Generlac (Page 2 of 2)

Pediatric

Very little information on the use of lactulose in young children and adolescents has been recorded. As with adults, the subjective goal in proper treatment is to produce 2 to 3 soft stools daily. On the basis of information available, the recommended initial daily oral dose in infants is 2.5 to 10 mL in divided doses. For older children and adolescents, the total daily dose is 40 to 90 mL. If the initial dose causes diarrhea, the dose should be reduced immediately. If diarrhea persists, Generlac Solution should be discontinued.

Rectal

When the adult patient is in the impending coma or coma stage of portal-systemic encephalopathy and the danger of aspiration exists, or when the necessary endoscopic or intubation procedures physically interfere with the administration of the recommended oral doses, Generlac Solution may be given as a retention enema via a rectal balloon catheter. Cleansing enemas containing soapsuds or other alkaline agents should not be used.

Three hundred mL of Generlac Solution should be mixed with 700 mL of water or physiologic saline and retained for 30 to 60 minutes. Generlac Solution enema may be repeated every 4 to 6 hours. If the enema is inadvertently evacuated too promptly, it may be repeated immediately.

The goal of treatment is reversal of the coma stage in order that the patient may be able to take oral medication. Reversal of coma may take place within 2 hours of the first enema in some patients. Generlac Solution, given orally in the recommended doses, should be started before Generlac Solution by enema is stopped entirely.

HOW SUPPLIED

Generlac Solution (Lactulose Solution, USP, 10 g/15 mL) is a colorless to yellow, unflavored solution containing 10 g of lactulose/15 mL (667 mg lactulose/mL). It is available in the following container sizes:

  • 1 Pint (473 mL) bottles (NDC 60432-038-16)
  • 2 Quart (1892 mL) bottles (NDC 60432-038-64)

STORAGE AND HANDLING

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

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 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 with child-resistant closure as defined in the USP.

To The Pharmacist: When ordering this product, include the product number (or NDC) in the description.

Rx Only

Product No.: 8038

Manufactured For:

Morton Grove Pharmaceuticals, Inc.

Morton Grove, IL 60053

Packaged By:

Morton Grove Pharmaceuticals, Inc.

Morton Grove, IL 60053

Distributed by:

Wockhardt USA, LLC.

Parsippany, NJ 07054

A50-8038-64

REV. 09-18

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

WOCKHARDT

NDC 60432-038-64

GENERLAC

SOLUTION

10 g/15 mL

(Lactulose Solution, USP)

For Oral or Rectal Administration

INDICATIONS: FOR THE PREVENTION

AND TREATMENT OF PORTAL-SYSTEMIC

ENCEPHALOPATHY. SEE INSERT

LABELING FOR FULL INFORMATION.

DO NOT USE IF INNER FOIL SEAL PRINTED “SEALED

FOR YOUR PROTECTION” IS BROKEN OR MISSING.

BULK CONTAINER —

NOT FOR HOUSEHOLD USE

Rx Only

NET: 2 Quarts (1892 mL)

Generlac Label
(click image for full-size original)

Generlac Label

GENERLAC
lactulose solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60432-038
Route of Administration ORAL, RECTAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LACTULOSE (LACTULOSE) LACTULOSE 10 g in 15 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:60432-038-16 473 mL in 1 BOTTLE, PLASTIC None
2 NDC:60432-038-64 1892 mL in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA074603 10/31/1996
Labeler — Morton Grove Pharmaceuticals, Inc. (801897505)
Registrant — Morton Grove Pharmaceuticals, Inc. (801897505)
Establishment
Name Address ID/FEI Operations
Morton Grove Pharmaceuticals, Inc. 801897505 ANALYSIS (60432-038), LABEL (60432-038), REPACK (60432-038)

Revised: 01/2019 Morton Grove Pharmaceuticals, Inc.

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