Lactulose is an osmotic laxative indicated for the treatment of constipation. It is available as oral solution and powder for oral solution for rectal use. MedsAcross supplies Lactulose for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
LACTULOSE For Oral Solution is indicated for the treatment of constipation. In patients with a history of chronic constipation, lactulose therapy increases the number of bowel movements per day and the number of days on which bowel movements occur.
Source: US FDA prescribing information
The usual adult dosage is 10 g to 20 g of lactulose daily. The dose may be increased to 40 g daily if necessary. Twenty-four to 48 hours may be required to produce a normal bowel movement. DIRECTIONS FOR PREPARATION Dissolve contents of packet in half a glass (4 ounces) of water. When Lactulose For Oral Solution is dissolved in water, the resulting solution may be colorless to a slightly pale yellow color.
Source: US FDA prescribing information
Since LACTULOSE For Oral Solution contains galactose (less than 0.3 g/10 g as a total sum with lactose), it is contraindicated in patients who require a low galactose diet.
Source: US FDA prescribing information
A theoretical hazard may exist for patients being treated with lactulose who may be required to undergo electrocautery procedures during proctoscopy or colonoscopy. Accumulation of H 2 gas in significant concentration in the presence of an electrical spark may result in an explosive reaction. Although this complication has not been reported with lactulose, patients on lactulose therapy undergoing such procedures should have a thorough bowel cleansing with a non-fermentable solution. Insufflation of CO 2 as an additional safeguard may be pursued but is considered to be a redundant measure.
Source: US FDA prescribing information
Precise frequency data are not available. Initial dosing may produce flatulence and intestinal cramps, which are usually transient. Excessive dosage can lead to diarrhea with potential complications such as loss of fluids, hypokalemia, and hypernatremia. Nausea and vomiting have been reported.
Source: US FDA prescribing information
Results of preliminary studies in humans and rats suggest that nonabsorbable antacids given concurrently with lactulose may inhibit the desired lactulose-induced drop in colonic pH. Therefore, a possible lack of desired effect of treatment should be taken into consideration before such drugs are given concomitantly with lactulose.
Source: US FDA prescribing information
STORE AT ROOM TEMPERATURE, 15°-30°C (59°-86°F).
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
9 presentations of Lactulose, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Lactulose 10 g/15 mL oral solutionOralGeneric name | — | US FDA | Available on request |
| Lactulose 10 g/15 mL oral solutionOral, rectalGeneric name | — | US FDA | Available on request |
| Lactulose 10 g/10 g powder for oral solutionOralGeneric name | — | US FDA | Available on request |
| Enulose 10 g/15 mL oral solutionOral, rectal | Actavis Pharma | US FDA | Available on request |
| Constulose 10 g/15 mL oral solutionOral | Actavis Pharma | US FDA | Available on request |
| Generlac 10 g/15 mL oral solutionOral, rectal | Chartwell RX | US FDA | Available on request |
| Kristalose 10 g/10 g powder for oral solutionOral | Cumberland Pharmaceuticals | US FDA | Available on request |
| Lactulose 10 g/10 g oral solutionOralGeneric name | — | US FDA | Available on request |
| LACTULOSE Crystalline 10 g/10 g powder for oral solutionOral | Cumberland Assured Products | US FDA | Available on request |
5 brand names across 1 markets.
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
| Register | Status | Source |
|---|---|---|
| US FDA | First approved 25 March 1976 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Conditions linked to Lactulose in public data. This is not a list of approved uses, see the clinical information.
Yes, on request. MedsAcross lists 9 presentations of Lactulose and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 5 brand names for Lactulose, including Constulose, Enulose, Generlac, Kristalose, LACTULOSE Crystalline.
Yes. The US FDA first approved Lactulose on 25 March 1976, according to Drugs@FDA.
No listed presentation of Lactulose is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Lactulose is classified under ATC code A06AD11 (Lactulose).
Tell us the strength, quantity and destination country. Our team replies with availability, lead time and the import documents needed.