Registered Rwanda · Rwanda FDA

OSMOWIN

Each 15 ml contains Lactulose concentrate USP equivalent to lactulose 10 g

Rwanda FDA-HMP-MA-1485 Syrup 10 g/15ml alimentary tract and metabolism INN generic

What it does

This medicine contains a variety of active ingredients that work together to help treat certain health conditions.

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Plain-language summary for general understanding - not medical advice. Always follow your pharmacist/doctor.

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Registration & product details

Registration no.
Rwanda FDA-HMP-MA-1485
Registration date
20/07/2024
Expiry date
19/07/2029
Status
Registered
Active ingredient
Each 15 ml contains Lactulose concentrate USP equivalent to lactulose 10 g
Dosage form
Syrup
Strength
10 g/15ml
Pack size
100ml and 200ml Bottles
Therapeutic class
-
ATC class (WHO)
A06AD - Osmotically acting laxatives
RxNorm RxCUI
6218
Manufacturer / MAH
G.s. Pharmbutor
Country of origin
INDIA
Manufacturer location
Modi Steel Compound, Modinagar, Uttar Pradesh 201204, India

Source: Rwanda Food and Drugs Authority · fetched 2026-03-11 22:07:12 · updated 2026-09-17 02:30:43

Disclaimer: This information is sourced from Rwanda Food and Drugs Authority (Rwanda). Always consult a qualified healthcare professional before using any medication.

About contains

This medicine contains a variety of active ingredients that work together to help treat certain health conditions.

How it works

The active ingredients in this medicine perform specific functions to help your body in various ways, depending on the condition being treated.

Who it's for

This medicine is meant for individuals with specific health issues as determined by a healthcare provider.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

About lactulose

Lactulose is a type of sugar that helps relieve constipation by making stools easier to pass.

What it treats

  • constipation
  • hepatic encephalopathy

How it works

Lactulose works by drawing water into the bowel, softening the stool, and promoting bowel movements.

Who it's for

Lactulose is suitable for adults and children experiencing constipation or liver-related brain issues.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

Clinical monograph: contains

Contains is a term generally used to refer to formulations that include one or more active pharmaceutical ingredients. The specific effects, uses, and formulations depend on the particular drug in question. It is often used in the context of drug labels to inform about the components of a medication.

Dosage

Children: Refer to specific drug information for detailed dosage recommendations.

Adults: Refer to specific drug information for detailed dosage recommendations.

Mechanism of action

The mechanism of action varies depending on the specific drug that 'contains' certain active ingredients. Each compound will have its own unique pharmacological pathway and target within the body, which can include receptor modulation, enzyme inhibition, or other biochemical interactions.

Pharmacodynamics

Pharmacodynamics will depend on the active ingredients in the formulation. It generally encompasses the biochemical and physiological effects of the drug and its mechanisms of action, including the relationship between drug concentration and effect.

Pharmacokinetics

Pharmacokinetics involves the absorption, distribution, metabolism, and excretion of the specific active ingredients within the formulation. This can vary significantly based on the drug's chemical properties, route of administration, and individual patient factors.

Pregnancy

Consult with a healthcare provider before use, as safety during pregnancy has not been established.

Breast-feeding

Consult with a healthcare provider before use, as it is not known if this drug is excreted in human milk.

Storage

Store in a cool, dry place away from direct sunlight. Keep out of reach of children.

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

Clinical monograph: Lactulose

BNF-referenced

Lactulose is a synthetic disaccharide laxative derived from lactose, consisting of one molecule of galactose and one of fructose. It is primarily used to treat constipation and to manage hepatic encephalopathy. Lactulose works by being metabolized by saccharolytic bacteria in the colon, leading to the production of organic acids that enhance gut motility and increase stool water content, aiding in bowel movements.

Indications

  • Chronic constipation
  • Portal-systemic encephalopathy

Dosage

Children: Child 1-11 months: 2.5 mL twice daily, adjusted according to response. Child 1-4 years: 5 mL twice daily, adjusted according to response. Child 5-10 years: 10 mL twice daily, adjusted according to response. Child 5-17 years: 5-20 mL twice daily, adjusted according

Adults: Initially 15 mL twice daily, adjusted according to response. For hepatic encephalopathy, doses can be 30-50 mL three times a day, adjusted to produce 2-3 soft stools per day.

Mechanism of action

Lactulose is broken down by saccharolytic bacteria in the large intestine into organic acids, such as lactic acid, which increases intraluminal gas formation and enhances peristaltic gut motility. This osmotic effect increases water content in stool, facilitating bowel movements. Additionally, it acidifies the colonic contents, helping to treat portal-systemic encephalopathy by promoting the conversion of ammonia to ammonium ions, which are less absorbable.

Pharmacodynamics

Lactulose has minimal systemic absorption, exerting its effects predominantly within the gastrointestinal tract. It enhances stool volume and softens stool, which may lead to increased bowel sounds, feelings of bloating, belching, flatus, and diarrhea. These effects contribute to its laxative properties and its role in treating hepatic encephalopathy.

Pharmacokinetics

Lactulose is poorly absorbed from the gastrointestinal tract and exerts its action locally. It typically takes 24 to 48 hours to manifest its laxative effect. The substance is not metabolized before reaching the colon, where it is fermented by gut bacteria, resulting in the production of short-chain fatty acids and gases.

Contra-indications

  • Galactosaemia
  • Gastrointestinal obstruction
  • Gastrointestinal perforation
  • Risk of gastrointestinal perforation
  • Lactose intolerance

Adverse effects

  • Diarrhoea
  • Gastrointestinal discomfort
  • Nausea
  • Abdominal pain
  • Flatulence
  • Vomiting
  • Electrolyte imbalance

Precautions

  • Caution in patients with a history of gastrointestinal disorders
  • Monitor for electrolyte imbalance in prolonged use

Pregnancy

Not known to be harmful, but manufacturer advises to avoid.

Breast-feeding

Manufacturer advises to avoid.

Storage

Store in a cool, dry place away from direct sunlight. Keep out of reach of children.

Formulations

  • Lactulose 10g/15ml oral solution
  • Lactulose 680 mg per 1 ml
  • Lactulose granules
BNF 85 (British National Formulary) p.77 BNF for Children 2019-2020 p.65 PubChem / pathway

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

Molecular reference: Lactulose

PubChem CID 11333

Molecular formula: C12H22O11

Mechanism of action

Lactulose is a synthetic disaccharide derivative of lactose that consists of one molecule of galactose and one molecule of fructose. Saccharolytic bacteria present in the large intestine subsequently break the substance down into organic acids like lactic acid and small amounts of formic and acetic acids. Such resultant volatile fatty acid metabolites, in combination with hydrogen and methane that is also generated consequently enhance intraluminal gas formation, peristaltic gut motility, and elicit an osmotic effect that facilitates an increase in the water content of stool as well as associated stool softening. All of these actions ultimately assist in facilitating and increasing the frequency of bowel movements in patients experiencing constipation, although it may take 24 to 48 hours after using the medication for this laxative effect to become evident. At the same time, the formation of such acids via the metabolism of lactulose by colonic bacteria also acidifies the contents of the colon, thereby contributing to the treatment of portal-systemic encephalopathy (PSE). As one of the principal features of PSE involves the accumulation of nitrogenous waste products like ammonia in the systemic circulation, a state in which the colonic contents become more acidic than blood allows ammonia in the circulation to diffuse into the colon.. Furthermore, ammonia that diffuses into the acidic colon is ionized to ammonium ions that are incapable of being absorbed back into the blood. These effects, combined with the laxative action of lactulose facilitates the excretion of excess ammonia. And finally, it is also believed that an acidic colonic environment results in the elimination of urease-producing bacteria that contribute to the formation of ammonia while surviving colonic bacteria use up any trapped ammonia in the colon as a source of nitrogen for protein synthesis.

Pharmacodynamics

Lactulose formulations are most commonly administered via the oral route or the rectal route. Consequently, because the substance experiences minimal absorption by the gut it typically remains localized in the gastrointestinal tract environment and ultimately demonstrates almost all of its pharmacologic effects within the gut. In particular, as lactulose elicits its laxative effects in enhancing stool amounts and softening stool, such biochemical and physiologic activities can cause increased bowel sounds (borborygmi), a feeling of bloatedness, belching, frequent flatus, and diarrhea.

Source: PubChem (NCBI) · pathways from PathBank, Reactome, WikiPathways & PharmGKB.

This drug in other countries

The same active ingredient registered across other registries we cover - including different brands.