Product image of Normase (Lactulose) supplied by GNH India

Normase

Active Ingredient:
Lactulose
Origin:
EU

Normase (Lactulose)

Lactulose, the active ingredient in Normase, is an osmotic laxative presented as an oral dosage form for oral use. It is used to treat constipation and hepatic encephalopathy in adult patients.
GNH India supplies Normase as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, 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 (lactulose) is an osmotic laxative employed in gastrointestinal and hepatic conditions.
  • Constipation: softens stool and promotes regular bowel movements.
  • Hepatic encephalopathy: lowers blood ammonia levels, helping to improve mental status.
  • Prevention of encephalopathy recurrence: maintains reduced ammonia concentrations to reduce relapse risk.

How It Works

  • In the colon, lactulose is metabolized by resident bacteria into short‑chain fatty acids such as lactic and acetic acid. These acids increase the osmotic pressure within the lumen, drawing water into the bowel and softening stool. The resulting acidification also traps ammonia as ammonium, decreasing its absorption and thereby lowering systemic ammonia levels in hepatic encephalopathy.

Side Effects

Lactulose may cause a range of adverse reactions, most of which are related to its osmotic activity in the gut.

Common Side Effects

  • Abdominal bloating or distension
  • Flatulence or excessive gas
  • Diarrhea or loose stools
  • Nausea or mild stomach discomfort
  • Cramping or abdominal pain
  • Increased thirst

Serious or Rare Side Effects

  • Severe electrolyte imbalance (e.g., hyponatremia, hypokalemia)
  • Marked dehydration requiring medical attention
  • Allergic reactions such as rash, itching, or swelling
  • Severe abdominal pain or colitis
  • Persistent vomiting
  • Rare cases of hepatic decompensation in vulnerable patients

Precautions & Warnings

  • When using lactulose, certain precautions help ensure safe and effective therapy.
  • Dose adjustment in renal impairment: monitor renal function and adjust dose if needed.
  • Electrolyte monitoring: check serum electrolytes regularly, especially with prolonged use.
  • Caution in diabetes: lactulose contains a small amount of sugar; monitor blood glucose.
  • Avoid in intestinal obstruction: do not use if a mechanical blockage is present.
  • Store at room temperature: keep in the original container, protect from moisture and direct sunlight.

Avoid Interactions

Lactulose can interact with other medicines, altering efficacy or safety.

Major Interactions (Avoid)

  • Antacids containing magnesium: may increase osmotic load and cause severe diarrhea.
  • Loop or thiazide diuretics: heightened risk of electrolyte disturbances.
  • Rifampin: may reduce lactulose's effectiveness in lowering ammonia.

Moderate Interactions (Monitor Closely)

  • Broad‑spectrum antibiotics: can alter gut flora and affect lactulose metabolism.
  • Probiotic supplements: may modify bacterial conversion of lactulose.
  • Other laxatives or stool softeners: additive laxative effect may lead to excessive bowel movements.

Frequently Asked Questions

Normase, which contains lactulose, is prescribed primarily for two clinical situations: relief of chronic constipation by softening stool and promoting bowel movements, and management of hepatic encephalopathy, where it helps lower blood ammonia levels and improve neurological function.

Lactulose reaches the colon unchanged, where intestinal bacteria ferment it into short‑chain fatty acids. These acids increase the osmotic pressure inside the lumen, drawing water into the bowel to soften stool, and they also convert ammonia to ammonium, reducing its absorption into the bloodstream.

The appropriate dose of Normase is determined by the prescribing clinician based on the patient’s condition, age, renal function, and response to therapy. Dosage may be adjusted over time to achieve the desired clinical effect while minimizing side effects.

Safety data for lactulose in pregnancy and lactation are limited. It is generally categorized as low risk because it is poorly absorbed, but the decision to use it should be made by a healthcare professional after weighing potential benefits against any uncertain risks.

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 and any necessary import documentation.

Lactulose is an osmotic laxative, differing from stimulant laxatives (e.g., bisacodyl) that increase intestinal motility. Its dual action—softening stool and reducing ammonia—makes it uniquely useful for hepatic encephalopathy, whereas many other laxatives lack this hepatic benefit.

Normase should be stored at room temperature, preferably below 25 °C. Keep the product in its original packaging, protect it from moisture and direct sunlight, and ensure the container is tightly closed to maintain stability.

Normase is taken orally, usually as a liquid solution or syrup. The dose is measured with a calibrated device or spoon, and it can be taken with or without food. Patients should follow the prescriber’s instructions regarding timing and frequency.

Serious risks, though uncommon, include severe electrolyte imbalances (especially low potassium or sodium), marked dehydration, and rare allergic reactions such as rash or swelling. Prompt medical attention is required if these symptoms develop.

Normase should be avoided in patients with known hypersensitivity to lactulose, in those with a mechanical intestinal obstruction, or in individuals with severe dehydration until the underlying condition is corrected. Clinicians should also exercise caution in patients with renal impairment.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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