KRISTALOSE 20 g/20g
lactulose · POWDER, FOR SOLUTION · Cumberland Pharmaceuticals Inc.
KRISTALOSE is a powder, for solution containing lactulose at 20 g/20g, taken oral. Manufactured by Cumberland Pharmaceuticals Inc..
Key Facts
- Brand Name
- KRISTALOSE
- Generic Name
- lactulose
- NDC Code (Product)
66220-729- Manufacturer
- Cumberland Pharmaceuticals Inc.
- Strength
- 20 g/20g
- Dosage Form
- POWDER, FOR SOLUTION
- Route
- ORAL
- Marketing Status
- Application #
- ANDA074712
- Drug Class
- Osmotic Laxative [EPC]
- Marketing Start
- 01/20/2012
Recall History
No Recall HistoryFull Prescribing Information
Indications & Usage
INDICATIONS AND USAGE KRISTALOSE ® (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.
Dosage & Administration
DOSAGE AND ADMINISTRATION 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.
Warnings
WARNINGS 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.
Contraindications
CONTRAINDICATIONS Since KRISTALOSE ® (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.
Drug Interactions
Drug Interactions 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.
Adverse Reactions
ADVERSE REACTIONS 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.
Frequently Asked Questions
What is KRISTALOSE used for?
KRISTALOSE contains lactulose. It is a powder, for solution taken oral. Consult your doctor for specific uses.
Is KRISTALOSE a controlled substance?
KRISTALOSE is not classified as a controlled substance by the DEA.
What is the generic name for KRISTALOSE?
The generic name for KRISTALOSE is lactulose. There are 12 other brand versions of lactulose.
What is the NDC code for KRISTALOSE 20 g/20g?
The NDC (National Drug Code) for KRISTALOSE 20 g/20g is 66220-729, listed by Cumberland Pharmaceuticals Inc..