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Analgesics & Antipyretics

Colchicine STADA® 1 mg

 

Pack size:

Box of 2 blisters x 10 tablets.

 

Composition: 
Each tablet contains colchicine 1.0 mg.

 

Shelf-life:

24 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
  • Adverse reactions
  • Precautions

  • For treatment ofacute gout and for short-term prophylaxis during initial therapy with allopurinol and uricosuric drugs.
     
  • Adults:
    Gout:
    1 mg initially, followed by 0.5 mg every two to three hours until reliefofpain is obtained or vomiting or diarrhoeaoccurs. A total dose of 6 mg should not be exceeded. The course should not be repeated within three days.
    Foruse with allopurinoloruricosuric drugs: 0.5 mg two to three times daily.
    Renal impairment: For mild/moderate renal impairment (creatinine clearance 10 - 50 ml/minute), reduce dose or increase interval between doses.
  • Elderly:
    To be given with great care.
  • Children:
    Not recommended.

Or as prescribed by physicians.
 

  • Hypersensitivity to colchicine or to any ingredient of the drug.
  • Pregnancy.
  • Patients undergoing haemodialysis since it cannot be removed by dialysis or exchange transfusion.
  • Patients with severe renal impairment (creatinine clearance less than 10 ml/minute).
  • Patients with renal or hepatic impairment who are talking a P-glycoprotein or a strong CYP3A4 inhibitor.

     

Common:

  • Nausea, vomiting, abdominal pain.
  • Large doses: Profuse diarrhea, gastrointestinal haemorrhage, rashes, renal damage.

Rare:

  • Peripheral neuritis, alopecia, blood dyscrasia (prolonged treatment), azoospermia (reversible).

Instructions about how to manage adverse and side effects:

  • The most common adverse effects of colchicine therapy are nausea, abdominal discomfort, vomiting and diarrhea. Colchicine should be discontinue if these gastrointestinal symptoms occur since this is an early
  • warning, indicating that more serious toxicity is about to develop. Therapy should then not be reinstituted until these symptoms disappear, which usually happen within 24 - 48 hours. The concomitant use of anti-diarrhoea or ralentissons ofintestinal transit drugs may be required to manage diarrhea caused by colchicine.
  • In long-term treatment: Frequent observation in patients who with or without side effects, blood cell counting and white cell formula frequently are recommended.
  • Appearance of the adverse effects is often the first signs of toxicity. There is an indication that colchicine therapy should be stopped or the dose reduced.

     

  • Colchicine should be given with care to elderly and debilitated patients as there is a greater risk of cumulative toxicity.
  • Care should also be exercised in those with cardiac, hepatic, gastrointestinal disease or if patients are breastfeeding.
  • Colchicine should be avoided in patients with blood disorders.
  • Reduce dose in patients with mild to moderate renal impairment.
  • Areduction in colchicine dosage or interruption of colchicine treatment is recommended in patients with normal renal and hepatic function iftreatment with a P-glycoprotein or a strong CYP3A4 inhibitor is required.
  • Contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
  • Pregnancy: Do not use in pregnancy as there is a risk offoetal chromosome damage.
  • Lactation: Colchicine is distributed into breast milk. Colchicine may be used with caution during breast-feeding.
  • 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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