Patient Medication Information: uses, side effects, how to take - Bi-Peglyte
ABOUT THIS MEDICATION
What the medication is used for:
Bi-PEGLYTE® is used for cleansing of the colon as a preparation for colonoscopy in adults.
What it does:
Bi-PEGLYTE® produces a watery stool which cleanses the bowel before colonoscopy examination. The bisacodyl component of Bi-PEGLYTE® acts as a stimulant laxative directly on the bowel to induce muscle contractions and to promote fluid accumulation in the bowel, and the polyethylene glycol binds to the water to help laxation and together the ingredients speed bowel emptying. The electrolytes help maintain the salt balance in this process.
When it should not be used:
Do not use if you are hypersensitive (allergic) to any ingredient in this formulation (see “What the nonmedicinal ingredients are”).
Do not take if you have any of the following stomach/intestine conditions (ask your doctor if you are unsure):
- Ileus (blockage in the bowel)
Gastric retention (problems with food and fluid emptying from stomach)
- Gastrointestinal (GI) obstruction (a blockage in bowel)
- Bowel perforation (an opening in the wall of your stomach or intestine)
- Toxic colitis (inflamed large bowel with damage to the intestinal wall)
- Toxic megacolon (acute swelling of the large bowel)
- Acute abdominal surgery
- Appendicitis (painful swelling and infection of the appendix, a small pouch attached to the large intestine)
- Rectal bleeding
- Gastroenteritis (inflammation in the gastrointestinal tract)
- Diverticulitis (a digestive disease found in the large intestine)
What the medicinal ingredients are:
Each sachet of PEG/Electrolytes powder gastrointestinal lavage preparation contains:
Polyethylene Glycol 3350…59.55 g
Sodium Sulphate……………5.74 g
Sodium Bicarbonate………..1.69 g
Sodium Chloride……………1.46 g
Potassium Chloride…………0.76 g
Each blister-pack of Bisacodyl delayed release tablets, USP contains: three (3) tablets of bisacodyl 5 mg each.
What the nonmedicinal ingredients are:
PEG/Electrolytes powder sachets (in alphabetical order): Fruit flavour and Sodium Saccharin.
Bisacodyl tablets (in alphabetical order): D&C Yellow No.10 Aluminum Lake, FD&C Yellow No.6 Aluminum Lake, Hypromellose, Lactose Monohydrate, Magnesium Stearate, Methylated Silica, Methylcellulose, Microcrystalline Cellulose, Polydextrose, Polydimethylsiloxane, Polyethylene Glycol, Polyvinyl Acetate Phthalate, Silica, Sodium Alginate, Sodium Bicarbonate, Sodium Carboxymethylcellulose, Sorbic Acid, Stearic Acid, Sulphuric Acid, Talc, Titanium Dioxide, Triacetin, Triethyl Citrate.
What dosage forms it comes in:
Bi-PEGLYTE® is a kit containing two sachets of PEG/Electrolytes powder for reconstitution (each sachet is dissolved into 1 L of water – see “Proper use of this Medication”) and one blister-pack containing 3 tablets of 5 mg each of bisacodyl. The entire contents of the kit should be used for the product to be effective.
WARNINGS AND PRECAUTIONS
BEFORE you use Bi-PEGLYTE® talk to your doctor or pharmacist if:
- You have taken any other medication within two hours of when you plan to start the PEG/Electrolyte solution (you may be removing this medication from your gastrointestinal tract by taking the PEG/Electrolyte solution)
- You have abdominal pain, nausea, or vomiting
- You have a history of electrolyte imbalance (e.g., change in blood salts (low blood sodium)) 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
In rare cases, serious heart arrhythmias (an irregular or fast heartbeat) have been associated with the use of medicines such as BI-PEGLYTE®. Tell your doctor if you have problems with your heart such as:
- a history of an abnormal electrical signal called “prolongation of the QT interval”
- an arrhythmia that is not under control
- a recent heart attack
- heart failure
- cardiomyopathy (a disease of the heart muscle that makes it harder for your heart to pump blood to the rest of your body)
Your doctor will decide whether you can take BI-PEGLYTE®.
Talk to your doctor if you have kidney or heart problems or 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 airways.
Bi-PEGLYTE contains polyethylene glycol (PEG), which may stop starch based food thickeners from working. This may cause certain mixtures to be watery and difficult to swallow.
Inform your doctor immediately if you experience severe abdominal pain or rectal bleeding.
INTERACTIONS WITH THIS MEDICATION
Oral medications taken within 2 hours of the start of administration of the PEG/Electrolytes powder may be flushed from the gastrointestinal tract and not absorbed.
Tell your doctor and pharmacist about all the medicines you are taking, including prescription and non-prescription medications, vitamins, nutritional supplements, and herbal products.
Bi-PEGLYTE® may interact with stimulant laxatives (e.g. bisacodyl). Stop taking Bi-PEGLYTE® and seek medical help if you experience severe abdominal pain and / or rectal bleeding.
