Picoprep

Each sachet contains the following active ingredients: Sodium picosulfate 10.0 mg, Light magnesium oxide 3.5 g, Anhydrous citric acid 12.0 g.
Excipients/Inactive Ingredients: Potassium hydrogen carbonate, natural sodium saccharin, spray dried orange flavour which contains gum arabic, lactose, ascorbic acid and butylated hydroxyanisole.

Pharmacotherapeutic group: Contact Laxatives.
Pharmacology: Pharmacodynamics: The active components of Sodium picosulfate + Magnesium oxide + Citric acid (PICOPREP) are sodium picosulfate and magnesium citrate. Sodium picosulfate is a locally acting stimulant cathartic, which after bacterial cleavage in the colon forms the active laxative compound, bis-(p-hydroxyphenyl)-pyridyl-2-methane (BHPM), which has a dual-action with stimulation of the mucosa of both the large intestine and of the rectum. Magnesium citrate acts as an osmotic laxative by retaining moisture in the colon. The combined action of the two substances is of a 'washing out' effect combined with peristaltic stimulation to clear the bowel.
The product is not intended for use as a routine laxative.
Pharmacokinetics: Both active components are locally active in the colon, and neither are absorbed in any detectable amounts.

To clean the bowel prior to X-ray examination or endoscopy.
To clean the bowel prior to surgery when judged clinically necessary.

Route of administration: Oral.
A low residue diet is recommended on the day prior to the procedure. A clear liquid diet is recommended on the day of the procedure. To avoid dehydration it is important to follow the liquid intake recommendation as advocated together with Sodium picosulfate + Magnesium oxide + Citric acid (PICOPREP) dosing while the effects of Sodium picosulfate + Magnesium oxide + Citric acid (PICOPREP) persist. Apart from the liquid intake together with the treatment regimen (PICOPREP + additional liquids), a normal, thirst driven intake of clear liquids is recommended. Clear liquids should include a variety of fruit juice without pulp, soft drinks, clear soup, tea, coffee (without milk, soy or cream). Do not drink only water.
Directions for reconstitution: Reconstitute the contents of one sachet in a cup of water (approximately 150 mL). Stir for 2-3 minutes, the solution should now become an off-white, cloudy liquid with a faint odour of orange. Drink the solution. If it becomes hot, wait until it cools sufficiently to drink.
Adults (including the elderly): (if the procedure is scheduled for the afternoon, it is recommended that the Split-Dose regimen should be used): Split-Dose Regimen (evening-before and day of the procedure): The first Sodium picosulfate + Magnesium oxide + Citric acid (PICOPREP) sachet is taken the night before the procedure, and the second is taken the next day, in the morning prior to the procedure.
On the day before the procedure: 1 sachet: The first reconstituted sachet is taken in the evening (e.g., 5:00 to 9:00PM), followed by at least five 250 mL drinks of clear liquids.
On the day of the procedure: 1 sachet: The second reconstituted sachet is taken in the morning (5-9 hours before the procedure), followed by at least three 250 mL drinks of clear liquids.
Clear liquids may be consumed until 1 hour before the time of the procedure.
Or DAY-BEFORE REGIMEN (evening-before the procedure only): The first Sodium picosulfate + Magnesium oxide + Citric acid (PICOPREP) sachet is taken in the afternoon or early evening and the second is taken approximately 6 hours later, the night before the procedure.
On the day before the procedure: 2 sachets: The first reconstituted sachet is taken in the afternoon or early evening (e.g., 4:00 to 6:00 PM), followed by at least five 250 mL drinks of clear liquids.
The second reconstituted sachet is taken in the late evening (e.g., 10:00 PM to 12:00 AM), followed by at least three 250 mL drinks of clear liquids.
Clear liquids may be consumed until 1 hour before the time of the procedure.
Children: The first dose reconstituted in water as directed, taken before 8 am on the day before the procedure. Second dose 6 to 8 hours later.
1-2 years: ¼ sachet morning, ¼ sachet afternoon.
2-4 years: ½ sachet morning, ½ sachet afternoon.
4-9 years: 1 sachet morning, ½ sachet afternoon.
9 and above: adult dose.

Overdosage would lead to profuse diarrhoea. Treatment is by general supportive measures and maintenance of fluid intake.

Hypersensitivity to any of the ingredients of the product; Congestive cardiac failure; Gastric retention; Gastro-intestinal ulceration; Toxic colitis; Toxic megacolon; Ileus; Nausea and vomiting; Acute surgical abdominal conditions such as acute appendicitis; Known or suspected gastro-intestinal obstruction or perforation; Severe dehydration; Rhabdomyolysis; Hypermagnesemia; Active inflammatory bowel disease; In patients with severely reduced renal function, accumulation of magnesium in plasma may occur. Another preparation should be used in such cases.

