HalfLytely and Bisacodyl Bowel Prep with Flavor Packs

HALFLYTELY AND BISACODYL BOWEL PREP WITH FLAVOR PACKS- peg-3350, sodium chloride, sodium bicarbonate and potassium chloride and bisacodyl
Braintree Laboratories, Inc.

1 INDICATIONS AND USAGE

HalfLytely and Bisacodyl Tablet Bowel Prep Kit is indicated for cleansing of the colon as a preparation for colonoscopy in adults.

2 DOSAGE AND ADMINISTRATION

The recommended HalfLytely and Bisacodyl Tablet Bowel Prep Kit oral dosage regimen for adults on the day prior to colonoscopy is as follows:

  • No solid food or milk (clear liquids only) should be consumed on the day of the preparation.
  • Take one 5 mg bisacodyl delayed-release tablet with water. Do NOT chew or crush the tablet.
  • No antacids should be taken within one hour of taking the bisacodyl delayed-release tablet.
  • Prepare the HalfLytely solution according to the instructions on the kit.
  • Add flavor pack of choice (if applicable) to the 2 liter container.
  • No additional ingredients (other than flavor packs provided) should be added to the solution.
  • Prepare the HalfLytely solution by filling the container to the 2 liter mark with water. Cap the container. Shake to dissolve the powder.
  • Wait for a bowel movement (or maximum of 6 hours) then drink the 2 liter HalfLytely solution at a rate of 8 ounces every 10 minutes. Drink all of the solution.
  • If you have abdominal distention or discomfort, stop drinking the HalfLytely solution temporarily or drink each portion at longer intervals until your symptoms improve.
  • Consume only clear liquids after taking the HalfLytely solution until your colonoscopy.

3 DOSAGE FORMS AND STRENGTHS

  • One pink, round, enteric coated 5 mg bisacodyl delayed-release tablet, stamped “BRA”
  • One 2 liter HalfLytely bottle with powder for reconstitution

4 CONTRAINDICATIONS

The HalfLytely and Bisacodyl Tablet Bowel Prep Kit is contraindicated in the following conditions:

  • Gastrointestinal (GI) obstruction
  • Bowel perforation
  • Toxic colitis and toxic megacolon
  • Gastric retention
  • Ileus

5 WARNINGS AND PRECAUTIONS

5.1 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 (7.1) ]

5.2 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.

5.3 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.

5.4 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.

5.5 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.

5.6 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.

5.7 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.

6 ADVERSE REACTIONS

6.1 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%
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