PICO SALAX Product Information
Read all of this information carefully before you start using this medicine
PICO-SALAX®
(picosulfate and magnesium oxide, and citric acid )
Purgative
Pharmacology:
The active components of Pico-Salax® are sodium picosulfate and magnesium citrate.
Picosulfate is a stimulant cathartic active locally in the colon.
Magnesium citrate (magnesium oxide and citric acid) acts as an osmotic laxative by retaining moisture in the colon. The action is of a powerful “washing out” effect combined with peristaltic stimulation to clear the bowel prior to radiography, colonoscopy or surgery. Full doses of the saline cathartic (e.g. 15 g of magnesium sulfate or its equivalent) produce a semi-fluid watery evacuation within 3-6 hours or less.
The product is not intended for routine use as a laxative.
Systemic Effects:
Some absorption of the component ions of the saline cathartics does occur, and in certain instances they may produce systemic toxicity. This is especially true for magnesium salts, since 20% or more of the administered cation is absorbed. If renal function is normal, the absorbed magnesium is rapidly excreted. However, if a magnesium cation is given to an individual with impaired renal function, the accumulation of magnesium ion in the body fluids may be sufficient to cause magnesium intoxication.
In most instances, salts that gain access to the systemic circulation are rapidly excreted by the kidneys.
Indications:
Pico-Salax® is used for clearance of the bowel prior to x-ray examination, endoscopy or surgery.
Contraindications:
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 and known or suspected gastro-intestinal obstruction or perforation.
In patients with severely reduced renal function, accumulation of magnesium in plasma may occur. Another preparation should be used in such cases.
Warnings and Precautions For Use:
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 (see Drug Interactions and Possible Side Effects).
Patients should avoid taking oral iron preparations for a week before colonoscopy. Constipating drugs (i.e. cholinergics, opioids) should be suspended for a few days before the procedure, after consulting with your doctor.
Pico-Salax® 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 (see Drug Interactions and Possible Side Effects).
An inadequate oral intake of water and electrolytes could create clinically significant, deficiencies, particularly in less fit patients. In this regard, 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 hyponatraemia.
The period of bowel cleansing should not exceed 24 hours because longer preparation may increase the risk of water and electrolyte imbalance.
Pregnancy and Lactation:
Reproduction studies with sodium picosulfate performed in animals have revealed no evidence of a harmful action on the fetus. However, clinical experience of the use of Pico-Salax® during pregnancy is limited and caution should be observed, particularly during the first trimester.
Neither sodium picosulfate nor magnesium citrate have been shown to be excreted in breast milk.
Drug Interactions:
As a purgative, Pico-Salax® 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 (see Warnings and Precautions for Use).
The efficacy of Pico-Salax® 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 Pico-Salax® is used in patients on nonsteroidal anti-inflammatory drugs (NSAIDS) or drugs known to induce Antidiuretic Hormone Secretion (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.
Possible Side-Effects:
Adverse reactions to Pico-Salax® are very rare ( < 1 in10,000) and are presented below by System Organ Class and Preferred term.
Immune system disorders
Anaphylactoid reaction, hypersensitivity
Metabolism and nutrition disorders
Hyponatraemia
Nervous system disorders
Epilepsy, grand mal convulsion, convulsions, confusional state, headache
Gastrointestinal disorders
Vomiting, diarrhoea, abdominal pain, nausea, proctalgia
Skin and subcutaneous tissue disorders
Rash (including erythematous and maculo-papular rash), urticaria, pruritus, purpura
General disorders
Drug interaction
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 (see Warnings and Precautions for Use). There have been isolated reports of anaphylactoid reaction (see Contraindications). Isolated cases of mild reversible aphthoid ileal ulcers have been reported.
Dosage:
ADULTS:
PRE-DOSING INSTRUCTIONS:
If you have special dietary requirements, please discuss this with your doctor.
At least 3 days prior to your procedure:
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Do not consume seeds or nuts due to digestive residue.
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Do not consume any fresh fruits or vegetables (e.g. no salads) and no multigrain bread.
ADULT DOSING INSTRUCTIONS:
Fill a mug with 150 ml (5 oz) of cold water. Empty contents of one sachet in the mug (rarely, mixture may heat up- allow to cool before drinking). Stir for 2-3 minutes until completely dissolved before you drink. Following each sachet, drink 1.5 to 2 Litres of clear fluids.
DRINK ONLY CLEAR FLUIDS – Water, clear power drinks, apple juice, white (not red) cranberry juice, white (not purple) grape juice, ginger ale, broth, tea (sweetened to taste, no milk, cream or soy). Do not drink liquids that your can’t see through. Diabetics can use a fibre free supplement/meal replacement.
One day before your procedure you should have clear fluids ONLY and no solid food. See list above.
Morning colonoscopy-before 12:00 pm (noon):
One day before your procedure: Take 1 sachet (first dose) at 5:00 pm followed by 1.5 to 2 Litres of clear fluids.
One day before your procedure: Take 1 sachet (second dose) at 10:00 pm followed by 1.5 to 2 Litres of clear fluids.
No fluid should be taken at least 2 hours prior to your procedure.
Afternoon colonoscopy - 12:00 pm (noon) or later:
One day before your procedure: Take 1 sachet (first dose) at 7:00 pm followed by 1.5 to 2 Litres of clear fluids.
On the same day as your procedure: Take 1 sachet (second dose) at 6:00 am, followed by 1.5 to 2 Litres of clear fluids.
In order to replace fluid lost from the body, it is important to drink plenty of clear fluids throughout the treatment with PICO-SALAX until the bowel movements have ceased.
No fluid should be taken at least 2 hours prior to your procedure.
PEDIATRIC DOSING INSTRUCTIONS:
Fill a mug with 150 ml (5 oz) of cold water. Empty contents of one sachet in the mug (rarely, mixture may heat up - allow to cool before drinking). Stir for 2-3 minutes until completely dissolved before you drink.
If possible, it is recommended that Pico-Salax should be given at least 5-6 hours before bedtime to avoid interference with sleep, therefore splitting the dose over two days is recommended for children as follows:
(1 to 6 years old):
One day before your procedure: Take ¼ of the prepared solution as per DOSING INSTRUCTIONS (first dose) at 6:00 pm followed by one cup of clear liquid (250 mL,
8 oz) every hour while the child is awake. No solid food should be taken after 6:00 PM
On the same day as your procedure: Take ¼ of the prepared solution as per DOSING INSTRUCTIONS (second dose) at 8:00 am, followed by one cup of clear liquid (250 mL, 8 oz) every hour up to 2 hours prior to your child’s procedure.
(6-12 years old)
One day before your procedure: Take ½ of the prepared solution as per DOSING INSTRUCTIONS (first dose) at 6:00 pm followed by one cup of clear liquid (250 mL,
8 oz) every hour while the child is awake. No solid food should be taken after 6:00 PM
On the same day as your procedure: Take ½ of the prepared solution as per DOSING INSTRUCTIONS (second dose) followed by one cup of clear liquid (250 mL,
8 oz) every hour up to 2 hours prior to your child’s procedure.
In order to replace fluid lost from the body, it is important to drink plenty of clear fluids throughout the treatment with PICO-SALAX® until the bowel movements have ceased. In general, patients should drink about 250 mL of water or clear fluid every hour while they feel the effects of PICO-SALAX®.
No fluid should be taken at least 2 hours prior to your procedure
OVERDOSE:
For management of suspected drug overdose, contact your regional poison control centre.
How Supplied:
Each sachet contains: sodium picosulphate 10 mg, magnesium oxide 3.5 g, and citric acid 12 g.
Non-medicinal ingredients: natural orange or natural cranberry flavour, potassium bicarbonate and saccharin sodium.
Each carton contains 1 or 2 sachets.
Ferring Inc.
Toronto, Ontario
M2J 5C1
Date of Revision: February 2011
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