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Halflytely

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HalfLytely and Bisacodyl Tablets

HalfLytely and Bisacodyl Tablets

WARNINGS

Included as part of the PRECAUTIONS section.

PRECAUTIONS

Serious Fluid and Serum Chemistry Abnormalities

Advise all patients to hydrate adequately before, during, and after the use of HalfLytely and Bisacodyl Tablet Bowel Prep Kit. If a patient develops significant vomiting or signs of dehydration after taking HalfLytely and Bisacodyl Tablet Bowel Prep Kit, 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 HalfLytely and Bisacodyl Tablet Bowel Prep Kit. In addition, 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 renal impairment. [see DRUG INTERACTIONS]

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. The seizure cases were associated with electrolyte abnormalities (e.g., hyponatremia, hypokalemia, hypocalcemia, and hypomagnesemia) and low serum osmolality. The neurologic abnormalities resolved with correction of fluid and electrolyte abnormalities.

Use caution when prescribing the HalfLytely and Bisacodyl Tablet Bowel Prep Kit for patients with a history of seizures and in patients at risk of seizure, such as patients taking medications that lower the seizure threshold (e.g., tricyclic antidepressants), patients withdrawing from alcohol or benzodiazepines, patients with known or suspected hyponatremia, or patients using concomitant medications (such as diuretics) that increase the risk of electrolyte abnormalities. Monitor baseline and post-colonoscopy laboratory tests (sodium, potassium, calcium, creatinine, and BUN) in these patients.

Renal Impairment

Patients with impaired water handling who experience severe vomiting should be closely monitored including measurement of electrolytes (sodium, potassium, calcium, BUN and creatinine). Use caution when prescribing HalfLytely and Bisacodyl Tablet Bowel Prep Kit for patients with impaired renal function or patients taking concomitant medications that may affect renal function (such as diuretics, angiotensin converting enzyme inhibitors, angiotensin receptor blockers, or non-steroidal anti-inflammatory drugs). Advise these patients of the importance of adequate hydration and consider performing baseline and post-colonoscopy laboratory tests (electrolytes, creatinine, and BUN) in these patients.

Cardiac Arrhythmias

There have been rare reports of serious arrhythmias associated with the use of ionic osmotic laxative products for bowel preparation. Use caution when prescribing HalfLytely and Bisacodyl Tablet Bowel Prep Kit for patients at increased risk of arrhythmias (e.g. patients with a history of prolonged QT, uncontrolled arrhythmias, recent myocardial infarction, unstable angina, congestive heart failure, or cardiomyopathy). Pre-dose and post-colonoscopy ECGs should be considered in patients at increased risk of serious cardiac arrhythmias.

Ischemic Colitis

There have been reports of ischemic colitis in patients with use of HalfLytely and 20 mg Bisacodyl Tablets Bowel Prep Kit and HalfLytely and 10 mg Bisacodyl Tablets Bowel Prep Kit. If patients develop severe abdominal pain or rectal bleeding, patients should be evaluated as soon as possible.

Patients with Significant Gastrointestinal Disease

If gastrointestinal obstruction or perforation is suspected, perform appropriate diagnostic studies to rule out these conditions before administering HalfLytely and Bisacodyl Tablet Bowel Prep Kit.

Use with caution in patients with severe active ulcerative colitis.

Aspiration

Use with caution in patients with impaired gag reflex and patients prone to regurgitation or aspiration. Such patients should be observed during administration of the HalfLytely and Bisacodyl Bowel Prep Kit solution.

Patient Counseling Information

See Medication Guide

  • Ask patients to let you know if they have trouble swallowing or are prone to regurgitation or aspiration.
  • Tell patients not to take other laxatives while they are taking HalfLytely and Bisacodyl Tablet Bowel Prep Kit.
  • Tell patients that if they experience severe bloating, distention or abdominal pain, the administration of the solution should be slowed or temporarily discontinued until the symptoms abate. Advise patients to report these events to their health care provider.
  • Advise patients that if they have hives, rashes, or any allergic reaction, they should discontinue the medication and contact their health care provider. Medication should be discontinued until they speak to their physician.
  • Instruct patients to contact their healthcare provider if they develop signs and symptoms of dehydration. [see WARNINGS AND PRECAUTIONS].
  • Inform patients that 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.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term studies in animals have not been performed to evaluate the carcinogenic potential of HalfLytely and Bisacodyl Tablet Bowel Prep Kit. Studies to evaluate its potential for impairment of fertility or its mutagenic potential have not been performed.

Use In Specific Populations

Pregnancy

Pregnancy Category C animal reproduction studies have not been conducted. It is not known whether HalfLytely and Bisacodyl Tablet Bowel Prep Kit can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. HalfLytely and Bisacodyl Tablet Bowel Prep Kit should be given to a pregnant or nursing woman only if clearly needed.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when HalfLytely and Bisacodyl Tablet Bowel Prep Kit is administered to a nursing woman.

Pediatric Use

Safety and effectiveness in pediatric patients has not been established.

Geriatric Use

Of the 148 patients who took HalfLytely and 5 mg Bisacodyl Tablet Bowel Prep Kit in clinical trials, 42 (28%) were 65 years of age or older, while 10 (7%) were 75 years of age or older. The rates of success appear to be lower in patients 65 years and older [see Clinical Studies].

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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