FDA

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

Approved 20 Aug 2014OralFor solution, tablet, delayed release

Indications

GaviLyte - H and bisacodyl delayed-release tablet, USP is indicated for cleansing of the colon as a preparation for colonoscopy in adults. GaviLyte - H and bisacodyl delayed-release tablet, USP is a combination of PEG-3350, an osmotic laxative and bisacodyl, a stimulant laxative, indicated for cleansing of the colon as a preparation for colonoscopy in adults ( 1 )

Contraindications

The GaviLyte - H and bisacodyl delayed-release tablet, USP is contraindicated in the following conditions: Gastrointestinal (GI) obstruction Bowel perforation Toxic colitis and toxic megacolon Gastric retention Ileus Gastrointestinal (GI) obstruction ( 4 ) Bowel perforation ( 4 ) Toxic colitis or toxic megacolon ( 4 ) Gastric retention ( 4 ) Ileus ( 4 )

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 impairment – use caution, ensure adequate hydration and consider testing ( 5.3 ) Ischemic colitis has been reported ( 5.5 ) Suspected GI obstruction or perforation – rule out the diagnosis before administration ( 5.6 ) Patients at risk for aspiration – observe during administration ( 5.7 )

5.1Serious Fluid and Serum Chemistry Abnormalities

Advise all patients to hydrate adequately before, during, and after the use of GaviLyte - H and bisacodyl delayed-release tablet, USP. If a patient develops significant vomiting or signs of dehydration after taking GaviLyte - H and bisacodyl delayed-release tablet, USP, consider performing post-colonoscopy lab tests (electrolytes, creatinine, and BUN). Fluid and electrolyte disturbances can lead to serious adverse events including cardiac arrhythmias, seizures and renal impairment.

Patients with electrolyte abnormalities should have them corrected before treatment with GaviLyte - H and bisacodyl delayed-release tablet, USP. In addition, use caution when prescribing GaviLyte - H and bisacodyl delayed-release tablet, USP for patients with conditions, or who are using medications, that increase the risk for fluid and electrolyte disturbances or may increase the risk of adverse events of seizure, arrhythmias, and renal impairment.[See Drug Interactions ( 7.1 )]

Indications

Contraindications

Warnings and precautions

5.1Serious Fluid and Serum Chemistry Abnormalities

Adverse reactions

Most common adverse reactions (>3%) are overall discomfort, abdominal fullness, abdominal cramping, nausea, and vomiting, ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Novel Laboratories, Inc. at 908-603-6000 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Studies Experience

Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in clinical studies of another drug and may not reflect the rates observed in practice. In a clinical study of GaviLyte - H and (5 mg vs. 10 mg) bisacodyl delayed-release tablet, USP, overall discomfort, abdominal fullness, abdominal cramping, nausea, and vomiting, were the most common adverse reactions (>3%).

The data in Table 1 reflects the 154 patients that received GaviLyte - H and 5 mg bisacodyl tablet vs. the 154 patients that received GaviLyte - H and 10 mg bisacodyl tablets. The GaviLyte - H and 5 mg bisacodyl delayed-release tablet, USP population was 29-87 years of age, 49% male, 51% female, 13% African American, 83% White, 5% Hispanic requiring a colonoscopy. The demographics of the comparator group were similar.

Table 1: Adverse Reactions Observed in at Least 3% of Randomized Patients GaviLyte - H and 5 mg Bisacodyl Delayed-release Tablet, USP(N=154)] GaviLyte - H and 10 mg Bisacodyl Delayed-release Tablet, USP(N=154) Overall Discomfort 57% 66% Abdominal fullness 40% 53% Abdominal cramping 38% 46% Nausea 34% 42% Vomiting 10% 7%

6.2Postmarketing Experience

The following adverse reactions have been identified during post approval use of GaviLyte - H and bisacodyl delayed-release tablet, USP. 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. Allergic Reactions: Cases of urticaria, rhinorrhea, dermatitis and anaphylactic reactions have been reported with PEG-based products.

Gastrointestinal: There are isolated reports of serious post-marketing events following the administration of PEG-based products in patients over 60 years of age. These adverse reactions include upper GI bleeding from a Mallory-Weiss tear, esophageal perforation, asystole, and acute pulmonary edema after vomiting and aspirating the PEG-based solution. In addition, during administration of 4 liters of PEG-3350 colon cleansing preparation the following serious adverse reactions were seen: two deaths in end stage renal failure patients who developed diarrhea, vomiting and dysnatremia [ see Warnings and Precautions ( 5.3 ) ].

Ischemic colitis has been reported with use of of GaviLyte - H and 20 mg and 10 mg bisacodyl delayed-release tablets, USP for colon preparation prior to colonoscopy. However, a causal relationship between these ischemic colitis cases and the use of GaviLyte - H and bisacodyl delayed-release tablets, USP has not been established. Neurologic: There have been reports of generalized tonic-clonic seizures associated with use of large volume (4 liter) PEG-based colon preparation products in patients with no prior history of seizures.

Cases of dizziness and syncope have been reported [see Warnings and Precautions ( 5.1 )] .

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

Indications

Contraindications

Warnings and precautions

5.1Serious Fluid and Serum Chemistry Abnormalities

Two medicines in one question?

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

Indications

Contraindications

Warnings and precautions

5.1Serious Fluid and Serum Chemistry Abnormalities

Two medicines in one question?

5.2Seizures

5.3Renal Impairment Patients

5.4Cardiac Arrhythmias

5.5Ischemic Colitis

5.6Patients with Significant Gastrointestinal Disease

5.7Aspiration Use

Interactions

7.1Drugs That May Increase Risks of Fluid and Electrolyte Abnormalities

7.2Potential for Altered Drug Absorption

7.3Interaction with Antacids Do

Adverse reactions

6.1Clinical Studies Experience

6.2Postmarketing Experience

Composition

Official product information

At a glance