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Sodium Sulfate, Potassium Sulfate, Magnesium Sulfate, and Polyethylene Glycol-Electrolyte Solution

Pronunciation

(SOW dee um SUL fate, poe TASS ee um SUL fate, mag NEE zhum SUL fate, & pol i ETH i leen GLY kol ee LEK troe lite soe LOO shun)

Index Terms

  • Sodium Sulfate, Potassium Sulfate, Magnesium Sulfate and PEG Solution
  • Sodium Sulfate, Potassium Sulfate, Magnesium Sulfate and PEG-Electrolyte Solution

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Kit, Oral [each kit contains]:

Suclear: Powder for solution, oral: PEG 3350 210 g, sodium bicarbonate 2.86 g, sodium chloride 5.6 g, potassium chloride 0.74 g (2000 mL) [contains cherry, lemon-lime, orange, and pineapple flavor packs]

Suclear: Solution, oral: Sodium sulfate 17.5 g, potassium sulfate 3.13 g, and magnesium sulfate 1.6 g (177 mL) [contains sodium benzoate] [DSC]

Brand Names: U.S.

  • Suclear™ [DSC]

Pharmacologic Category

  • Laxative, Osmotic

Pharmacology

Induces catharsis by the osmotic effects of the unabsorbed sulfate salts and polyethylene glycol (PEG) in the GI tract. Specifically, sulfate salts provide sulfate anions, which are poorly absorbed, and PEG, which is primarily unabsorbed, causes water to be retained in the GI tract resulting in watery diarrhea.

Absorption

PEG 3350: Minimal; Sulfates: Poor; ~20% absorbed systemically

Excretion

Feces/rectal effluent (primary route of excretion for unabsorbed sulfates and PEG); urine (predominant route for absorbed sulfates and PEG)

Time to Peak

Serum sulfate: ~5.5 hours

Half-Life Elimination

Serum sulfate: 8.5 hours

Special Populations: Renal Function Impairment

Moderate renal impairment (CrCl 30-49 mL/minute) resulted in a 43% higher Cmax and a 16% lower urinary clearance of serum sulfates compared to healthy patients

Use: Labeled Indications

Bowel cleansing prior to colonoscopy

Contraindications

Hypersensitivity to sodium sulfate, potassium sulfate, magnesium sulfate, polyethylene glycol or any component of the formulation; GI obstruction, bowel perforation, gastric retention, ileus, toxic colitis, toxic megacolon

Dosing: Adult

Bowel cleansing prior to colonoscopy: Oral: May be administered as the split-dose (2-day) regimen (preferred method) or the day-before (1-day) regimen (alternative method).

Split-dose (2-day) regimen: Total volume of liquid consumed over the course of treatment: 3440 mL (~115 oz)

Dose 1: Evening before colonoscopy (10-12 hours prior to Dose 2): Dilute the contents of the 6-ounce oral solution bottle to a final volume of 480 mL (16 oz), and drink the contents within 20 minutes. Refill container with 16 ounces of water and drink over the next 2 hours. Refill the container with the second refill of 16 oz of water, and finish drinking before bedtime (2 refills totaling 960 mL [32 oz]). Total volume of liquid consumed with Dose 1: 1440 mL (48 oz).

Dose 2: Morning of the colonoscopy (beginning at least 3.5 hours prior to colonoscopy): Drink the entire contents of the reconstituted powder which has been diluted to a final volume of 2000 mL (2 L [~67 oz]) as follows: Using the 16-ounce container provided, drink at a rate of 480 mL (16 oz) every 20 minutes (four 16-ounce containers over ~1.5 hours). Complete at least 2 hours prior to colonoscopy. Total volume of liquid consumed with Dose 2: 2000 mL (~67 oz)

Day-before (1-day) regimen: Total volume of liquid consumed over the course of treatment: 3440 mL (~115 oz)

Dose 1: Evening before colonoscopy (beginning at least 3.5 hours prior to bedtime): Drink the diluted contents of the 6-ounce oral solution bottle, which has been further diluted to a final volume of 480 mL (16 oz), preferably within 20 minutes. Refill container with 480 mL (16 oz) of water, and drink over the next 2 hours. Total volume of liquid consumed with Dose 1: 960 mL (32 oz).

Dose 2: Evening before colonoscopy (~2 hours after starting Dose 1): Drink the entire contents of the reconstituted powder which has been diluted to a final volume of 2000 mL (2 L [~67 oz]) as follows: Using the 16-ounce container provided, drink at a rate of 480 mL (16 oz) every 20 minutes (four 16-ounce containers over ~1.5 hours). Refill the container with 480 mL (16 oz) of water and finish drinking before bedtime. Total volume of liquid consumed with Dose 2: 2480 mL (~83 oz).

Dosing: Geriatric

Refer to adult dosing.

Dosing: Renal Impairment

No dosage adjustment provided in manufacturer’s labeling (safety has not been adequately studied); however, use caution and ensure adequate hydration in patients with renal impairment or at risk for impairment. Moderate renal impairment (CrCl 30-49 mL/minute) resulted in a 43% higher Cmax and a 16% lower urinary clearance of serum sulfates compared to healthy patients.

Dosing: Hepatic Impairment

No dosage adjustment provided in manufacturer’s labeling.

Reconstitution

Prior to administration, each component of the dosing regimen (oral solution and powder for oral solution) must be diluted with water as follows:

Oral solution: Further dilute the 6 ounce oral solution by pouring the entire contents of the bottle into the provided 16 ounce mixing container and filling that container with cool water to the fill line for a final volume of 16 ounces (480 mL). Following dilution, the oral solution should be consumed within 20 minutes.

