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

Brand and Other Names:Prepopik
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

sodium picosulfate/magnesium oxide/anhydrous citric acid

powder for oral solution

  • Each of the 2 packets contains: 10mg/3.5g/12g per 16.1 g of powder
  • Flavors: Orange, cranberry
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Bowel Preparation

Indicated for colon cleansing as a preparation for colonoscopy in adults

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 (upper line on the dosing cup) 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 (upper line on the dosing cup) 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

Administration

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

Take with additional clear liquids according to either split-dose or day-before dose directions

Safety and efficacy not established

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Interactions

Interaction Checker

and sodium picosulfate/magnesium oxide/anhydrous citric acid

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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)

            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

            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 Category: B

            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.

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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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            Formulary

            FormularyPatient Discounts

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            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
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            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
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            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
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