INFORMATION FOR PATIENTS REQUIRING GASTROINTESTINAL EXAMINATION OR SURGERY :

COLYTE produces a watery stool which cleanses the bowel prior to examination. For best results, solid food should not be eaten during the 3 to 4 hours period before you start drinking the solution. The rate of administration is 240 ml (8oz) every 10 minutes. Rapid drinking of each portion is preferred rather than drinking small amounts continuously. The first bowel movement should occur approximately one 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 drinking of approximately 3-4 litres, although more or less may be required in some patients. The unused portion should be discarded.

PREPARATION OF SOLUTION :

1. Remove cap.
2. Add water to FILL LINE.
3. Replace cap and shake well until all INGREDIENTs have been dissolved.
4. No additional flavourings or INGREDIENTs should be added to the solution.
5. Refrigerate the solution, as chilling improves the taste.
6. Reconstituted solution should be used within 48 hours  after mixing if stored at room temperature. If kept refrigerated at 2-8^oC, use within 30 days.

DOSAGE AND ADMINISTRATION : COLYTE can be administered orally or by nasogastric tube. Patients should fast at least 3 hours prior to administration. A one-hour waiting period after the appearance of clear liquid stools should be allowed prior to examination to complete bowel evacuation. No foods except clear liquids should be permitted prior to examination after COLYTE administration.

ORAL : The recommended adult dose is 240 mL (8oz) every 10 minutes. Lavage is complete when fecal discharge is clear. Lavage is usually complete after the ingestion of 3-4 litres or follow your physician’s direction for use.

NASOGASTRIC TUBE : COLYTE is administered at a rate of 20 to 30 mL/minute (1.2-1.8 L/hour).

DESCRIPTION : COLYTE is a colon lavage preparation provided as water-soluble components for reconstitution as follows :

Polyethylene Glycol 3350	240 grams
Sodium Chloride	5.84 grams
Potassium Chloride	2.98 grams
Sodium Bicarbonate	6.72 grams
Sodium Sulphate (anhydrous)	22.72 grams

NON-MEDICINAL INGREDIENTS (alphabetically) :  Magnasweet 185, Pineapple flavour and Sodium Saccharin. After reconstitution with water, final 4-litre solution contains 125 mEq/L Sodium, 10 mEq/L Potassium, 20 mEq/L Bicarbonate, 80 mEq/L Sulphate, 35 mEq/L Chloride and 17.9 mEq/L Polyethylene Glycol 3350. The reconstituted solution is isosmotic and has a mild fruit flavour. COLYTE is administrated orally or via nasogastric tube.

CLINICAL PHARMACOLOGY : COLYTE cleanses the bowel by induction of diarrhea. The osmotic activity of polyethylene glycol 3350, in combination with the electrolyte concentration, results in virtually no net absorption or secretion of ions or water. Accordingly, large volumes may be administered without significant changes in fluid and electrolyte balance.

INDICATIONS : COLYTE is indicated for bowel cleansing prior to colonoscopy or barium enema x-ray examination or surgical procedures requiring a clean colon.

CONTRAINDICATIONS : COLYTE is contraindicated in patients with ileus, gastric retention, bowel perforation, gastrointestinal obstruction, toxic colitis and toxic megacolon.

WARNINGS : No additional flavourings or ingredients should be added to the solution. COLYTE should be used with CAUTION in patients with severe ulcerative colitis.

PRECAUTIONS : General : Patients with impaired gag reflex, unconscious or semiconscious patients and patients prone to regurgitation or aspiration should be observed during the administration of COLYTE, especially if it is administered via nasogastric tube. If gastrointestinal obstruction or perforation is suspected, appropriate studies should be performed to rule out these conditions before administration of COLYTE.

DRUG INTERACTIONS : Oral medications administered within one hour of the start of administration of COLYTE may be flushed from the gastrointestinal tract and not absorbed.

CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT OF FERTILITY : Long-term carcinogenic and reproductive studies with animals have not been performed. PREGNANCY : Animal reproduction studies have not been conducted with COLYTE, and it is not known whether COLYTE can affect reproductive capacity or harm the fetus when administered to a pregnant patient. COLYTE should be given to a pregnant patient only if clearly needed.

ADVERSE REACTIONS : Nausea, abdominal fullness and bloating are the most frequent adverse reactions, occurring in up to 50% of patients. Abdominal cramps, vomiting and anal irritation occur less frequently. These adverse reactions are transient. Isolated case of urticaria, rhinorrhea, dermatitis and, rarely anaphylaxis, angioedema, tongue edema, and face edema have been reported which may represent allergic reactions.

HOW SUPPLIED : In powder form, for oral administration as a solution following reconstitution. Store powder between 15^oC and 30^oC.

INFORMATION FOR PHYSICIANS REGARDING CHRONIC CONSTIPATION AND PEDIATRIC USE :

COLYTE is also indicated for the treatment of constipation and has been used occasionally in children. This should only be carried out under the supervision of a physician.

DOSAGE :  Chronic constipation : 240 to 480 mL/day orally or as recommended by a physician. Pediatric use : Dosage should be adjusted bearing in mind the weight of the child. CAUTION should be exercised to avoid dehydration.