NDC 0121-4577 Lactulose
Solution Oral

Product Information

Product Code0121-4577
Proprietary Name What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Lactulose
Non-Proprietary Name What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Lactulose
Product Type What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
Human Prescription Drug
Dosage FormSolution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
Administration Route(s) What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.
  • Oral - Administration to or by way of the mouth.
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.
Pharmaceutical Associates, Inc,
Labeler Code0121
FDA Application Number What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
ANDA074623
Marketing Category What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
07-30-1966
Listing Expiration Date What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.
12-31-2022
Exclude Flag What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".
N
NDC Code Structure

Usage Information


Product Characteristics

Color(s)YELLOW (C48330 - YELLOW-ORANGE)
Flavor(s)PINEAPPLE (C73409 - PINEAPPLE-ORANGE)

Product Packages

NDC 0121-4577-06

Package Description: 6 CARTON in 1 CASE > 16 CUP, UNIT-DOSE in 1 CARTON > 15 mL in 1 CUP, UNIT-DOSE

NDC 0121-4577-15

Package Description: 15 mL in 1 CUP, UNIT-DOSE

NDC 0121-4577-40

Package Description: 4 TRAY in 1 CASE > 10 CUP, UNIT-DOSE in 1 TRAY > 15 mL in 1 CUP, UNIT-DOSE

Product Details

Lactulose is a human prescription drug product labeled by Pharmaceutical Associates, Inc,. The product's dosage form is solution and is administered via oral form.


What are Lactulose Active Ingredients?

The following is the list of active ingredients in this product. An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.


NDC to RxNorm Crosswalk

What is RxNorm? RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct code indicates a single concept unique identifier (RXCUI) is associated with this product:


Inactive Ingredient(s)

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)


Pharmacologic Class(es)

A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.


* Please review the disclaimer below.

Patient Education

Lactulose

Lactulose is pronounced as (lak' tyoo lose)

Why is lactulose medication prescribed?
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 s...
[Read More]

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Lactulose Labeling and Warnings

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



Other



I05770920
R09/20

Rx ONLY


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



For the treatment of constipation. In patients with a history of chronic constipation, lactulose solution therapy increases the number of bowel movements per day and the number of days on which bowel movements occur.


Contraindications



Since lactulose solution contains galactose (less than 1.6 g/15 mL), it is contraindicated in patients who require a low galactose diet.


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 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.


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 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.


Nursing Mothers



It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when lactulose solution is administered to a nursing woman.


Pediatric Use



Safety and effectiveness in pediatric patients have not been established.


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 Pharmaceutical Associates, Inc. at 1-800-845-8210.


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.


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 0121-0577-08:    8 fl oz (237 mL) bottles
NDC 0121-0577-16:    16 fl oz (473 mL) bottles
NDC 0121-0577-32:    32 fl oz (946 mL) bottle

NDC 0121-4577-15:    15 mL unit dose cup
NDC 0121-4577-40:    Case contains 40 unit dose cups of 15 mL (0121-4577-15) packaged in 4 trays of 10 unit dose cups each.

NDC 0121-4577-06:    Case contains 96 unit dose cups of 15 mL (0121-4577-15) packaged in 6 cartons of 16 unit dose cups each.

NDC 0121-1154-30:    30 mL unit dose cup
NDC 0121-1154-40:    Case contains 40 unit dose cups of 30 mL (0121-1154-30) packaged in 4 trays of 10 unit dose cups each.
NDC 0121-1154-00:    Case contains 100 unit dose cups of 30 mL (0121-1154-30) packaged in 10 trays of 10 unit dose cups each.

NDC 0121-1154-06:    Case contains 96 unit dose cups of 30 mL (0121-1154-30) packaged in 6 cartons of 16 unit dose cups each.

Lactulose solution contains lactulose 667 mg/mL (10 g/15 mL).


Storage And Handling



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.


Manufactured By



pai
Pharmaceutical
Associates, Inc.

Greenville, SC 29605

R02/19


Principal Display Panel - 473 Ml Bottle Label



NDC 0121-0577-16

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)

Pharmaceutical
Associates, Inc.

Greenville, SC 29605


Principal Display Panel - 15 Ml Cup Lid



UNIT DOSE
Delivers 15 mL
NDC 0121-4577-15

LACTULOSE
SOLUTION USP 10 g/15 mL

Indication: For the treatment
of constipation. See Insert.
FOR INSTITUTIONAL USE ONLY

Rx ONLY
PHARMACEUTICAL ASSOCIATES, INC.
GREENVILLE, SC 29605

F45771500


Principal Display Panel - 30 Ml Cup Lid - Ndc 0121-1154-30



UNIT DOSE
Delivers 30 mL
NDC 0121-1154-30

LACTULOSE
SOLUTION USP 20 g/30 mL

Indication: For the treatment
of constipation. See Insert.
FOR INSTITUTIONAL USE ONLY

Rx ONLY
PHARMACEUTICAL ASSOCIATES, INC.
GREENVILLE, SC 29605

A45773001


* Please review the disclaimer below.