5.1 Neurologic

There have been reports of generalized tonic-clonic seizures in patients with 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 severe vomiting, excessive beverage consumption and electrolyte abnormalities (for example, hyponatremia, hypokalemia). The neurologic abnormalities resolved with correction of fluid and electrolyte abnormalities. Therefore, HalfLytely and Bisacodyl Tablets Bowel Prep Kit should be used with caution in patients using concomitant medications (such as diuretics) that increase the risk of electrolyte abnormalities or patients with known or suspected hyponatremia. Monitor baseline and post-colonoscopy laboratory tests (sodium, potassium, calcium, creatinine, and BUN) in these patients.

5.2 Gastrointestinal

Use with caution in patient with severe ulcerative colitis, ileus or gastric retention. Observe patients with impaired gag reflex and patients prone to regurgitation or aspiration during administration of HalfLytely solution. If GI obstruction or perforation is suspected, appropriate studies should be performed to rule out these conditions before administration. There have been reports of ischemic colitis in patients with use of HalfLytely and 20 mg Bisacodyl Tablets Bowel Prep Kit. If patients develop severe abdominal pain or rectal bleeding, patients should be evaluated as soon as possible.

5.3 Renal Insufficiency

Patients with impaired water handling who experience severe vomiting should be closely monitored including measurement of electrolytes (sodium, potassium, calcium, BUN and creatinine).

5.4 Allergic Reaction

Hives and skin rashes have been reported with PEG-3350 based products which are suggestive of an allergic reaction.

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 (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 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.

6.2 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.

8.1 Pregnancy

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

8.3 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 Tablets Bowel Prep Kit is administered to a nursing woman.

8.4 Pediatric Use

Safety and effectiveness in pediatric patients has not been established.

8.5 Geriatric Use

Of the 222 patients who received HalfLytely and 10 mg Bisacodyl Tablets Bowel Prep Kit in clinical trials, 73 (33%) were 65 years of age or older, while 18 (8%) were 75 years of age or older. No overall differences in safety or effectiveness were observed between geriatric patients and younger patients, and other reported clinical experience has not identified differences in responses between geriatric patients and younger patients but greater sensitivity of some older individuals cannot be ruled out.

12.1 Mechanism of Action

HalfLytely and Bisacodyl Tablets Bowel Prep Kit induces diarrhea which cleanses the colon.

12.2 Pharmacodynamics

Bisacodyl, a stimulant laxative, is hydrolyzed by intestinal brush border enzymes and colonic bacteria to form an active metabolite [bis-(p-hydroxyphenyl) pyridyl-2 methane; (BHPM)] that acts directly on the colonic mucosa to produce colonic peristalsis.

12.3 Pharmacokinetics

The osmotic activity of HalfLytely solution results in no net absorption or excretion of ions or water.

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

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

Storage:

Store at 20-25°C (68-77°F). Excursions permitted between 15-30°C (59-86°F). The reconstituted HalfLytely solution, which may be refrigerated, should be used within 48 hours.

Lemon-Lime HalfLytely and Bisacodyl Tablets Bowel Prep Kit            NDC 52268-522-01

HalfLytely and Bisacodyl Tablets Bowel Prep Kit with Flavor Packs   NDC 52268-521-01

17.4 FDA-Approved Patient Labeling

• HalfLytely and Bisacodyl Tablets Bowel Prep Kit produces a watery stool which cleanses the colon.
• No solid food or milk (clear liquids only) should be consumed on the day of the preparation.
• Take two 5 mg bisacodyl delayed release tablets with water (do NOT chew or crush tablets).
• Prepare the HalfLytely solution according to the instructions on the kit.
• No additional ingredients (other than flavor packs provided) should be added to the solution.
• After you have a bowel movement, or waiting a maximum of six hours, drink ALL of the HalfLytely solution.
• Drink the 2 liter HalfLytely solution at a rate of 8 ounces every 10 minutes. Rapid drinking of each portion is better than drinking small amounts continuously.
• No antacids should be taken within one hour of taking the bisacodyl delayed release tablets.
• Do not drink large quantities of clear liquids after taking the HalfLytely solution until your colonoscopy.
• The first bowel movement should occur approximately 1-6 hours after taking the two bisacodyl delayed release tablets.
• Abdominal bloating or distention may occur before the first bowel movement. If your abdominal distention or discomfort continues stop drinking the HalfLytely solution temporarily or drink each portion at longer intervals until your symptoms disappear.

Distributed by Braintree Laboratories, Inc. Braintree, MA 02185