Because a clinically relevant benefit of bowel cleansing prior to elective, open colorectal surgery could not be proven, bowel cleansers should only be administered before bowel surgery if clearly needed. The risks of the treatment should be carefully weighed against possible benefits and needs depending on surgical procedures performed.
Recent gastro-intestinal surgery. Care should also be taken in patients with renal impairment, heart disease or inflammatory bowel disease.
Use with caution in patients on drugs that might affect water and/or electrolyte balance e.g. diuretics, corticosteroids, lithium.
Sodium picosulfate + Magnesium oxide + Citric acid (PICOPREP) may modify the absorption of regularly prescribed oral medication and should be used with caution e.g. there have been isolated reports of seizures in patients on antiepileptics, with previously controlled epilepsy.
An inadequate oral intake of water and electrolytes could create clinically significant, deficiencies, particularly in less fit patients. In this regard children, the elderly, debilitated individuals and patients at risk of hypokalaemia may need particular attention. Prompt corrective action should be taken to restore fluid/electrolyte balance in patients with signs or symptoms of hypokalemia. Hyponatraemia. Drinking only water to replace the fluid losses may lead to electrolyte imbalance.
The period of bowel cleansing should not exceed 24 hours because longer preparation may increase the risk of water and electrolyte imbalance.
This medicine contains 5 mmol (or 195 mg) potassium per sachet. This should be taken into consideration by patients with reduced kidney function or patients on a controlled potassium diet.
This medicine contains lactose as a component of the flavour. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Sodium picosulfate + Magnesium oxide + Citric acid (PICOPREP) should not be used as a routine laxative.
Effects on Ability to Drive and Use Machines: Not applicable.

For Sodium picosulfate + Magnesium oxide + Citric acid (PICOPREP) no clinical data on exposed pregnancy are available. Studies in animals have shown reproductive toxicity. As picosulfate is a stimulant laxative, for safety measure, it is preferable to avoid the use of Sodium picosulfate + Magnesium oxide + Citric acid (PICOPREP) during pregnancy.
There is no experience with the use of Sodium picosulfate + Magnesium oxide + Citric acid (PICOPREP) in nursing mothers. However, due to the pharmacokinetic properties of the active ingredients, treatment with Sodium picosulfate + Magnesium oxide + Citric acid (PICOPREP) may be considered for females who are breastfeeding.

The most frequent adverse reactions seen in clinical trials are nausea, headache and vomiting. (See table.)

Click on icon to see table/diagram/image

Diarrhoea and faecal incontinence are the primary clinical effect of Sodium picosulfate + Magnesium oxide + Citric acid (PICOPREP). Isolated cases of severe diarrhoea have been reported post-marketing.
Hyponatraemia has been reported with or without associated convulsions. In epileptic patients, there have been isolated reports of seizure/grand mal convulsion without associated hyponatraemia. There have been isolated reports of anaphylactoid reaction.

As a purgative, Sodium picosulfate + Magnesium oxide + Citric acid (PICOPREP) increases the gastrointestinal transit rate. The absorption of other orally administered medicines (e.g. anti-epileptics, contraceptives, anti-diabetics, antibiotics) may therefore be modified during the treatment period. Tetracycline and fluoroquinolone antibiotics, iron, digoxin, chlorpromazine and penicillamine, should be taken at least 2 hours before and not less than 6 hours after administration of Sodium picosulfate + Magnesium oxide + Citric acid (PICOPREP) to avoid chelation with magnesium.
The efficacy of Sodium picosulfate + Magnesium oxide + Citric acid (PICOPREP) is lowered by bulk-forming laxatives.
Care should be taken with patients already receiving drugs which may be associated with hypokalaemia (such as diuretics or corticosteroids, or drugs where hypokalaemia is a particular risk i.e. cardiac glycosides). Caution is also advised when Sodium picosulfate + Magnesium oxide + Citric acid (PICOPREP) is used in patients on NSAIDs or drugs known to induce SIADH e.g. tricyclic antidepressants, selective serotonin re-uptake inhibitors, antipsychotic drugs and carbamazepine as these drugs may increase the risk of water retention and/or electrolyte imbalance.

Incompatibilities: Not applicable.

Store at temperatures not exceeding 30°C. Store in the original package in order to protect from moisture.
Shelf-Life: 3 years.
Once the sachet has been opened, use immediately and discard any unused powder or solution.

Laxatives, Purgatives

A06AB58 - sodium picosulfate, combinations ; Belongs to the class of contact laxatives.

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