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 HalfLytely and (10 mg vs. 20 mg) Bisacodyl Tablets Bowel Prep Kit multicentered, controlled clinical trials, abdominal pain/cramping, nausea, vomiting and headache were the most common adverse reactions ( < 3%) after the administration of HalfLytely and (10 mg or 20 mg) Bisacodyl Tablets Bowel Prep Kit. Less than 1% of patients exposed to HalfLytely and 10 mg Bisacodyl Tablets Bowel Prep Kit reported vomiting and abdominal pain/cramping.

The data in Table 1 reflects exposure in 222 patients to HalfLytely and 10 mg bisacodyl tablets vs. 223 patients exposed to HalfLytely and 20 mg bisacodyl tablets. The HalfLytely and 10 mg Bisacodyl Tablets Bowel Prep Kit population was 20-85 years of age, 46% male, 54% female, 10% African American, 85% Caucasian, 8% Hispanic requiring a colonoscopy. The demographics of the comparator group were similar.

Table 1: Adverse Reactions Observed in at Least 1% of Patients

Table 2 displays patient diary ratings of their symptoms associated with HalfLytely and Bisacodyl Tablets Bowel Prep Kits (10 mg bisacodyl vs. 20 mg bisacodyl tablets) in the controlled trial.

Table 2: Percentage of Patients Reporting in their Diaries “bothersome” to “severely distressing” Symptoms in Controlled Clinical HalfLytely and Bisacodyl Tablets Bowel Prep Kit Trial¹

Postmarketing Experience

The following adverse reactions have been identified during postapproval use of HalfLytely and Bisacodyl Tablets Bowel Prep Kit. 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 which may represent allergic reactions.

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.

Ischemic colitis has been reported with use of HalfLytely and 20 mg Bisacodyl Tablets Bowel Prep Kit for colon preparation prior to colonoscopy. However, a causal relationship between these ischemic colitis cases and the use of HalfLytely and Bisacodyl Tablets Bowel Prep Kit 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].

• Oral medication administered within one hour of the start of administration of HalfLytely solution may be flushed from the GI tract and the medication may not be absorbed.
• Do not take the bisacodyl delayed release tablets within one hour of taking an antacid.

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