Details for: PICO-SALAX
Company: FERRING INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02254794 | PICO-SALAX | CITRIC ACID; MAGNESIUM OXIDE; SODIUM PICOSULFATE | 12 G / SACHET; 3.5 G / SACHET; 10 MG / SACHET | POWDER FOR SOLUTION | ORAL |
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
PICO-SALAX is a white powder. It is a very strong purgative (i.e. to empty bowels). PICO-SALAX is used to cleanse the bowel of faecal matter and secretions prior to x-ray examination, endoscopy or surgery. This product is not intended for routine use as a laxative.
What it does
Magnesium oxide and citric acid combine together (chemical reaction) in water to form magnesium citrate, which works as an osmotic laxative drawing water into the bowel to help make the stool soft and more watery. Sodium picosulfate works as a stimulant laxative to increase the bowel movements to move- the contents along. Together they work to empty the bowel prior to medical procedures.
When it should not be used
- If you are allergic to any of the ingredients (see above).
- If you have any of the following; gastric retention (reduced ability of the stomach to empty), gastric or intestinal ulcers, appendicitis, gastrointestinal blockage or perforation.
- If you have ileus (intestinal blockage or failure of normal movements), toxic colitis (damage to intestinal wall) or toxic megacolon (acute dilatation of the large bowel). In these conditions, transit of the contents of the bowel may be impaired or prevented. Symptoms include nausea, vomiting, diarrhoea, abdominal pain, tenderness or swelling, colicky pain and fever.
- If you have congestive cardiac failure (the heart is unable to pump blood efficiently around the body).
- If you have severely reduced kidney function.
What the medicinal ingredient is
Each sachet contains 16.1 g of powder which has three active ingredients: sodium picosulfate 10 mg, magnesium oxide 3.5 g and citric acid 12 g;, the later two form magnesium citrate in solution.
What the non-medicinal ingredients are
Natural orange or natural cranberry flavour, potassium bicarbonate and saccharin sodium
What dosage form it comes in
Powder
Warnings and precautions
Please consult your doctor before taking PICO-SALAX® if you:
- Have recently had gastrointestinal surgery,
- Have a medical condition affecting the heart or kidneys,
- Have inflammatory bowel disease such as ulcerative colitis or Crohn’s disease,
- Are using bulk forming laxatives e.g. bran.
- Have heart problems such as a recent heart attack, irregular or fast heartbeat ( arrhythmia), lengthened heart beat (QT prolongation) or angina
- Have a history of seizures
- Have an impaired gag reflex
Pregnancy or Breast-Feeding: If you are pregnant or are breast-feeding, ask your doctor or pharmacist for advice before taking PICO-SALAX.
Interactions with this medication
Taking Other Medicines:
Please inform your doctor or pharmacist:
- If you are taking or have recently taken or used any other medicines – even those that are available without a prescription.
- If you are taking anti-epileptics, contraceptives, antibiotics, diabetes medications and cardiac glycosides as they may be affected during treatment with PICOSALAX.
- If you are taking diuretics, corticosteroids and lithium as these drugs may affect electrolyte balance.
- If you are taking nonsteroidal anti-inflammatory drugs (NSAIDS), tricyclic antidepressants, antipsychotic drugs or carbamazapine as these drugs may add to the electrolyte imbalance.
- If you are taking oral iron preparations for a week before colonoscopy.
- If you are taking constipating drugs (e.g. cholinergics, opioids); they should be temporarily discontinued for a few days before the procedure.
- If you are taking Tetracycline and fluoroquinolone antibiotics, digoxin, chlorpromazine and penicillamine they should be taken 2 hours before or not less than 6 hours after taking Pico-Salax, to avoid loss of effectiveness of these other medications
Proper use of this medication
PRE-DOSING INSTRUCTIONS:
If you have special dietary requirements, please discuss this with your doctor.
At least 3 days prior to your procedure:
- Do not consume seeds or nuts due to digestive residue
- Do not consume any fresh fruits or raw vegetables (i.e. 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 a variety of clear fluids over 4 hours.
DO NOT DRINK JUST WATER ALONE. Drinking only water to replace the fluid losses may lead to electrolyte imbalance, particularly to hyponatremia and possibly seizures. A good option is to also drink a balanced electrolyte solution as recommended by a health professional to replace fluid losses. A good option is to also drink a balanced electrolyte solution (e.g. Gastrolyte†, Pedialyte†) as recommended by a health professional to replace fluid losses.
Recommended clear fluids include any fluid that you can see through, that is not red or purple; such as sports drinks (e.g. Gatorade†), Gastrolyte†, Pedialyte†, Kool-Aid†, clear broth (chicken, vegetable or beef stock with no noodles, meat or vegetables), fruit juices (e.g. apple, white (not red) cranberry, white (not purple) grape), tea or coffee (black, sweetened to taste, no milk, cream or soy), clear sodas (e.g. ginger ale), plain Jell-O† (not red or purple), Popsicles† (not red or purple) and water.
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 a variety 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 a variety 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 a variety 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 a variety 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 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) 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.
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 bowel movements have ceased. In general, patients should drink about 250 mL of water or clear fluid and/or a balanced electrolyte solution (e.g.: Gastrolyte†, Pedialyte†) as recommended by a health care professional, every hour while they feel the effects of PICOSALAX.
No fluid should be taken at least 2 hours prior to your procedure
Side effects and what to do about them
Like all medicines, PICO-SALAX can cause side effects, although not everybody gets them. Adverse reactions to PICO-SALAX are very rare (< 1 in 10, 000). Some examples include: hyponatraemia, epilepsy, grand mal convulsions, nausea, rash, headache, anaphylactoid reaction, hypersensitivity.
If any side effects become serious or persist, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
| Symptom / effect | Talk with your doctor or pharmacist Only if severe | Talk with your doctor or pharmacist In all cases | Stop taking drug and call your doctor or pharmacist |
|---|---|---|---|
| Uncommon | |||
| Hyponatraemia is a metabolic condition in which there is not enough sodium (salt) in the body fluids outside the cells, Symptoms can include vomiting, confusion, fatigue and irritability | ✔ | ✔ | |
| Convulsion, epilepsy, confusional state, headache. | ✔ | ✔ | |
| Vomiting, diarrhea, abdominal pain, nausea. | ✔ | ||
This is not a complete list of side effects. For any unexpected effects while taking PICO-SALAX, contact your doctor or pharmacist.
How to store
Store at room temperature (15°C to 25°C).
Keep out of reach of children.
Reporting side effects
You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:
- Report online at www.healthcanada.gc.ca/medeffect
- Call toll-free at 1-866-234-2345
- Complete a Canada Vigilance Reporting Form and:
- Fax toll-free to 1-866-678-6789, or
- Mail to: Canada Vigilance Program
Health Canada
Postal Locator 0701D
Ottawa, Ontario
K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect™ Canada Web site at www.healthcanada.gc.ca/medeffect.
NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.
More information
This document plus the full product monograph, prepared for health professionals, can be provided by contacting the manufacturer, Ferring Inc., at: 1-800-263-4057.
This leaflet was prepared by Ferring Inc.
Last revised: October 25, 2012
© 2012 Ferring Inc. all rights reserved
® Registered Trademark of Ferring bv
† All other trademarks are the property of their respective
owners