Macrogol 3350 Norgine Enfants (Sodium Hydrogen Carbonate, Potassium Chloride, Sodium Chloride, Macrogol 3350)

Macrogol 3350 is an osmotic laxative used to treat constipation in the pediatric population.

• Functional constipation: softens stool and facilitates regular bowel movements in children with functional constipation.
• Chronic constipation: provides ongoing relief by maintaining stool hydration over extended periods.
• Occasional constipation: offers rapid symptom relief for intermittent constipation episodes in children.

• Macrogol 3350 acts as a high‑molecular‑weight polyethylene glycol that is not absorbed from the gastrointestinal tract. It retains water within the intestinal lumen by creating an osmotic gradient, increasing stool water content and volume. The resulting softer, bulkier stool stimulates peristalsis, promoting more frequent and easier defecation without significant electrolyte shifts. The polymer’s large size prevents systemic absorption, ensuring its action remains confined to the gut.

Macrogol 3350 may cause a range of adverse reactions, most of which are mild and transient.

Common Side Effects

• Abdominal bloating: feeling of fullness or swelling in the abdomen.
• Flatulence: increased gas production leading to passing of wind.
• Nausea: mild sensation of wanting to vomit.
• Diarrhoea: loose, watery stools occurring after dosing.
• Headache: mild head discomfort.

Serious or Rare Side Effects

• Severe electrolyte imbalance: abnormal levels of sodium, potassium or chloride that may require medical attention.
• Allergic reaction: rash, itching, swelling or difficulty breathing.
• Persistent abdominal pain: intense or prolonged pain that does not resolve.

When prescribing Macrogol 3350 for children, several safety considerations should be observed.

• Renal impairment: assess kidney function before use and monitor in patients with reduced renal clearance.
• Electrolyte disorders: avoid in children with existing electrolyte abnormalities such as hyponatremia or hyperkalemia.
• Dehydration: ensure adequate fluid intake to prevent worsening dehydration.
• Intestinal obstruction: do not use in cases of suspected or confirmed bowel blockage.
• Pediatric dosing supervision: dosing must be determined and supervised by a qualified healthcare professional.
• Store at room temperature: keep in the original container, protect from moisture and excessive heat.

Macrogol 3350 can affect the absorption or activity of several concomitant medicines.

Major Interactions (Avoid)

• Lithium: concurrent use may increase lithium serum concentrations, risking toxicity.
• Digoxin: reduced absorption may alter therapeutic levels, requiring close monitoring.

Moderate Interactions (Monitor Closely)

• Oral antibiotics (e.g., tetracycline, quinolones): macrogol may decrease their bioavailability, consider spacing administration.
• Anticoagulants (e.g., warfarin): possible alteration in effect due to changes in gut flora; monitor INR.
• Antidiabetic agents: potential variability in glucose control; observe blood sugar levels.