Preparation:
EzyColon Powder for Oral Solution:
Each Packet contains 10 mg of Sodium Picosulfate BP, 3.5 gm of Magnesium Oxide BP and 12 gm of Anhydrous Citric Acid BP in 16.1gm powder for Oral Solution.
Description:
Sodium Picosulfate is hydrolyzed by colonic bacteria to form an active metabolite: bis-(p-hydroxy-phenyl)-pyridyl-2-methane, BHPM, which acts directly on the colonic mucosa to stimulate colonic peristalsis. Magnesium oxide and citric acid react to create magnesium citrate in solution, which is an osmotic agent that causes water to be retained within the gastrointestinal tract.
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, which is a prodrug, is converted to its active metabolite, BHPM, by colonic bacteria.
Indications:
EzyColon (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 9years & above. Also used in barium enema x-ray exam or surgical procedures that require a clean colon.
Dosage & Administrations:
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:
• Take the first dose (1 bottle/1 sachet) during the evening before the colonoscopy (e.g., 5:00 to 9:00 PM) followed by 1200 ml liquid (5x 240 ml) drinks (using provided measuring cup) of clear liquids before bed. Consume clear liquids within 5 hours.
• Take second dose (1 bottle/1 sachet) the next day approximately 5 hours before the colonoscopy followed by at least 720 ml (3x240 ml) drinks of clear liquids before the colonoscopy. Consume clear liquids within next 5 hours but atleast 2 hours before the time of the colonoscopy.
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:
• Take the first dose (1 bottle/1 sachet) in the afternoon or early evening (e.g., 4:00 to 6:00 PM) before the colonoscopy followed 1200 ml (5x 240 ml) using provided measuring cup of clear liquids before the next dose. Consume clear liquids within 5 hours.
• Take the second dose (1 bottle/1 sachet) approximately 6 hours later in the late evening (e.g., 10:00 PM to 12:00 AM), the night before the colonoscopy followed by at least 720 ml (3x240 ml) drinks of clear liquids before bed. Consume clear liquids within 5 hours.
Additional fluids must be consumed after every dose in both dosing regimens.
Instruct patients to consume only clear liquids (no solid food or milk) on the day before the colonoscopy up until 2 hours before the time of the colonoscopy. Instruct patients that if they experience severe bloating, distention, or abdominal pain following the first dose, delay the second dose until their symptoms resolve.
EzyColon Powder for Oral Solution supplied as a powder, must be reconstituted with cold water right before its use.
Reconstitution of the EzyColon Powder
The reconstitution procedure of EzyColon powder is as follows:
(a) Reconstitute the EzyColon powder right before each administration. Do not prepare the solution in advance.
(b) Take 150 ml of cold water in a glass using provided measuring cup and pour in the contents of one packet of EzyColon powder.
(c) Stir for 2 to 3 minutes. The reconstituted EzyColon solution may become slightly warm as the powder dissolves.
EzyColon Oral Solution supplied as ready to drink oral Solution and no need of reconstitution.
Warning & Precautions:
Serious Fluid and Serum Chemistry Abnormalities, Advise patients to hydrate adequately before, during and after the use of EzyColon. 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 EzyColon, 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 EzyColon. 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.
Side Effects:
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).
Drug Interactions:
Drugs that may increase risks of fluid and electrolyte abnormalities: Use caution when prescribing EzyColon 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 EzyColon is used in patients on nonsteroidal anti-inflammatory drugs (NSAIDS) 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 EzyColon to avoid chelation with magnesium.
Antibiotics: Prior or concomitant use of antibiotics with EzyColon may reduce efficacy of EzyColon.
Use in Special Groups:
Pregnancy
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, EzyColon should be used during pregnancy only if clearly needed.
Nursing Mothers
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 EzyColon is administered to a nursing woman.
Pediatric Use
The safety and effectiveness of EzyColon 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 EzyColon. In patients with severely reduced renal function (creatinine clearance < 30 mL/min), accumulation of magnesium in plasma may occur.
Contraindications:
EzyColon is contraindicated in the following conditions:
• Patients with severely reduced renal function (creatinine clearance less than 30 ml/minute) which may result in accumulation of magnesium.
• Gastrointestinal obstruction or ileus.
• Bowel perforation
• Toxic colitis or toxic megacolon
• Gastric retention
• An allergy to any of the ingredients in EzyColon
Storage Conditions:
Store at temperature 15°- 30°C.
Commercial Pack:
EzyColon Powder for Oral Solution is supplied in a box containing 2 packets for oral solution along with a pre-marked dosing cup.
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