Details for: PEGLYTE POWDER
Company: PENDOPHARM DIVISION OF PHARMASCIENCE INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 00777838 | PEGLYTE POWDER | MACROGOL; SODIUM SULFATE; SODIUM BICARBONATE; SODIUM CHLORIDE; POTASSIUM CHLORIDE | 238.18 G / BOTTLE; 22.96 G / BOTTLE; 6.76 G / BOTTLE; 5.85 G / BOTTLE; 3.05 G / BOTTLE | 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
- Bowel cleansing prior to examination (e.g., colonoscopy) or surgical procedures requiring a clean colon.
- The treatment of constipation following consultation with your doctor.
What it does
The polyethylene glycol binds to the water and helps laxation. The electrolytes help maintain the salt balance in this process.
When it should not be used
Do not take if you have any of the following conditions (ask your doctor if you are unsure):
- ileus (blockage in the bowel)
- gastric retention
- bowel perforation
- gastrointestinal obstruction
- toxic colitis (inflamed large bowel with damage to the intestinal wall)
- toxic megacolon (acute swelling of the large bowel)
- or if you are hypersensitive (allergic) to any ingredient in this formulation (See What the non-medicinal ingredients are).
What the medicinal ingredient is
| 70 g sachet | 280 g bottle | |
| Polyethylene Glycol 3350 | 59.55 g | 238.18 g |
| Sodium Sulphate | 5.74 g | 22.96 g |
| Sodium Bicarbonate | 1.69 g | 6.76 g |
| Sodium Chloride | 1.46 g | 5.85 g |
| Potassium Chloride | 0.76 g | 3.05 g |
What the non-medicinal ingredients are
Sodium Saccharin, Fruit flavours.
What dosage form it comes in
Powder for oral solution (fruit flavoured):
- Box of 4 sachets of 70 g powder
- Bottle of 280 g powder
Warnings and precautions
BEFORE you use PegLyte, talk to your doctor or pharmacist if:
- You have taken any other medication within 2 hours of when you plan to start taking PegLyte (you may be removing this medication from your gastrointestinal tract by taking the PegLyte).
- You have a history of electrolyte imbalance (e.g., hyponatremia) or are using diuretics.
- You have ulcerative colitis or any other inflammatory bowel disease (e.g., Crohn’s disease).
- You are pregnant or nursing.
- You have difficulty swallowing or have a pronounced gag reflex or are prone to vomiting.
- You have any allergies to this drug or its ingredients.
Talk to your doctor if you have kidney or heart problemsor any tendency to regurgitate (bring up) food from your stomach into your esophagus or any tendency to accidentally inhale food or regurgitate food into the trachea (breathing tube to the lungs).
Contact your doctor if the following occurs while taking PegLyte:
- You develop severe bloating, abdominal pain or distension.
- Do not take this medication if you have abdominal pain, nausea or vomiting.
Interactions with this medication
Oral medications taken within 2 hours of the start of administration of PegLyte may be flushed from the gastrointestinal tract and not absorbed.
Drug interaction studies have not been done for PegLyte.
Proper use of this medication
Preparation of the solution:
PegLyte 280 g bottle: Add tap water to the fill line (total volume 4 L). Replace cap tightly and mix well until all ingredients have dissolved.
PegLyte 70 g sachet: Dissolve the entire contents of one sachet in 1 L (32 ounces) of water and stir rapidly to dissolve. Repeat for the other 3 sachets, one at a time, as needed.
Do not add any other ingredients (e.g., flavouring, juice) to the solution. Keep refrigerated during treatment, for optimal storage and to improve the taste. Using a straw can help to make the solution taste better and easier to drink.
Usual Dose
Colon cleansing before examination
On the day before your procedure or examination, have breakfast no later than 11h00 AM or as specified by your doctor. After breakfast, no solid foods or milk, except clear liquids, should be taken. You can resume eating solid foods and milk only after your procedure or examination.
Dosing regimens your healthcare practitioner might prescribe:
Day before procedure:**
1. In the afternoon, rapidly drink a glassful (250 mL) of PegLyte every 10-15 minutes until 2 L are consumed.
Day of the procedure (at least 4 hours before the procedure):**
2. Rapidly drink a glassful (250 mL) of PegLyte every 10-15 minutes until 2 L are consumed.
Day before procedure**
1. In the evening**, rapidly drink a glassful (250 mL) of PegLyte every 10-15 minutes until 4 L are consumed.
*Follow instructions as prescribed by your physician. Your physician may choose to prescribe a full-dosing or split-dosing regimen. **Time to be confirmed by your physician.
The first bowel movement should occur approximately 1 hour after the start of PegLyte administration. Administration of PegLyte should be continued until the watery stool is clear and free of solid matter. Make sure to take the entire bowel preparation solution as instructed by your doctor. This will help ensure that the colon will be optimally cleaned and minimize the need to reschedule your procedure.
Constipation
Drink 240 to 480 mL/day for a week or less or as recommended by your doctor. Do not take any type of laxatives for more than one week, unless your doctor has ordered a special schedule for you. Treatment for 2 to 4 days may be required to produce a bowel movement. If no bowel movement occurs in 4 days, contact your doctor.
Overdose
Side effects and what to do about them
Like all medications, PegLyte can cause some side effects. You may not experience any of them. For most patients, these side effects are likely to be minor and temporary.
The most frequent side effects for a colon preparation (occurring in up to 50% of patients) are:
- nausea
- abdominal fullness
- bloating
- abdominal cramps
- vomiting
- anal irritation
For patients using PegLyte in the treatment of constipation, the side effects may include:
- nausea
- abdominal bloating
- cramping
- gas
- diarrhea. If diarrhea occurs, stop taking PegLyte.
This is not a complete list of side effects. For any unexpected effects while taking PegLyte, contact your doctor or pharmacist.
How to store
Store the powder at room temperature (between 15 and 30oC). Keep out of reach and sight of children.
Once reconstituted, the solution should be used within 48 hours after mixing if stored at room temperature. If kept refrigerated (between 2- 8°C), use within 30 days. Discard unused portion.
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:
- Fax toll-free to 1-866-678-6789, or
- Mail to: Canada Vigilance Program
Health Canada
Postal Locator 0701E
Ottawa, Ontario
K1A 0K9
Report online at www.healthcanada.gc.ca/medeffect
Call toll-free at 1-866-234-2345
Complete a Canada Vigilance Reporting Form and:
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 prescribing information, prepared for health professionals, can be obtained by contacting PENDOPHARM, Division of Pharmascience Inc. at 1-888-550-6060.
This leaflet was prepared by
PENDOPHARM, Division of Pharmascience Inc.
Montreal, Quebec
H4P 2T4
Last revised: October 2, 2015
®Registered trademark of Pharmascience Inc.