NDC 70436-003 Lactulose Solution

Lactulose Solution

NDC Product Code 70436-003

NDC Code: 70436-003

Proprietary Name: Lactulose Solution 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.

Non-Proprietary Name: Lactulose Solution 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.


Code Structure
  • 70436 - Slate Run Pharmaceuticals Llc
    • 70436-003 - Lactulose Solution

NDC 70436-003-10

Package Description: 100 mL in 1 BOTTLE

NDC 70436-003-11

Package Description: 120 mL in 1 BOTTLE

NDC 70436-003-13

Package Description: 200 mL in 1 BOTTLE

NDC 70436-003-14

Package Description: 300 mL in 1 BOTTLE

NDC 70436-003-16

Package Description: 500 mL in 1 BOTTLE

NDC 70436-003-18

Package Description: 1000 mL in 1 BOTTLE

NDC Product Information

Lactulose Solution with NDC 70436-003 is a a human prescription drug product labeled by Slate Run Pharmaceuticals Llc. The generic name of Lactulose Solution is lactulose solution. The product's dosage form is solution and is administered via oral form.

Labeler Name: Slate Run Pharmaceuticals Llc

Dosage Form: Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.

Product Type: Human Prescription Drug 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.


Lactulose Solution Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • LACTULOSE 10 g/15mL

Inactive Ingredient(s)

About the 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.

  • GALACTOSE (UNII: X2RN3Q8DNE)
  • LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)
  • WATER (UNII: 059QF0KO0R)

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.

Pharmacological Class(es)

What is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

  • Osmotic Laxative - [EPC] (Established Pharmacologic Class)
  • Osmotic Activity - [MoA] (Mechanism of Action)
  • Acidifying Activity - [MoA] (Mechanism of Action)
  • Stimulation Large Intestine Fluid/Electrolyte Secretion - [PE] (Physiologic Effect)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Slate Run Pharmaceuticals Llc
Labeler Code: 70436
FDA Application Number: ANDA209517 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.

Marketing Category: ANDA - A product marketed under an approved Abbreviated New Drug Application. 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.

Start Marketing Date: 04-01-2019 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2019 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.

Exclude Flag: N 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. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Lactulose Solution Product Label Images

Lactulose Solution Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

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 water. The pH range is 2.5 to 6.5.Lactulose is a colonic acidifier which promotes laxation.The chemical name for lactulose is 4-O-β-D-galactopyranosyl-D-fructofuranose. The molecular formula is C12H22O11. 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 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 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 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.

General

Since lactulose solution contains galactose (less than 1.6 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 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 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.

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 of 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 EffectsPregnancy 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 Slate Run Pharmaceuticals, LLC at 1-888-341-9214 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Overdosage

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 LD50: The acute oral LD50 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

Lactulose Solution is a colorless to amber syrupy liquid. It is available in 100 mL (NDC 70436-003-10), 120 mL (NDC 70436-003-11), 200 mL (NDC 70436-003-13), 300 mL (NDC 70436-003-14), 500 mL (NDC 70436-003-16), and 1000 mL (NDC 70436-003-18) bottles.Lactulose Solution USP contains 667 mg/mL (10 g/15 mL).Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Do not freeze. Keep tightly closed.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 semi-solid, too viscous to pour. Viscosity will return to normal upon warming to room temperature.Dispense in original container or in a tight, light-resistant container as defined in the USP, with a child-resistant closure.Manufactured and Packaged by: LIFEPharma FZE, Jebel Ali Free Zone, Dubai, United Arab Emirates Distributed by: Slate Run Pharmaceuticals, LLC, Columbus, Ohio 43215Rev. August 201710000013/01

Package/Label Display Panel

NDC 70436-003-11, 120 mL Bottle

NDC 70436-003-13, 200 mL Bottle

NDC 70436-003-14, 300 mL Bottle

NDC 70436-003-16, 500 mL Bottle

NDC 70436-003-18, 1000 mL Bottle

* Please review the disclaimer below.

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