Each HalfLytely and Bisacodyl Tablets Bowel Prep Kit [Polyethylene glycol (PEG) 3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution and bisacodyl delayed release tablets] consists of one 2 liter bottle of HalfLytely (PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution) powder for reconstitution and two 5 mg bisacodyl, delayed release tablets.

• Bisacodyl delayed release tablets: Each pink, round, enteric coated bisacodyl delayed release tablet (stamped “BRA”) contains 5 mg of bisacodyl, USP (C₂₂H₁₉NO₄) with a molecular weight of 361.40. Inactive ingredients include lactose (anhydrous) NF, microcrystalline cellulose NF, croscarmellose sodium NF, magnesium stearate NF, Eudragit L 30-55, polyethylene glycol 400, talc USP, gelatin, calcium sulfate (anhydrous) NF, confectioners sugar, kaolin USP, sucrose NF, Opalux pink, beeswax, and carnauba wax. The bisacodyl delayed release tablets are administered orally prior to drinking the HalfLytely solution [see DOSAGE AND ADMINISTRATION].
• HalfLytely (PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution): A white powder for reconstitution containing 210 grams of PEG-3350, 2.86 grams of sodium bicarbonate, 5.6 grams of sodium chloride, 0.74 grams of potassium chloride and 1 gram of flavoring ingredient (if applicable). Flavor Packs are available in Cherry, Lemon-Lime and Orange. This preparation can be used without the addition of a Flavor Pack. When dissolved in water to a volume of 2 liters, the HalfLytely solution is isosmotic, clear, and colorless. The HalfLytely solution is administered orally after taking the two bisacodyl delayed release tablets [see DOSAGE AND ADMINISTRATION].

Last updated on RxList: 10/15/2007

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

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

• Take two 5 mg bisacodyl delayed release tablets with water. Do NOT chew or crush the tablets.
• 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.

Dosage Forms And Strengths

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

Storage And Handling

Each HalfLytely and Bisacodyl Tablets Bowel Prep Kit contains:

One pack of bisacodyl delayed release tablets containing two pink, round, enteric coated 5 mg bisacodyl delayed release tablets, stamped “BRA”

One 2 liter bottle of HalfLytely (PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution) powder for reconstitution containing 210 grams of polyethylene glycol (PEG) 3350, 2.86 grams of sodium bicarbonate, 5.6 grams of sodium chloride, 0.74 grams of potassium chloride, and 1 gram of flavoring ingredient (if applicable). After adding 2 liters of water, the reconstituted HalfLytely solution (clear and colorless) contains 31.3 mmol/L of PEG-3350, 65 mmol/L of sodium, 53 mmol/L of chloride, 17 mmol/L of bicarbonate and 5 mmol/L of potassium.

Lemon-Lime HalfLytely and Bisacodyl Tablets Bowel Prep Kit contains 1 gram lemon-lime flavoring ingredient. HalfLytely and Bisacodyl Tablets Bowel Prep Kit with Flavor Packs contains 3 packs (1gram each Cherry, Lemon-Lime and Orange flavors).

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 52268-502-02

HalfLytely and Bisacodyl Tablets Bowel Prep Kit with Flavor Packs.........................NDC 52268-520-05

Distributed by Braintree Laboratories, Inc. Braintree, MA 02185. FDA Rev date: 9/21/2007

Last updated on RxList: 10/15/2007

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 1: Adverse Reactions Observed in at Least 1% of Patients

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.

Table 2: Percentage of Patients Reporting in their Diaries “bothersome” to “severely distressing” Symptoms in Controlled Clinical HalfLytely and Bisacodyl Tablets Bowel Prep Kit Trial¹

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.

Allergic Reactions: Cases of urticaria, rhinorrhea, dermatitis and anaphylactic reactions have been reported with PEG-based products which may represent allergic reactions.

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.

Ischemic colitis has been reported with use of HalfLytely and 20 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 Tablets 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].

• 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.
• Do not take the bisacodyl delayed release tablets within one hour of taking an antacid.

Last updated on RxList: 10/15/2007

Included as part of the PRECAUTIONS section.

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, hyponatemia, 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.

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.

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).

Allergic Reaction

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

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 Tablets 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 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.

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.

Pediatric Use

Safety and effectiveness in pediatric patients has not been established.

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.

Last updated on RxList: 10/15/2007

No information provided.

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

• Known allergies to polyethylene glycol or other components of the kit
• Gastrointestinal (GI) obstruction
• Bowel perforation
• Toxic colitis
• Toxic megacolon

Last updated on RxList: 10/15/2007

Mechanism of Action

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

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.

Pharmacokinetics

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

Clinical Studies

The colon cleansing efficacy of HalfLytely and Bisacodyl Tablets Bowel Prep Kit (with 10 mg of bisacodyl) was evaluated in a randomized, single blind, active-controlled, multicenter study. In this study, 444 adult patients were included in the efficacy analysis. Patients ranged in age from 19 to 86 years old (mean age 57 years old) with 53% female and 47% male patients. Race was distributed as follows: 86% Caucasian, 9% African American, 7% Hispanic or Latino, and 3% other.

Patients were randomized to one of the following two colon preparations: 1) HalfLytely and Bisacodyl Tablets Bowel Prep Kit [20 mg of bisacodyl tablets were given at noon on the day before colonoscopy followed by 2 liters of HalfLytely (after the first bowel movement or maximum of 6 hours)] at a rate of 8 ounces every 10 minutes and 2) a modified HalfLytely and Bisacodyl Tablets Bowel Prep Kit [containing 10 mg of bisacodyl tablets given at noon on the day before colonoscopy followed by 2 liters of HalfLytely (after the first bowel movement or maximum of 6 hours)] at a rate of 8 ounces every 10 minutes.

