PEG Electrolytes Solution

DESCRIPTION

COLYTE^® and COLYTE^®-FLAVORED
PEG-3350 & ELECTROLYTES For Oral Solution
For Gastrointestinal Lavage
R_XOnly

COLYTE^® and COLYTE^®-FLAVORED are colon lavage preparations provided as water-soluble components for solution. In solution each COLYTE^® and COLYTE^®-FLAVORED preparation delivers the following, in grams per liter.

• Polyethylene glycol 3350 60.00
• Sodium chloride 1.46
• Potassium chloride 0.745
• Sodium bicarbonate 1.68
• Sodium sulfate 5.68
• Flavor ingredients (COLYTE^®-FLAVORED) 0.463

When dissolved in sufficient water to make 4 liters, the final solution contains 125 mEq/L sodium, 10 mEq/L potassium, 20 mEq/L bicarbonate, 80 mEq/L sulfate, 35 mEq/L chloride and 18 mEq/L polyethylene glycol 3350. The reconstituted solution is isosmotic and has a mildly salty taste. COLYTE^® and COLYTE^®-FLAVORED are administered orally or via nasogastric tube.

CLINICAL PHARMACOLOGY

COLYTE^® and COLYTE^®- FLAVORED cleanse 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 excretion of ions or water. Accordingly, large volumes may be administered without significant changes in fluid and electrolyte balance.

INDICATIONS

COLYTE^® and COLYTE^®- FLAVORED are indicated for bowel cleansing prior to colonoscopy or barium enema X-ray examination.

DOSAGE AND ADMINISTRATION

COLYTE^® or COLYTE^®-FLAVORED 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 stool should be allowed prior to examination to complete bowel evacuation. No foods except clear liquids should be permitted prior to examination after COLYTE^® or COLYTE^®-FLAVORED administration.

Oral

The recommended adult oral dose is 240 ml (8 fl. oz.) every 10 minutes (see PATIENT INFORMATION section). Lavage is complete when fecal discharge is clear. Lavage is usually complete after the ingestion of 3-4 liters.

Nasogastric Tube

COLYTE^® or COLYTE^®-FLAVORED is administered at a rate of 20-30 mL per minute (1.2-1.8 L/hour).

Preparation Of Colyte^® or Colyte^®-Flavored Solution

• 4 Liter: Add tap water to FILL line. Replace cap tightly and mix or shake well until all ingredients have dissolved. (No additional ingredients, e.g. flavorings, should be added to the solution.)
• One Gallon: The preparation is made by dissolving the contents of the bottle in a food-grade container, in a sufficient quantity of water to produce the final volume according to package directions. (No additional ingredients, e.g. flavorings, should be added to the solution.) Mix well.

HOW SUPPLIED

COLYTE^® and COLYTE^®-FLAVORED are supplied in 4 liter (NDC 0091-4401-23 and NDC 0091-4403-05, respectively) and 18 oz. (NDC 0091-4401-49 and NDC 0091-4403-13, respectively) bottles in powdered form, for oral administration as a solution. Each contains the following:

• 4 liter, (NDC 0091-4401-23 and NDC 0091-4403-05): 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, flavor ingredients (COLYTE^®-FLAVORED only) 1.85 g, in a bottle.



• 18 oz., (NDC 0091-4401-49 and NDC 0091-4403-13): polyethylene glycol 3350 227.10 g, sodium chloride 5.53 g, potassium chloride 2.82 g, sodium bicarbonate 6.36 g, sodium sulfate (anhydrous) 21.50 g, flavor ingredients (COLYTE^®-FLAVORED only) 1.75 g, in a bottle.

Strorage: Store powder at controlled room temperature 15°-30°C (59°-86°F).

Keep reconstituted solution refrigerated. Use within 48 hours. Discard unused portions.

SIDE EFFECTS

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 cases of urticaria, rhinorrhea and dermatitis have been reported which may represent allergic reactions.

DRUG INTERACTIONS

Oral medication administered within one hour of the start of administration of COLYTE^® or COLYTE^®-FLAVORED may be flushed from the gastrointestinal tract and not absorbed.

WARNINGS

No additional ingredients (e.g., flavorings) should be added to the solution. COLYTE^® and COLYTE^®-FLAVORED 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^® or COLYTE^®-FLAVORED, 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^® or COLYTE^®-FLAVORED.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Studies to evaluate carcinogenic or mutagenic potential or potential to adversely affect male or female fertility have not been performed.

Pregnancy

Category C. Animal reproduction studies have not been conducted with COLYTE^® (PEG-3350 & ELECTROLYTES For Oral Solution) or COLYTE^®-FLAVORED, and it is not known whether COLYTE^® or COLYTE^®-FLAVORED can affect reproductive capacity or harm the fetus when administered to a pregnant patient. COLYTE^® or COLYTE^®-FLAVORED should be given to a pregnant patient only if clearly needed.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.