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.
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
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
GENERLAC lactulose solution | |||||||||||||||||
| |||||||||||||||||
| |||||||||||||||||
| |||||||||||||||||
|
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.
All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.