CLENPIQ® (sodium picosulfate, magnesium oxide, and anhydrous citric acid) oral solution

CLENPIQ® (sodium picosulfate, magnesium oxide, and anhydrous citric acid) oral solution

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CLENPIQ® (sodium picosulfate, magnesium oxide, and anhydrous citric acid)

CLENPIQ (sodium picosulfate, magnesium oxide, and anhydrous citric acid) oral solution is a stimulant and osmotic laxative that is provided as a cranberry-flavored, colorless to slightly yellow, clear solution with possible presence of visible particles. CLENPIQ is supplied as two bottles in each carton.

Each bottle of CLENPIQ contains 10 mg sodium picosulfate, USP; 3.5 g magnesium oxide, USP; and 12 g anhydrous citric acid, USP. The product also contains the following inactive ingredients: acesulfame potassium, cranberry flavor, disodium edetate, malic acid, sodium benzoate, sodium hydroxide, sodium metabisulfite, sucralose, and water. The cranberry flavor contains glyceryl triacetate (triacetin), maltodextrin, and sodium octenyl succinated starch.

The following is a description of the three active ingredients contained in CLENPIQ: Sodium picosulfate is a stimulant laxative.

Sodium Picosulfate

  • Chemical name: 4,4´-(2-pyridylmethylene) diphenyl bis(hydrogen sulfate) disodium salt, monohydrate
  • Chemical formula: C18H13NNa2O8S2·H2O
  • Molecular weight: 499.4

Magnesium citrate, which is formed in solution by the combination of magnesium oxide and anhydrous citric acid, is an osmotic laxative.

Magnesium Oxide

  • Chemical name: Magnesium oxide
  • Chemical formula: Mg O
  • Molecular weight: 40.3

Anhydrous Citric Acid

  • Chemical name: 2-hydroxypropane-1,2,3-tricarboxylic acid
  • Chemical formula: C6H8O7
  • Molecular weight: 192.1

Indications and usage

CLENPIQ® is a combination of sodium picosulfate, a stimulant laxative, and magnesium oxide and anhydrous citric acid, which form magnesium citrate, an osmotic laxative, indicated for cleansing of the colon as a preparation for colonoscopy in adults and pediatric patients ages 9 years and older.

Mechanism of Action

Sodium picosulfate is hydrolyzed by colonic bacteria to form an active metabolite: bis-(p-hydroxy-phenyl)-pyridyl-2-methane, BHPM, which acts directly on the colonic mucosa to stimulate colonic peristalsis. Magnesium oxide and citric acid react to create magnesium citrate in solution, which is an osmotic agent that causes water to be retained within the gastrointestinal tract.

Pharmacodynamics

The stimulant laxative activity of sodium picosulfate together with the osmotic laxative activity of magnesium citrate produces a purgative effect which, when ingested with additional fluids, produces watery diarrhea.

Dosage and administration

  • Correct fluid and electrolyte abnormalities before administration of CLENPIQ.
  • CLENPIQ is ready to drink. It is a clear solution with possible presence of visible particles and it does not need to be diluted prior to administration. One bottle of CLENPIQ is equivalent to one dose.
  • Two doses of CLENPIQ are required for a complete preparation for colonoscopy as a Split-Dose regimen.
  • The Split-Dose method consists of two separate doses: the first dose during the evening before the colonoscopy and the second dose the next day, during the morning prior to the colonoscopy.
  • Additional liquids must be consumed after every dose of CLENPIQ: five or more 8-ounce cups of clear liquids after the first dose and four or more 8-ounce cups of clear liquids after the second dose.
  • Consume only clear liquids (no solid food) from the start of CLENPIQ treatment until after the colonoscopy.
  • Do not eat solid food or dairy and do not drink anything colored red or purple.
  • Do not drink alcohol.
  • Do not take other laxatives while taking CLENPIQ.
  • Do not take oral medications within one hour of starting CLENPIQ.
  • If taking tetracycline or fluoroquinolone antibiotics, iron, digoxin, chlorpromazine, or penicillamine, take these medications at least 2 hours before and not less than 6 hours after administration of CLENPIQ.
  • Stop consumption of all liquids at least 2 hours before the colonoscopy

