Chuanbeiqing Magnesium Sulfate Sodium Sulfate and Potassium Sulfate Concentrate Oral Solution

1. Indications and Usage
Bowel Cleansing:
Indicated for bowel cleansing in adult patients prior to any procedure requiring a clean bowel, including endoscopy, radiographic examination, or surgical procedures.
Contraindications / Not Indicated For:
This product is not indicated for the treatment of constipation. It is contraindicated in patients with hypersensitivity to any components, congestive heart failure, severe dehydration, active inflammatory bowel disease, gastrointestinal perforation, toxic megacolon, bowel obstruction, gastric retention, acute abdominal conditions (e.g., appendicitis), nausea and vomiting, ascites, and severe renal impairment.
2. Dosage and Administration
Route of Administration:
Oral Use ONLY. Must be diluted before use.
Recommended Dosage (Adults):
The appropriate bowel cleansing regimen requires two bottles of the solution.
Split-Dose Regimen:
Day Before Procedure: In the evening (e.g., 6:00 PM), dilute one bottle to approximately 0.5 liters with water and drink. Within two hours after drinking, consume an additional 1 liter of water or clear liquids.
Day of Procedure: In the morning (10 to 12 hours after the evening dose), repeat the process with the second bottle. Drink an additional 1 liter of water or clear liquids within two hours.
Administration Instructions:
Timing: Dosing should be completed at least 1 hour before the procedure without anesthesia, or at least 2 hours before if under anesthesia.
Clear Liquids Allowed: Water, tea or coffee (without milk/cream), carbonated/non-carbonated non-alcoholic beverages, strained pulp-free juice (non-red/purple), and clear broth/soup. Red or purple liquids, milk, and alcohol are strictly prohibited.
Post-Procedure Hydration: Patients should be encouraged to drink sufficient fluids post-procedure to maintain hydration.
3. Mechanism of Action
Osmotic Laxative:
The sulfate salts have limited absorption in the body. Unabsorbed sulfates exert an osmotic effect that retains water in the gastrointestinal tract, thereby producing a laxative effect for bowel cleansing.
4. Safety and Warnings
Electrolyte Abnormalities and Dehydration:
May cause severe electrolyte abnormalities and dehydration. Ensure adequate fluid intake. Use with caution in elderly patients and those with mild-to-moderate hepatic or renal impairment; it is contraindicated in severe renal impairment.
Seizures:
Seizures have been reported in patients without a history of seizure disorders, often associated with electrolyte disturbances.
Arrhythmias:
Cases of arrhythmia (e.g., atrioventricular block) have been reported during clinical trials. Monitor patients with underlying cardiac conditions.
Uric Acid Elevation:
Transient increases in uric acid may occur. Exercise caution in patients with gout or hyperuricemia.
5. Adverse Reactions
Most Common:
Diarrhea is a predictable and expected effect. Other very common adverse reactions include malaise, abdominal distension, abdominal pain, nausea, and vomiting.
Other Reported Reactions:
Headache, dizziness, chills, dry mouth, anorectal discomfort, dysuria, elevated liver enzymes, blood chemistry disturbances (hyponatremia, hypokalemia, hypocalcemia, hyperphosphatemia, hyperuricemia), and hypersensitivity reactions (urticaria, pruritus, rash, dyspnea).
6. Drug Interactions
Medications Absorbed via Gastrointestinal Tract:
Bowel cleansing may impair the absorption of other orally administered medications (e.g., oral contraceptives, antiepileptics). Administer such medications at least 1 hour before starting the bowel preparation or consult a physician regarding alternative dosing.
Nephrotoxic or Ototoxic Agents:
Use with extreme caution when co-administered with drugs known to affect renal function or electrolyte balance due to the risk of compounding fluid and electrolyte disturbances.
7. Pharmaceutical Information
Chemical Composition:
Active Ingredients per Bottle: Magnesium Sulfate (as MgSO4) 1.6 g, Sodium Sulfate (Na2SO4) 17.5 g, and Potassium Sulfate (K2SO4) 3.13 g.
Excipients: Citric acid, L-malic acid, sodium benzoate, sucralose, raspberry flavor.
Description:
A colorless to slightly yellow clear liquid with a sweet taste and fruity odor.
Storage:
Store at controlled room temperature. Keep out of reach of children.