GaviLyte - C TM 240 g/278.26g
polyethylene glycol-3350 and electrolytes with Flavor Pack · POWDER, FOR SOLUTION · Lupin Pharmaceuticals,Inc.
GaviLyte - C TM is a prescription powder, for solution containing polyethylene glycol-3350 and electrolytes with flavor pack at 240 g/278.26g, taken oral. Manufactured by Lupin Pharmaceuticals,Inc..
Key Facts
- Brand Name
- GaviLyte - C TM
- Generic Name
- polyethylene glycol-3350 and electrolytes with Flavor Pack
- NDC Code (Product)
43386-060- Manufacturer
- Lupin Pharmaceuticals,Inc.
- Strength
- 240 g/278.26g
- Dosage Form
- POWDER, FOR SOLUTION
- Route
- ORAL
- Marketing Status
- HUMAN PRESCRIPTION DRUG
- Application #
- ANDA090186
- Drug Class
- Increased Large Intestinal Motility [PE]; Increased Large Intestinal Motility [PE]
- Marketing Start
- 01/06/2009
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE GaviLyte- C with flavor pack is indicated for bowel cleansing prior to colonoscopy or barium enema X-ray examination.
Dosage & 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 …
Warnings
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.
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.
Frequently Asked Questions
What is GaviLyte - C TM used for?
GaviLyte - C TM contains polyethylene glycol-3350 and electrolytes with Flavor Pack. It is a powder, for solution taken oral. Consult your doctor for specific uses.
Is GaviLyte - C TM a controlled substance?
GaviLyte - C TM is not classified as a controlled substance by the DEA.
What is the generic name for GaviLyte - C TM?
The generic name for GaviLyte - C TM is polyethylene glycol-3350 and electrolytes with Flavor Pack. There are no other listed brand versions of polyethylene glycol-3350 and electrolytes with Flavor Pack.
What is the NDC code for GaviLyte - C TM 240 g/278.26g?
The NDC (National Drug Code) for GaviLyte - C TM 240 g/278.26g is 43386-060, listed by Lupin Pharmaceuticals,Inc..
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)