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Gastrointestinal System

Lactulose STADA®

 

Pack sizes:

Box of 20 sachets x 15 ml.

Box of 1 bottle x 225 ml.


Composition:

Each 15 ml of solution contains lactulose 10 g.

 

Shelf-life:  

24 months from the date of manufacturing.

In-use shelf-life: 30 days from the date of first opening.

Store in a well-closed container, in a dry place. Do not store above 30°C.

 

  • Indications and Dosage & Administration
  • Contraindications
  • Adverse reactions
  • Precautions

For the treatment of:

  • Chronic constipation.
  • Hepatic encephalopathy (HE), hepatic coma.
  • Lactulose STADA® is administered orally. In case of single daily dose, this should be taken at the same time.
    During the therapy with laxatives it is recommended to drink sufficient amounts of fluids (1.5-2 litres, equal to 6-­ 8 glasses) during the day.
     
  • Chronic constipation
    Adults:
    10-20 g lactulose (15 - 30 ml of oral solution) daily, given in a single dose or in 2 divided doses, increase to 40 g lactulose (60 ml of oral solution) daily if necessary.
    The dose should be adjusted to the needs of the individual.
    Paediatric:
    The following oral doses should be recommended, doses may be adjusted according to response:
    Infants (1 month to 1 year): 2.5 ml of oral solution twice daily.
    Children aged 1 to 5 years: 5 ml of oral solution twice daily.
    Children aged 5 to 10 years: 10 ml of oral solution twice daily.
    Children aged 10 to 18 years: 15 ml of oral solution twice daily.
    To restore bowel movements in hemorrhoidectomy patients:
    10 g lactulose (15 ml of oral solution) was given twice during the day before surgery and twice daily for 5 days postoperatively.
    To induce bowel evacuation in geriatric patients with colonic retention of barium and severe constipation:
    3.3-6.7 g lactulose (5-10 ml of oral solution) twice daily for 1-4 weeks.
     
  • Hepatic encephalopathy (HE)
    Adults:
    Initially 20-30 g lactulose (30-45 ml of oral solution) 3 times daily. Subsequently adjust the dose every 1-2 days as necessary to produce two or three soft stools each day.
    Improvement in the clinical condition of the patient usually occurs within 1-3 days.
    The duration of treatment depends on clinical symptoms.
    The dosage can be adjusted according to the acidity of the colonic contents by measuring stool pH (with indicator paper) at the start of therapy and adjusting the dosage until stool pH is about 5, which is usually achieved when the patient has 2 or 3 soft stools daily during lactulose therapy.
    Continuous long-term therapy with lactulose may decrease the severity and prevent the recurrence of PSE/HE (Portal-Systemic Encephalopathy or Hepatic Encephalopathy).
    Treatment of acute episodes of hepatic encephalopathy in adults:
    20-30 g lactulose (30-45 ml of oral solution), given at 1- to 2- hour intervals to induce rapid laxation. When the laxative effect has been achieved, the dose of lactulose is reduced to the amount required to produce 2 or 3 soft stools daily.
    Hepatic pre-coma or coma:
    Lactulose is used rectally, and other preparation is recommended.
    Paediatric:
    The safety and efficacy in children (newborn to 18 years of age) with HE have not been established. No data are available .


Or as advised by physicians.
 

  • Hypersensitivity to any component.
  • Patients with galactosemia or requiring a low lactose diet.

 

Common: 

  • Flatulence, diarrhoea.

Uncommon:

  • Abdominal discomfort, nausea, vomiting, hypematremia.

     

  • Painful abdominal symptoms of undetermined cause before the treatment is started.
  • Insufficient therapeutic effect after several days.
  • Lactulose should be administered with care to patients who are intolerant to lactulose.
  • The dose normally used in constipation should not pose a problem for diabetics.
  • The dose used in the treatment of HE is usually much higher and may need to be taken into consideration for diabetics.
  • Chronic use of unadjusted doses and misuse can lead to diarrhoea and disturbance of the electrolyte balance.
  • Lactulose STADA® contains lactose, galactose and small amounts of fructose. Patients with rare hereditary problems of galactose or fructose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicines.
  • Use of laxatives in children should be exceptional and under medical supervision.
     
  • Pregnancy: No effects during pregnancy are anticipated, since systemic exposure to lactulose is negligible. Lactulose can be used during pregnancy.
  • Lactation: No effects on the breastfed newborn/infant are anticipated since the systemic exposure of the breast-feeding woman to lactulose is negligible. Lactulose can be used during breast-feeding.
     
  • Lactulose STADA® has no or negligible influence on the ability to drive and use machines.

     

Contact us

FACTORY 1: K63/1 Nguyen Thi Soc St., Xuan Thoi Dong, Hoc Mon, HCMC
Tel: +84 28 3718 2141 - Fax: +84 28 3718 2140

FACTORY 2: 40 Tu Do Avenue, VietNam-Singapore Industrial Park, Binh Duong
Tel: +84 274 376 7470 - Fax: +84 274 376 7469
Email : stada@stada.com.vn
Website: www.stada.com.vn



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