Colyte: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

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 nonmedicinal ingredients are).

What the medicinal ingredient are:

Each bottle contains:

Polyethylene glycol 3350: 240 g

Sodium chloride: 5.84 g

Potassium chloride: 2.98 g

Sodium bicarbonate: 6.72 g

Sodium sulfate (anhydrous): 22.72 g

What the important nonmedicinal ingredients are:

(alphabetical) Magnasweet 185, Pineapple Flavour and Sodium Saccharin.

What dosage forms it comes in:

Powder for oral solution: bottle of 278 g powder

WARNINGS AND PRECAUTIONS

BEFORE you use Colyte^®, talk to your doctor or pharmacist if:

• You have taken any other medication within two hours of when you plan to start taking Colyte^® (you may be removing this medication from your gastrointestinal tract by taking the

  • Colyte^®)
  • You have a history of electrolyte imbalance (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

  • In rare cases, serious heart arrhythmias (an irregular or fast heartbeat) have been associated with the use of medicines such as Colyte^®. 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 Colyte^®.

Talk to your doctor if you have kidney or heart problems, kidney impairment or heart failure or any tendency to regurgitate (bring up) food from your stomach into your esophagus or any tendency to accidentally inhale food or regurgitated food into the trachea (breathing tube to the lung).

Colyte^® 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.

Contact your doctor if the following occurs while taking Colyte^®:

• You develop severe bloating, abdominal pain or distension
• Do not take this medication if you have abdominal pain, nausea or vomiting and contact your doctor

INTERACTIONS WITH THIS MEDICATION

Oral medications taken within 2 hours of the start of administration of Colyte® may be flushed from the gastrointestinal tract and not absorbed.

Colyte® may interact with stimulant laxatives (e.g. bisacodyl). Stop taking Colyte® and seek medical help if you experience severe abdominal pain and / or rectal bleeding.

Drug interaction studies have not been done for Colyte^®.

PROPER USE OF THIS MEDICATION

Preparation of the solution:

Add lukewarm tap water until half full, replace cap tightly and mix well. Fill the bottle the rest of the way to the fill line (total volume 4 L). Replace cap tightly and mix well until all ingredients have completely dissolved. Do not use cold water.

No additional ingredients, e.g. flavouring, should be added to the solution. Keep refrigerated during treatment, for optimal storage and to improve the taste.

Drink plenty of water (or liquids) before, during and after using Colyte^®.

Usual adult dose:

Colon cleansing before examination

No solid food should be consumed during the period 3 hours before Colyte^® consumption.

Drink 240 mL (8 oz) every 10 minutes. Rapid drinking of each portion is preferred rather than drinking small amounts continuously.

The first bowel movement should occur approximately 1 hour after the start of Colyte^® administration. Administration of Colyte^® should be continued until the watery stool is clear and free of solid matter. This normally requires the consumption of approximately 3 to 4 L, although more or less may be required in some patients. The unused portion should be discarded.

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, Colyte^® 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

Less frequent side effects include:

• abdominal cramps
• vomiting
• anal irritation
• Seizures have also occurred in patients using PEG-based colon preparations.

For patients using Colyte^® in the treatment of constipation, the side effects may include:

• nausea

  • abdominal bloating
  • cramping
  • gas
  • diarrhea. If diarrhea occurs, stop taking Colyte^®.

Isolated cases of urticaria (hives), rhinorrhea (nasal discharge) and dermatitis (skin inflammation) have been reported. These may be signs of an allergic reaction. If you experience these symptoms, seek urgent medical attention.

Serious side effects and what to do about them

This is not a complete list of side effects. For any unexpected effects while taking Colyte^®, contact your doctor or pharmacist.

HOW TO STORE IT

Store the powder at room temperature (between 15 and 30^oC). Keep out of reach of children.

Once reconstituted, the solution should be used within 48 hours after mixing if stored at room temperature. If kept refrigerated (between 2° and 8°C), use within 30 days. Discard unused portion.

REPORTING SUSPECTED SIDE EFFECTS

MORE INFORMATION

This document plus the full prescribing information, prepared for health professionals, can be obtained by contacting the sponsor at 1-888-550-6060.

PENDOPHARM, Division of Pharmascience Inc.

Montreal, Quebec

H4P 2T4

Last revised: March 25, 2021

® Registered trademark used under license by PENDOPHARM, Division of Pharmascience Inc.