Sodium Picosulphate, Magnesium Oxide, Citric Acid

Pharmacologic Category

Laxative, Osmotic; Laxative, Stimulant

Dosing: Adult

Bowel cleansing: Oral: Note: Correct fluid and electrolyte imbalances prior to administration.

Clenpiq:

Split-dose regimen: 160 mL (1 bottle) the evening before the colonoscopy (5 PM to 9 PM), followed by a second 160 mL dose ~5 hours before the colonoscopy.

Prepopik:

Split-dose regimen (preferred): 150 mL (5 oz) the evening before the colonoscopy (5 PM to 9 PM), followed by a second 150 mL (5 oz) dose ~5 hours before the colonoscopy.

Day-before regimen (alternative): 150 mL (5 oz) in the early evening before the colonoscopy (4 PM to 6 PM), followed by a second 150 mL (5 oz) dose 6 hours later (10 PM to 12 AM) the night before the colonoscopy.

Pico-Salax; Purg-Odan [Canadian products]:

Early colonoscopy (before 12 PM): One sachet (mixed and dissolved in water) in the evening (5 PM) the day prior to the procedure, followed by a second dose of one sachet 5 hours later (10 PM) the night before the procedure

Late colonoscopy (after 12 PM): One sachet (mixed and dissolved in water) in the late evening (7 PM) the day prior to the procedure, followed by a second dose of one sachet in the morning (6 AM) on the day of the procedure

Dosing: Geriatric

Refer to adult dosing.

Dosing: Renal Impairment: Adult

CrCl ≥30 mL/minute: There are no dosage adjustments provided in the manufacturer's labeling.

CrCl <30 mL/minute: Use is contraindicated.

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Pediatric

Bowel cleansing: Note: Administered as a 2-dose regimen prior to colonoscopy; timing of doses and volume administered may vary between products; use precaution.

Children ≥9 years and Adolescents: Note: Following each dose, varying amounts of clear liquids should be consumed; see Administration: Pediatric for additional information.

Clenpiq: Split-dose regimen: First dose: 160 mL (1 bottle) administered the evening before the colonoscopy (eg, 5 PM to 9 PM). Second dose: 160 mL dose (1 bottle) administered the next morning ~5 hours before the colonoscopy.

Prepopik: Note: Sachets should be dissolved in water (5 oz) prior to administration (see Preparation for Administration: Pediatric).

Split-dose regimen (preferred): First dose: 1 packet administered the evening before the colonoscopy (eg, 5 PM to 9 PM). Second dose: 1 packet administered the next morning ~5 hours before the colonoscopy.

Day-before regimen: First dose: 1 packet administered the early evening before the colonoscopy (eg, 4 PM to 6 PM). Second dose: 1 packet administered 6 hours later (eg, 10 PM to 12 AM) the night before the colonoscopy.

Canadian labeling: Pico-Salax; Purg-Odan:

Children 1 to 5 years: 1/4 of 1 sachet (mixed and dissolved in water) in the evening (6 PM) the day prior to the procedure, followed by a second dose of 1/4 of 1 sachet in the morning (8 AM) on the day of the procedure.

Children 6 to 12 years: 1/2 of 1 sachet (mixed and dissolved in water) in the evening (6 PM) the day prior to the procedure, followed by a second dose of 1/2 of 1 sachet in the morning (8 AM) on the day of the procedure.

Dosing: Renal Impairment: Pediatric

Children ≥9 years and Adolescents:

Mild to moderate impairment (CrCl ≥30 mL/minute): There are no adjustments provided in the manufacturer labeling. Magnesium-containing bowel preparations should be used with caution in patients with mild to moderate renal impairment or patients receiving concomitant medications which may affect renal function (eg, diuretics, angiotensin converting enzyme inhibitors, angiotensin II receptor blockers, nonsteroidal anti-inflammatory drugs) due to increased risk of renal injury; ensure adequate hydration.

Severe impairment (CrCl <30 mL/minute): Use is contraindicated.

Dosing: Hepatic Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling.

