Citric Acid Anhydrous + Magnesium Oxide + Sodium Picosulfate

Citric Acid Anhydrous + Magnesium Oxide + Sodium Picosulfate is used for: Bowel Preparation

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

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

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 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

Hypersensitivity Severe renal impairment (ie, CrCl <30 mL/minute) GI obstruction or ileus Bowel perforation Toxic colitis or toxic megacolon Gastric retention

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

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 this drug and any potential adverse effects on breastfed infant or underlying maternal condition

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)

Side effects of Citric Acid Anhydrous + Magnesium Oxide + Sodium Picosulfate : >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%)

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