Dosing & Uses
Dosage Form & Strengths
sodium sulfate/potassium sulfate/magnesium sulfate
oral solution for dilution
- (17.5g/3.13g/1.6g)/6 oz bottle for adults
- Each kit contains 2 bottles of concentrated oral solution (6 oz each) for further dilution and a mixing bottle
Bowel Prep
Indicated for cleansing of the colon in preparation for colonoscopy
Administer in a split dose (2-day regimen) for a total volume of 96 oz (2880 mL)
Day prior to colonoscopy
- May consume light breakfast or only clear liquids on day before (no solid foods)
- Avoid red and purple liquids, milk, and alcoholic beverages
- Early evening before colonoscopy: Dilute 1st 6-oz bottle to 16 oz (480 mL) with water in provided mixing container and drink entire amount
- Drink additional 32 oz (960 mL) of water over the next hour
Day of colonoscopy
- Have only clear liquids until after colonoscopy
- Avoid red and purple liquids, milk, and alcoholic beverages
- Morning of colonoscopy (10-12 hr after evening dose and at least 3.5 hr before colonoscopy): Prepare 2nd 6-oz bottle by diluting contents to 16 oz (480 mL) in provided mixing container and drink entire amount
- Drink additional 32 oz (960 mL) of water over the next hour
- Complete all of the bowel kit and required water at least 2 hr before colonoscopy
Dosage Form & Strengths
sodium sulfate/potassium sulfate/magnesium sulfate
oral solution for dilution
- (13.13g/2.35g/1.2g)/4.5 oz bottle for children aged ≥12 yr
- Each kit contains 2 bottles of concentrated oral solution (4.5 oz each) for further dilution and a mixing bottle
Bowel Prep
Indicated for cleansing of the colon in preparation for colonoscopy for adolescents aged ≥12 yr
≥12 years
Administer in a split dose (2-day regimen) for a total volume of liquid using 2 bottles is 72 oz (~2130 mL)
-
Day prior to colonoscopy
- May consume light breakfast or only clear liquids on day before (no solid food)
- Avoid red and purple liquids, milk, and alcoholic beverages
- Early evening before colonoscopy: Dilute 1st 4.5-oz bottle to 12 oz (360 mL) with cool water in provided mixing container and drink entire amount
- Drink additional 24 oz (720 mL) of water over the next hour
-
Day of colonoscopy
- Have only clear liquids until after colonoscopy
- Avoid red and purple liquids, milk, and alcoholic beverages
- Morning of colonoscopy (10-12 hr after evening dose and at least 3.5 hr before colonoscopy): Prepare 2nd 4.5-oz bottle by diluting contents to 12 oz (360 mL) in provided mixing container and drink entire amount
- Drink additional 24 oz (720 mL) of water over the next hour
- Complete all of the bowel kit and required water at least 2 hr before colonoscopy
In clinical trials, 25% of participants were aged 65 yr or older; no overall differences were noted with the split-dose (2-day) regimen; however, geriatric patients tended to have more vomiting when administered as a 1-day regimen
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Adverse Effects
>10%
Adults
- Discomfort (54%)
- Abdominal distension (40%)
- Abdominal pain (36%)
- Nausea (36%)
- Decreased bicarbonate (13%)
- Hyperuricemia (23.5%)
- Metabolic acidosis (12.7%)
- Hypercalcemia (10.4%)
Aged 12-16 years
- Nausea
- Abdominal pain
- Abdominal bloating
- Vomiting
1-10% (Adults)
Elevated anion gap (8.9%)
Hyperbilirubinemia (8.5%)
Vomiting (8%)
Hyperosmolality (5.8%)
Hyponatremia (3.1%)
Hyperchloremia (2.4%)
Elevated serum creatinine (1.9%)
Hyperkalemia (1.8%)
Elevated BUN (1.6%)
Headache (1.1%)
Warnings
Contraindications
Hypersensitivity
Gastrointestinal obstruction or ileus
Bowel perforation
Gastric retention
Toxic colitis or toxic megacolon
Cautions
Caution with increased incidence of elevated serum electrolytes, serum creatinine, and BUN
Caution in patients with renal impairment or patients taking concomitant medications that may affect renal function; patients may be at risk for renal injury; advise patients of importance of adequate hydration before, during and after use of product and consider performing baseline and post-colonoscopy laboratory tests
