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NDC 00527-5120-68 LACTULOSE 10 g/15mL Details
LACTULOSE 10 g/15mL
LACTULOSE is a ORAL SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Lannett Company, Inc.. The primary component is LACTULOSE.
MedlinePlus Drug Summary
Lactulose is a synthetic sugar used to treat constipation. It is broken down in the colon into products that pull water out from the body and into the colon. This water softens stools. Lactulose is also used to reduce the amount of ammonia in the blood of patients with liver disease. It works by drawing ammonia from the blood into the colon where it is removed from the body. This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.
Related Packages: 00527-5120-68Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Lactulose
Product Information
| NDC | 00527-5120 |
|---|---|
| Product ID | 0527-5120_bfb6944f-ad8c-4bcf-98bf-b0eb806e9172 |
| Associated GPIs | 46600020002010 |
| GCN Sequence Number | 029054 |
| GCN Sequence Number Description | lactulose SOLUTION 10 G/15 ML ORAL |
| HIC3 | D6S |
| HIC3 Description | LAXATIVES AND CATHARTICS |
| GCN | 10167 |
| HICL Sequence Number | 001396 |
| HICL Sequence Number Description | LACTULOSE |
| Brand/Generic | Generic |
| Proprietary Name | LACTULOSE |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | LACTULOSE |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | SOLUTION |
| Route | ORAL |
| Active Ingredient Strength | 10 |
| Active Ingredient Units | g/15mL |
| Substance Name | LACTULOSE |
| Labeler Name | Lannett Company, Inc. |
| Pharmaceutical Class | Acidifying Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA074623 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 00527-5120-68 (00527512068)
| NDC Package Code | 0527-5120-68 |
|---|---|
| Billing NDC | 00527512068 |
| Package | 237 mL in 1 BOTTLE (0527-5120-68) |
| Marketing Start Date | 1996-07-30 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 8658d2ee-7708-47d0-bb93-74c1f4e17960 Details
DESCRIPTION
Lactulose is a synthetic disaccharide in solution form for oral administration. Each 15 mL of Lactulose Solution contains: 10 g lactulose (and less than 1.6 g galactose, less than 1.2 g lactose, and 1.2 g or less of other sugars). Also contains FD&C Yellow No. 6, purified water, and flavoring. Sodium hydroxide used to adjust pH. The pH range is 2.5 to 6.5.
Lactulose is a colonic acidifier which promotes laxation.
The chemical name for lactulose is 4-0-ß-D-galactopyranosyl-D-fructofuranose. It has the following structural formula:
The molecular weight is 342.30. It is freely soluble in water.
CLINICAL PHARMACOLOGY
Lactulose is poorly absorbed from the gastrointestinal tract, and no enzyme capable of hydrolysis of this disaccharide is present in human gastrointestinal tissue. As a result, oral doses of lactulose solution reach the colon virtually unchanged. In the colon, lactulose is broken down primarily to lactic acid, and also to small amounts of formic and acetic acids, by the action of colonic bacteria, which results in an increase in osmotic pressure and slight acidification of the colonic contents. This in turn causes an increase in stool water content and softens the stool.
Since lactulose does not exert its effect until it reaches the colon, and since transit time through the colon may be slow, 24 to 48 hours may be required to produce the desired bowel movement.
Lactulose solution given orally to man and experimental animals resulted in only small amounts reaching the blood.
Urinary excretion has been determined to be 3% or less and is essentially complete within 24 hours.
INDICATIONS AND USAGE
CONTRAINDICATIONS
WARNINGS
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 H2 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 CO2 as an additional safeguard may be pursued but is considered to be a redundant measure.
PRECAUTIONS
General:
Since lactulose solution contains galactose (less than1.6 g/15 mL) and lactose (less than 1.2 g/15 mL), it should be used with caution in diabetics.
Information for Patients:
In the event that an unusual diarrheal condition occurs, contact your physician.
Laboratory Tests:
Elderly, debilitated patients who receive lactulose solution for more than six months should have serum electrolytes (potassium, chloride, carbon dioxide) measured periodically.
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 solution.
Carcinogenesis, Mutagenesis, Impairment of Fertility:
There are no known human data on long-term potential for carcinogenicity, mutagenicity, or impairment of fertility.
There are no known animal data on long-term potential for mutagenicity.
Administration of lactulose solution in the diet of mice for 18 months in concentrations of 3 and 10 percent (V/W) did not produce any evidence of carcinogenicity.
In studies in mice, rats, and rabbits, doses of lactulose solution up to 6 or 12 mL/kg/day produced no deleterious effects in breeding, conception, or parturition.
Pregnancy:
Teratogenic Effects.
Pregnancy Category B: Reproduction studies have been performed in mice, rats, and rabbits at doses up to 3 or 6 times the usual human oral dose and have revealed no evidence of impaired fertility or harm to the fetus due to lactulose. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
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.
To report SUSPECTED ADVERSE REACTIONS, contact Lannett Company, Inc. at 1-844-834-0530.
OVERDOSAGE
DOSAGE AND ADMINISTRATION
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.
HOW SUPPLIED
NDC 0527-5120-68: 8 fl oz (237 mL) bottle
NDC 0527-5120-70: 16 fl oz (473 mL) bottle
NDC 0527-5120-78: 32 fl oz (946 mL) bottle
Lactulose solution contains lactulose 667 mg/mL (10 g/15 mL).
Store at controlled room temperature, 20°-25°C (68°-77°F). [See USP] Do not freeze.
Under recommended storage conditions, a normal darkening of color may occur. Such darkening is characteristic of sugar solutions and does not affect therapeutic action. Prolonged exposure to temperatures above 30°C (86°F) or to direct light may cause extreme darkening and turbidity which may be pharmaceutically objectionable. If this condition develops, do not use.
Prolonged exposure to freezing temperatures may cause change to a semisolid, too viscous to pour. Viscosity will return to normal upon warming to room temperature.
Keep tightly closed.
Dispense in original container or tight, light-resistant container with a child-resistant closure.
To the Pharmacist: When ordering this product, include the product number (or NDC) in the description.
PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label
NDC 0527-5120-70
Lactulose Solution USP
10 g/15 mL
Each 15 mL contains: 10 g lactulose (and less than
1.6 g galactose, less than 1.2 g lactose, and 1.2 g or
less of other sugars). Also contains FD&C Yellow
No. 6, purified water, and flavoring. Sodium hydroxide
used to adjust pH. The pH range is 2.5 to 6.5.
Dispense in original container or tight, light-resistant
container with a child-resistant closure.
To the Pharmacist: When ordering this product,
include the product number (or NDC) in the
description.
Rx ONLY
16 fl oz (473 mL)
Lannett
INGREDIENTS AND APPEARANCE
| LACTULOSE
lactulose solution |
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| Labeler - Lannett Company, Inc. (002277481) |