Use: Labeled Indications

Bowel cleansing: Cleansing of colon prior to colonoscopy in adults and children ≥9 years of age

Administration: Oral

Clenpiq: Ready to drink oral solution; dilution is not required. Consume only clear liquids on the day prior to the colonoscopy and up until 2 hours before the time of the procedure; stop consumption of all fluids at least 2 hours prior to the procedure. Do not eat solid food or dairy, consume red or purple liquids, consume alcohol, or take other laxatives while taking Clenpiq; do not take oral medications within 1 hour of beginning the cleansing.

Following the first dose, administer 5 or more 8-ounce clear liquid drinks within 5 hours and before bed; following the second dose, administer 4 or more 8-ounce clear liquid drinks up to 2 hours before colonoscopy. The second dose may be delayed if severe bloating, distention, or abdominal pain occurs following the first dose.

Prepopik: Consume only clear liquids on the day prior to the colonoscopy and until ≤2 hours before the time of the procedure. Following the first dose, administer at least five 8-ounce clear liquid drinks (eg, water, clear broth, apple juice, white cranberry juice, white grape juice, ginger ale, plain gelatin [not purple or red], frozen juice bars [not purple or red]) within 5 hours. Following the second dose, administer at least three 8-ounce clear liquid drinks at least 2 hours before colonoscopy (split-dose regimen) or within 5 hours (day-before regimen). For either regimen, the second dose may be delayed if severe bloating, distention, or abdominal pain occurs following the first dose.

Pico-Salax; Purg-Odan [Canadian products]:

At least 3 days prior to the procedure: Avoid eating seeds, nuts, fresh fruits and vegetables, and multigrain bread.

Day prior to the procedure: Consume clear liquids only (eg, water, clear power drinks, apple juice, white [not red] cranberry juice, white [not purple] grape juice, ginger ale, broth, tea [without milk, cream, or soy]), and no solid food. Patients with diabetes may drink a fiber-free supplement.

Following each dose: Adults should drink 1.5 to 2 L of a variety of clear fluids (including a balanced electrolyte solution) over 4 hours up until 2 hours prior to the procedure; children should drink one 8-ounce drink every hour while awake and up until 2 hours prior to the procedure.

Administration: Pediatric

Oral:

Children ≥9 years and Adolescents: Consume only clear liquids on the day prior to the colonoscopy and until ≤2 hours before the time of the procedure. Administer orally at prescribed times. Dissolve Prepopik packet prior to administration. Clenpiq is a ready to drink oral solution; dilution is not required.

Split-dose regimen: Following the first dose, administer five or more 8 oz clear liquid drinks (eg, water, clear broth, apple juice, white cranberry juice, white grape juice, ginger ale, plain gelatin [not purple or red], frozen juice bars [not purple or red]) using the supplied dosing cup (fill up to the upper line) within 5 hours. Following the second dose, administer four or more 8 oz clear liquid drinks using the supplied dosing cup (up to the upper line) at least 2 hours before colonoscopy. The second dose may be delayed if severe bloating, distention, or abdominal pain occurs following the first dose.

Day-before regimen: Prepopik: Following the first dose, administer at least five 8 oz clear liquid drinks (eg, water, clear broth, apple juice, white cranberry juice, white grape juice, ginger ale, plain gelatin [not purple or red], frozen juice bars [not purple or red]) using the supplied dosing cup (fill up to the upper line) within 5 hours. Following the second dose, administer at least three 8 oz clear liquid drinks using the supplied dosing cup (up to the upper line) within 5 hours of administration. The second dose may be delayed if severe bloating, distention, or abdominal pain occurs following the first dose.

Canadian labeling: Pico-Salax; Purg-Odan: Children and Adolescents: Administer orally at prescribed times. Dissolve sachet prior to administration.

At least 3 days prior to the procedure: Avoid eating seeds, nuts, fresh fruits and vegetables (raw), and multigrain bread.

Day prior to the procedure: Consume clear liquids only (eg, water, clear power drinks, apple juice, white [not red] cranberry juice, white [not purple] grape juice, ginger ale, broth, tea [without milk, cream, or soy]), and no solid food. Patients with diabetes may drink a fiber-free supplement.

Following each dose: Administer one 8 oz drink every hour while awake and up until 2 hours prior to the procedure.

Storage/Stability

Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F).

Additional product-specific considerations:

Clenpiq: Do not refrigerate or freeze.

Prepopik: Use the reconstituted solution immediately.

