HalfLytely and Bisacodyl Side Effects

Please note - some side effects for HalfLytely and Bisacodyl may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

HalfLytely and Bisacodyl Side Effects - for the Professional

HalfLytely and Bisacodyl

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 (5 mg vs. 10 mg) Bisacodyl Tablets Bowel Prep Kit 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 HalfLytely and 5 mg bisacodyl tablet vs. the 154 patients that received HalfLytely and 10 mg bisacodyl tablets. The HalfLytely and 5 mg Bisacodyl Tablet Bowel Prep Kit 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.

Postmarketing Experience

The following adverse reactions have been identified during post approval use of HalfLytely and Bisacodyl Tablet 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.

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 HalfLytely and 20 mg and 10 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 Tablet 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 (5.1)].

Side Effects by Body System - for Healthcare Professionals

Gastrointestinal

Mallory-Weiss tears are quite rare with administration of PEG-ELS. In one study it occurred in only 0.06% of over 3,000 patients.

Complete rectal prolapse was reported in a 71-year-old who had been given 4 L of PEG-ELS. The patient was observed for 2 days and had no recurrence of the prolapse.

During administration of PEG-ELS (4 liters) two deaths occurred in patients with end-stage renal failure following the development of vomiting, diarrhea and dysnatremia.

Gastrointestinal side effects have been reported the most frequently. These have included nausea (17.1%), cramping (9.1%), abdominal fullness (22.3%), vomiting (5.9%) and overall discomfort (19.1%).

A small percentage of patients who received PEG-ELS have reportedly experienced Mallory-Weiss tears of the esophagus and esophageal perforation. In addition, at least one case of rectal prolapse has been reported.

Dermatologic

Dermatologic side effects reported with PEG-ELS have rarely included urticaria and dermatitis.

Cardiovascular

Cardiovascular side effects of PEG-ELS have included arrhythmias and asystole.

Cardiac arrhythmias, especially increased ventricular ectopy, have been associated with PEG-ELS use.

The manufacturer notes an isolated case of asystole following ingestion of PEG-ELS in a geriatric patient (equal to or greater than 60 years of age).

Hypersensitivity

A 70-year-old male developed shortness of breath, wheezing, skin flushing, and lowered blood pressure after drinking a second glass of PEG-ELS.

Hypersensitivity side effects with PEG-ELS have rarely included anaphylaxis.

Other

Other side effects with PEG-ELS have included rhinorrhea.

Respiratory

Respiratory side effects with PEG-ELS have included sudden dyspnea with pulmonary edema, and 'butterfly-like' infiltrate on chest X-ray.

The manufacturer notes isolated reports of 'butterfly-like' infiltrate on chest X-ray following vomiting and aspiration of PEG-ELS and sudden dyspnea with pulmonary edema in geriatric patients (equal to or greater than 60-years-old).

Nervous system

Tonic-clonic seizures have been reported in patients with and without previous history of seizures following administration of PEG-ELS (4 liters).

Nervous system side effects have included tonic-clonic seizures.

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