polyethylene glycol/electrolytes and bisacodyl (HalfLytely Bowel Prep Kit)

Dosing and uses of HalfLytely Bowel Prep Kit (polyethylene glycol/electrolytes and bisacodyl)

• Adult
• Pediatric

 

Adult dosage forms and strengths

October 7, 2016: Withdrawn from U.S. market; this drug is listed by the FDA as a product that has been withdrawn or removed from the market for reasons of safety or effectiveness

oral delayed-release tablet

• One 5-mg tablets in kit

oral powder for solution

• After reconstitution contains: 210 g PEG-3350, 2.86 g sodium bicarbonate, 5.6 sodium chloride, 0.74 g potassium chloride

 

Gastrointestinal Lavage

October 7, 2016: Withdrawn from U.S. market; this drug is listed by the FDA as a product that has been withdrawn or removed from the market for reasons of safety or effectiveness

Indicated for colon cleansing on day prior to colonoscopy

Bisacodyl: 5 mg PO with water; do NOT chew or crush the tablets

PEG/electrolyte solution: Wait for bowel movement stimulated by bisacodyl (or maximum of 6 hr), then drink 2 L of solution at rate of 8 oz q10minutes

 

Administration

PEG/electrolyte solution preparation

• Add flavor pack of choice (if applicable) to the 2 L container
• No additional ingredients (other than flavor packs provided) should be added to the solution
• Prepare the solution by filling the container to the 2 L mark with water
• Cap the container and shake to dissolve the powder
• To improve palatability; may prepare earlier the same day as ingested and refrigerate
• Drinking solution through straw and serving over ice also improves palatability

 

Pediatric dosage forms and strengths

Safety and efficacy not established

 

HalfLytely Bowel Prep Kit (polyethylene glycol/electrolytes and bisacodyl) adverse (side) effects

>10%

Nausea (34%)

Fullness (40%)

Cramping (38%)

 

1-10%

Vomiting

 

< 1%

Asystole

Aspiration

Dizziness

Ischemic colitis

Dyspnea

Dermatitis

Rhinorrhea

Seizure

 

Warnings

Contraindications

Hypersensitivity

GI obstruction

Bowel perforation

Gastric retention

Ileus

Toxic colitis

Toxic megacolon

 

Cautions

Generalized tonic-clonic seizures (reported rarely) with use of large volume (4 L) with no prior history of seizures; cases were associated with severe vomiting, excessive consumption, and electrolyte abnormalities (eg, hyponatremia, hypokalemia)

Monitor closely if impaired gag reflex or prone to regurgitation or aspiration

Use with caution in renal impairment and ulcerative colitis

If GI obstruction or perforation suspected, performed appropriate studies to rule out these conditions before administration

Ischemic colitis has been reported; if severe abdominal pain or rectal bleeding occurs, evaluate as soon as possible

If severe vomiting occurs, check serum electrolytes

Serious arrythmias reported

 

Pregnancy and lactation

Pregnancy category: C

Lactation: Unknown whether distributed in breast milk; use caution

 

Pregnancy categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

 

Pharmacology of HalfLytely Bowel Prep Kit (polyethylene glycol/electrolytes and bisacodyl)

Mechanism of action

Bisacodyl: stimulant laxative that acts directly on colonic mucosa to produce peristalsis

PEG/electrolyte solution: Elicits osmotic laxative effect and replenishes electrolytes; induces catharsis through strong electrolyte and osmotic effects