Product image of Normase Eps (Lactulose) supplied by GNH India

Normase Eps

Active Ingredient:
Lactulose
Origin:
EU

Normase Eps (Lactulose)

Lactulose, the active ingredient in Normase Eps, is an osmotic laxative presented as an oral formulation for oral use. It is employed to relieve constipation and to lower blood ammonia levels in patients with hepatic encephalopathy, thereby improving neurological function in individuals with liver disease. The drug works by drawing water into the colon, softening stools and facilitating the removal of nitrogenous waste.

GNH India supplies Normase Eps as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, transplant centres, oncology centres, pharmacies and clinics worldwide.

Manufacturer / TM Owner

L. Molteni And C. Dei F.Lli Alitti Società Di Esercizio S.P.A.

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Indications & Clinical Uses

Normase Eps (lactulose) acts as an osmotic laxative and ammonia‑lowering agent in the gastrointestinal tract.

  • Constipation: softens stool and increases bowel frequency to relieve chronic constipation.
  • Hepatic encephalopathy: reduces intestinal ammonia absorption, helping prevent and treat episodes of hepatic encephalopathy.
  • Hyperammonemia in liver disease: lowers systemic ammonia levels, supporting neurological stability in patients with advanced liver dysfunction.

How It Works

  • Lactulose reaches the colon unchanged, where bacterial enzymes hydrolyze it into lactic and acetic acids. The resulting short‑chain fatty acids lower colonic pH, converting ammonia (NH₃) to ammonium (NH₄⁺), which is poorly absorbed. The osmotic effect of the unabsorbed sugars draws water into the lumen, softening stool and promoting peristalsis while simultaneously reducing systemic ammonia levels. This dual action contributes to its therapeutic benefit in both constipation and hepatic encephalopathy.

Side Effects

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

Common Side Effects

  • Flatulence: increased gas from bacterial fermentation.
  • Abdominal cramps: intermittent stomach discomfort.
  • Diarrhea: loose stools, especially at higher doses.

Serious or Rare Side Effects

  • Severe dehydration: excessive fluid loss that may need medical care.
  • Electrolyte imbalance: abnormal potassium or sodium levels.
  • Allergic reaction: rash, itching, or facial swelling.

Precautions & Warnings

When prescribing or dispensing lactulose, several safety considerations should be observed.

  • Assess renal function: adjust use in patients with impaired kidney clearance.
  • Monitor electrolytes: watch for potassium or sodium disturbances during prolonged therapy.
  • Use caution in diabetes: lactulose contains carbohydrate that may affect blood glucose.
  • Avoid abrupt discontinuation: taper dose to prevent rebound constipation.
  • Adjust dose in pediatric patients: follow pediatric dosing guidelines if applicable.
  • Store at room temperature: keep in the original container, protect from moisture and direct sunlight.

Avoid Interactions

Lactulose can influence the absorption or efficacy of certain medicines, requiring attention to possible drug interactions.

Major Interactions (Avoid)

  • Antacids containing magnesium or aluminum: may reduce lactulose’s osmotic effect.
  • Oral antibiotics with broad‑spectrum activity: can alter colonic flora and diminish lactulose conversion.

Moderate Interactions (Monitor Closely)

  • Digoxin: increased gastrointestinal transit may lower digoxin absorption.
  • Metformin: altered gut motility could affect metformin’s plasma levels.
  • Diuretics: combined risk of electrolyte imbalance, especially potassium loss.

Frequently Asked Questions

Normase Eps contains lactulose, which is used primarily to treat chronic constipation and to lower elevated blood ammonia levels in patients with hepatic encephalopathy. By softening stools and reducing ammonia absorption, it helps improve bowel regularity and supports neurological function in individuals with liver‑related disorders.

Lactulose is not absorbed in the small intestine; it reaches the colon where gut bacteria split it into short‑chain acids. These acids lower the colonic pH, converting ammonia to ammonium, which is poorly absorbed. The resulting osmotic gradient draws water into the lumen, softening stool and promoting evacuation while simultaneously decreasing systemic ammonia.

The dose of lactulose is individualized by the prescribing clinician based on the patient’s condition, age, renal function and response. Typical regimens start with a low dose that is gradually increased until the desired bowel movement frequency or ammonia reduction is achieved. Patients should follow the prescriber’s instructions and not adjust the dose on their own.

Safety data for lactulose during pregnancy and lactation are limited. It is generally categorized as a drug that should be used only if the potential benefit justifies any possible risk to the fetus or infant. Women who are pregnant, planning to become pregnant, or breastfeeding should discuss the use of Normase Eps with their healthcare provider.

To place an order, visit the product page on gnhindia.com, enter the required quantity and submit the enquiry form. GNH India works with hospitals, pharmacies and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, shipping details (including any cold‑chain requirements) and the necessary import documentation.

Lactulose is an osmotic laxative that works by retaining water in the colon, whereas stimulant laxatives such as bisacodyl increase intestinal motility, and bulk‑forming agents add fiber to stool. Lactulose also lowers ammonia levels, a benefit not shared by most other laxatives. Its onset is slower than stimulant agents, but it is generally well‑tolerated for long‑term use.

Normase Eps should be stored at room temperature, below 25 °C, in its original packaging to protect it from moisture and direct sunlight. Keep the container tightly closed when not in use and store out of reach of children. No refrigeration is required for this oral formulation.

Normase Eps is taken orally, usually as a liquid or syrup. The product is measured with a calibrated dosing device or spoon, mixed with a small amount of water or juice if desired, and swallowed. It should be taken with or without food as directed by the prescriber, and the patient should stay well‑hydrated during therapy.

The most serious adverse events include severe dehydration, significant electrolyte disturbances (especially low potassium), and rare allergic reactions such as rash, facial swelling or difficulty breathing. Patients experiencing persistent diarrhea, dizziness, muscle weakness or signs of an allergic response should seek medical attention promptly.

Lactulose is contraindicated in individuals with known hypersensitivity to lactulose or any of its excipients. Patients with intestinal obstruction, perforated bowel, or severe inflammatory bowel disease should avoid its use. Caution is also advised for those with uncontrolled diabetes due to its carbohydrate content, and for patients with renal impairment where dose adjustment may be required.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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