Preparation for Administration: Adult

Prepopik: Reconstitute immediately prior to each administration; do not prepare the solution in advance. To reconstitute, fill the supplied dosing cup with 5 ounces of cold water (up to the lower line) and add the contents of one packet to the cup; stir for 2 to 3 minutes.

Preparation for Administration: Pediatric

Prepopik: Using the supplied dosing cup, fill with cold water up to the lower 5 oz (150 mL) line; add contents of 1 packet to water and stir for 2 to 3 minutes; solution may become warm as it dissolves. Use immediately, do not store.

Canadian labeling: Pico-Salax; Purg-Odan: Add 1 sachet to 5 oz (150 mL) of cold water; stir for 2 to 3 minutes until dissolved; after preparation, divide dose as appropriate for administration.

Medication Patient Education with HCAHPS Considerations

What is this drug used for?

• It is used to clean out the GI (gastrointestinal) tract.

Frequently reported side effects of this drug

• Headache

• Nausea

• Vomiting

Other side effects of this drug: Talk with your doctor right away if you have any of these signs of:

• Fluid and electrolyte problems like mood changes, confusion, muscle pain or weakness, abnormal heartbeat, severe dizziness, passing out, fast heartbeat, increased thirst, seizures, loss of strength and energy, lack of appetite, unable to pass urine or change in amount of urine passed, dry mouth, dry eyes, or nausea or vomiting

• Abdominal pain

• Bloating

• Abdominal cramps

• Abdominal swelling

• Black, red, or tarry stools

• Vomiting blood

• Rectal bleeding

• Rectal pain

• Trouble swallowing

• Signs of a significant reaction like 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. Talk to your doctor if you have questions.

Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Medication Guide and/or Vaccine Information Statement (VIS)

An FDA-approved patient medication guide, which is available with the product information and at https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209589s005lbl.pdf#page=14, must be dispensed with this medication.

Contraindications

Hypersensitivity to sodium picosulfate, magnesium oxide, anhydrous citric acid, or any component of the formulation; GI obstruction or ileus; bowel perforation; gastric retention; toxic colitis; toxic megacolon; severe renal impairment (CrCl <30 mL/minute).

Canadian labeling: Additional contraindications (not in US labeling): Congestive heart failure; GI ulceration; nausea; vomiting; acute surgical abdominal conditions (eg, acute appendicitis).

Warnings/Precautions

Concerns related to adverse effects:

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

• Fluid and electrolyte abnormalities: May cause fluid and electrolyte disturbances, particularly in patients at increased risk (eg, renal impairment, concomitant medications that alter electrolyte balance). Any preexisting electrolyte abnormalities should be corrected prior to use and patients should be adequately hydrated before, during, and after use. Consider evaluating for and treating postcolonoscopy electrolyte abnormalities in patients who develop significant vomiting, dehydration, or orthostatic hypotension.

• GI effects: Osmotic laxatives may produce colonic mucosal aphthous ulcerations, including cases of ischemic colitis. Use caution when interpreting colonoscopy results in patients with inflammatory bowel disease.

• Seizures: Seizures associated with electrolyte abnormalities (eg, hyponatremia, hypokalemia, hypocalcemia, hypomagnesemia) 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:

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

• Renal impairment: Use with caution in patients with renal impairment and/or in patients taking medications that may adversely affect renal function (eg, diuretics, NSAIDs, ACE inhibitors, ARBs); adequate hydration is particularly important in these patients. Patients with impaired renal function who develop severe vomiting should be closely monitored including measurement of electrolytes. Use is contraindicated in severe renal impairment (CrCl <30 mL/minute).

• Ulcerative colitis: Use with caution in patients with severe active ulcerative colitis. If obstruction or perforation is suspected, diagnostic studies should be performed to rule out conditions prior to therapy initiation.

Concurrent drug therapy issues:

• Antibiotics: Sodium picosulfate requires the presence of colonic bacteria for the conversion to the active metabolite; prior or concomitant administration of antibiotics may reduce the efficacy of sodium picosulfate.

• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.

• Oral medications: Oral medications administered ≤1 hour prior to the start of the bowel preparation regimen may not be absorbed. Chlorpromazine, digoxin, fluoroquinolones, iron, penicillamine, and tetracycline should be administered at least 2 hours before and 6 hours after administration of magnesium oxide to avoid chelation with magnesium.

