Sodium Picosulfate, Magnesium Oxide, and Anhydrous Citric Acid oral solution/powder for oral solution is indicated for bowel cleansing as a preparation for colonoscopy in adults and children 9 years and above. It is also used before barium enema, X-ray examinations, or surgical procedures that require a completely clean colon.

Sodium Picosulfate is hydrolyzed by colonic bacteria into its active metabolite, bis-(p-hydroxyphenyl)-pyridyl-2-methane (BHPM), which acts directly on the colonic mucosa to stimulate colonic peristalsis. Magnesium oxide and citric acid react together in solution to form magnesium citrate, which acts as an osmotic agent, causing water retention within the gastrointestinal tract.

The combined stimulant laxative action of Sodium Picosulfate and the osmotic action of Magnesium Citrate produces a strong purgative effect. When taken with adequate fluids, this results in watery diarrhea, effectively cleansing the bowel. Sodium Picosulfate, being a prodrug, is converted into its active form (BHPM) by colonic bacteria. This combination is used in adults to empty the colon before colonoscopy, allowing clear visualization of the intestinal walls for detection of abnormalities such as colon cancer. It is also used in children aged 9 years and older for the same purpose prior to colonoscopy.

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 (5 × 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 (3 × 240 ml) drinks of clear liquids before the colonoscopy. Consume clear liquids within next 5 hours but at least 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 by 1200 ml (5 × 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 (3 × 240 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. If patients experience severe bloating, distention, or abdominal pain following the first dose, they should delay the second dose until their symptoms resolve.

• Use with caution in patients receiving drugs that may increase the risk of fluid and electrolyte imbalance, as this may lead to complications such as seizures, arrhythmias, and prolonged QT interval. These include medications that can cause hypokalemia (e.g., diuretics, corticosteroids, and cardiac glycosides) or hyponatremia. Caution is also required when used with NSAIDs or drugs associated with SIADH, such as tricyclic antidepressants, SSRIs, antipsychotics, and carbamazepine, as they may increase the risk of fluid retention and electrolyte disturbances.
• Tetracycline and fluoroquinolone antibiotics, iron, digoxin, chlorpromazine, and penicillamine should be taken at least 2 hours before or not less than 6 hours after this solution to avoid chelation with magnesium.
• Concomitant or prior use of antibiotics may reduce the effectiveness of this preparation.

This solution is contraindicated in:

• Severe renal impairment (creatinine clearance <30 mL/min) due to risk of magnesium accumulation
• Gastrointestinal obstruction or ileus
• Bowel perforation
• Toxic colitis or toxic megacolon
• Gastric retention
• Known hypersensitivity to any component of the product

Common adverse effects (>1%) include nausea, headache, and vomiting. Other effects such as abdominal bloating, distension, abdominal pain/cramps, and watery diarrhea may occur but were generally not clinically significant.

Pregnancy Category B. Adequate and well-controlled studies in pregnant women are not available. Use during pregnancy only if clearly needed, as animal studies may not fully predict human response. It is not known whether this drug is excreted in human milk. Caution should be exercised when administering to nursing mothers.

Ensure adequate hydration before, during, and after use to prevent serious fluid and electrolyte disturbances. Use with caution in patients with congestive heart failure. Patients developing significant vomiting or signs of dehydration (including orthostatic hypotension) should be evaluated for electrolyte imbalance and treated appropriately. Electrolyte disturbances may lead to serious adverse outcomes such as cardiac arrhythmias, seizures, or renal impairment. Any existing imbalance should be corrected before administration. Rare cases of generalized tonic-clonic seizures have been reported, often associated with electrolyte disturbances (hyponatremia, hypokalemia, hypocalcemia, hypomagnesemia) and low serum osmolality. These abnormalities usually resolve after correction of fluids and electrolytes.

Pediatric Use: Safety and efficacy in pediatric patients have not been established.

Renal Insufficiency: Use with caution in patients with impaired renal function or those taking nephrotoxic or renal-affecting drugs (e.g., diuretics, ACE inhibitors, ARBs). Adequate hydration is essential. In severe renal impairment (creatinine clearance <30 mL/min), magnesium accumulation may occur.

Enema & bowel cleansing solution

Store at temperature 15°-30°C.