LACTULOSE solution

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

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

Tillgänglig från:

Chartwell RX, LLC.

Administreringssätt:

ORAL

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

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 C 12 H 22 O 11 . It has the following structural formula: The molecular weight is 342.30. It is freely soluble in water.

Produktsammanfattning:

Lactulose Solution is a colorless to amber syrupy liquid. It is available in 8 fl oz (237 mL)   (NDC 62135-003-37), 16 fl oz (473 mL) (NDC 62135-003-47), 32 fl oz (946 mL)  (NDC 62135-003-94) and 4 Quarts (3785 mL) (NDC 62135-003-78) 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 for: Chartwell RX, LLC. Congers, NY 10920 L70427       Rev: 09/2020 

Bemyndigande status:

Abbreviated New Drug Application

Produktens egenskaper

LACTULOSE- LACTULOSE SOLUTION
CHARTWELL RX, LLC.
----------
LACTULOSE SOLUTION
LACTULOSE SOLUTION, USP
FOR ORAL ADMINISTRATION
RX ONLY
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 C
H
O
. 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
12
22
11
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.
INDICATION 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.
CONTRAINDICTIONS
Since lactulose solution contains galactose (less than 1.6 g/15 mL),
it is contraindicated
in