sodium picosulfate/magnesium oxide/anhydrous citric acid (Rx)

Brand and Other Names:Prepopik, Clenpiq
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

sodium picosulfate/magnesium oxide/anhydrous citric acid

powder for oral solution (Prepopik)

  • 10mg/3.5g/12g per 16.1 g of powder (available as carton containing two 16.1 g packets of powder)
  • Flavors: Orange, cranberry

solution, ready-to-drink (Clenpiq)

  • (10mg/3.5g/12g)/160mL (available as carton containing two 160-mL bottles)
  • Flavor: Cranberry

Bowel Preparation

Indicated for colon cleansing as a preparation for colonoscopy in adults

Two doses are required to complete the colonoscopy preparation by either a split dose regimen or a day before regimen

Prepopik: 1 dose is provided by 1 packet dissolved in 5-oz cold water in provided measuring cup

Clenpiq: 1 dose is provided by 1 bottle (160 mL) ready-to-drink solution

Instruct patients to only drink clear liquids all day the day before the colonoscopy, and the next day until 2 hours before the colonoscopy; stop drinking all fluids at least 2 hr before the colonoscopy

Do not eat solid food or dairy and do not drink anything colored red or purple

Do not drink alcohol

Also see Administration

Split dose

  • Preferred dosing method
  • First dose: Take during the evening before the colonoscopy (eg, 5:00 to 9:00 PM) followed by five 8-ounce drinks of clear liquids before bed; consume clear liquids within 5 hr
  • Second dose: Take the next day ~5 hr before the colonoscopy followed by at least three 8-ounce drinks of clear liquids before the colonoscopy; consume clear liquids within 5 hr up until 2 hr before the time of the colonoscopy

Day before dose

  • Alternate method
  • First dose: Take in the afternoon or early evening (eg, 4:00 to 6:00 PM) before the colonoscopy followed by five 8-ounce drinks of clear liquids before the next dose; consume clear liquids within 5 hr
  • Second dose: Take ~6 hr later in the late evening (eg, 10:00 PM to 12:00 AM), the night before the colonoscopy followed by three 8-ounce drinks of clear liquids before bed; consume clear liquids within 5 hr

sodium picosulfate/magnesium oxide/anhydrous citric acid

powder for oral solution (Prepopik)

  • 10mg/3.5g/12g per 16.1 g of powder (available as carton containing two 16.1 g packets of powder)
  • Flavors: Orange, cranberry

solution, ready-to-drink (Clenpiq)

  • (10mg/3.5g/12g)/160mL (available as carton containing two 160-mL bottles)
  • Flavor: Cranberry

Bowel Preparation

Indicated for cleansing of the colon as a preparation for colonoscopy in patients aged ≥9 years

<9 years: Safety and efficacy not established

≥9 years

  • Two doses are required to complete the colonoscopy preparation by either a split dose regimen or a day before regimen
  • Prepopik: 1 dose is provided by 1 packet dissolved in 5-oz cold water in provided measuring cup
  • Clenpiq: 1 dose is provided by 1 bottle (160 mL) ready-to-drink solution
  • Instruct patients to only drink clear liquids all day the day before the colonoscopy, and the next day until 2 hours before the colonoscopy; stop drinking all fluids at least 2 hr before the colonoscopy
  • Do not eat solid food or dairy and do not drink anything colored red or purple
  • Do not drink alcohol
  • Split dose

    • Preferred dosing method
    • First dose: Take during the evening before the colonoscopy (eg, 5:00 to 9:00 PM) followed by five 8-ounce drinks of clear liquids before bed; consume clear liquids within 5 hr
    • Second dose: Take the next day ~5 hr before the colonoscopy followed by at least three 8-ounce drinks of clear liquids before the colonoscopy; consume clear liquids within 5 hr up until 2 hr before the time of the colonoscopy
  • Day before dose

    • Alternate method
    • First dose: Take in the afternoon or early evening (eg, 4:00 to 6:00 PM) before the colonoscopy followed by five 8-ounce drinks of clear liquids before the next dose; consume clear liquids within 5 hr
    • Second dose: Take ~6 hr later in the late evening (eg, 10:00 PM to 12:00 AM), the night before the colonoscopy followed by three 8-ounce drinks of clear liquids before bed; consume clear liquids within 5 hr
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Interactions

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            Adverse Effects

            >10%

            Decreased eGFR (10-13.1%)

            Increased magnesium (8.7-11.6%)

            1-10%

            Increased serum creatinine (1.9-4.5%)

            Vomiting (3-4%)

            Decreased potassium (4.7-7.3%)

            Decreased sodium (1-3.7%)

            Decreased chloride (1-3.7%)

            Nausea (2.6-3%)

            Headache (1.6-2.7%)

            Postmarketing Reports

            Allergic reactions including rash, urticaria, and purpura

            Electrolyte abnormalities including hypokalemia, hyponatremia, and hypermagnesemia

            Gastrointestinal reactions including abdominal pain, diarrhea, fecal incontinence, and proctalgia; also isolated reports of aphthoid ileal ulcers and ischemic colitis (causal relationship not established)