PROPER USE OF THIS MEDICATION
On the day before the procedure no solid foods or milk, except clear liquids, should be taken after 11h00 AM or as specified by your doctor. You can resume eating solid foods and milk only after your procedure or examination. No antacids should be taken within one hour of taking the bisacodyl tablets. Your physician will tell you what time of the day to start your treatment.
Drink plenty of water (or clear liquids) before, during and after using Bi-PEGLYTE®.
You should have been given specific instructions about when to take Bi-PEGLYTE® by your doctor or nurse. Your treatment with
Bi-PEGLYTE® must be completed before your clinical procedure.
Preparation of the solution:
- 1. Dissolve the entire contents of one sachet in 1 L (32 ounces) of lukewarm water and mix rapidly until a clear solution forms. Do not use cold water. Repeat the step with the second sachet. Do not add any other ingredients (e.g. flavouring, juice) to the solution.
- 2.
Refrigerate the solution as chilling improves the taste. Using a straw may help the solution taste better and easier
- to drink.
- 3. Use the freshly-made solution within 48 hours and discard unused portion.
Dosing regimens your healthcare practitioner may prescribe:
| SPLIT-DOSING REGIMEN* |
Day before procedure:**
- 1. Take 3 bisacodyl tablets (total of 15 mg) with water in the afternoon (at around 2:00 PM)**. Do not chew or crush the tablets.
- 2. In the evening (at around 8:00 PM or 6 hours after taking the bisacodyl tablets)**, rapidly drink a glassful (250 mL) of the PEG/Electrolytes solution every 10 minutes until the 1 litre solution is finished.
Day of the procedure (about 4 hours before the procedure):**
3.Take the second PEG/Electrolytes solution and rapidly drink a glassful (250 mL) of the solution every 10 minutes until the 1 litre solution is finished, or as directed by a physician.
| FULL-DOSING REGIMEN* |
Day before procedure (start in the afternoon):**
1.Take 3 bisacodyl tablets (total of 15 mg) with water. Do not chew or crush the tablets.
- 2. Wait for a bowel movement (or maximum of 6 hours).
3.After a bowel movement, or if there is no bowel movement within 6 hours of taking the Bisacodyl tablets, rapidly drink a glassful (250 mL) of the PEG/Electrolytes solution every 10 minutes until the 1 litre solution is finished.
- 4. Take the second PEG/Electrolytes solution and rapidly drink a glassful (250 mL) of the solution every 10 minutes until the 1 litre solution is finished or as directed by a physician.
*Follow instructions as prescribed by your physician. Your physician may choose to prescribe a full-dosing or a split-dosing regimen. **Time to be confirmed by your physician.
You will begin to have watery bowel movements within 1 hour after the start of PEG/Electrolytes administration and you will continue to have loose bowel movements for 1 to 2 hours after finishing the solution. Lavage is complete when 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.
Abdominal bloating or distention may occur before the first bowel movement. If your abdominal distention or discomfort continues, stop drinking the PEG/Electrolyte solution temporarily or drink each portion at longer intervals until your symptoms disappear. If you experience severe bloating, distention or abdominal pain, administration of the solution should be slowed or temporarily discontinued until the symptoms subside. Report these events to your doctor. Inform your doctor immediately if you experience severe abdominal pain or rectal bleeding.
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
Nausea, abdominal fullness and bloating are the most frequent side effects occurring in up to half of patients taking PEG/Electrolytes preparations. Abdominal cramps, vomiting and anal irritation occur less frequently. These side effects normally do not last long.
Mild cramping has occurred in some patients after bisacodyl administration.
Bi-PEGLYTE® may cause loss of body fluid (dehydration) and changes in blood salts (electrolytes) in your blood. These changes may cause:
- seizures
- kidney problems
- abnormal heartbeats
Drink sufficient amount of balance salt-containing fluid as directed by your doctor to prevent loss of body fluid and related side-effects.
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM | ||||
|---|---|---|---|---|
| Symptom / effect | Talk with your doctor or pharmacist | Stop taking drug and get immediate medical help | ||
| Only if severe | In all cases | |||
| Unknown | Ischemic colitis (lack of blood flow to intestines): severe abdominal pain, rectal bleeding | √ | ||
| Isolated Cases | Allergic reactions with symptoms such as skin rash, hives and runny nose | √ | ||
This is not a complete list of side effects. For any unexpected effects while taking Bi-PEGLYTE®, contact your doctor or pharmacist.
HOW TO STORE IT
Store the contents of the Bi-PEGLYTE® carton at room temperature (15-30°C). The freshly-reconstituted PEG/Electrolyte solution should be used within 48 hours if stored at room temperature. Discard unused portion.
Keep out of reach and sight 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 0701E
Ottawa, ON
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 on 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 found by contacting PENDOPHARM, Division of Pharmascience Inc. at 1-888-550-6060.
PENDOPHARM, Division of Pharmascience Inc.
Montreal, Quebec
H4P 2T4
Last revised: March 25, 2021
® Registered trademark of Pharmascience Inc.