Other warnings/precautions:

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

Warnings: Additional Pediatric Considerations

Orthostatic changes have been reported in pediatric patients; a study of patients 9 to 16 years of age reported changes in blood pressure and/or heart rate in approximately 20% of patients compared to the comparator pediatric treatment group (7%); the orthostatic changes were observed to occur up to 5 days postcolonoscopy.

Pregnancy Considerations

Adverse events were not observed in animal reproduction studies using doses similar to a human dose.

Breast-Feeding Considerations

Lactating women (n=8) were administered sodium picosulfate 10 mg as an oral solution once daily for 8 days. The active metabolite, BPHM, was detected in plasma and urine, but below the limit of detection in breast milk (<1 ng/mL) (Friedrich 2011). According to the manufacturer, the decision to continue or discontinue breastfeeding during therapy should take into account the risk of infant exposure, the benefits of breastfeeding to the infant, and benefits of treatment to the mother. Also refer to magnesium oxide individual monograph.

Adverse Reactions

>10%:

Cardiovascular: Altered blood pressure (≤20%), change in pulse (≤20%)

Endocrine & metabolic: Hypermagnesemia (2% to 26%)

Genitourinary: Decreased estimated GFR (eGFR; ≤48 hours after colonoscopy: 10% to 29%)

1% to 10%:

Central nervous system: Headache (2% to 3%), dizziness (≤2%)

Endocrine & metabolic: Decreased serum potassium (5% to 8%), hypochloremia (1% to 5%), decreased serum sodium (≤4%), decreased serum calcium (≤2%), dehydration (≤2%), decreased serum bicarbonate (1%)

Gastrointestinal: Nausea (children & adolescents: >5%; adults: 3%), vomiting (children & adolescents: >5%; adults: 1%), abdominal pain (children & adolescents: >5%; adults: 2%)

Renal: Increased serum creatinine (1% to 5%)

Frequency not defined: Endocrine & metabolic: Decreased serum glucose (children & adolescents: 6%)

<1%, postmarketing, and/or case reports: Anaphylaxis, aphthous stomatitis (ileal), diarrhea, fecal incontinence, ischemic colitis, nonthrombocytopenic purpura, rectal pain, skin rash, tonic clonic epilepsy, urticaria

Allergy and Idiosyncratic Reactions

• Diphenylmethane Laxative Allergy

Metabolism/Transport Effects

None known.

Drug Interactions Open Interactions

Alfacalcidol: May increase the serum concentration of Magnesium Salts. Risk D: Consider therapy modification

Alpha-Lipoic Acid: Magnesium Salts may decrease the absorption of Alpha-Lipoic Acid. Alpha-Lipoic Acid may decrease the absorption of Magnesium Salts. Risk D: Consider therapy modification

Aluminum Hydroxide: Citric Acid Derivatives may increase the absorption of Aluminum Hydroxide. Risk C: Monitor therapy

Antibiotics: May diminish the therapeutic effect of Sodium Picosulfate. Management: Consider using an alternative product for bowel cleansing prior to a colonoscopy in patients who have recently used or are concurrently using an antibiotic. Exceptions: Acetic Acid (Otic); Acetic Acid (Topical); Aluminum Acetate; Azithromycin (Ophthalmic); Aztreonam (Oral Inhalation); Bacitracin (Ophthalmic); Bacitracin (Topical); Chlortetracycline; Ciprofloxacin (Ophthalmic); Clindamycin (Topical); Dapsone (Topical); Dibrompropamidine (Ophthalmic); Dibrompropamidine (Topical); Erythromycin (Ophthalmic); Erythromycin (Topical); Framycetin; Fusidic Acid (Ophthalmic); Fusidic Acid (Topical); Gatifloxacin; Gentamicin (Ophthalmic); Gentamicin (Topical); MetroNIDAZOLE (Topical); Mupirocin; Nitrofurazone; Ozenoxacin; Sulfacetamide (Ophthalmic); Tobramycin (Ophthalmic). Risk D: Consider therapy modification

Baloxavir Marboxil: Polyvalent Cation Containing Products may decrease the serum concentration of Baloxavir Marboxil. Risk X: Avoid combination

