AND BISACODYL (POLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL) KIT FOR USE INITIAL U.APPROVAL: 2004 RECENT MAJOR CHANGES Dosage and Administration 9/2007 INDICATIONS AND USAGE HalfLytely and Bisacodyl Tablets Bowel Prep Kit is a gastrointestinal lavage indicated for cleansing of the colon as a preparation for colonoscopy in adults () DOSAGE AND ADMINISTRATION Take two 5 mg bisacodyl delayed release tablets with water.NOT chew or crush the tablets.Prepare the HalfLytely solution by filling the container to the 2 liter mark with water.The container.To dissolve the powder.This preparation can be used without the addition of a Flavor Pack.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.Of the solution.DOSAGE FORMS AND STRENGTHS Two 5 mg bisacodyl delayed release tablets () One 2 liter HalfLytely bottle with powder for reconstitution () CONTRAINDICATIONS Patients known to be allergic to polyethylene glycol () Gastrointestinal (GI) obstruction () Bowel perforation () Toxic colitis () Toxic megacolon () WARNINGS AND PRECAUTIONS Neurologic () Gastrointestinal () Renal Insufficiency () Allergic Reaction () ADVERSE REACTIONS Mostmon adverse reactions (< 3%) are abdominal pain/cramping, nausea, vomiting and headache () To report SUSPECTED ADVERSE REACTIONS, contact Braintree Laboratories, Inc.1-800-874-6756 or FDA at 1-800-FDA-1088 or DRUG INTERACTIONS 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.See for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling REVISED: 10/2007 FULL PRESCRIBING INFORMATION: CONTENTS Sections or subsections omitted from the full prescribing information are not listed 1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION 3 DOSAGE FORMS AND STRENGTHS 4 CONTRAINDICATIONS 5 WARNINGS AND PRECAUTIONS 5.5.5.INSUFFICIENCY 5.6 ADVERSE REACTIONS 6.STUDIES EXPERIENCE 6.EXPERIENCE 7 DRUG INTERACTIONS 8 USE IN SPECIFIC POPULATIONS 8.8.MOTHERS 8.USE 8.11 DESCRIPTION 12 CLINICAL PHARMACOLOGY 12.OF ACTION 12.12.13 NONCLINICAL TOXICOLOGY 13.MUTAGENESIS, IMPAIRMENT OF FERTILITY 14 CLINICAL STUDIES 16 HOW SUPPLIED/STORAGE AND HANDLING 17 PATIENT COUNSELING INFORMATION 17.PATIENT LABELING FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE HalfLytely and Bisacodyl Tablets Bowel Prep Kit is indicated for cleansing of the colon as a preparation for colonoscopy in adults.2 DOSAGE AND ADMINISTRATION The rmended 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.NOT chew or crush the tablets.Add flavor pack of choice (if applicable) to the 2 liter container.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.Container.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.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 4 CONTRAINDICATIONS The HalfLytely and Bisacodyl Tablets Bowel Prep Kit is contraindicated in the following conditions: Known allergies to polyethylene glycol or otherponents of the kit Gastrointestinal (GI) obstruction Bowel perforation Toxic colitis Toxic megacolon 5 WARNINGS AND PRECAUTIONS 5.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.Cases were associated with severe vomiting, excessive beverage consumption and electrolyte abnormalities (for example, hyponatremia, hypokalemia).Neurologic abnormalities resolved with correction of fluid and electrolyte abnormalities.HalfLytely and Bisacodyl Tablets Bowel Prep Kit should be used with caution in patients using coitant medications (such as diuretics) that increase the risk of electrolyte abnormalities or patients with known or suspected hyponatremia.Baseline and post-colonoscopy laboratory tests (sodium, potassium, calcium, creatinine, and BUN) in these patients.5.Use with caution in patient with severe ulcerative colitis, ileus or gastric retention.Patients with impaired gag reflex and patients prone to regurgitation or aspiration during administration of HalfLytely solution.GI obstruction or perforation is suspected, appropriate studies should be performed to rule out these conditions before administration.Been reports of ischemic colitis in patients with use of HalfLytely and 20 mg Bisacodyl Tablets Bowel Prep Kit.Patients develop severe abdominal pain or rectal bleeding, patients should be evaluated as soon as possible.5.