Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid oral solution/powder for oral solution is indicated for cleansing of the colon as a preparation for colonoscopy in adults and child 9 years & above. Also used in barium enema, x-ray exam or surgical procedures that require a clean colon.
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There are two dosing regimens, each requires two separate dosing times:
Split-Dose Dosing Regimen (Preferred Method): The Split-Dose regimen is the preferred dosing method. Instruct patients to take two separate doses in conjunction with fluids, as follows:
Day-Before Dosing Regimen (Alternative Method): The Day-Before regimen is the alternative dosing method for patients for whom the Split-Dosing is inappropriate. Instruct patients to take two separate doses in conjunction with fluids, as follows:
This solution is contraindicated in the following conditions:
Most common adverse reactions (>1%) are nausea, headache and vomiting (abdominal bloating, distension, pain/cramping and watery diarrhea not requiring an intervention were not collected).
Pregnancy Category B. There are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this solution should be used during pregnancy only if clearly needed. It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when this solution is administered to a nursing woman.
Serious Fluid and Serum Chemistry Abnormalities, Advise patients to hydrate adequately before, during and after the use of this solution. 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 this solution, 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. Fluid and electrolyte abnormalities should be corrected before treatment with this solution. 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.
Enema & bowel cleansing solution
Store at temperature 15°-30°C.
Pediatric Use: The safety and effectiveness of this oral solution in pediatric patients has not been established.
Renal Insufficiency: 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 patients of the importance of adequate hydration before, during and after the use of this oral solution. In patients with severely reduced renal function (creatinine clearance <30 mL/min), accumulation of magnesium in plasma may occur.
This Powder for this oral solution supplied as a powder, must be reconstituted with cold water right before its use. Reconstitution of this Powder. The reconstitution procedure of this powder is as follows: