GoLYTELY (Page 2 of 3)

5.7 Aspiration

Use with caution in patients with impaired gag reflex, unconscious, or semiconscious patients, and patients prone to regurgitation or aspiration. Observe these patients during administration of GoLYTELY, especially if it is administered via nasogastric tube.Use with caution in patients with impaired gag reflex, unconscious, or semiconscious patients, and patients prone to regurgitation or aspiration. Observe these patients during administration of GoLYTELY, especially if it is administered via nasogastric tube.

Do not combine GoLYTELY with starch-based thickeners [see Dosage and Administration ( 2.1)] . Polyethylene glycol (PEG), a component of GoLYTELY, when mixed with starch- thickened liquids reduces the viscosity of the starch-thickened liquid. When a PEG-based product used for another indication was mixed in starch-based pre-thickened liquids used in patients with dysphagia, thinning of the liquid occurred and cases of choking and potential aspiration were reported.

5.8 Hypersensitivity Reactions

GoLYTELY contains PEG and may cause serious hypersensitivity reactions including anaphylaxis, angioedema, rash, urticaria, and pruritus [see Adverse Reactions ( 6)] . Inform patients of the signs and symptoms of anaphylaxis and instruct them to seek immediate medical care should signs and symptoms occur.

6 ADVERSE REACTIONS

The following clinically significant adverse reactions are described elsewhere in the labeling:

  • Renal impairment [see Warnings and Precautions ( 5.4)]
  • Colonic mucosal ulcerations and ischemic colitis [see Warnings and Precautions ( 5.5)]
  • Patients with significant gastrointestinal disease [see Warnings and Precautions ( 5.6)]
  • Aspiration [see Warnings and Precautions ( 5.7)]

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 [see Warnings and Precautions ( 5.2)] .
  • Nervous system: tremor, seizure [see Warnings and Precautions ( 5.3)]
  • Hypersensitivity: Urticaria/rash, pruritus, dermatitis, rhinorrhea, dyspnea, chest and throat tightness, fever, angioedema, anaphylaxis and anaphylactic shock [see Contraindications ( 4), Warnings and Precautions ( 5.8)]
  • 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)].

7 DRUG INTERACTIONS

7.1 Drugs that May Increase Risks Due to Fluid and Electrolyte Abnormalities

Use caution when prescribing GoLYTELY for patients with conditions and/or who are using medications that increase the risk for fluid and electrolyte disturbances or may increase the risk of renal impairment, seizure, arrhythmias, and prolonged QT in the setting of fluid and electrolyte abnormalities [ see Warnings and Precautions ( 5.1, 5.2, 5.3, 5.4) ]. Consider additional patient evaluations as appropriate.

7.2 Potential for Reduced Drug Absorption

GoLYTELY can reduce the absorption of other administered drugs. Administer oral medications within one hour before the start of administration of GoLYTELY [see Dosage and Administration ( 2.1)] .

7.3 Stimulant Laxatives

Concurrent use of stimulant laxatives and GoLYTELY may increase the risk of mucosal ulceration or ischemic colitis. Avoid use of stimulant laxatives (e.g., bisacodyl, sodium picosulfate) while taking GoLYTELY [see Warnings and Precautions ( 5.5)] .

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Animal reproduction studies have not been conducted with GoLYTELY. It is also not known whether GoLYTELY can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. GoLYTELY should be given to a pregnant woman only if clearly needed.

8.3 Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when GoLYTELY is administered to a nursing woman.

8.4 Pediatric Use

Safety and effectiveness of GoLYTELY in pediatric patients have not been established.

8.5 Geriatric Use

Clinical studies of GoLYTELY did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients.

8.6 Renal Impairment

Use GoLYTELY with caution in patients with renal impairment or patients taking concomitant medications that may affect renal function [see Drug Interactions ( 7.1)] . These patients may be at risk for renal injury. Advise these patients of the importance of adequate hydration before, during and after use of GoLYTELY and consider performing baseline and post-colonoscopy laboratory tests (electrolytes, creatinine, and BUN) in these patients [see Warnings and Precautions ( 5.4)] .

11 DESCRIPTION

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

Polyethylene Glycol 3350 Structural Formula

Sodium Sulfate, USP

The chemical name is Na 2 SO 4 . The average Molecular Weight is 142.04. The structural formula is:

Sodium Sulfate Structural Formula

Sodium Bicarbonate, USP

The chemical name is NaHCO 3 . The average Molecular Weight is 84.01. The structural formula is:

Sodium Bicarbonate Structural Formula

Sodium Chloride, USP

The chemical name is NaCl. The average Molecular Weight: 58.44. The structural formula is:

Na + Cl

Potassium Chloride, USP

The chemical name is KCl. The average Molecular Weight: 74.55. The structural formula is:

K-Cl

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