeze the bottle.
Take the recommended dose or as directed by your doctor or pharmacist.
Replace protective cap after use.
In case of overdose, immediately contact the Poisons Information Centre (call 13 11 26) for advice.
If high doses are taken, diarrhoea, abdominal cramps and a clinically significant loss of fluid, potassium and other electrolytes can occur. Furthermore, cases of colonic mucosal ischaemia have been reported in association with doses of sodium picosulfate considerably higher than those recommended for the routine management of constipation.
Within a short time after ingestion, absorption can be minimised or prevented by inducing vomiting or gastric lavage. Replacement of fluids and correction of electrolyte imbalance may be required. This is especially important in the elderly and the young. Administration of antispasmodics may be of some value.
DULCOLAX SP Drops is a clear, colourless to yellowish or slightly yellowish-brown, slightly viscous solution. Each 1 mL (approximately 15 drops) contains 7.5 mg sodium picosulfate. Available in bottles of 15 mL and 30 mL. Not all pack sizes are distributed in Australia.
DULCOLAX SP Drops should be stored below 25degC. Protect from light.
Unscheduled
Boehringer Ingelheim Pty Limited ABN 52 000 452 308 78 Waterloo Road North Ryde NSW 2113 Text prepared on 23 November 2006. Text updated on 26 May 2011.