2 Split-Dose Dosage Regimen

The recommended dosage in adults and pediatric patients 9 years of age and older is shown below. Instruct patients to take two separate doses in conjunction with liquids, as follows:

Dose 1 – On the day before colonoscopy:

  • Instruct patients to consume only clear liquids (no solid food or dairy) on the day before the colonoscopy up until 2 hours before the time of the colonoscopy.
  • Take the first dose (1 bottle) of CLENPIQ during the evening before the colonoscopy (e.g., 5:00 PM to 9:00 PM).
  • Follow CLENPIQ by drinking five or more 8-ounce cups (cup provided) of clear liquids within 5 hours and before bed.
  • If severe bloating, distention, or abdominal pain occurs, following the first dose, delay the second dose until the symptoms resolve.

Dose 2 – Next morning on the day of colonoscopy (start approximately 5 hours prior to colonoscopy):

  • Continue to consume only clear liquids (no solid food or dairy).
  • Take the second dose (the second bottle) of CLENPIQ.
  • Following the CLENPIQ dose, drink four or more 8-ounce cups (cup provided) of clear liquids up to 2 hours before the colonoscopy.

Contraindications

CLENPIQ is contraindicated in the following conditions:

  • Patients with severe renal impairment (creatinine clearance less than 30 mL/minute), which may result in accumulation of magnesium.
  • Gastrointestinal obstruction or ileus
  • Bowel perforation.
  • Toxic colitis or toxic megacolon.
  • Gastric retention.
  • Hypersensitivity to any of the ingredients in CLENPIQ

Warnings and precautions

Serious Fluid and Electrolyte Abnormalities: Advise patients to hydrate adequately before, during, and after the use of CLENPIQ. Use caution in patients with congestive heart failure when replacing fluids. If a patient develops significant vomiting or signs of dehydration including signs of orthostatic hypotension after taking CLENPIQ, consider performing post-colonoscopy lab tests (electrolytes, creatinine, and BUN) and treat accordingly.

Seizures: There have been reports of generalized tonic-clonic seizures with the use of bowel preparation products in patients with no prior history of seizures. The seizure cases were associated with electrolyte abnormalities (e.g., hyponatremia, hypokalemia, hypocalcemia, and hypomagnesemia) and low serum osmolality. The neurologic abnormalities resolved with correction of fluid and electrolyte abnormalities.

Use caution when prescribing CLENPIQ for patients with a history of seizures and in patients at risk of seizure, such as patients taking medications that lower the seizure threshold (e.g., tricyclic antidepressants), patients withdrawing from alcohol or benzodiazepines, patients with known or suspected hyponatremia

Use in Patients with Renal Impairment: As with other magnesium containing bowel preparations, use caution when prescribing CLENPIQ for patients with impaired renal function or patients taking concomitant medications that may affect renal function (such as diuretics, angiotensin-converting enzyme inhibitors, angiotensin receptor blockers, or non-steroidal anti-inflammatory drugs). These patients may be at increased risk for renal injury. Advise these patients of the importance of adequate hydration before, during, and after the use of CLENPIQ. Consider performing baseline and post-colonoscopy laboratory tests (electrolytes, creatinine, and BUN) in these patients. CLENPIQ is contraindicated in patients with severe renal impairment (creatinine clearance less than 30 mL/min), as accumulation of magnesium in plasma may occur

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Cardiac Arrhythmias: There have been rare reports of serious arrhythmias associated with the use of ionic osmotic laxative products for bowel preparation. Use caution when prescribing CLENPIQ for patients at increased risk of arrhythmias (e.g., patients with a history of prolonged QT, uncontrolled arrhythmias, recent myocardial infarction, unstable angina, congestive heart failure, or cardiomyopathy). Consider predose and post-colonoscopy ECGs in patients at increased risk of serious cardiac arrhythmias.

Colonic Mucosal Ulceration, Ischemic Colitis, and Ulcerative Colitis: Osmotic laxatives may produce colonic mucosal aphthous ulcerations and there have been reports of more serious cases of ischemic colitis requiring hospitalization. Concurrent use of additional stimulant laxatives with CLENPIQ may increase this risk. Consider the potential for mucosal ulcerations when interpreting colonoscopy findings in patients with known or suspected inflammatory bowel disease

Use in Patients with Significant Gastrointestinal Disease: If gastrointestinal obstruction or perforation is suspected, perform appropriate diagnostic studies to rule out these conditions before administering CLENPIQ. Use with caution in patients with severe active ulcerative colitis.

