Generic Name
Glycol-3350
Brand Names
GoLYTELY, GaviLyte, Peg-3350, electrolyteswith, GaviLyte-N
FDA approval date: July 13, 1984
Classification: Osmotic Laxative
Form: Powder
What is GoLYTELY (Glycol-3350)?
Polyethylene Glycol 3350 and electrolytes for oral solution, is a combination of PEG 3350, an osmotic laxative, and electrolytes indicated for cleansing of the colon in preparation for colonoscopy and barium enema X-ray examination in adults. Polyethylene Glycol 3350 and electrolytes for oral solution is indicated for bowel cleansing prior to colonoscopy and barium enema X-ray examination in adults.
Approved To Treat
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Brand Information
GoLYTELY (Polyethylene Glycol 3350, Sodium Sulfate Anhydrous, Sodium Bicarbonate, Sodium Chloride, Potassium Chloride)
1INDICATIONS AND USAGE
GoLYTELY is indicated for bowel cleansing prior to colonoscopy and barium enema X-ray examination in adults.
2DOSAGE FORMS AND STRENGTHS
For Oral Solution: 236 g polyethylene glycol 3350, 22.74 g sodium sulfate (anhydrous), 6.74 g sodium bicarbonate, 5.86 g sodium chloride and 2.97 g potassium chloride as a white powder. When reconstituted with water to a volume of 4 liters, the solution contains 59 g/L PEG-3350, 5.69 g/L sodium sulfate, 1.69 g/L sodium bicarbonate, 1.47 g/L sodium chloride and 0.743 g/L potassium chloride.
3CONTRAINDICATIONS
GoLYTELY is contraindicated in the following conditions:
- Gastrointestinal (GI) obstruction
- Bowel perforation
- Toxic colitis or toxic megacolon
- Gastric retention
- Ileus
- Hypersensitivity to any component of GoLYTELY
4ADVERSE REACTIONS
The following clinically significant adverse reactions are described elsewhere in the labeling:
- Renal impairment
- Colonic mucosal ulcerations and ischemic colitis
- Patients with significant gastrointestinal disease
- Aspiration
The following adverse reactions associated with the use of GoLYTELY were identified in clinical trials or postmarketing reports. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency, reliably, or establish a causal relationship to drug exposure.
- Cardiovascular: arrhythmia, atrial fibrillation, peripheral edema, asystole, and acute pulmonary edema after aspiration
- Nervous system: tremor, seizure
- Hypersensitivity: Urticaria/rash, pruritus, dermatitis, rhinorrhea, dyspnea, chest and throat tightness, fever, angioedema, anaphylaxis and anaphylactic shock
- Gastrointestinal: Nausea, abdominal fullness and bloating are the most common adverse reactions (occurred in up to 50% of patients). Other less common adverse reactions include: abdominal cramps, vomiting, “butterfly-like” infiltrates on chest X-ray after vomiting and aspirating PEG, anal irritation, and upper GI bleeding from Mallory-Weiss Tear, esophageal perforation [usually with gastroesophageal reflux disease (GERD)].
5DESCRIPTION
GoLYTELY is a combination of polyethylene glycol 3350, an osmotic laxative, and electrolytes (sodium sulfate, sodium chloride, sodium bicarbonate and potassium chloride) for oral solution supplied in a 4-liter disposable jug containing 236 g polyethylene glycol 3350, 22.74 g sodium sulfate (anhydrous), 6.74 g sodium bicarbonate, 5.86 g sodium chloride, and 2.97 g potassium chloride as a white powder.
Polyethylene Glycol 3350, USP
Sodium Sulfate, USP
The chemical name is Na
Sodium Bicarbonate, USP
The chemical name is NaHCO
Sodium Chloride, USP
The chemical name is NaCl. The average Molecular Weight: 58.44. The structural formula is:
Na
Potassium Chloride, USP
The chemical name is KCl. The average Molecular Weight: 74.55. The structural formula is:
K-Cl
6HOW SUPPLIED/STORAGE AND HANDLING
GoLYTELY (polyethylene glycol 3350 and electrolytes for oral solution) is supplied in a 4-liter disposable jug containing 236 g polyethylene glycol 3350, 22.74 g sodium sulfate (anhydrous), 6.74 g sodium bicarbonate, 5.86 g sodium chloride and 2.97 g potassium chloride as a white powder.
- When reconstituted with water to a volume of 4 liters, the solution contains 59 g/L PEG-3350, 5.69 g/L sodium sulfate, 1.69 g/L sodium bicarbonate, 1.47 g/L sodium chloride and 0.743 g/L potassium chloride.
GoLYTELY 4 Liter Disposable Jug NDC 52268-100-01
7PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-Approved Patient Labeling (Medication Guide and Instructions for Use).
Instruct Patients:
- To reconstitute GoLYTELY with water prior to ingestion.
- Not to take other laxatives while they are taking GoLYTELY.
- Not to take oral medications within 1 hour before the start or during the administration of GoLYTELY.
- To take only clear liquids but avoid red and purple liquids.
- To consume water or other clear liquids during the bowel preparation and after completion of the bowel preparation up until 2 hours before the time of the colonoscopy.
- To follow the directions in the
- If they experience severe bloating, distention or abdominal pain, to slow or temporarily discontinue drinking the solution and to contact their healthcare provider.
- To contact their healthcare provider if they develop signs and symptoms of dehydration or if they experience altered consciousness or seizures.
- To discontinue administration of the solution and contact their healthcare provider if they develop symptoms of a hypersensitivity reaction
Manufactured by Braintree Laboratories, Inc. 270 Centre Street Holbrook, MA 02343
Marketed by Braintree, a Part of Sebela Pharmaceuticals®. 60 Columbian Street West Braintree, MA 02185