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sodium sulfate/potassium sulfate/magnesium sulfate (Suprep, BC)

 

Classes: Laxatives, Osmotic

Dosing and uses of Suprep, BC (sodium sulfate/potassium sulfate/magnesium sulfate)

 

Adult dosage forms and strengths

sodium sulfate/potassium sulfate/magnesium sulfate

oral suspension

  • (17.5g/3.13g/1.6g)/6 oz bottle
  • 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

  • Light breakfast may be consumed, or have only clear liquids on day before
  • Avoid red and purple liquids, milk, and alcoholic beverages
  • Early evening before colonoscopy: Dilute 1 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): prepare 2nd 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 at least 2 hr before colonoscopy

 

Pediatric dosage forms and strengths

Safety and efficacy not established

 

Geriatric dosage forms and strengths

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

 

Suprep, BC (sodium sulfate/potassium sulfate/magnesium sulfate) adverse (side) effects

>10%

Abdominal distension (40%)

Abdominal pain (36%)

Nausea (36%)

Discomfort (54%)

Decreased bicarbonate (13%)

Hyperuricemia (23.5%)

Metabolic acidosis (12.7%)

Hypercalcemia (10.4%)

 

1-10%

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

Bowel perforation

Gastric retention

Ileus

Toxic colitis or toxic megacolon

 

Cautions

Administration in an evening-only (1-day) doing regiment not recommended; elevated levels of total bilirubin, BUN, serum creatinine, osmolality, potassium, and uric acid observed; also, increased risk of vomiting (particularly in elderly)

Caution with conditions/medications that increase risk for fluid and electrolyte disturbances, or may increase risk of adverse events of seizure, arrhythmias, and prolonged QT in the setting of fluid and electrolyte abnormalities

Adequate hydration before, during, and after use is essential to prevent consequences of fluid/electrolyte disturbances

Oral medication administered within 1 hr before Suprep may not be absorbed properly

Not for direct ingestion, each bottle must be diluted with water to final volume (16 oz) and ingested with additional water

Rule out GI obstruction/perforation before administration

Caution with severe active ulcerative colitis

Osmotic laxatives may cause colonic mucosal aphthous ulceration; concurrent use with stimulant laxatives increases this risk

Caution with impaired gag reflex

Caution with impaired renal function; increased incidence of elevated serum electrolytes, serum creatinine, and BUn

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

 

Pregnancy and lactation

Pregnancy category: C

Lactation: Unknown whether distributed in breast milk

 

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 Suprep, BC (sodium sulfate/potassium sulfate/magnesium sulfate)

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