Patients were instructed to refrain from solid food and to have clear liquids on the day before colonoscopy. In addition, patients were instructed to consume nothing by mouth, except clear liquids, from the time the preparation was completed until midnight. Patients were instructed not to eat or drink anything from midnight until after the colonoscopy was completed. The primary efficacy endpoint was the proportion of patients with successful colon cleansing (assessed by the colonoscopists), see Table 3 below.

Table 3: Colon Cleansing Efficacy*

Last updated on RxList: 10/15/2007

See FDA-Approved Patient Labeling

• If a patient experiences severe bloating, distention or abdominal pain, administration of the solution should be slowed or temporarily discontinued until the symptoms abate. Patients should be advised to report these events to their physician.
• Hives and skin rashes have been reported that are suggestive of an allergic reaction. Patients should be advised to report to their physician any allergic reaction. Medication should be discontinued.
• Instruct patients NOT to drink large quantities of clear liquids [see Warnings and PRECAUTIONS].
• Consider performing baseline and post-colonoscopy laboratory tests (sodium, potassium, calcium, creatinine, and BUN) in patients with impaired water handling (renal insufficiency, taking diuretics) [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.

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.

Last updated on RxList: 10/15/2007

IMPORTANT NOTE: This is a summary and does not contain all possible information about this product. For complete information about this product or your specific health needs, ask your health care professional. Always seek the advice of your health care professional if you have any questions about this product or your medical condition. This information is not intended as individual medical advice and does not substitute for the knowledge and judgment of your health care professional. This information does not contain any assurances that this product is safe, effective, or appropriate for you.

POLYETHYLENE GLYCOL (PEG) 3350 W/ ELECTROLYTE AND BISACODYL - ORAL

(pol-ee-ETH-i-leen GLYE-kole/) (ee-LECK-tro-lite and bis-a-KOE-dil)

COMMON BRAND NAME(S): HalfLytely

USES: This medication is used to clean the intestine to prepare you for rectal or bowel examinations.

This product is a combination of two laxatives, bisacodyl and PEG with electrolyte. Bisacodyl works directly on the large intestine to make you have bowel movements. It is known as a stimulant-type laxative. PEG with electrolyte works by holding water in the stool to cause watery bowel movements. It is known as an osmotic-type laxative.

HOW TO USE: Take this product by mouth exactly as directed by your doctor. Do not take antacids for at least one hour before starting this product. Take the prescribed number of bisacodyl tablets with water before using the PEG with electrolyte oral solution. Do not chew or crush the tablets. You should have a bowel movement usually within 1 to 6 hours after taking the bisacodyl tablets. After you have your first bowel movement or after waiting for a maximum of 6 hours, begin drinking the PEG with electrolyte oral solution.

The PEG with electrolyte powder must be mixed with water before use. Follow the instructions provided with the product or as directed by your doctor or pharmacist. Fill the container with the correct amount of water, cap the bottle, and shake well to make sure the powder dissolves completely. Do not add any other ingredients to the solution. Drink one full glass (8 ounces or 240 milliliters) of the solution every 10 minutes until you finish the total amount prescribed by your doctor. Rapid drinking of each glassful is preferred to drinking small amounts continuously. Do not save any unused solution for future use. Ask your doctor or pharmacist if you have any questions about how to use this product.

Do not take any other medication by mouth within one hour of starting this product since the other medication may not be absorbed. Talk to your doctor or pharmacist about rescheduling your other medications while you are taking this product.

Be sure to follow your doctor's instructions about your diet before starting this product, while you are taking it, and after you finish the product. It is usually recommended that you drink only clear liquids and do not eat any solid food when you are preparing for your bowel examination. Do not drink large amounts of fluids after taking this product. Ask your doctor or pharmacist if you have any questions.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these rare but very serious side effects occur: persistent or severe nausea/vomiting, severe stomach/abdominal pain, vomit that is bloody or looks like coffee grounds, bloody stools, slowed heartbeat, muscle weakness, seizures.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching, swelling, severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

Contact your doctor for medical advice about side effects. The following numbers do not provide medical advice, but in the US you may report side effects to the Food and Drug Administration (FDA) at 1-800-FDA-1088. In Canada, you may call Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking this medication, tell your doctor or pharmacist if you are allergic to polyethylene glycol; or to bisacodyl; or if you have any other allergies.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: certain stomach/intestinal disorders (e.g., ileus, gastric retention, bowel obstruction or perforation, toxic colitis or megacolon).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: problems with the esophagus (e.g., esophagitis), swallowing problems (e.g., dysphagia, history of aspiration), certain bowel diseases (e.g., ulcerative colitis), certain heart diseases (e.g., abnormal heart rhythms, congestive heart failure), severe kidney disease, mineral imbalances, persistent nausea/vomiting/abdominal pain.

The elderly may be more sensitive to the side effects of this product.

During pregnancy, this product should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known if this product passes into breast milk. Consult your doctor before breast-feeding.

Your healthcare professionals (e.g., doctor or pharmacist) may already be aware of any possible drug interactions and may be monitoring you for it. Do not start, stop, or change the dosage of any other medicine before checking with them first.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use.

Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly.

NOTES: Do not share this medication with others.

Laboratory tests (e.g., electrolytes, kidney function) may be performed before and after you take this medication to check for side effects. Consult your doctor for more details.

MISSED DOSE: If you forget to take this medication when directed or remember too late to finish it, call your doctor for instructions.

STORAGE: Store at room temperature between 68-77 degrees F (20-25 degrees C) away from light and moisture. Brief storage between 59-86 degrees F (15-30 degrees C) is permitted. After the oral solution is mixed, refrigerate it and use within 48 hours. Do not store in the bathroom. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised July 2008 Copyright(c) 2008 First DataBank, Inc.