Lactulose (Page 2 of 2)

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, lactulose solution may be given as a retention enema via a rectal balloon catheter. Cleansing enemas containing soap suds or other alkaline agents should not be used.

Three hundred mL of lactulose solution should be mixed with 700 mL of water or physiologic saline and retained for 30 to 60 minutes. Lactulose enema may be repeated every 4 to 6 hours. If this lactulose 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. Lactulose given orally in the recommended doses, should be started before lactulose by enema is stopped entirely.

HOW SUPPLIED

Lactulose Solution, USP, 10 g/15 mL is a clear, colorless to pale brownish-yellow viscous, unflavored solution supplied in 8 fl oz (237 mL) NDC # 39328-541-08, 16 fl oz (473 mL) NDC # 39328-541-16 and 32 fl oz (946 mL) NDC # 39328-541-32 bottles. Lactulose Solution contains: 667 mg lactulose / mL (10 g/15 mL).

Store between 2° to 30°C (36° to 86°F). 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 86°F (30°C) 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 a tight, light-resistant container as defined in the USP, with a child-resistant closure.

Manufactured by:
Bio-Pharm, Inc.
Levittown, PA 19057

Manufactured for:
Patrin Pharma, Inc.
Skokie, IL 60076

Rev. 07/16

PRINCIPAL DISPLAY PANEL — 237 mL Bottle Label

Rx Only

NDC
39328- 541 -08

Lactulose Solution, USP

10 g/15 mL

For Oral or Rectal Administration

8 fl oz (237 mL)

PATRIN
PHARMA

PRINCIPAL DISPLAY PANEL -- 237 mL Bottle Label
(click image for full-size original)
LACTULOSE
lactulose liquid
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:39328-541
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:39328-541-08 237 mL in 1 BOTTLE None
2 NDC:39328-541-16 473 mL in 1 BOTTLE None
3 NDC:39328-541-32 946 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203762 09/01/2016 03/31/2019
Labeler — Patrin Pharma (806841677)

Revised: 01/2019 Patrin Pharma

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