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TRICAL-D:

 
 
 
   
   
   
 
    
 
 
   Abridged Prescribing Information
     
     
 
  Composition
   
  Each tablet of TRICAL-D 250 / 500 contains:
  Calcium carbonate from an organic source (oyster cell)…625 / 1250 mg
  Equivalent to elemental calcium...250 / 500 mg
  Vitamin D (coated)...125 / 250 IU
   
  Each 5 ml of TRICAL-D Suspension contains:
  Calcium carbonate from an organic source (oyster cell)…625 mg
  Equivalent to elemental calcium...250 mg
  Vitamin D (coated)...125 IU
   
   
  Therapeutic Indications & Usage
   
 
TRICAL-D is indicated for the treatment of hypocalcemia for those conditions / situations such as due to rapid growth or pregnancy, and requiring a prompt increase in blood plasma calcium concentrations. It is also useful for vitamin D deficiency, alkalosis, hyperphosphatemia in chronic renal failure, and for the prevention of hypocalcemia during exchange transfusions. TRICAL-D can also be administered as adjunctive therapy in a number of conditions, including rickets, osteomalacia and osteoporosis.
   
   
  Contraindications
   
 
TRICAL-D is contraindicated in those hypersensitive to its ingredients, hypercalcemia and hypercalciuria (e.g., in hyperparathyroidism, vitamin D overdosage, decalcifying tumors such as plasmocytoma, bone metastases), severe renal or cardiac diseases like ventricular fibrillation.
   
  Precautions & Warnings
   
 
TRICAL-D must be advocated with caution in renal impairment, or diseases associated with hypercalcemia such as sarcoidosis and some malignancies. Vitamin D (in TRICAL-D) is to be used with caution in heart disease and in infants.
   
 
In mild hypercalciuria (exceeding 300 mg/24 hours) as well as in chronic renal failure, or where there is evidence of stone formation in the urinary tract, adequate checks must be kept on urinary calcium excretion whilst on TRICAL-D; if necessary, the dosage of TRICAL-D should be reduced or calcium therapy discontinued. Additional high vitamin D intake should be avoided during TRICAL-D therapy unless especially indicated. When severe hypocalcemia co-exists with hyperphosphatemia (>6 mmol/L), patients should be treated for hyperphosphatemia prior to the administration of TRICAL-D; the aim is to achieve a proper calcium/phosphate ratio in order to prevent extraskeletal deposition of calcium. Vitamin D (in TRICAL-D) intake is usually detrimental In those already Receiving an adequate intake through diet and exposure to sunlight. TRICAL-D must be given 3 hours apart from other agents whose absorption may be hindered by calcium carbonate. In view of vitamin D's potential to interact, TRICAL-D must be advocated cautiously along with carbamazepine, phenobarbital, phenytoin, primidone, rifampicin and isoniazid.
   
   
  Adverse Reactions
   
 
Hypersensitivity reactions could occur due to the ingredients in TRICAL-D. Calcium carbonate (in TRICAL-D) can occasionally cause constipation and flatulence; high doses or prolonged use may lead to gastric hypersecretion and acid rebound. Alkalosis and rarely, milk-alkali syndrome and tissue calcification may occur due to calcium carbonate (in TRICAL-D).
   
 
Hypersensitivity reactions could occur due to the ingredients in TRICAL-D. Calcium carbonate (in TRICAL-D) can occasionally cause constipation and flatulence; high doses or prolonged use may lead to gastric hypersecretion and acid rebound. Alkalosis and rarely, milk-alkali syndrome and tissue calcification may occur due to calcium carbonate (in TRICAL-D).
   
   
  Drug Interactions:
   
 
Hpercalcemia can occur if TRICAL-D is given with thiazides. The ionotropic and toxic effects of cardiac glycosides and calcium (in TRICAL-D) are synergistic and arrhythmias may occur if these drugs are given together. Calcium reduces the absorption of many drugs such as tetracyclines, bisphosphonates, fluorides, and some quinolones; hence, TRICAL-D must ideally be advocated along with these agents at least 3 hours apart.
   
  Vitamin D (in TRICAL-D) requirements can be increased by carbamazepine, phenobarbital,phenytoin and primidone; rifampicin and isoniazid may reduce its effectiveness.
   
   
  Recommended Dosage & Administration
   
 
ADULTS: 1-3 TRICAL-D 250 Tabs or 1-2 TRICAL-D 500 Tabs daily in divided doses, or as prescribed.
   
 
HYPERPHOSPHATEMIA: 5 TRICAL-D 500 Tabs daily in divided doses initially, or as prescribed. Maximum 17 g calcium daily supplementation is advocated.
   
 
CHILDREN:
   
 
6-12 years: 1-2 TRICAL-D 250 Tabs / 1-2 tsf TRICAL-D Susp once or twice daily, or as prescribed.
   
  3 mths-6 years: 1-2 tsf TRICAL-D Suspension daily, or as prescribed.
   
  <3 mths: 1 tsf TRICAL-D Suspension daily, or as prescribed.
   
   
  Presentations
   
  TRICAL-D 250 Tablets: Blister of 30s.
  TRICAL-D 500 Tablets: Blister of 15s.
  TRICAL-D Suspension: Bottles of 150 ml.
   
 
 
 
   
 
         
 
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