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Lactulose

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Overview

What is Constulose?

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--D-galactopyranosyl-D-fructofuranose. It has the following structural formula:

The molecular weight is 34230. It is freely soluble in water.



What does Constulose look like?



What are the available doses of Constulose?

Sorry No records found.

What should I talk to my health care provider before I take Constulose?

Sorry No records found

How should I use Constulose?

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.

The usual dose is 1 to 2 tablespoonfuls (15 to 30 mL, containing 10 g to 20 g of lactulose) daily. The dose may be increased to 60 mL daily if necessary. Twenty-four to 48 hours may be required to produce a normal bowel movement.

Note: Some patients have found that lactulose solution may be more acceptable when mixed with fruit juice, water or milk.


What interacts with Constulose?

Sorry No Records found


What are the warnings of Constulose?

Sorry No Records found


What are the precautions of Constulose?

Sorry No Records found


What are the side effects of Constulose?

Sorry No records found


What should I look out for while using Constulose?

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

A theoretical hazard may exist for patients being treated with lactulose solution who may be required to undergo electrocautery procedures during proctoscopy or colonoscopy. Accumulation of H gas in significant concentration in the presence of an electrical spark may result in an explosive reaction. Although this complication has not been reported with lactulose, patients on lactulose therapy undergoing such procedures should have a thorough bowel cleansing with a non-fermentable solution. Insufflation of CO as an additional safeguard may be pursued but is considered to be a redundant measure.


What might happen if I take too much Constulose?

Signs and Symptoms:

There have been no reports of accidental overdosage. In the event of overdosage, it is expected that diarrhea and abdominal cramps would be the major symptoms. Medication should be terminated.

Oral LD

:

.

Dialysis:


How should I store and handle Constulose?

Care should be exercised in handling of THALOMID. THALOMID capsules should not be opened or crushed. If powder from THALOMID contacts the skin, wash the skin immediately and thoroughly with soap and water. If THALOMID contacts the mucous membranes, flush thoroughly with water. Procedures for proper handling and disposal of anticancer drugs should be considered. Several guidelines on the subject have been published.Rx only and only able to be prescribed and dispensed under the terms of the THALOMID REMS Restricted Distribution Program.Care should be exercised in handling of THALOMID. THALOMID capsules should not be opened or crushed. If powder from THALOMID contacts the skin, wash the skin immediately and thoroughly with soap and water. If THALOMID contacts the mucous membranes, flush thoroughly with water. Procedures for proper handling and disposal of anticancer drugs should be considered. Several guidelines on the subject have been published.Rx only and only able to be prescribed and dispensed under the terms of the THALOMID REMS Restricted Distribution Program.Care should be exercised in handling of THALOMID. THALOMID capsules should not be opened or crushed. If powder from THALOMID contacts the skin, wash the skin immediately and thoroughly with soap and water. If THALOMID contacts the mucous membranes, flush thoroughly with water. Procedures for proper handling and disposal of anticancer drugs should be considered. Several guidelines on the subject have been published.Rx only and only able to be prescribed and dispensed under the terms of the THALOMID REMS Restricted Distribution Program.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 GmbHEstermannstraße 174020 Linz AustriaDistributed by:Actavis Pharma, Inc.Parsippany, NJ 07054 USARev. March 2016Lactulose 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 GmbHEstermannstraße 174020 Linz AustriaDistributed by:Actavis Pharma, Inc.Parsippany, NJ 07054 USARev. March 2016Lactulose 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 GmbHEstermannstraße 174020 Linz AustriaDistributed by:Actavis Pharma, Inc.Parsippany, NJ 07054 USARev. March 2016Lactulose 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 GmbHEstermannstraße 174020 Linz AustriaDistributed by:Actavis Pharma, Inc.Parsippany, NJ 07054 USARev. March 2016Lactulose 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 GmbHEstermannstraße 174020 Linz AustriaDistributed by:Actavis Pharma, Inc.Parsippany, NJ 07054 USARev. March 2016Lactulose 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 GmbHEstermannstraße 174020 Linz AustriaDistributed by:Actavis Pharma, Inc.Parsippany, NJ 07054 USARev. March 2016Lactulose 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 GmbHEstermannstraße 174020 Linz AustriaDistributed by:Actavis Pharma, Inc.Parsippany, NJ 07054 USARev. March 2016Lactulose 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 GmbHEstermannstraße 174020 Linz AustriaDistributed by:Actavis Pharma, Inc.Parsippany, NJ 07054 USARev. March 2016Lactulose 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 GmbHEstermannstraße 174020 Linz AustriaDistributed by:Actavis Pharma, Inc.Parsippany, NJ 07054 USARev. March 2016


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Clinical Information

Chemical Structure

No Image found
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.

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

A theoretical hazard may exist for patients being treated with lactulose solution who may be required to undergo electrocautery procedures during proctoscopy or colonoscopy. Accumulation of H gas in significant concentration in the presence of an electrical spark may result in an explosive reaction. Although this complication has not been reported with lactulose, patients on lactulose therapy undergoing such procedures should have a thorough bowel cleansing with a non-fermentable solution. Insufflation of CO as an additional safeguard may be pursued but is considered to be a redundant measure.

Results of preliminary studies in humans and rats suggest that non-absorbable antacids given concurrently with lactulose may inhibit the desired lactulose-induced drop in colonic pH. Therefore, a possible lack of desired effect of treatment should be taken into consideration before such drugs are given concomitantly with lactulose solution.

Since lactulose solution contains galactose (less than 1.6 g/15 mL) and lactose (less than 1.2 g/15 mL) it should be used with caution in diabetics.

Precise frequency data are not available.

Initial dosing may produce flatulence and intestinal cramps, which are usually transient. Excessive dosage can lead to diarrhea with potential complications such as loss of fluids, hypokalemia, and hypernatremia.

Nausea and vomiting have been reported.

To report SUSPECTED ADVERSE EVENTS, contact the FDA at 1-800-FDA-1088 or http://www.fda.gov/ for voluntary reporting of adverse reactions.

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Interactions

Interactions

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