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Gastrointestinal System

Cimetidin STADA® 400 mg

 

Pack size:

Box of 5 blisters x 10 tablets.

 

Composition:

Each tablet contains cimetidine 400 mg.

 

Shelf -life:

60 months from the date of manufacturing.

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

 

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

Adults

  • Short-term treatment:
    Active duodenal ulcer.
    Maintenance therapy for duodenal ulcer patients at reduced dosage after ulcer healing.
    Active benign gastric ulcer and duodenal ulceration:
    A single daily dose of 800 mg at bedtime is recommended, which should be given for at least 4 weeks in the case of duodenal, and for at least 6 weeks in the case of gastric, ulcers. A maintenance dose of 400 mg may then be given once daily at bedtime, or twice daily in the morning and at bedtime.
    Gastro-oesophageal reflux disease:
    400 mg four times daily (with meals and at bedtime), or 800 mg twice daily, for 4 to 8 weeks.
    Pathological hypersecretory states such as the Zollinger-Ellison syndrome, multiple endocrine adenomas:
    300 mg or 400 mg four times daily is normally used, although sometimes higher doses may be necessary.
  • Treatment of upper gastrointestinal bleeding secondary to gastric ulcer, duodenal ulcer:
    200 mg to 400 mg every 4 to 6 hours.
  • Prevention of upper gastrointestinal bleeding in critically ill patient.
  • Patients at risk of acid aspiration (choked on lung) during general anaesthesia or child birth.
    A dose of 400 mg by mouth may be given 90 to 120 minutes before the induction of anaesthesia or at the start of labour.
  • Reduce malabsorption and fluid losing patient with the short bowel syndrome, reduce the degradation of enzyme supplements given to patients with pancreatic insufficiency.
    May be given cimetidine 800 to 1600 mg daily by mouth in 4 divided doses, 60 to 90 minutes before meals.
  • Patients with renal impairment:
    CC over 50 ml/minute: Normal dosage.
    CC 30 to 50 ml/minute: 200 mg four times daily.
    CC 15 to 30 ml/minute: 200 mg three times daily.
    CC 0 to 15 ml/minute: 200 mg twice daily.


Or as prescribed by physicians.

 

  • Patients with known hypersensitivity to cimetidine or to any ingredient of the drug.

     

  • Adverse reactions to cimetidine and other histamine H2-antagonists are generally infrequent. The commonest adverse effects reported have been diarrhoea and other gastrointestinal disturbances, dizziness, tiredness, headache, and rashes.
  • Altered liver function tests have occurred and there have been rare reports of hepatotoxicity. Reversible confusional states, especially in the elderly or in seriously ill patients such as those with renal failure, have occasionally occurred. Other adverse effects that have been reported rarely are hypersensitivity reactions and fever, arthralgia and myalgia, blood disorders including agranulocytosis and thrombocytopenia, acute pancreatitis, hallucinations and depression, and cardiovascular disorders including bradycardia and heart block.
  • Cimetidine has a weak anti-androgenic effect and gynaecomastia and impotence have also occasionally occurred in men receiving relatively high doses for conditions such as the Zollinger-Ellison syndrome.

     

  • Before giving cimetidine or other histamine H2-antagonists to patients with gastric ulcers the possibility of malignancy should be considered since these drugs may mask symptoms and delay diagnosis.
  • Pregnancy: There are no adequate and controlled studies to date using cimetidine in pregnant women, and the drug should be used during pregnancy only when clearly needed.
    Lactation: Since cimetidine is distributed into milk, nursing should generally not be undertaken during therapy with the drug.
  • Effect on ability to drive and use machines: None known.

     

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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