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Halflytely

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HalfLytely and Bisacodyl Tablets

HalfLytely and Bisacodyl Tablets

SIDE EFFECTS

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.

Table 1: Adverse Reactions Observed in at Least 3% of Randomized Patients

  HalfLytely and 5 mg Bisacodyl Tablet
Bowel Prep Kit (N=154)
HalfLytely and 10 mg Bisacodyl Tablets
Bowel Prep Kit (N=154)
Overall Discomfort 57% 66%
Abdominal fullness 40% 53%
Abdominal cramping 38% 46%
Nausea 34% 42%
Vomiting 10% 7%

 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].

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].

Read the HalfLytely and Bisacodyl Tablets (sodium chloride-sodium bicarbonate and potassium chloride) Side Effects Center for a complete guide to possible side effects

DRUG INTERACTIONS

Drugs That May Increase Risks of Fluid and Electrolyte Abnormalities

Use caution when prescribing HalfLytely and Bisacodyl Tablet Bowel Prep Kit 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 prolonged QT in the setting of fluid and electrolyte abnormalities. Consider additional patient evaluations as appropriate [see WARNINGS AND PRECAUTIONS] in patients taking these concomitant medications.

Potential for Altered Drug Absorption

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 completely.

Interaction with Antacids

Do not take the bisacodyl delayed-release tablet within one hour of taking an antacid.

Last reviewed on RxList: 8/4/2010
This monograph has been modified to include the generic and brand name in many instances.

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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