Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 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.
6.1 Clinical 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% 6.2 Postmarketing Experience The following adverse reactions have been identified during post approval use of GaviLyte - H and bisacodyl delayed-release tablet, USP.
5 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 ) 5.1 Serious 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 )] 5.2 Seizures There have been reports of generalized tonic-clonic seizures with the use of large volume (4 liter) PEG-based colon preparation products in patients with no prior history of seizures.
Like all medications, Gavilyte-H And Bisacodyl can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: