What Pico-Salax is used for and how to use it
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Pico-Salax - Consumer Medicine Information

Manufacture: Ferring Pharmaceuticals
Country: Canada
Condition: Bowel Preparation
Class: Laxatives
Form: Powder
Ingredients: sodium picosulfate, magnesium oxide, citric acid, potassium bicarbonate, saccharin sodium

Magnesium oxide, citric acid and sodium picosulfate

Powder for oral solution

Purgative

About This Medication

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.

When it Should not be Used

  1. If you are allergic to any of the ingredients (see above).
  2. 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.
  3. 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.
  4. If you have congestive cardiac failure (the heart is unable to pump blood efficiently around the body).
  5. If you have severely reduced kidney function.

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.

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 Important Nonmedicinal Ingredients Are

Natural orange or synthetic cranberry flavour, potassium bicarbonate and saccharin sodium

What Dosage Forms 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 PICO-SALAX.
  • 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 to2 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 seethrough,that isnot 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 shouldbe 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 PICO-SALAX.

No fluid should be taken at least 2 hours prior to your procedure

Overdose

In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

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.

Serious Side Effects, how Often They Happen and What to Do About Them

Symptom/effectTalk with your doctor or pharmacistStop taking
drug and
call your
doctor or
pharmacist
Only if
severe
In all
cases
UncommonHyponatraemia 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 It

Store at room temperature (15°C to 25°C).

Keep out of reach of children

Reporting Suspected 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, ON K1A 0K9

    Postage paid labels, Canada Vigilance Reporting Forms 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: 1-866-384-1314.