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.REACTION Hives and skin rashes have been reported with PEG-3350 based products which are suggestive of an allergic reaction.6 ADVERSE REACTIONS 6.EXPERIENCE Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directlypared 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.Mg) Bisacodyl Tablets Bowel Prep Kit multicentered, controlled clinical trials, abdominal pain/cramping, nausea, vomiting and headache were the mostmon adverse reactions (< 3%) after the administration of HalfLytely and (10 mg or 20 mg) Bisacodyl Tablets Bowel Prep Kit.Than 1% of patients exposed to HalfLytely and 10 mg Bisacodyl Tablets Bowel Prep Kit reported vomiting and abdominal pain/cramping.The data in reflects exposure in 222 patients to HalfLytely and 10 mg bisacodyl tablets vs.Patients exposed to HalfLytely and 20 mg bisacodyl tablets.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.Of theparator group were similar.Table 1: Adverse Reactions Observed in at Least 1% of Patients HalfLytely and 10 mg Bisacodyl Tablets Bowel Prep Kit (N=222)HalfLytely and 20 mg Bisacodyl Tablets Bowel Prep Kit (N=223) Abdominal pain/cramping 1% 2% Nausea 1% 2% Vomiting 1% 2% Headache 2% 1% displays patient diary ratings of their symptoms associated with HalfLytely and Bisacodyl Tablets Bowel Prep Kits (10 mg bisacodyl vs.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 1 Patients were specifically asked about the occurrence of the following symptoms: nausea, abdominal cramping, fullness, vomiting, and overall difort.Half Lytely and 10 mg Bisacodyl Tablets Bowel Prep Kit (N=222)HalfLytely and 20 mg Bisacodyl Tablets Bowel Prep Kit (N=223) Nausea 13% 21% Abdominal cramping 7% 14% Abdominal fullness 11% 13% Vomiting 5% 8% Overall Difort 14% 20% 6.EXPERIENCE The following adverse reactions have been identified during postapproval use of HalfLytely and Bisacodyl Tablets Bowel Prep Kit.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.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.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.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.Dizziness and syncope have been reported .7 DRUG INTERACTIONS 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.USE IN SPECIFIC POPULATIONS 8.Pregnancy Category C.Reproduction studies have not been conducted.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.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.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.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.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.11 DESCRIPTION Each HalfLytely and Bisacodyl Tablets Bowel Prep Kit 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.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.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.Bisacodyl delayed release tablets are administered orally prior to drinking the HalfLytely solution .(PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution): A white powder for reconstitution containing 210 grams of PEG-3350, 2.Of sodium bicarbonate, 5.Of sodium chloride, 0.Of potassium chloride and 1 gram of flavoring ingredient (if applicable).Packs are available in Cherry, Lemon-Lime and Orange.Preparation can be used without the addition of a Flavor Pack.Dissolved in water to a volume of 2 liters, the HalfLytely solution is isosmotic, clear, and colorless.HalfLytely solution is administered orally after taking the two bisacodyl delayed release tablets .CLINICAL PHARMACOLOGY 12.OF ACTION HalfLytely and Bisacodyl Tablets Bowel Prep Kit induces diarrhea which cleanses the colon.12.A stimulant laxative, is hydrolyzed by intestinal brush border enzymes and colonic bacteria to form an active metabolite 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.13 NONCLINICAL TOXICOLOGY 13.