Bictegravir: Polyvalent Cation Containing Products may decrease the serum concentration of Bictegravir. Management: Administer bictegravir under fasting conditions at least 2 hours before or 6 hours after polyvalent cation containing products. Coadministration of bictegravir with or 2 hours after most polyvalent cation products is not recommended. Risk D: Consider therapy modification

Bisphosphonate Derivatives: Polyvalent Cation Containing Products may decrease the serum concentration of Bisphosphonate Derivatives. Management: Avoid administration of oral medications containing polyvalent cations within: 2 hours before or after tiludronate/clodronate/etidronate; 60 minutes after oral ibandronate; or 30 minutes after alendronate/risedronate. Exceptions: Pamidronate; Zoledronic Acid. Risk D: Consider therapy modification

Calcitriol (Systemic): May increase the serum concentration of Magnesium Salts. Management: Consider using a non-magnesium-containing antacid or phosphate-binding product in patients also receiving calcitriol. If magnesium-containing products must be used with calcitriol, serum magnesium concentrations should be monitored closely. Risk D: Consider therapy modification

Calcium Channel Blockers: May enhance the adverse/toxic effect of Magnesium Salts. Magnesium Salts may enhance the hypotensive effect of Calcium Channel Blockers. Risk C: Monitor therapy

Calcium Polystyrene Sulfonate: Laxatives (Magnesium Containing) may enhance the adverse/toxic effect of Calcium Polystyrene Sulfonate. More specifically, concomitant use of calcium polystyrene sulfonate with magnesium-containing laxatives may result in metabolic alkalosis or with sorbitol may result in intestinal necrosis. Management: Avoid concomitant use of calcium polystyrene sulfonate (rectal or oral) and magnesium-containing laxatives. Risk X: Avoid combination

Deferiprone: Polyvalent Cation Containing Products may decrease the serum concentration of Deferiprone. Management: Separate administration of deferiprone and oral medications or supplements that contain polyvalent cations by at least 4 hours. Risk D: Consider therapy modification

Dichlorphenamide: Laxatives may enhance the hypokalemic effect of Dichlorphenamide. Risk C: Monitor therapy

Dolutegravir: Magnesium Salts may decrease the serum concentration of Dolutegravir. Management: Administer dolutegravir at least 2 hours before or 6 hours after oral magnesium salts. Administer the dolutegravir/rilpivirine combination product at least 4 hours before or 6 hours after oral magnesium salts. Risk D: Consider therapy modification

Doxercalciferol: May enhance the hypermagnesemic effect of Magnesium Salts. Management: Consider using a non-magnesium-containing antacid or phosphate-binding product in patients also receiving doxercalciferol. If magnesium-containing products must be used with doxercalciferol, serum magnesium concentrations should be monitored closely. Risk D: Consider therapy modification

Eltrombopag: Polyvalent Cation Containing Products may decrease the serum concentration of Eltrombopag. Management: Administer eltrombopag at least 2 hours before or 4 hours after oral administration of any polyvalent cation containing product. Risk D: Consider therapy modification

Elvitegravir: Polyvalent Cation Containing Products may decrease the serum concentration of Elvitegravir. Management: Administer elvitegravir 2 hours before or 6 hours after the administration of polyvalent cation containing products. Risk D: Consider therapy modification

Gabapentin: Magnesium Salts may enhance the CNS depressant effect of Gabapentin. Specifically, high dose intravenous/epidural magnesium sulfate may enhance the CNS depressant effects of gabapentin. Magnesium Salts may decrease the serum concentration of Gabapentin. Management: Administer gabapentin at least 2 hours after use of a magnesium-containing antacid. Monitor patients closely for evidence of reduced response to gabapentin therapy. Monitor for CNS depression if high dose IV/epidural magnesium sulfate is used. Risk D: Consider therapy modification

Levothyroxine: Magnesium Salts may decrease the serum concentration of Levothyroxine. Management: Separate administration of oral levothyroxine and oral magnesium salts by at least 4 hours. Risk D: Consider therapy modification

Multivitamins/Fluoride (with ADE): Magnesium Salts may decrease the serum concentration of Multivitamins/Fluoride (with ADE). Specifically, magnesium salts may decrease fluoride absorption. Management: To avoid this potential interaction separate the administration of magnesium salts from administration of a fluoride-containing product by at least 1 hour. Risk D: Consider therapy modification

