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 The following serious or otherwise important adverse reactions for bowel preparations are described elsewhere in the labeling: Serious Fluid and Electrolyte Abnormalities [see Warnings and Precautions ( 5.1 )] Cardiac Arrhythmias [see Warnings and Precautions ( 5.2 )] Seizures [see Warnings and Precautions ( 5.3 )] Patients with Risk of Renal Injury [see Warnings and Precautions ( 5.4 )] Colonic Mucosal Ulceration and Ischemic Colitis [see Warnings and Precautions ( 5.5 )] Patients with Significant Gastrointestinal Disease [see Warnings and Precautions ( 5.6 )] Hypersensitivity Reactions [see Warnings and Precautions ( 5.7 )] Risk of Gastrointestinal Complications with Ingestion of Desiccant [see Warnings and Precautions ( 5.8 )] Most common gastrointestinal adverse reactions are nausea, abdominal distension, vomiting and upper abdominal pain.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Azurity Pharmaceuticals, Inc.
at 1-800-461-7449 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1 Clinical Trials 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.
The safety of SUTAB was evaluated in two randomized, parallel group, multicenter, investigator-blinded clinical trials in 941 adult patients undergoing colonoscopy.
The active comparators were polyethylene glycol 3350, sodium sulfate, sodium chloride, potassium chloride, ascorbic acid and sodium ascorbate for oral solution in Study 1 and sodium picosulfate, magnesium oxide, and anhydrous citric acid for oral solution in Study 2 [see Clinical Studies ( 14 )] .
Adverse Gastrointestinal Reactions Reported by Symptom Questionnaire In Studies 1 and 2, patients were queried for selected gastrointestinal adverse reactions of stomach cramping (upper abdominal pain), stomach bloating (abdominal distention), nausea and vomiting using a standard questionnaire following completion of study drug and prior to colonoscopy on the day of colonoscopy.
Patients reporting selected gastrointestinal symptom(s) rated the intensity as mild, moderate or severe.
A total of 52% (287/552) of patients in Study 1 and 52% (202/389) in Study 2 reported at least one selected gastrointestinal adverse reaction when queried using the standard questionnaire.
Tables 1 and 2 show results for each gastrointestinal adverse reaction reported by patients using the standard questionnaire, including severity.
5 WARNINGS AND PRECAUTIONS Risk of fluid and electrolyte abnormalities : Encourage adequate hydration, assess concurrent medications and consider laboratory assessments prior to and after each use.
( 5.1 , 7.1 ) Cardiac arrhythmias : Consider pre-dose and post-colonoscopy ECGs in patients at increased risk.
(5.2) Seizures : Use caution in patients with a history of seizures and patients at increased risk of seizures, including medications that lower the seizure threshold.
( 5.3 , 7.1 ) Patients with renal impairment or taking concomitant medications that affect renal function : Use caution, ensure adequate hydration and consider laboratory testing.
( 5.4 , 7.1 ) Colonic mucosal ulcerations : Consider potential for mucosal ulcerations when interpreting colonoscopy findings in patients with known or suspected inflammatory bowel disease.
Like all medications, Sutab 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: