Osmotic Laxative

Peg-3350, Potassium Chloride, Sodium Bicarbonate, Sodium Chloride

Approved 27 May 2009OralFor solution

The FDA lists this product in 4 strengths and forms.

Indications

GaviLyte-N is a combination of PEG 3350, an osmotic laxative, and electrolytes indicated for cleansing of the colon in preparation for colonoscopy in adults and pediatric patients aged 6 months or greater ( 1 ) GaviLyte-N is indicated for bowel cleansing prior to colonoscopy in adults and pediatric patients aged 6 months or greater.

Contraindications

Gastrointestinal (GI) obstruction, ileus, or gastric retention ( 4 , 5.6 ) Bowel perforation ( 4 , 5.6 ) Toxic colitis or toxic megacolon ( 4 ) Known allergy or hypersensitivity to components of GaviLyte-N ( 4 , 11 ) GaviLyte-N is contraindicated in the following conditions: Gastrointestinal (GI) obstruction, ileus, or gastric retention Bowel perforation Toxic colitis or toxic megacolon Known allergy or hypersensitivity to any component of GaviLyte-N for oral solution [see How Supplied/Storage and Handling (16) ]

Warnings and precautions

Risk of fluid and electrolyte abnormalities, arrhythmias, seizures and renal impairment– assess concurrent medications and consider testing in some patients ( 5.1 , 5.2 , 5.3 , 5.4 ) Patients with renal insufficiency– use caution, ensure adequate hydration and consider testing ( 5.4 ) Suspected GI obstruction or perforation – rule out the diagnosis before administration ( 4 , 5.6 ) Patients at risk for aspiration – observe during administration ( 5.7 ) Not for direct ingestion – dilute and take with additional water ( 5.8 )

5.1Serious Fluid and Serum Chemistry Abnormalities

Advise patients to hydrate adequately before, during, and after the use of GaviLyte-N. Use caution in patients with congestive heart failure when replacing fluids. If a patient develops significant vomiting or signs of dehydration including signs of orthostatic hypotension after taking GaviLyte-N, consider performing post-colonoscopy lab tests (electrolytes, creatinine, and BUN) and treat accordingly. Fluid and electrolyte disturbances can lead to serious adverse events including cardiac arrhythmias, seizures and renal impairment.

Indications

Contraindications

Warnings and precautions

5.1Serious Fluid and Serum Chemistry Abnormalities

Adverse reactions

Most common adverse reactions (≥3%) are: nausea, abdominal fullness and bloating. Abdominal cramps, vomiting and anal irritation occur less frequently ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Lupin Pharmaceuticals, Inc. at 1-866-403-7592 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . The following serious or otherwise important adverse reactions are described elsewhere in the labeling: Serious Fluid and Serum Chemistry Abnormalities [see Warnings and Precautions ( 5.1 )] .

Cardiac Arrhythmias [see Warnings and Precautions ( 5.2 )] . Seizures [see Warnings and Precautions ( 5.3 )] . Renal Impairment [see Warnings and Precautions ( 5.4 )] . Colonic Mucosal Ulcerations, Ischemic Colitis and Ulcerative 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 )] .

Direct Ingestion [see Warnings and Precautions ( 5.8 )] . The following adverse reactions have been identified during post-approval use of GaviLyte-N. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Nausea, abdominal fullness and bloating are the most common adverse reactions (occurred in up to 50% of patients) to administration of GaviLyte-N.

Abdominal cramps, vomiting and anal irritation occur less frequently. These adverse reactions are transient and usually subside rapidly. Isolated cases of urticaria, rhinorrhea, dermatitis and (rarely) anaphylactic reaction have been reported which may represent allergic reactions. Published literature contains isolated reports of serious adverse reactions following the administration of PEG-electrolyte solution products in patients over 60 years of age.

These adverse events include upper GI bleeding from Mallory-Weiss Tear, esophageal perforation, asystole, sudden dyspnea with pulmonary edema, and "butterfly-like" infiltrates on chest X-ray after vomiting and aspirating PEG.

Peg-3350, Potassium Chloride, Sodium Bicarbonate, Sodium Chloride

Indications

Contraindications

Warnings and precautions

5.1Serious Fluid and Serum Chemistry Abnormalities

Two medicines in one question?

Peg-3350, Potassium Chloride, Sodium Bicarbonate, Sodium Chloride

Indications

Contraindications

Warnings and precautions

5.1Serious Fluid and Serum Chemistry Abnormalities

Two medicines in one question?

5.2Cardiac Arrhythmias

5.3Seizures

5.4Renal Impairment

5.5Colonic Mucosal Ulcerations and Ischemic Colitis Administration

5.6Use in Patients with Significant Gastrointestinal Disease

5.7Aspiration Use

5.8Not for Direct Ingestion

Interactions

7.2Potential for Altered Drug Absorption

7.3Stimulant Laxatives

Pregnancy and breastfeeding

8.1Pregnancy

Adverse reactions

Composition

Strengths and forms

Official product information

At a glance