Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED KRISTALOSE ® (LACTULOSE) For Oral Solution is available in single dose packets of 10 g (NDC 66220-719-01) and single dose packets of 20 g (NDC 66220-729-01). The packets are supplied as follows: NDC 66220-719-30 (Carton of thirty 10 g packets) NDC 66220-729-30 (Carton of thirty 20 g packets) STORE AT ROOM TEMPERATURE, 15°-30°C (59°-86°F). To report SUSPECTED ADVERSE REACTIONS, contact Cumberland Pharmaceuticals Inc. at 1-877-484-2700 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Manufactured for: CUMBERLAND PHARMACEUTICALS INC. Nashville, TN 37203 KRISTALOSE is a registered trademark of Cumberland Pharmaceuticals Inc. Issued: July 2018; Principal Display panel – 10 Grams Carton Label NDC 66220-719-30 Kristalose ® ( lactulose ) For Oral Solution 10 Grams 30 Single Dose Packets CUMBERLAND ® PHARMACEUTICALS Rx only Principal Display panel – 10 Grams Carton Label; Principal Display Panel – 10 Grams Pouch Label NDC 66220-719-01 Kristalose ® ( lactulose ) For Oral Solution CUMBERLAND ® PHARMACEUTICALS 10 Grams Single Dose Packet Rx only CONTENTS: Each packet contains 10 grams lactulose (and less than 0.3 g galactose and lactose as a total sum). This unit dose packet is not child resistant. INDICATIONS: For the treatment of constipation. See accompanying package insert. USUAL ADULT DOSAGE: 10 to 20 grams daily. See accompanying package insert. Since lactulose does not exert its effect until it reaches the colon, and since transit time through the colon may be slow, 24-48 hours may be required to produce a normal bowl movement. DIRECTIONS FOR PREPARATION: Dissolve contents of packet in half a glass (4 ounces) of water. Store at room temperature, 15°-30°C (59°-86°F). Manufactured for: Cumberland Pharmaceuticals Inc. Nashville, TN, USA, 37203 Principal Display Panel – 10 Grams Pouch Label; Principal Display panel – 20 Grams Carton Label NDC 66220-729-30 Kristalose ® ( lactulose ) For Oral Solution 20 Grams 30 Single Dose Packets CUMBERLAND ® PHARMACEUTICALS Rx only Principal Display panel – 20 Grams Carton Label; Principal Display Panel – 20 Grams Pouch Label NDC 66220-729-01 Kristalose ® ( lactulose ) For Oral Solution CUMBERLAND ® PHARMACEUTICALS 20 Grams Single Dose Packet Rx only CONTENTS: Each packet contains 20 grams lactulose (and less than 0.6 g galactose and lactose as a total sum). This unit dose packet is not child resistant. INDICATIONS: For the treatment of constipation. See accompanying package insert. USUAL ADULT DOSAGE: 10 to 20 grams daily. See accompanying package insert. Since lactulose does not exert its effect until it reaches the colon, and since transit time through the colon may be slow, 24-48 hours may be required to produce a normal bowl movement. DIRECTIONS FOR PREPARATION: Dissolve contents of packet in half a glass (4 ounces) of water. Store at room temperature, 15°-30°C (59°-86°F). Manufactured for: Cumberland Pharmaceuticals Inc. Nashville, TN, USA, 37203 Principal Display Panel – 20 Grams Pouch Label
- HOW SUPPLIED KRISTALOSE ® (LACTULOSE) For Oral Solution is available in single dose packets of 10 g (NDC 66220-719-01) and single dose packets of 20 g (NDC 66220-729-01). The packets are supplied as follows: NDC 66220-719-30 (Carton of thirty 10 g packets) NDC 66220-729-30 (Carton of thirty 20 g packets) STORE AT ROOM TEMPERATURE, 15°-30°C (59°-86°F). To report SUSPECTED ADVERSE REACTIONS, contact Cumberland Pharmaceuticals Inc. at 1-877-484-2700 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Manufactured for: CUMBERLAND PHARMACEUTICALS INC. Nashville, TN 37203 KRISTALOSE is a registered trademark of Cumberland Pharmaceuticals Inc. Issued: July 2018
- Principal Display panel – 10 Grams Carton Label NDC 66220-719-30 Kristalose ® ( lactulose ) For Oral Solution 10 Grams 30 Single Dose Packets CUMBERLAND ® PHARMACEUTICALS Rx only Principal Display panel – 10 Grams Carton Label
- Principal Display Panel – 10 Grams Pouch Label NDC 66220-719-01 Kristalose ® ( lactulose ) For Oral Solution CUMBERLAND ® PHARMACEUTICALS 10 Grams Single Dose Packet Rx only CONTENTS: Each packet contains 10 grams lactulose (and less than 0.3 g galactose and lactose as a total sum). This unit dose packet is not child resistant. INDICATIONS: For the treatment of constipation. See accompanying package insert. USUAL ADULT DOSAGE: 10 to 20 grams daily. See accompanying package insert. Since lactulose does not exert its effect until it reaches the colon, and since transit time through the colon may be slow, 24-48 hours may be required to produce a normal bowl movement. DIRECTIONS FOR PREPARATION: Dissolve contents of packet in half a glass (4 ounces) of water. Store at room temperature, 15°-30°C (59°-86°F). Manufactured for: Cumberland Pharmaceuticals Inc. Nashville, TN, USA, 37203 Principal Display Panel – 10 Grams Pouch Label
- Principal Display panel – 20 Grams Carton Label NDC 66220-729-30 Kristalose ® ( lactulose ) For Oral Solution 20 Grams 30 Single Dose Packets CUMBERLAND ® PHARMACEUTICALS Rx only Principal Display panel – 20 Grams Carton Label
- Principal Display Panel – 20 Grams Pouch Label NDC 66220-729-01 Kristalose ® ( lactulose ) For Oral Solution CUMBERLAND ® PHARMACEUTICALS 20 Grams Single Dose Packet Rx only CONTENTS: Each packet contains 20 grams lactulose (and less than 0.6 g galactose and lactose as a total sum). This unit dose packet is not child resistant. INDICATIONS: For the treatment of constipation. See accompanying package insert. USUAL ADULT DOSAGE: 10 to 20 grams daily. See accompanying package insert. Since lactulose does not exert its effect until it reaches the colon, and since transit time through the colon may be slow, 24-48 hours may be required to produce a normal bowl movement. DIRECTIONS FOR PREPARATION: Dissolve contents of packet in half a glass (4 ounces) of water. Store at room temperature, 15°-30°C (59°-86°F). Manufactured for: Cumberland Pharmaceuticals Inc. Nashville, TN, USA, 37203 Principal Display Panel – 20 Grams Pouch Label
Overview
KRISTALOSE (lactulose) is a synthetic disaccharide in the form of crystals for reconstitution prior to use for oral administration Each 10 g of lactulose contains less than 0.3 g galactose and lactose as a total sum. The pH range is 3.0 to 7.0. 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 formula is C 12 H 22 O 11 . The molecular weight is 342.30. It is freely soluble in water. Structural Formula
Indications & 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
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 & Precautions
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
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.
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.
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.
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