Seizures: Reports of generalized tonic-clinic seizures with use of bowel preparations products; associated with electrolyte abnormalities (eg, hyponatremia, hypokalemia, hypocalcemia, hypomagnesemia); caution in patients at risk of seizures (alcohol withdrawal, drugs lowering seizure threshold, suspected/known hyponatremia)
Cardiac arrhythmias: Rare reports of serious arrhythmias associated with ionic osmotic laxative products
Osmotic laxative products may produce colonic mucosal aphthous ulcerations; reports of serious cases of ischemic colitis requiring hospitalization; coadministration with stimulant laxatives may increase risk
If GI obstruction or perforation suspected, perform appropriate diagnostic studies to rule out these conditions before administering; caution with severe active ulcerative colitis
Patients with impaired gag reflex or other swallowing abnormalities are at risk for regurgitation or aspiration of bowel prep solution
Fluid and serum chemistry abnormalities
- Advise patients to hydrate adequately before, during, and after use
- Correct fluid and electrolyte abnormalities before treatment to avoid serious adverse effects (eg, arrhythmias, seizures, renal impairment)
- Caution in patients with conditions or medications that increase risk for fluid and electrolyte disturbances or may increase the risk of adverse events of seizure, arrhythmias, and renal impairment
- If significant vomiting or signs of dehydration develops consider performing post-colonoscopy laboratory tests (eg, electrolytes, creatinine, BUN)
- Can cause temporary elevations in uric acid; monitor patients with gout for acute flare
Drug interaction overview
- Oral medication administered within 1 hr before bowel prep may not be absorbed properly
- Caution if coadministration with drugs that increase risk of fluid and electrolyte disturbances or may increase risk of seizure, arrhythmias, or prolonged QT
- Avoid coadministration with stimulant laxatives owing to increased risk of mucosal ulceration or ischemic colitis
- Caution if coadministered with medications that may affect renal function (eg, diuretics, ACE inhibitors, ARBs, NSAIDs)
-
Chelation with magnesium
- Take tetracycline or fluoroquinolone antibiotics, iron, digoxin, chlorpromazine, or penicillamine at least 2 hr before and not less than 6 hr after administration of bowel prep to avoid chelation
Pregnancy & Lactation
Pregnancy
Data are unavailable data on use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes
Animal reproductive studies have not been conducted
Lactation
There are no data available on presence of drug combination in human or animal milk, effects on breastfed child, or on milk production; developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for prep kit and any potential adverse effects on breastfed child from product or from underlying maternal condition
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
Mechanism of Action
Osmotic laxative; sulfate salts provide sulfate anions and associated cations causing water retention within bowel; osmotic effect of unabsorbed ions and large volume of water ingested produces copious watery diarrhea
Pharmacokinetics
Half-Life: 8.5 hr
Peak Plasma Time (serum sulfate): 17 hr (1st dose); 5 hr (2nd dose); renal impairment increases Tmax by 44% and AUC by 54%
Excretion (sulfate): predominantly in feces
Administration
Oral Preparation
Correct fluid and electrolyte abnormalities before treatment
Dilute bowel prep kit in water before ingestion
Consume additional water after each dose of bowel prep
On day before colonoscopy, consume only a light breakfast or clear liquids (eg, water, strained fruit juice without pulp, lemonade, plain coffee or tea, chicken broth, gelatin dessert without fruit)
On day of colonoscopy only consume clear liquids up to 2 hours before colonoscopy Do not eat solid food, drink milk, or eat or drink anything colored red or purple
Do not drink alcohol
Do not take other laxatives while taking bowel prep
Do not take oral medications within 1 hr of starting each dose of bowel prep
Stop consumption of all fluids at least 2 hr before colonoscopy
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Patient Handout
Formulary
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