Mycophenolate: Magnesium Salts may decrease the serum concentration of Mycophenolate. Management: Separate doses of mycophenolate and oral magnesium salts. Monitor for reduced effects of mycophenolate if taken concomitant with oral magnesium salts. Risk D: Consider therapy modification

Neuromuscular-Blocking Agents: Magnesium Salts may enhance the neuromuscular-blocking effect of Neuromuscular-Blocking Agents. Risk C: Monitor therapy

PenicillAMINE: Polyvalent Cation Containing Products may decrease the serum concentration of PenicillAMINE. Management: Separate the administration of penicillamine and oral polyvalent cation containing products by at least 1 hour. Risk D: Consider therapy modification

Phosphate Supplements: Magnesium Salts may decrease the serum concentration of Phosphate Supplements. Management: Administer oral phosphate supplements as far apart from the administration of an oral magnesium salt as possible to minimize the significance of this interaction. Exceptions: Sodium Glycerophosphate Pentahydrate. Risk D: Consider therapy modification

Polyethylene Glycol-Electrolyte Solution: Sodium Picosulfate may enhance the adverse/toxic effect of Polyethylene Glycol-Electrolyte Solution. Risk C: Monitor therapy

Raltegravir: Magnesium Salts may decrease the serum concentration of Raltegravir. Management: Avoid the use of oral / enteral magnesium salts with raltegravir. No dose separation schedule has been established that adequately reduces the magnitude of interaction. Risk X: Avoid combination

Sodium Polystyrene Sulfonate: Laxatives (Magnesium Containing) may enhance the adverse/toxic effect of Sodium Polystyrene Sulfonate. More specifically, concomitant use of sodium polystyrene sulfonate with magnesium-containing laxatives may result in metabolic alkalosis or with sorbitol may result in intestinal necrosis. Management: Avoid concomitant use of sodium polystyrene sulfonate (rectal or oral) and magnesium-containing laxatives. Risk X: Avoid combination

Trientine: Polyvalent Cation Containing Products may decrease the serum concentration of Trientine. Management: Avoid concomitant administration of trientine and oral products that contain polyvalent cations. If oral iron supplements are required, separate the administration by 2 hours. If other oral polyvalent cations are needed, separate administration by 1 hour. Risk D: Consider therapy modification

Monitoring Parameters

Serum electrolytes and renal function tests (baseline and post-colonoscopy) in patients with or at risk for renal impairment or seizure, and in patients who have a history of electrolyte abnormality; consider ECG (baseline and post-colonoscopy) in patients at risk for prolonged QT or arrhythmias.

Advanced Practitioners Physical Assessment/Monitoring

Correct electrolyte abnormalities prior to treatment. Use caution in patients with heart failure when replacing fluids. Monitor for signs of dehydration. Monitor for orthostatic changes including blood pressure and heart rate, which may occur up to 7 days post-colonoscopy, especially in patients with delicate fluid balance and underlying renal dysfunction. Electrolyte abnormalities may occur with use; obtain ECGs in patients at increased risk of cardiac arrhythmias.

Nursing Physical Assessment/Monitoring

Monitor patients prone to regurgitation or aspiration during administration. "Split dose" administration method preferred. Educate patient about proper use and function of bowel cleansing.

Reconstitute with cold water right before use, do not prepare solution in advance. Not for direct ingestion; must be dissolved and taken with additional water. Separate dosing of patient's usual medications from the administration of this one by 1 hour.

Monitor for severe bloating, distention, or abdominal pain. If present, delay the second dose until symptoms resolve. Specific patient groups may be sensitive to fluid shifts (older adults, patients taking routine medications that cause fluid shifts, patients with underling heart disease). Monitor them closely and educate them about rehydration.