Powder for oral solution: Dissolve the powder in the provided 2 L bottle by adding water to the fill line for a final volume of 2 L (2000 mL). Close tightly and shake the container until all powder is dissolved; solution should be clear and colorless. Flavor packs (provided with the product) may also be added if desired. Following reconstitution of the powder for oral solution, the solution may be refrigerated and should be used within 48 hours.

Administration

Oral: Each bottle must be diluted prior to use. The entire contents should be consumed followed by each postdose hydration amount, as directed depending on the regimen. Only clear liquids should be consumed from the start of the dosing regimen until 2 hours prior to colonoscopy; thereafter, nothing should be consumed until after colonoscopy. Patients should avoid solid foods, red and purple liquids, milk, and alcoholic beverages on the day prior and the day of the colonoscopy. Oral medications should not be administered within 1 hour of start of therapy.

Dietary Considerations

Patient should not eat solid food from start of solution administration until after colonoscopy. Patient may have clear liquids (no solid food or milk) until 2 hours prior to colonoscopy.

Storage

Store unused kits at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F). Keep out of reach of children. Following dilution, the oral solution should be consumed within 20 minutes. Following reconstitution of the powder for oral solution, the solution may be refrigerated and should be used within 48 hours.

Adverse Reactions

>10%:

Central nervous system: Malaise (62% to 69%)

Gastrointestinal: Abdominal distension (52%), nausea (42% to 46%), abdominal pain (38% to 40%), vomiting (11% to 14%)

Hepatic: Increased serum bilirubin (8% to 11%)

Renal: Renal insufficiency (9% to 25%)

1% to 10%:

Central nervous system: Headache (1% to 2%)

Endocrine & metabolic: Acidosis (3% to 10%), hypercalcemia (4% to 9%), increased serum glucose (2% to 7%), hyperuricemia (4% to 6%), hypokalemia (4%), decreased serum bicarbonate (3% to 4%), increased urine osmolality (2% to 4%), hypophosphatemia (≤3%), hypochloremia (1%), hyponatremia (≤1%), decreased serum magnesium (≤1%)

Neuromuscular & skeletal: Increased creatine phosphokinase (7%)

Renal: Increased serum creatinine (1% to 2%)

Warnings/Precautions

Concerns related to adverse effects:

• Arrhythmias: Serious arrhythmias have occurred rarely with the use of osmotic laxative products; use caution in patients at increased risk for cardiac arrhythmias (eg, recent MI, uncontrolled arrhythmias, unstable angina, cardiomyopathy, history of prolonged QT, HF); consider pre-dose and post-colonoscopy ECGs in these patients.

• Fluid and electrolyte abnormalities: Fluid and electrolyte disturbances can lead to arrhythmias, seizures, and renal impairment. Advise patients to maintain adequate hydration before, during, and after treatment. If patient becomes dehydrated or experiences significant vomiting after treatment, consider post-colonoscopy laboratory tests (electrolytes, creatinine, and BUN). Instruct patients to avoid alcohol beginning the day before colonoscopy and until after the completion of the colonoscopy; alcohol consumption may increase risk of dehydration.

• GI effects: Osmotic laxatives may produce colonic mucosal aphthous ulcerations, including cases of ischemic colitis requiring hospitalization. Concomitant use of stimulant laxatives and this preparation may increase the risk and should be avoided. Use caution when interpreting colonoscopy results in patients with known or suspected inflammatory bowel disease.

• Seizures: Seizures associated with electrolyte abnormalities (eg, hyponatremia, hypokalemia) and low serum osmolality have occurred; use with caution in patients with underlying electrolyte disturbances and in patients at increased risk for seizures (eg, concomitant medications that lower seizure threshold, withdrawal from alcohol or benzodiazepines).

Disease-related concerns:

• Gout: May cause transient increases in uric acid; use caution in patients with gout.

• Impaired gag reflex: Observe unconscious or semiconscious patients with impaired gag reflex or those who are otherwise prone to regurgitation or aspiration during administration.

• Renal impairment: Use caution in patients with renal impairment; adequate hydration is particularly important in these patients or in patients receiving concomitant medications that may affect renal function (eg, diuretics, angiotensin converting enzyme inhibitors, angiotensin receptor blockers, NSAIDs). Consider baseline and post-colonoscopy electrolytes, creatinine, and BUN levels in patients at increased risk for renal impairment.

• Ulcerative colitis: Use with caution in patients with severe, active ulcerative colitis; increased risk of exacerbation of ulcerative colitis with use.

Other warnings/precautions:

• Appropriate use: Evaluate patients with symptoms of bowel obstruction/perforation (nausea, vomiting, abdominal pain or distension) prior to use. Each bottle must be diluted with water prior to use; inadvertent administration of undiluted solution may increase the risk of nausea, vomiting, and fluid/electrolyte abnormalities.

Monitoring Parameters

Consider baseline and postprocedure labwork (eg, electrolytes, BUN, creatinine) in patients at risk for renal impairment, seizure, or who have a history of electrolyte abnormality; post-colonoscopy labwork (electrolytes, creatinine, and BUN) is recommended in any patient experiencing significant vomiting or signs of dehydration following use. ECG (prior to therapy and post-colonoscopy) in patients with risks for prolonged QT or arrhythmias.

Pregnancy Risk Factor

C

Pregnancy Considerations

Animal reproduction studies have not been conducted.

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience nausea, vomiting, or bloating. Have patient report immediately to prescriber inability to ingest solution, tachycardia, severe abdominal pain, severe headache, severe rectal bleeding, or severe rectal pain (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.

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