            Neurologic effects including generalized tonic-clonic seizures associated with and without hyponatremia in epileptic patients

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            Warnings

            Contraindications

            Hypersensitivity

            Severe renal impairment (ie, CrCl <30 mL/minute)

            GI obstruction or ileus

            Bowel perforation

            Toxic colitis or toxic megacolon

            Gastric retention

            Cautions

            Adequate hydration essential before, during, and after the use

            Caution with congestive heart failure when replacing fluids

            If significant vomiting or signs of dehydration including signs of orthostatic hypotension develop after use, consider performing post-colonoscopy lab tests (electrolytes, creatinine, and BUN) and treat accordingly

            Fluid and electrolyte disturbances can lead to serious adverse events including cardiac arrhythmias or seizures and renal impairment

            Reports of generalized tonic-clonic seizures with the use of bowel preparation products in patients with no prior history of seizures; these cases were associated with electrolyte abnormalities

            Orthostatic changes occurred in ~20% of patients in clinical trials on the day of colonoscopy and were documented out to 7 days post colonoscopy

            Uncorrected magnesium concentration reached a maximum of ~1.9 mEq/L, which occurred at 10 hr post initial packet administration; this represents an ~20% increase from baseline

            Increased magnesium plasma levels may occur with severe renal impairment (ie, CrCl <30 mL/min) (see Contraindications)

            Renal impairment or coadministration with medications that may affect renal function (eg, diuretics, ACE inhibitors, ARBs, NSAIDs) may increase risk for renal injury; adequate hydration before during and after the use is particularly important in these patients; consider performing baseline and post-colonoscopy laboratory tests (electrolytes, creatinine, and BUN)

            Caution with severe active ulcerative colitis; osmotic laxatives may cause colonic mucosal aphthous ulcerations and there have been reports of more serious cases of ischemic colitis requiring hospitalization

            Rule out significant GI disease before use (eg, obstruction, perforation) (see Contraindications)

            Caution with impaired gag reflex or patients prone to aspiration; these patients should be observed during administration

            Must reconstitute powder into solution, direct ingestion of powder may result in nausea, vomiting, dehydration, and electrolyte disturbances

            Drug interaction overview

            • Oral medications taken within 1 hour of each dosing may be flushed from GI tract and not properly absorbed
            • Administer drugs prone to chelation with magnesium (eg, tetracycline, iron, digoxin) at least 2 hr before or at least 6 hr after administration
            • Prior or concomitant antibiotics may reduce efficacy by decreasing colonic bacteria-mediated conversion of sodium picosulfate to the active metabolite (BHPM)
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            Pregnancy & Lactation

            Pregnancy

            No data are available regarding use in pregnant women

            In animal reproduction studies, no adverse developmental effects were observed in pregnant rats when administered at doses 1.2 times the recommended human dose based on body surface area during organogenesis

            Lactation

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

            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.

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            Pharmacology

            Mechanism of Action

            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

            Sodium picosulfate: Hydrolyzed by colonic bacteria to form an active metabolite, bis-(p-hydroxy-phenyl)-pyridyl-2-methane (BHPM); BHPM acts directly on the colonic mucosa to stimulate colonic peristalsis

            Magnesium oxide and anhydrous citric acid: These 2 ingredients react to create magnesium citrate in solution, an osmotic agent that causes water to be retained within the GI tract

            Absorption

            Peak Plasma Time: 7 hr (sodium picosulfate, 2 packets)

            Peak Plasma Concentration: 3.2 ng/mL (sodium picosulfate after 2 doses); active metabolite BHPM below level of quantification

            Metabolism

            Sodium picosulfate, a prodrug, is converted to its active metabolite, bis-(p-hydroxy-phenyl)-pyridyl-2-methane (BHPM), by colonic bacteria

            Magnesium oxide and citric acid react in water to create magnesium citrate

            Elimination

            Half-life: 7.4 hr (sodium picosulfate)

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            Administration

            Oral Preparation

            Prepopik powder for solution

            • Do not prepare solution in advance
            • Reconstitute powder with cold water immediately before each dose
            • Fill the supplied dosing cup with cold water up to the lower (5-ounce) line on the cup and pour in the contents of 1 packet of Prepopik powder
            • Stir solution for 2-3 minutes; reconstituted solution may become slightly warm as the powder dissolves

            Oral Administration

            Take with additional clear liquids after each dose according to either split-dose or day-before dose directions (see Adult Dosing)

            Do not take oral medications within 1 hr of start of each dose

            If taking tetracycline or fluoroquinolone antibiotics, iron, digoxin, chlorpromazine, or penicillamine, take these medications at least 2 hr before and not less than 6 hr after administering prep

            Do not take with other laxatives

            Storage

            Prepopik

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

            Clenpiq

            • Store at 25°C (77°F); excursions permitted at 15-30°C (59-86°F)
            • Do not refrigerate or freeze
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            Formulary

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            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
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            NC NOT COVERED – Drugs that are not covered by the plan.
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.