Aspiration: Patients with impaired gag reflex are at risk for regurgitation or aspiration during the administration of CLENPIQ. Observe these patients during the administration of CLENPIQ.

Adverse reactions

Hypersensitivity: rash, urticaria, and purpura

Gastrointestinal: abdominal pain, diarrhea, fecal incontinence, proctalgia, vomiting, reversible aphthoid ileal ulcers, and ischemic colitis

Neurologic: generalized tonic-clonic seizures with and without hyponatremia in epileptic patients

Drug interactions

Drugs That May Increase Risks of Fluid and Electrolyte Abnormalities: Use caution when prescribing CLENPIQ for patients with conditions or who are taking other drugs, that increase the risk for fluid and electrolyte disturbances or may increase the risk of renal impairment, seizures, arrhythmias or QT prolongation in the setting of fluid and electrolyte abnormalities

Potential for Reduced Drug Absorption: CLENPIQ can reduce the absorption of other co-administered drugs:

  • Administer oral medications at least one hour before of the start of administration of CLENPIQ.
  • Administer tetracycline and fluoroquinolone antibiotics, iron, digoxin, chlorpromazine, and penicillamine at least 2 hours before and not less than 6 hours after administration of CLENPIQ to avoid chelation with magnesium.

Antibiotics: Prior or concomitant use of antibiotics with CLENPIQ may reduce efficacy of CLENPIQ as conversion of sodium picosulfate to its active metabolite BHPM is mediated by colonic bacteria.

Use in specific populations

Pregnancy: There are no data with CLENPIQ use in pregnant women to determine a drug-associated risk of adverse developmental outcomes.

Lactation: There are no data on the presence of magnesium oxide or anhydrous citric acid in either human or animal milk, the effects on the breastfed infant, or the effects on milk production. Published data on lactating women indicate that the active metabolite of sodium picosulfate, bis-(p-hydroxyphenyl)-pyridyl-2-methane (BHPM) remained below the limit of detection (1 ng/mL) in breast milk after both single and multiple doses of 10 mg/day. There are no data on the effects of sodium picosulfate on the breastfed infant or on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for CLENPIQ and any potential adverse effects on the breastfed infant from CLENPIQ or the underlying maternal condition.

Pediatric Use: The safety and effectiveness of CLENPIQ have been established for cleansing of the colon as a preparation for colonoscopy in pediatric patients 9 years of age and older. Use of CLENPIQ in this age group is supported by evidence from adequate and wellcontrolled trials in adults and a single, dose-ranging, controlled trial in 78 pediatric patients 9 to 16 years of age all of which evaluated another oral product of sodium picosulfate, magnesium oxide, and anhydrous citric acid. The safety profile in this pediatric population was similar to that seen in adults. Monitor for possible hypoglycemia in pediatric patients, as CLENPIQ has no caloric substrate. The safety and effectiveness of CLENPIQ in pediatric patients less than 9 years of age have not been established.

Geriatric Use: Of the 448 adult patients in Study 1 who received CLENPIQ, 124 (28%) patients were 65 years of age or older. No overall differences in safety or effectiveness were observed between geriatric patients and younger patients, and other reported clinical experience has not identified differences in responses between elderly and younger patients. Elderly patients are more likely to have decreased hepatic, renal, or cardiac function and may be more susceptible to adverse reactions resulting from fluid and electrolyte abnormalities

Renal Impairment: CLENPIQ is contraindicated in patients with severe renal impairment (creatinine clearance less than 30 mL/min), as accumulation of magnesium in plasma may occur. Patients with less severe renal impairment or patients taking concomitant medications that may affect renal function may be at increased risk for renal injury. Advise these patients of the importance of adequate hydration before, during, and after the use of CLENPIQ. Consider performing baseline and post-colonoscopy laboratory tests (electrolytes, creatinine, and BUN) in these patients.

Overdosage

Overdosage of more than the recommended dose of CLENPIQ may lead to severe electrolyte disturbances, as well as dehydration and hypovolemia, with signs and symptoms of these disturbances. Monitor for fluid and electrolyte disturbances and treat symptomatically.

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