Bisacodyl

Bisacodyl relieves occasional constipation and irregularity.

Bisacodyl belongs to a group of drugs called stimulant laxatives. It works by increasing activity of the intestines to cause a bowel movement.

This medication comes in tablet form and is typically taken once a day as needed, with a full glass of water.  Do not use bisacodyl within 1 hour after taking an antacid or milk.

Do not chew or crush tablet(s). Swallow tablets whole.

Bisacodyl also comes as a suppository and is typically given once a day as needed.

Bisacodyl also comes as an enema that is given per rectum once a day as needed.

Common side effects of bisacodyl include stomach discomfort, faintness and/or cramps.

Bisacodyl relieves occasional constipation and irregularity. Bisacodyl is also used to empty the bowels before surgery and certain medical procedures.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Bisacodyl tablets

Common side effects include:

• stomach discomfort
• faintness
• cramps

Bisacodyl suppository and enema

Common side effects include:

• stomach discomfort
• faintness
• rectal burning
• mild cramps

This is not a complete list of bisacodyl side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Take bisacodyl exactly as directed.

Bisacodyl comes in tablet and suppository form and is taken once a day as needed. Do NOT take/use bisacodyl tablets and/or suppository for longer than 1 week unless directed by a doctor.

Bisacodyl also comes as an enema and is given once a day as needed.

Bisacodyl tablets

Bisacodyl tablets generally produces bowel movement in 6 to 12 hours

• do not chew or crush tablet(s)
• take with a glass of water
• do not use within 1 hour after taking an antacid or milk

Bisacodyl suppository

Bisacodyl suppository generally produces bowel movement in 15 minutes to 1 hour

• Detach one suppository from the strip and remove from foil
• Carefully insert one suppository well into the rectum

Bisacodyl enema

Bisacodyl enema generally produces a bowel movement in 5-20 minutes

How to use Enema:

• shake bottle well before removing protective shield
• REMOVE ORANGE PROTECTIVE SHIELD FROM ENEMA COMFORTIP® BEFORE INSERTING
• with steady pressure, gently insert enema tip in to rectum with a slight side-to-side movement, with tip pointing toward navel. Insertion may be easier if person receiving enema bears down, as if having a bowel movement. This helps relax the muscles around the anus.
• do not force the enema tip into rectum as this can cause injury squeeze bottle until nearly all liquid is gone. It is not necessay to empty the bottle completely ,as it contains more liquid than needed.
• remove Comfortip® from rectum and maintain position until urge to evacuate is strong

Positions for using this enema:

• Left-side position: lie on left side with knee bent ,and ams resting comfortably
• Knee-chest position: kneel, then lower head and chest forward until left side of face is resting on surface with left arm folded comfortably

Bisacodyl, a diphenylmethane laxative, is a stimulant laxative.b c e

CONTRAINDICATIONS 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 Toxic megacolon (4)

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.

Safety and effectiveness in pediatric patients has not been established

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
( 2)].
•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
( 2)].

13 NONCLINICAL TOXICOLOGY 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 AND HANDLING17
PATIENT COUNSELING INFORMATION17.4 FDA-Approved Patient Labeling * Sections or subsections omitted from the full prescribing information are not listed page 2 of 6 FULL PRESCRIBING INFORMATION1 INDICATIONS AND USAGEHalfLytely and Bisacodyl Tablets Bowel Prep Kit is indicated for cleansing of the colon as a preparation for colonoscopy in adults.
2 DOSAGE AND ADMINISTRATIONThe recommended HalfLytely and Bisacodyl Tablets Bowel Prep Kit oral dosage regimen for adults on the day prior to colonoscopy isas 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) shouldbe 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 thepowder.Wait for a bowel movement (or maximum of 6 hours) then drink the 2 liter HalfLytely solution at a rate of 8 ounces every 10minutes. Drink all of the solution.3 DOSAGE FORMS AND STRENGTHS Two pink, round, enteric coated 5 mg Bisacodyl delayed release tablets, stamped 223BRA224 One 2 liter HalfLytely bottle with powder for reconstitution4 CONTRAINDICATIONSThe 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 megacolon5 WARNINGS AND PRECAUTIONS5.
1 NeurologicThere have been reports of generalized tonic-clonic seizures in patients with use of large volume (4 liter) PEG-based colon preparationproducts in patients with no prior history of seizures.
The seizure cases were associated with severe vomiting, excessive beverageconsumption and electrolyte abnormalities (for example, hyponatremia, hypokalemia).
The neurologic abnormalities resolved withcorrection of fluid and electrolyte abnormalities. Therefore, HalfLytely and Bisacodyl Tablets Bowel Prep Kit should be used withcaution in patients using concomitant medications (such as diuretics) that increase the risk of electrolyte abnormalities or patients withknown or suspected hyponatremia. Monitor baseline and post-colonoscopy.

Tablet: Do not administer within 1 hour of milk, dairy products, or an antacid.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Notes

No monograph available at this time.

Missed Dose

Consult your pharmacist.

Storage

Consult your pharmacist.

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 2016. Copyright(c) 2016 First Databank, Inc.