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.To evaluate its potential for impairment of fertility or its mutagenic potential have not been performed.14 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.This study, 444 adult patients were included in the efficacy analysis.In age from 19 to 86 years old (mean age 57 years old) with 53% female and 47% male patients.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 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.Addition, patients were instructed to consume nothing by mouth, except clear liquids, from the time the preparation waspleted until midnight.Were instructed not to eat or drink anything from midnight until after the colonoscopy waspleted.The primary efficacy endpoint was the proportion of patients with successful colon cleansing (assessed by the colonoscopists), see below.Table 3: Colon Cleansing Efficacy 1 Responders were patients whose colon preparations were graded excellent (no more than small bits of adherent feces/fluid) or good (small amounts of feces or fluid not interfering with the exam) by the colonoscopist; 2 Non-responders were patients whose colon preparations were graded fair (enough feces or fluid to prevent apletely reliable exam) or poor (large amounts of fecal residue requiring additional cleansing) by the colonoscopists or patients who were unable to tolerate their colon preparation.The HalfLytely and 20 mg Bisacodyl Tablets Bowel Prep Kit does not provide any additional efficacy benefits over the HalfLytely and 10 mg Bisacodyl Tablets Bowel Prep Kit.Treatment Group Responders1 n/N(%)Non-responders2 n/N(%) HalfLytely and 20 mg Bisacodyl Tablets Bowel Prep Kit (N=223) 196/223 (88) 27/223 (12) HalfLytely and 10 mg Bisacodyl Tablets Bowel Prep Kit (N=221) 192/221 (87) 29/221 (13) 16 HOW SUPPLIED/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.Of sodium bicarbonate, 5.Of sodium chloride, 0.Potassium chloride, and 1 gram of flavoring ingredient (if applicable).2 liters of water, the reconstituted HalfLytely solution (clear and colorless) contains 31.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.And Bisacodyl Tablets Bowel Prep Kit with Flavor Packs contains 3 packs (1 gram each Cherry, Lemon-Lime and Orange flavors).Storage: Store at 20-25C (68-77F).Permitted between 15-30C (59-86F).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 PATIENT COUNSELING INFORMATION 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.Should be advised to report these events to their physician.Hives and skin rashes have been reported that are suggestive of an allergic reaction.Should be advised to report to their physician any allergic reaction.Should be discontinued.Instruct patients NOT to drink large quantities of clear liquids Consider performing baseline and post-colonoscopy laboratory tests (sodium, potassium, calcium, creatinine, and BUN) in patients with impaired water handling (renal insufficiency, taking diuretics) .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.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.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.