Chelova 500 mg (Dispersible Tablet)

Unit Price: ৳ 100.00 (5 x 6: ৳ 3,000.00)
Strip Price: ৳ 600.00

Medicine Details

Category Details
Generic Deferasirox
Company Jenphar bangladesh ltd
Also available as
Chelova 250 mg tablet

Indications

  • Treatment of chronic iron overload
  • For patients aged 2 years and over with thalassaemia
  • For patients with sickle cell disease and myelodysplastic syndrome
  • Treatment for non-transfusion-dependent thalassemia syndromes aged 10 years and older
  • Indicated after the transfusion of approximately 20 units of packed red blood cells
  • Presence of chronic iron overload (e.g. serum ferritin > 1,000 microgram/L)

Pharmacology

  • Chelator highly selective for iron
  • Tridentate ligand
  • Binds iron with high affinity in a 2:1 ratio
  • Promotes excretion of iron in faeces
  • Low affinity for zinc and copper
  • Mean net excretion induced at different daily doses

Dosage

  • Recommended initial daily dose of 20-40 mg/kg body weight per day
  • To be taken on an empty stomach
  • Dispersion in water or juice until a fine suspension
  • Serum ferritin to be monitored every month
  • Dose adjusted based on trends in serum ferritin
  • Dose reduction steps to maintain serum ferritin at 500 microgram/l

Administration

  • Taken once daily on an empty stomach at least 30 minutes before food
  • Tablets to be dispersed in water or juice until a fine suspension
  • Tablets must not be chewed or swallowed whole
  • Dispersion in carbonated drinks or milk not recommended

Interaction

  • Should not be taken with aluminium-containing antacids
  • Caution with drugs metabolized through CYP3A4
  • Dose increase with concomitant use of certain drugs
  • Caution with drugs with ulcerogenic potential or anticoagulants

Contraindications

  • Hypersensitivity to the active substance or excipients
  • Creatinine clearance less than 40 ml/min
  • Serum creatinine > 2 times the upper limit of normal

Side Effects

  • Cytopenias
  • Gastrointestinal symptoms
  • Headache and dizziness
  • Elevation of hepatic transaminases
  • Cases of Stevens-Johnson syndrome and skin rash
  • Auditory and ocular disturbances

Pregnancy & Lactation

  • Pregnancy Category C
  • No adequate and well-controlled studies in pregnant women
  • Potential risk to the fetus
  • Unknown excretion in human milk

Precautions & Warnings

  • Gastrointestinal bleeding, ulceration, and irritation may occur
  • Cautious use with drugs that have ulcerogenic or hemorrhagic potential
  • Monitor blood counts
  • Serious hypersensitivity reactions reported

Use in Special Populations

  • Safety and efficacy in pediatric patients
  • Similar response in younger and older pediatric patients
  • Elderly patients at increased risk for toxicity
  • Not studied in patients with renal or hepatic impairment

Overdose Effects

  • Maximal dose of 40 mg/kg body weight
  • No information about overdose

Therapeutic Class

  • Antidote preparations

Storage Conditions

  • Store in a dry place below 25°C
  • Protect from light
  • Keep out of the reach of children

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