Bisacodyl and polyethylene glycol (PEG) 3350 with electrolytes

Bisacodyl and PEG-3350 is a laxative that stimulates bowel movements. This medication also contains potassium, sodium, and other minerals to replace electrolytes that are passed from the body in the stool.

Bisacodyl and PEG-3350 is used to clean the bowel before colonoscopy or other intestinal procedure.

Bisacodyl and PEG-3350 may also be used for purposes not listed in this medication guide.

Do not use this medication if you are allergic to:

• bisacodyl (Bisac-Evac, Carter's Little Pills, Dulcolax, Fleet, and others);

• polyethylene glycol (GlycoLax, MiraLax); or

• any other electrolyte solutions (such as Pedialyte or Gatorade).

You should not use bisacodyl and PEG-3350 with electrolytes if you have a perforated bowel, a bowel obstruction or severe constipation, or colitis or toxic megacolon. If you have any these conditions, you could have dangerous or life-threatening side effects from bisacodyl and PEG-3350.

People with eating disorders (such as anorexia or bulimia) should not use this medication without the advice of a doctor.

To make sure you can safely use this medication, tell your doctor if you have any of these other conditions:

• kidney disease;

• nausea, vomiting, or trouble swallowing;

• a history of bowel obstruction, diverticulitis, ulcerative colitis, or other chronic bowel disease; or

• if you are taking a diuretic ("water pill").

FDA pregnancy category C. It is not known whether this medication will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

It is not known whether bisacodyl and PEG-3350 passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Do not give this medicine to a child unless your doctor has told you to.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor if you have any of these serious side effects:

• seizure (convulsions);

• severe nausea, severe stomach pain or bloating;

• coughing up blood or vomit that looks like coffee grounds;

• rectal bleeding;

• no bowel movement within 6 hours after use; or

• gagging, choking, or vomiting.

Some of these side effects may be prevented by drinking the medication more slowly, or not using it for a short time. Follow your doctor's instructions.

Less serious side effects may include:

• mild nausea or vomiting;

• mild stomach cramps, or full feeling;

• rectal pain or irritation;

• passing gas; or

• headache.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Usual Adult Dose for Bowel Preparation:

Bisacodyl 20 mg (4 tablets) orally once. Following first bowel movement, or 6 hours after ingestion of bisacodyl tablets, begin PEG-ELS 240 mL every 10 minutes until 2 liters is totally consumed.

Bisacodyl 20 mg (4 tablets) orally once. Following first bowel movement, or 6 hours after ingestion of bisacodyl tablets, begin PEG-ELS 240 mL every 10 minutes until 2 liters is totally consumed.

Animal studies with bisacodyl have failed to reveal evidence of teratogenicity or fetotoxicity. At doses 70 times the maximum recommended human dose, there is evidence of decreased litter survival at weaning. Bisacodyl tablets have been used during human pregnancy without evidence of uterine relaxation. Due to the minimal absorption of bisacodyl, fetal risk is considered low.

Bisacodyl-PEG-ELS has been assigned to pregnancy category C by the FDA. Animal studies have not been reported. There are no controlled data in human pregnancy. Bisacodyl-PEG-ELS is recommended for use during pregnancy when there are no alternatives and the potential benefits outweigh the potential risks.

There are no data on the excretion of bisacodyl-PEG-ELS into human milk. The manufacturer recommends caution when bisacodyl-PEG-ELS is administered to nursing women.