Polyethylene Glycol-3350 And Electrolytes With Flavor Pack
FDA Drug Information • Also known as: Gavilyte - C Tm
- Brand Names
- Gavilyte - C Tm
- Drug Class
- Osmotic Laxative [EPC]
- Route
- ORAL
- Dosage Form
- POWDER, FOR SOLUTION
- Product Type
- HUMAN PRESCRIPTION DRUG
Description
DESCRIPTION GaviLyte- C with flavor pack is a white, colon lavage preparation provided as water-soluble components for solution. In solution this preparation with lemon flavor pack added delivers the following, in grams per liter. Polyethylene glycol 3350 240.00 Sodium chloride 5.84 Potassium chloride 6.72 Sodium bicarbonate 2.98 Sodium sulfate 22.72 Flavor ingredients 0.500 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 an isosmotic solution, for oral administration, having mild salty taste. This preparation can be used without the lemon flavor pack and is administered orally or via nasogastric tube. Each lemon flavor pack (2 g) contains natural lemon flavor powder, saccharin sodium, maltodextrin.
What Is Polyethylene Glycol-3350 And Electrolytes With Flavor Pack Used For?
INDICATIONS AND USAGE GaviLyte- C with flavor pack is indicated for bowel cleansing prior to colonoscopy or barium enema X-ray examination.
Dosage and Administration
DOSAGE AND ADMINISTRATION GaviLyte- C with flavor pack 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 GaviLyte- C with flavor pack administration. ORAL: The recommended adult oral dose is 240 mL (8 fl. oz.) every 10 minutes (see INFORMATION FOR PATIENTS). Lavage is complete when fecal discharge is clear. Lavage is usually complete after the ingestion of 3 to 4 liters. NASOGASTRIC TUBE: GaviLyte- C with flavor pack is administered at a rate of 20 to 30 mL per minute (1.2 to 1.8 L/hour). PREPARATION OF GaviLyte- C with flavor pack SOLUTION: This preparation can be used with or without the lemon flavor pack. 1. To add flavor, tear open lemon flavor pack at the indicated marking and pour contents into the bottle BEFORE reconstitution. 2. SHAKE WELL to incorporate flavoring into the powder. 3. Add tap water to FILL line. Replace cap tightly and mix or shake well until all ingredients have dissolved. (No other additional ingredients, e.g. flavorings, should be added to the solution.) Note: If not using flavor pack, omit steps one and two, above.
Side Effects (Adverse Reactions)
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 cases of urticaria, rhinorrhea, dermatitis, and rarely anaphylaxis, angioedema, tongue edema, and face edema have been reported which may represent allergic reactions.
Warnings and Precautions
WARNINGS Flavor pack is for use only in combination with the contents of the accompanying 4 liter container. No other additional ingredients (e.g., flavorings) should be added to the solution. GaviLyte- C with flavor pack should be used with caution in patients with severe ulcerative colitis.
Contraindications
CONTRAINDICATIONS GaviLyte- C with flavor pack is contraindicated in patients known to be hypersensitive to any of the components. GaviLyte- C with flavor pack is contraindicated in patients with ileus, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis or toxic megacolon.
How Supplied
HOW SUPPLIED GaviLyte- C with flavor pack is supplied in 4 liter bottles with an attached lemon flavor pack. Each 4 liter 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. This preparation is supplied in powdered form, for oral administration as a solution. GaviLyte- C with flavor pack 4liter: NDC 43386-060-19 Store at 20° to 25°C (68° to 77°F): excursions permitted between 15° to 30°C (59° to 86°F). KEEP RECONSTITUTED SOLUTION REFRIGERATED. USE WITHIN 48 HOURS. DISCARD UNUSED PORTION. LUPIN and the are registered trademarks of Lupin Pharmaceuticals, Inc. Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873, USA Manufactured for: Lupin Pharmaceuticals, Inc. Naples FL, 34108 SAP Code: 278922 Rev. 11/2024 Image
About This Information
This drug information is sourced from FDA-approved labeling via the openFDA database. It is intended for educational and reference purposes only. This is not medical advice. Always consult your healthcare provider before making decisions about medication. Drug information may be updated by the FDA; check with your pharmacist for the most current information.
What are side effects?
Side effects are unwanted reactions that can occur when taking a medication. They range from mild (headache, nausea) to severe (allergic reactions, organ damage). Not everyone experiences side effects, and severity varies. Report any concerning side effects to your doctor.
What are drug interactions?
Drug interactions occur when a medication is affected by another drug, food, or supplement. Interactions can make medications less effective or cause dangerous side effects. Always tell your doctor about all medications and supplements you take.