sodium sulfate/potassium sulfate/magnesium sulfate/polyethylene glycol (Suclear)

Dosing and uses of Suclear (sodium sulfate/potassium sulfate/magnesium sulfate/polyethylene glycol)

• Adult
• Pediatric

 

Adult dosage forms and strengths

oral solution & powder for oral solution

• Oral solution: (17.5g sodium sulfate/3.13g potassium sulfate/1.6g magnesium sulfate)/6oz
• Powder for oral solution: (210g PEG-3350/5.6g sodium chloride/2.86g sodium bicarbonate/0.74g potassium chloride)/2 L

 

Bowel Prep

Indicated for cleansing of the colon in preparation for colonoscopy

Administer as either a split dose (2-day) regimen (preferred method) or day-before (1-day) regimen

Split dose (2-day) regimen (preferred)

• Dose 1 - Evening before the colonoscopy (10-12 hours prior to Dose 2)
• a) Dilute 6-oz oral solution prior to use by pouring the entire contents of the bottle into the 16-oz mixing container and then filling the container with cool water to the fill line and mix
• b) Drink the entire solution in the container, it is best to complete drinking the solution within 20 minutes
• c) Refill the container with 16 oz of water to the fill line and drink it over the next 2 hours
• d) Refill the container with 16 oz of water to the fill line and finish drinking it before going to bed
• Dose 2 - Next morning on the day of the colonoscopy (start at least 3.5 hr prior to colonoscopy)
• a) Dissolve the powder of Dose 2 by adding water to the fill line on the jug
• b) Shake the jug until all the powder is dissolved (can be used with or without the addition of a flavor pack); when dissolved in water to a volume of 2 liters, the solution is clear and colorless; may be refrigerated after adding water and should be used within 48 hr of reconstitution
• c) Using the 16-oz container provided with the kit, drink all the solution in the jug at a rate of one 16-oz container every 20 minutes (this is four 16-oz containers over a period of 1.5 hr)
• d) Complete drinking the solution at least 2 hr before the colonoscopy
• e) Consume only clear liquids until 2 hr prior to colonoscopy; thereafter, nothing should be consumed until the completion of colonoscopy

Day-before (1-day) regimen (alternative method)

• On the evening before the colonoscopy: Dose 1 - (Begin at least 3.5 hr prior to bedtime)
• a) Dilute the 6-oz oral solution prior to use by pouring the entire contents of the bottle into the 16-oz mixing container and then filling the container with cool water to the fill line and mix
• b) Drink the entire solution in the container within 20 minutes
• c) Refill the container with 16 oz of water to the fill line and drink it over the next 2 hr Dose 2 - (Approximately 2 hr after starting Dose 1)
• d) Dissolve the powder of Dose 2 by adding water to the fill line on the jug
• e) Shake the jug until all the powder is dissolved (can be used with or without the addition of a flavor pack); when dissolved in water to a volume of 2 liters, the solution is clear and colorless; may be refrigerated after adding water and should be used within 48 hr of reconstitution
• f) Using the 16-oz container provided with the kit, drink all the solution in the jug at a rate of one 16-oz container every 20 minutes (this is four 16-oz containers over a period of 1.5 hr)
• g) Refill the container with 16 oz of water to the fill line and finish drinking it before going to bed
• h) Consume only clear liquids until 2 hr prior to colonoscopy; thereafter, nothing should be consumed until the completion of colonoscopy

 

Pediatric dosage forms and strengths

Safety and efficacy not established

 

Suclear (sodium sulfate/potassium sulfate/magnesium sulfate/polyethylene glycol) adverse (side) effects

>10%

Abdominal distention (52%)

Nausea (46%)

Abdominal pain (38%)

Vomiting (14%)

High bilirubin (11%)

 

1-10%

High anion gap (10%)

Low GFR (9%)

High creatine kinase (7%)

Low bicarbonate (4%)

High calcium (4%)

High osmolality (4%)

Low potassium (4%)

High uric acid (4%)

Low Phosphate (3%)

High creatinine (3%)

Headache (2%)

High glucose (2%)

Low sodium (1%)

Low chloride (1%)

High creatinine (1%)

 

Warnings

Contraindications

Hypersensitivity

GI obstruction or ileus

Bowel perforation

Gastric retention

Toxic colitis or toxic megacolon

 

Cautions

Hydrate adequately before, during, and following to decrease risk of fluid and electrolyte abnormalities

Rare reports of serious arrhythmias and seizures with use of osmotic bowel preparations

Consider the risks in patients with impaired renal function or patients taking concomitant medications that may affect renal function (eg, diuretics, ACE inhibitors, ARBs, NSAIDs)

Osmotic laxatives may produce colonic mucosal aphthous ulcerations, and there have been reports of more serious cases of ischemic colitis requiring hospitalization

Evaluate for GI obstruction, GI perforation, and aspiration risk before administration

Ingestion of the undiluted solution may increase the risk of nausea, vomiting, dehydration or other serious adverse reactions

 

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 Suclear (sodium sulfate/potassium sulfate/magnesium sulfate/polyethylene glycol)

Mechanism of action

The bowel evacuation effect is the result of the osmotic effect of unabsorbed PEG, sulfate anions and the associated cations which causes water to be retained within the gastrointestinal tract

 

Absorption

Bioavailability: 20% (oral sulfates)

Peak plasma time: 5.5 hr (serum sulfate)

 

Elimination

Half-life: 8.5 hr (sulfates)

Excretion: 80% feces