Product Name

Cadla Tablets


Composition

Each Tablet Contains: Each tablet contains 0.5µg Alfacalcidol.

Pack
2 x 10's

Mode of Action

CADLA increases bone mineralisation by increasing circulation of 1,25-dihydroxyvitamin D3.
CADLA relieves bone and muscle pain by decreasing plasma parathyroid hormone levels and decreases bone resorption. Treatment of intestinal calcium malabsorption associated with postmenopausal, senile and steroid induced osteoporosis with CADLA improves the calcium balance.
Alfacalcidol is a precursor of the active metabolite of vitamin D, one of the important elements in the calcium homeostasis. Acting independently on renal function, alfacalcidol allow the body itself to produce the active metabolite without requiring the formerly indispensable stage of renal 1 - hydroxylation.


Therapeutic Classification
Vitamin D Analogue (Active form of Vitamin D3)

Prescribing Information
Indications: CADLA is used for treating disturbances in the calcium metabolism due to impaired 1-hydroxylation that happens due to insufficient renal function, osteoporosis and disorders related with vitamin D deficiencies such as:
- Osteoporosis
- Renal osteodystrophy
- Hyperparathyroidism associated with bone disease
- Idiopathic and postoperative hypoparathyroidism
- Nutritional and malabsorption rickets and osteomalacia
- Hypophosphataemic vitamin D resistant rickets and osteomalacia
- Pseudo deficiency (D Dependent Type I) rickets with osteomalacia

Contraindications:
CADLA should not be given to patients with hypercalcemia, hyperphosphataemia (except due to hypoparathyroidism), hypermagnesaemia or evidence of vitamin D toxicity.

Precautions: Throughout the treatment with CADLA regular serum calcium determinations are essential.

Drug Interactions: Digitalis Glycosides: Patients taking digitalis preparations concurrently with CADLA must be closely monitored because hypercalcemia in these patients may lead to cardiac arrhythmias.

Magnesium: Chronic renal dialysis patients taking magnesium based antacids along with CADLA must be closely monitored because there are chances of hypermagnesaemia development.

Calcium and Thiazides: The risk of hypercalcaemia increases in patients taking calcium or thiazides with Alfacalcidol.

Vitamin D and Derivatives: Alfacalcidol is a potent derivative of vitamin D and therefore concurrent administration should be avoided to eliminate the risk of hypercalcaemia.

Barbiturates or Enzyme inducing anticonvulsant drugs: Patients taking these drugs requires high doses of CADLA for desired effects.

Drug affecting intestinal absorption: Concurrent use of aluminium based antacids, mineral oil, Cholestyramine and colestipol may affect the absorption of CADLA.

Pregnancy: Though animal studies have not revealed any hazard, CADLA should only be used during pregnancy if treatment is essential and no better alternative is available.

Lactation: Although not definitely establishment, it is likely that increased level of 1, 25- dihydroxy vitamin D3 will be found in breast milk of mothers treated with CADLA. This might have some influence on calcium metabolism of breast fed infant and discontinuation of breast feeding should be considered.

Overdosage: Hypercalcemia is treated by stopping treatment with Alfacalcidol. Severe hypercalcemia may require additional treatment with a "loop" diuretic, intravenous fluids and corticosteriods.

Side Effects: The only side effect of alfacalcidol treatment is hypercalcaemia. Hypercalcaemia manifest muscle fatigue, gastrointestinal disturbances, thirst, nausea, constipation, polyuria, muscle pain, join pain. In dialysis patients with hypercalcaemia the calcium influx from the dialysis should be considered.

Dosage & Administration: Initial Dose
Adults and children above 20 kg body weight: 1µg daily Children under 20 kg body weight: 0.05µg/kg/day.
Osteoporosis: 0.5µg/day.
It is important to adjust the dosage according to the biochemical responses to avoid hypercalcemia. Indices of response include level of serum calcium, alkaline phosphates, parathyroid hormones, urinary calcium excretion as well as radiographic and histological investigations. Patients will marked bone disease may tolerate higher doses without developing hypercalcemia.
However, failure of the serum calcium to rise promptly in osteomalacia patients does not necessarily mean that a higher dose is required since calcium absorption may be incorporated into demineralized bone.
Most patients will respond to doses between 1 and 3 mcg daily. The dose requirements generally decreases in patients with bone disease when there is biochemical or radiographic evidence of bone healing and in hypoparathyroid patients after normal serum level have been obtained. Maintenance doses are generally in the range of 0.5 to 2 mcg daily.
Patients currently taking barbiturate or other anticonvulsant may need larger doses of CADLA to produce desired effect.

 
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