CONSTULOSE- lactulose solution

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

LACTULOSE (UNII: 9U7D5QH5AE) (LACTULOSE - UNII:9U7D5QH5AE)

제공처:

Actavis Pharma, Inc.

INN (국제 이름):

LACTULOSE

구성:

LACTULOSE 10 g in 15 mL

관리 경로:

ORAL

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

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

제품 요약:

Lactulose Solution, USP is a natural colored and an unflavored solution available in 8 fl oz (237 mL) and 1 quart (946 mL) bottles. Lactulose Solution, USP contains lactulose 670 mg/mL (10 g/15 mL). Store between 36° to 86°F (2° to 30°C). 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 and packaged by: Fresenius Kabi Austria GmbH Estermannstraße 17 4020 Linz, Austria Manufactured for: Teva Pharmaceuticals Parsippany, NJ 07054 USA Revised – June 2022

승인 상태:

Abbreviated New Drug Application

제품 특성 요약

CONSTULOSE- LACTULOSE SOLUTION
ACTAVIS PHARMA, INC.
----------
(LACTULOSE SOLUTION USP, 10 G/15 ML)
DESCRIPTION
Lactulose is a synthetic disaccharide in solution form for oral
administration. Each 15 mL
of lactulose solution, USP contains: 10 g lactulose (and less than 1.6
g galactose, less
than 1.2 g lactose, and 0.1 g or less of fructose).
Lactulose is a colonic acidifier which promotes laxation.
The chemical name for lactulose is
4-O-_β_-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 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
lactu