Dosage Forms: US

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

Powder for solution, Oral [kit]:

Prepopik: Sodium picosulfate 10 mg, magnesium oxide 3.5 g, and citric acid 12 g per packet (2s) [orange flavor, cranberry flavor; packaged with dosing cup]

Solution, Oral:

Clenpiq: Sodium picosulfate 10 mg, magnesium oxide 3.5 g, and citric acid 12 g per 160 mL (2 x 160 mL) [contains disodium edetate, sodium benzoate, sodium metabisulfite; cranberry flavor]

Dosage Forms: Canada

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

Powder for solution, oral [kit]:

Pico-Salax: Sodium picosulphate 10 mg, magnesium oxide 3.5 g, and citric acid 12 g per sachet (1s, 2s) [orange or cranberry flavor]

Purg-Odan: Sodium picosulphate 10 mg, magnesium oxide 3.5 g, and citric acid 12 g per sachet (1s, 2s) [orange flavor]

Anatomic Therapeutic Chemical (ATC) Classification

• A06AB58

Generic Available (US)

No

Pricing: US

Pack (Prepopik Oral)

10-3.5-12 mg-gm-gm (per each): $81.96

Solution (Clenpiq Oral)

10-3.5-12 MG-GM-GM/160ML (per mL): $0.54

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Mechanism of Action

Sodium picosulfate, a prodrug, is hydrolyzed by colonic bacteria to an active metabolite which stimulates colonic peristalsis.

Magnesium oxide and citric acid react to create magnesium citrate which induces catharsis by the osmotic effects of the unabsorbed ions in the GI tract.

Pharmacodynamics/Kinetics

Absorption: Magnesium cation: ≥20%.

Metabolism: Sodium picosulfate: Hydrolyzed by colonic bacteria to the active compound bis-(p-hydroxy-phenyl)-pyridyl-2-methane (BHPM).

Half-life elimination: Terminal: Sodium picosulfate: ~7.5 hours.

Time to peak: Sodium picosulfate: ~7 hours; Magnesium: 10 hours.

Excretion: Urine.

Local Anesthetic/Vasoconstrictor Precautions

No information available to require special precautions

Effects on Dental Treatment

No significant effects or complications reported

Effects on Bleeding

No information available to require special precautions

Related Information

• Laxatives, Classification and Properties

Index Terms

Citric Acid, Sodium Picosulfate, and Magnesium Oxide; DA-1773; Magnesium Oxide, Sodium Picosulfate, and Citric Acid; Sod Picosulf/Mag Ox/Citric Ac; Sodium Picosulfate, Magnesium Oxide, and Anhydrous Citric Acid; Sodium Picosulphate, Magnesium Oxide, and Citric Acid

FDA Approval Date

July 16, 2012

References

Clenpiq (sodium picosulfate/magnesium oxide/citric acid) [prescribing information]. Parsippany, NJ: Ferring Pharmaceuticals; October 2019.

Friedrich C, Richter E, Trommeshauser D, et al, “Absence of Excretion of the Active Moiety of Bisacodyl and Sodium Picosulfate into Human Breast Milk: An Open-Label, Parallel-Group, Multiple-Dose Study in Healthy Lactating Women,” Drug Metab Pharmacokinet, 2011, 26(5):458-64.[PubMed 21697613]

Hoy S, Scott L, and Wagstaff A, “Sodium Picosulfate/Magnesium Citrate: A Review of Its Use as a Colorectal Cleanser,” Drugs, 2009, 69(1):123-36.[PubMed 19192941]

Pico-Salax (sodium picosulfate/magnesium oxide/citric acid) [product monograph]. North York, Ontario, Canada: Ferring Pharmaceuticals; October 2012.

Prepopik (sodium picosulfate/magnesium oxide/citric acid) [prescribing information]. Parsippany, NJ: Ferring Pharmaceuticals Inc; August 2018.

Purg-Odan (sodium picosulfate/magnesium oxide/citric acid) [product monograph]. Pointe-Claire, Quebec, Canada: Odan Laboratories Ltd; February 2016.

Brand Names: International

CitraFleet (DE, DK, ES, FI, FR, IE, IS, NO, PT, SE, SK); Dramrin (EG); Pico-Salax (IL); Picolax (GB, HK, IE, MT); Picolight Powder (KR); Picoprep (AE, BE, BG, CZ, DK, EE, FR, HN, IS, JO, JP, KW, LB, LT, LU, LV, NL, NO, NZ, PH, PT, RO, SE, SK, TH, ZA); Picoprep Powder (CY, KR, QA, SA); Picoprep Powder for Oral Solution (HK); PicoPrep Powder for Solution (AU); Picosalax (NZ); Picosalax Powder for Oral Administration (AU); Pikoprep (UA); Tsytraflit (UA)

Last Updated 3/20/20

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