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.Your abdominal distention or difort continues stop drinking the HalfLytely solution temporarily or drink each portion at longer intervals until your symptoms disappear.Braintree Laboratories, Inc.MA 02185 HalfLytely and Bisacodyl (polyethylene glycol 3350, sodium chloride, sodium bicarbonate, potassium chloride and bisacodyl) PRODUCT INFO Product Code 52268-522 Dosage Form KIT PACKAGING # NDC Package Description Multilevel Packaging 1 52268-522-01 1 KIT In 1 CARTON None QUANTITY OF PARTS Part # Package Quantity Total Product Quantity PART 1 1 BLISTER PACK 2 TABLET In 1 PART 2 1 BOTTLE, PLASTIC 2 LITER In 1 Part 1 of 2 Bisacodyl (Bisacodyl) Route Of Administration ORAL Dosage Form TABLET, DELAYED RELEASE DEA Schedule INGREDIENTS Name (Active Moiety) Type Strength BISACODYL (bisacodyl) Active 5 MILLIGRAM In 1 TABLET LACTOSE Inactive MICROCRYSTALLINE CELLULOSE Inactive CROSCARMELLOSE SODIUM Inactive MAGNESIUM STEARATE Inactive EUDRAGIT L 30-55 Inactive POLYETHYLENE GLYCOL 400 Inactive TALC Inactive GELATIN Inactive CALCIUM SULFATE Inactive CONFECTIONS SUGAR Inactive KAOLIN Inactive SUCROSE Inactive OPALUX PINK Inactive BEESWAX Inactive CARNUBA WAX Inactive IMPRINT INFORMATION Characteristic Appearance Characteristic Appearance Color pink (Pink) Score 1 Shape ROUND (ROUND) Symbol false Imprint Code BRA Coating true Size 5mm PACKAGING # NDC Package Description Multilevel Packaging 1 52268-504-02 2 TABLET In 1 BLISTER PACK None Part 2 of 2 HalfLytely (polyethylene glycol 3350, sodium chloride, sodium bicarbonate and potassium chloride) Route Of Administration ORAL Dosage Form POWDER, FOR SOLUTION DEA Schedule INGREDIENTS Name (Active Moiety) Type Strength POLYETHYLENE GLYCOL 3350 (polyethylene glycol 3350) Active 210 GRAM In 2 LITER SODIUM BICARBONATE (sodium bicarbonate) Active 2.In 2 LITER SODIUM CHLORIDE (sodium chloride) Active 5.In 2 LITER POTASSIUM CHLORIDE (potassium chloride) Active 0.In 2 LITER FLAVOR INGREDIENT Inactive 1.In 2 LITER IMPRINT INFORMATION Characteristic Appearance Characteristic Appearance Color Score Shape Symbol Imprint Code Coating Size PACKAGING # NDC Package Description Multilevel Packaging 1 2 LITER In 1 BOTTLE, PLASTIC None HalfLytely and Bisacodyl (polyethylene glycol 3350, sodium chloride, sodium bicarbonate, potassium chloride and bisacodyl) PRODUCT INFO Product Code 52268-521 Dosage Form KIT PACKAGING # NDC Package Description Multilevel Packaging 1 52268-521-01 1 KIT In 1 CARTON None QUANTITY OF PARTS Part # Package Quantity Total Product Quantity PART 1 1 BLISTER PACK 2 TABLET In 1 PART 2 1 BOTTLE, PLASTIC 2 LITER In 1 Part 1 of 2 Bisacodyl (Bisacodyl) Route Of Administration ORAL Dosage Form TABLET, DELAYED RELEASE DEA Schedule INGREDIENTS Name (Active Moiety) Type Strength BISACODYL (bisacodyl) Active 5 MILLIGRAM In 1 TABLET LACTOSE Inactive MICROCRYSTALLINE CELLULOSE Inactive CROSCARMELLOSE SODIUM Inactive MAGNESIUM STEARATE Inactive EUDRAGIT L 30-55 Inactive POLYETHYLENE GLYCOL 400 Inactive TALC Inactive GELATIN Inactive CALCIUM SULFATE Inactive CONFECTIONS SUGAR Inactive KAOLIN Inactive SUCROSE Inactive OPALUX PINK Inactive BEESWAX Inactive CARNUBA WAX Inactive IMPRINT INFORMATION Characteristic Appearance Characteristic Appearance Color pink (Pink) Score 1 Shape ROUND (ROUND) Symbol false Imprint Code BRA Coating true Size 5mm PACKAGING # NDC Package Description Multilevel Packaging 1 52268-504-02 2 TABLET In 1 BLISTER PACK None Part 2 of 2 HalfLytely (polyethylene glycol 3350, sodium chloride, sodium bicarbonate and potassium chloride) Route Of Administration ORAL Dosage Form POWDER, FOR SOLUTION DEA Schedule INGREDIENTS Name (Active Moiety) Type Strength POLYETHYLENE GLYCOL 3350 (polyethylene glycol 3350) Active 210 GRAM In 2 LITER SODIUM BICARBONATE (sodium bicarbonate) Active 2.In 2 LITER SODIUM CHLORIDE (sodium chloride) Active 5.In 2 LITER POTASSIUM CHLORIDE (potassium chloride) Active 0.In 2 LITER CHERRY FLAVOR Inactive 1.In 2 LITER LEMON-LIME FLAVOR Inactive 1.Read more A phase ii study of oxaliplatin with low-dose leucovorin and bolus and continuous infusion 5-fluorouracil (modified folfox-4) for gastric cancer patients with malignant ascites
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