Product image of Lactulose Novalie (Lactulose) supplied by GNH India

Lactulose Novalie

Active Ingredient:
Lactulose
Origin:
EU

Lactulose Novalie (Lactulose)

Lactulose, the active ingredient in Lactulose Novalie, is an osmotic laxative presented as an oral formulation for systemic use. It is employed to relieve constipation and to reduce ammonia absorption in patients with hepatic encephalopathy, acting across adult and pediatric populations as directed by a healthcare professional.

GNH India supplies Lactulose Novalie as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide.

Manufacturer / TM Owner

Novalie Pharma S.L.

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Indications & Clinical Uses

Lactulose is used to manage conditions that benefit from increased intestinal water content and reduced ammonia absorption.

  • Constipation: softens stools and promotes regular bowel movements.
  • Hepatic encephalopathy: lowers intestinal ammonia levels, helping to improve neurological symptoms.
  • Prevention of recurrent hepatic encephalopathy: maintains low ammonia concentrations to reduce episode frequency.

How It Works

  • Lactulose is a synthetic disaccharide that is not absorbed in the small intestine. In the colon, bacterial enzymes hydrolyze it to lactic and acetic acids, lowering colonic pH. This osmotic effect draws water into the lumen, facilitating stool softening, while the acidic environment converts ammonia to non‑absorbable ammonium, decreasing systemic ammonia levels.

Side Effects

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

Common Side Effects

  • Abdominal bloating: sensation of fullness or swelling.
  • Flatulence: increased intestinal gas.
  • Diarrhea: loose, watery stools.
  • Nausea: feeling of sickness.
  • Stomach cramps: intermittent abdominal pain.
  • Increased thirst: due to fluid shifts.

Serious or Rare Side Effects

  • Severe electrolyte imbalance: abnormal sodium or potassium levels.
  • Dehydration: excessive fluid loss.
  • Allergic reaction: rash, itching, swelling, or difficulty breathing.
  • Severe abdominal pain: persistent or worsening discomfort.
  • Hypotension: unusually low blood pressure.
  • Persistent vomiting: inability to retain fluids.

Precautions & Warnings

When prescribing Lactulose, clinicians should consider several safety measures.

  • Dose adjustment in renal impairment: monitor kidney function and modify dose as needed.
  • Electrolyte monitoring: check serum electrolytes during prolonged therapy.
  • Caution in diabetes: monitor blood glucose as Lactulose may affect sugar levels.
  • Avoid abrupt discontinuation: taper to prevent rebound constipation.
  • Store at room temperature: keep in the original container, protect from moisture and direct sunlight.

Avoid Interactions

Lactulose can interact with other medicines, requiring attention to avoid reduced efficacy or increased toxicity.

Major Interactions (Avoid)

  • Concurrent use with magnesium‑containing laxatives: may cause excessive diarrhea.
  • Co‑administration with antidiarrheal agents (e.g., loperamide): may diminish Lactulose effect.
  • Use with drugs that increase ammonia production (e.g., valproate): may counteract therapeutic benefit.

Moderate Interactions (Monitor Closely)

  • Insulin or oral hypoglycemics: Lactulose may affect glucose control; monitor blood sugar.
  • Diuretics: risk of electrolyte disturbances; check electrolytes regularly.
  • Antibiotics altering gut flora: may modify Lactulose metabolism; observe clinical response.

Frequently Asked Questions

Lactulose Novalie is indicated for the treatment of constipation and for managing hepatic encephalopathy. In constipation, it softens stools and promotes regular bowel movements. In hepatic encephalopathy, it reduces intestinal ammonia absorption, helping to improve neurological symptoms.

Lactulose is a synthetic sugar that reaches the colon unchanged. Gut bacteria break it down into acidic metabolites, lowering colonic pH. This creates an osmotic gradient that draws water into the bowel, softening stool, while the acidic environment converts ammonia to ammonium, which is poorly absorbed, thereby lowering systemic ammonia levels.

The appropriate dose of Lactulose Novalie is determined by the prescribing clinician based on the patient’s condition, age, weight, and response to therapy. Dosage may be adjusted during treatment to achieve the desired clinical effect while minimizing adverse reactions.

Safety data for Lactulose Novalie in pregnancy and lactation are limited. Healthcare providers should weigh the potential benefits against any possible risks before prescribing to pregnant or nursing women. The decision should be individualized and made in consultation with a qualified professional.

To place an order, submit an enquiry on the product page at gnhindia.com, specifying the required quantity. GNH India works with hospitals, pharmacies, and procurement teams worldwide, and will request trade or institutional credentials. After verification, the team provides pricing, availability, shipping details, and assists with any necessary import documentation.

Lactulose is an osmotic laxative that works by increasing water content in the colon, whereas stimulant laxatives such as bisacodyl act by stimulating intestinal motility. Compared with bulk‑forming agents, Lactulose provides a rapid softening effect and also offers the unique benefit of lowering ammonia levels, making it useful in hepatic encephalopathy.

Lactulose Novalie should be stored at room temperature, 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.

Lactulose Novalie is taken orally, usually as a liquid or tablet, as directed by the prescriber. It can be mixed with water or other suitable fluids if a liquid formulation is used. The dose is typically spaced throughout the day to maintain consistent therapeutic effect.

Serious risks include severe electrolyte imbalance, dehydration, and rare allergic reactions such as rash, swelling, or difficulty breathing. Patients should be monitored for signs of these conditions, especially during high‑dose or prolonged therapy, and seek medical attention if they occur.

Lactulose Novalie is contraindicated in individuals with known hypersensitivity to lactulose or any of its excipients. Caution is advised for patients with severe intestinal obstruction, acute abdominal conditions, or those requiring strict fluid restriction, as the osmotic effect may exacerbate these issues.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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