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Gastrointestinal System

Misoprostol STADA® 200 mcg

 

Pack size:

Box of 3 blisters x 10 tablets.

 

Composition:

Each tablet contains misoprostol 200 mcg.

 

Shelf-life:  

36 months from the date of manufacturing.

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

 

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

  • Reducing the risk of nonsteroidal anti-inflammatory agent-induced gastric ulcer in patients at high risk of developing gastric ulceration and complications from these ulcers.
  • Short-term treatment of active duodenal ulcer and active benign gastric ulcer.
  • Maintenance therapy following healing of gastric ulcer to reduce ulcer recurrence.
  • Adjunct to mifepristone for the medical termination of intrauterine pregnancy.
  • Administered orally. The incidence of misoprostol induced diarrhea may be minimized by administering the drug in divided doses after meals and at bedtime and by avoiding concomitant administration with a magnesium-containing or other laxative antacid.
     
  • Prevention of NSAID-induced ulcers:
    Usual adult dosage:200 mcg 4 times daily. Dosage can be reduced to 100 mcg 4 times daily in patients who do not tolerate the usual dosage; however, this reduced dosage may be somewhat less effective.
    Misoprostol dosages of 200 mcg twice daily also have been used.
  • Gastric ulcer:
    Adults: 100 or 200 mcg 4 times daily for 8 weeks.
  • Duodenal ulcer:
    Adults: 100 or 200 mcg 4 times daily or 400 mcg twice daily for 4-8 weeks have been used in adults. 
  • Termination of pregnancy:
    400 mcg of misoprostol is administered orally on day 3 (2 days after mifepristone administration) unless abortion has occurred and has been confirmed by clinical examination or ultrasonographic scan.
  • Dosage in renal impairment and in geriatric patients:
    Routine reduction of misoprostol dosage in patients with renal impairment or in geriatric patients does not appear to be necessary; however, if patients are unable to tolerate the usual adult dosage, dosage can be reduced.


Or as prescribed by physicians.

 

  • Misoprostol is contraindicated in pregnant women and in women planning a pregnancy as it increases uterine tone and contractions in pregnancy which may cause partial or complete expulsion of the products of conception. Use in pregnancy has been associated with birth defects.
  • Patients with a known allergy to prostaglandins.
  • Safety and efficacy of misoprostol in children younger than 18 years of age have not been established.

     

  • The commonest adverse effect of misoprostol is diarrhea.
  • Other gastrointestinal effects include abdominal pain, dyspepsia, flatulence, nausea and vomiting. Increased uterine contractility and abnormal vaginal bleeding (including menorrhagia and intermenstrual bleeding) have been reported. Other adverse effects include skin rashes, headache, dizziness.
  • Hypotension is rarely seen at doses recommended for peptic ulcer disease.

     

  • Because severe adverse cardiovascular effects have been reported with misoprostol, the drug should be used with caution in patients with pre-existing cardiovascular disease.
  • Misoprostol may exacerbate intestinal inflammation and produce severe diarrhea in patients with inflammatory bowel disease, the drug should be used with extreme caution in these patients and their condition monitored carefully. Because dehydration rarely may occur secondary to misoprostol-induced diarrhea, the drug also should be used with careful monitoring in patients prone to dehydration or in whom its consequences would be dangerous.Pregnancy
  • Misoprostol exhibits abortifacient activity and therefore can cause serious fetal harm when administered to pregnant women. Misoprostol should not be used in pregnant women or in such women until the possibility of pregnancy has been excluded and an effective method of contraception has been started.
  • It is not known if the active metabolite of misoprostol is excreted in breast milk, therefore misoprostol should not be administered during breast feeding.

     

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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