Description

Drugs that may increase risks of fluid and electrolyte abnormalities: Use caution when prescribing this solution for patients with conditions or who are using medications that increase the risk for fluid and electrolyte disturbances or may increase the risk of seizure, arrhythmias and prolonged QT in the setting of fluid and electrolyte abnormalities. This includes patients receiving drugs which may be associated with hypokalemia (such as diuretics or corticosteroids, or drugs where hypokalemia is a particular risk, such as cardiac glycosides) or hyponatremia. Use caution when this solution is used in patients on nonsteroidal anti-inflammatory drugs (NSAID) or drugs known to induce Antidiuretic Hormone Secretion (SIADH), such as tricyclic antidepressants, selective serotonin re-uptake inhibitors, antipsychotic drugs and carbamazepine, as these drugs may increase the risk of water retention and/or electrolyte imbalance. Tetracycline and fluoroquinolone antibiotics, iron, digoxin, chlorpromazine and penicillamine, should be taken at least 2 hours before and not less than 6 hours after administration of this solution to avoid chelation with magnesium. Antibiotics: Prior or concomitant use of antibiotics with this solution may reduce the efficacy of this solution.

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.

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.

Enema & bowel cleansing solution

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: Reconstitute the powder right before each administration. Do not prepare the solution in advance. Take 150 ml of cold water in a glass using provided measuring cup and pour in the contents of one packet of this powder. Stir for 2 to 3 minutes. The reconstituted solution may become slightly warm as the powder dissolves. This Oral Solution is supplied as ready to drink oral Solution and no need of reconstitution.