lactulose
Pharmaranks rates Lactulose 3.4/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Lactulose is an osmotic laxative used to treat Constipation, Hepatic Encephalopathy.
Osmotic Laxative · by Fresenius Kabi USA
Generic of Cephulac
Based on 1 source · Recall-safety score from FDA recall history — this product's own recalls and its manufacturer's record. Not an efficacy or quality rating. methodology →
Key facts
- Active ingredient
- Lactulose
- Drug class
- Osmotic Laxative
- Form
- Solution, Powder
- Strength
- Lactulose 10GM/15ML
- Type
- Prescription (Rx)
- Brand or generic
- Generic
- May treat
- constipation, hepatic encephalopathy
- Manufacturer
- Fresenius Kabi USA
- What the pharmacy pays
- ~$0.73 for 30 — not your price
- FDA application
- ANDA090503
What is Lactulose?
From the FDA label:Lactulose is a synthetic disaccharide in solution form for oral administration. Each 15 mL of lactulose solution, USP contains: 10 g lactulose (and less than 1.6 g galactose, less than 1.2 g lactose, and 0.1 g or less of fructose). Lactulose is a colonic acidifier which promotes laxation. The chemical name for lactulose is 4-O- β -D-galactopyranosyl-D-fructofuranose. It has the following structural formula: The molecular weight is 342 . 30. It is freely soluble in water. 3bfff862-figure-01
How to use
Lactulose is sold in more than one form (Solution and Powder), and each is dosed differently. The instructions below come from the FDA label for application ANDA090503 — follow the label that came with the product you were actually prescribed.
The usual dose is 1 to 2 tablespoonfuls (15 to 30 mL, containing 10 g to 20 g of lactulose) daily. The dose may be increased to 60 mL daily if necessary. Twenty-four to 48 hours may be required to produce a normal bowel movement. Note: Some patients have found that lactulose solution may be more acceptable when mixed with fruit juice, water or milk.
Side effects
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. To report SUSPECTED ADVERSE EVENTS, contact the FDA at 1-800-FDA-1088 or http://www.fda.gov/ for voluntary reporting of adverse reactions.
Warnings
Important safety information
A theoretical hazard may exist for patients being treated with lactulose solution 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.
Who should not take Lactulose
Since lactulose solution contains galactose (less than 1.6 g/15 mL), it is contraindicated in patients who require a low galactose diet.
Overdose — what happens if you take too much
Signs and Symptoms: There have been no reports of accidental overdosage. In the event of overdosage, it is expected that diarrhea and abdominal cramps would be the major symptoms. Medication should be terminated. Oral LD 50 : The acute oral LD 50 of the drug is 48 . 8 mL/kg in mice and greater than 30 mL/kg in rats. Dialysis: Dialysis data are not available for lactulose. Its molecular similarity to sucrose, however, would suggest that it should be dialyzable.
U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.
Interactions
Results of preliminary studies in humans and rats suggest that non-absorbable 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 solution.
Drug class
May treat (source: NIH RxClass)
Dosage forms
Solution and Powder
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
Same active ingredient, far cheaper. Is there a generic? →
Request a 90-day supply
Bulk fills usually lower the per-dose price vs monthly refills.
Use copay cards
Manufacturer copay cards & patient-assistance programs — especially for brand drugs.
Compare alternatives
A same-class option may cost less. See alternatives →
Frequently asked questions
- What does Lactulose treat?
- Lactulose (Lactulose) may be used to treat constipation, hepatic encephalopathy, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- How is Lactulose rated?
- pharmaranks gives Lactulose a composite score of 3.4 out of 5, currently based on 1 weighted source (FDA regulatory recall-safety data weighted highest). See our methodology at /how-we-rate.
- How much does Lactulose cost?
- Nobody can tell you what you will pay — your price is set by your insurer's formulary, your deductible and the pharmacy's markup, and none of those are published. What IS published is what the pharmacy paid to acquire it: about $0.73 for 30, per the CMS NADAC survey. Treat that as the floor, not the quote — ask the pharmacist for the cash price as well as your copay, because for cheap generics the cash price often wins.
- Is there a coupon or discount for Lactulose?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Lactulose. To pay less, Lactulose is already a generic — usually the lowest-cost version — so the main levers are comparing cash prices between pharmacies and using a pharmacy discount-card service. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Lactulose?
- Lactulose is marketed by Fresenius Kabi USA. You can see Fresenius Kabi USA's full profile, rating, and other products on pharmaranks.
- Is Lactulose a brand-name or generic drug?
- Lactulose is a generic medication; its active ingredient is Lactulose. Generics contain the same active ingredient as the brand-name original and are usually lower cost.
- Is Lactulose available over the counter?
- No. Lactulose is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Lactulose come in?
- Lactulose is currently marketed as solution and powder, per the FDA's National Drug Code Directory.
- What class of drug is Lactulose?
- Lactulose is classified as osmotic laxative, per the FDA's Established Pharmacologic Class.
- Is Lactulose FDA-registered?
- Lactulose is on record with the U.S. FDA under application number ANDA090503. You can verify this on its official FDA label.
- Has Lactulose been recalled by the FDA?
- Lactulose has no FDA recalls recorded under its own application in the openFDA enforcement database. Its recall-safety score reflects its manufacturer's overall recall record. This is general reference, not medical advice — check the FDA recall database for the latest alerts.
- Is Lactulose safe?
- There's no single safe-or-not verdict. pharmaranks gives Lactulose a recall-safety score of 68/100, based on its FDA recall history (no recalls under its own FDA application) — not an efficacy or side-effect rating. Review its FDA-label side effects and warnings before use, and always consult a licensed professional.
- What are the side effects of Lactulose?
- Lactulose's side effects are taken directly from its FDA label. From the label: 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.… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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lactulose
68/100