Trade Name: LACTULOSE

Following information is meant for : Wholesalers, Suppliers, Exporters, Doctors, CROs, Comparator Supplies, Hospitals, MOH Tender Supplies, Generic, Brand, Cooperate Sourcing, India, Institutional Buyers.

Manufacturer: VistaPharm, Inc.

Presentation: SOLUTION, HUMAN PRESCRIPTION DRUG

Strength: 10 g/15mL

Storage and handling

LACTULOSE Osmotic Laxative [EPC],Osmotic Activity [MoA],Acidifying Activity [MoA],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]

Disclaimer:
  1. These products are NOT FOR SALE in US territories. We offer them for Exports outside of US Territories to Trade Professionals or patients with a valid prescription.
  2. Trademark shown are property of their respective owners and GNH India does not lay any claim on them.
  3. Read more
  • No data
  • Lactulose is a synthetic disaccharide in solution form for oral administration. Each 15 mL of lactulose solution contains: 10 g lactulose (and less than 16 g galactose, less than 12 g lactose, and 1.2 g of other sugars). Also contains FD&C Yellow No. 6, purified water, USP and wild cherry flavoring. A minimal quantity of sodium hydroxide, NF is used to adjust pH when necessary. 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-u03b2-D-galactopyranosyl-D-fructofuranose. It has the following structural formula:
  • CHOn
  • The molecular weight is 34230. It is freely soluble in water.
  • 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.
  • 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 16 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.
  • No data
  • 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.
  • 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.
  • 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.
  • Lactulose Solution is available as a cherry-flavored solution, 10 g/15 mL, supplied as follows:
  • NDC 66689-039-01: 15 mL unit dose cup.
  • NDC 66689-039-50: Case contains 50 unit dose cups of 15 mL (66689-039-01), packaged in 5 trays of 10 unit dose cups each.
  • Lactulose Solution is available as a cherry-flavored solution, 20 g/30 mL, supplied as follows:
  • NDC 66689-038-01: 30 mL unit dose cup.
  • NDC 66689-038-50: Case contains 50 unit dose cups of 30 mL (66689-038-01), packaged in 5 trays of 10 unit dose cups each.
  • NDC 66689-038-99: Case contains 100 unit dose cups of 30 mL (66689-038-01), packaged in 10 trays of 10 unit dose cups each.
  • Lactulose Solution contains lactulose 667 mg/mL (10 g/15 mL).
  • When ordering this product, include the product code number or NDC in the description.
  • Store at 20u00b0-25u00b0C (68u00b0-77u00b0F) [See USP Controlled Room Temperature]. Avoid subfreezing temperatures.
  • 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 86u00b0F (30u00b0C) 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.
  • Rx Only.
  • Manufactured by:n n
  • VP2051R210/19
  • Xact DOSEu2122
  • LACTULOSESOLUTION, USP20 g/30 mL
  • NDC 66689-038-01
  • INDICATIONS AND DOSAGE: For thetreatment of constipation. See insert.Avoid subfreezing temperatures.Store at 20u00b0u201325u00b0C (68u00b0u201377u00b0F)[See USP CONTROLLED RM TEMP]
  • Rx Only u00a0u00a0u00a0u00a0This cup delivers 30 mL
  • Manufactured by VistaPharm, Inc.Largo, FL 33771
  • Xact DOSEu2122
  • LACTULOSESOLUTION, USP10 g/15 mL
  • NDC 66689-039-01
  • INDICATIONS AND DOSAGE: For thetreatment of constipation. See insert.Avoid subfreezing temperatures.Store at 20u00b0u201325u00b0C (68u00b0u201377u00b0F)[See USP CONTROLLED RM TEMP]
  • Rx Only u00a0u00a0u00a0u00a0This cup delivers 15 mL
  • Manufactured by VistaPharm, Inc.Largo, FL 33771

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler, Supplier, Exporters from India of LACTULOSE (LACTULOSE) which is also known as LACTULOSE and Manufactured by VistaPharm, Inc.. It is available in strength of 10 g/15mL.

LACTULOSE (LACTULOSE) is supplied for Tenders, Emergency imports, Un - licensed, Specials, Orphan drug, Name patient line, RLD supplies, Reference listed drugs, Comparator Drug, Bio-Similar, Innovator samples, For Clinical trials. Click to know price.

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