CALCILEAP INJECTION

CALCILEAP (Calcitriol Injection USP)

PRESENTATION

CALCILEAP INJECTION is available as 1 mcg/ml in 1 ml Ampoule.

DESCRIPTION

CALCILEAP (Calcitriol) is synthetically manufactured calcitriol and is available as a sterile, isotonic, clear, colorless to yellow, aqueous solution for intravenous injection. Calcitriol Injection USP is available in 1 ml ampoules. Each 1 ml contains: Active: Calcitriol 1 mcg. Inactives: Dibasic Sodium Phosphate, Anhydrous 7.6 mg; Edetate Disodium, Dihydrate 1.1 mg; Monobasic Sodium Phosphate, Monohydrate 1.8 mg; Polysorbate 20, 4 mg; Sodium Ascorbate 10 mg; Sodium Chloride 1.5 mg; pH Range is from 6.5 to 8.0 and Water for Injection.

INDICATIONS AND USAGE

CALCILEAP (Calcitriol) injection is indicated in the management of hypocalcemia in patients undergoing chronic renal dialysis. It has been shown to significantly reduce elevated parathyroid hormone levels. Reduction of PTH has been shown to result in an improvement in renal osteodystrophy.

DOSAGE AND ADMINISTRATION

The recommended initial dose of Calcitriol Injection, depending on the severity of the hypocalcemia and/or secondary hyperparathyroidism, is 1 mcg (0.02 mcg/kg) to 2 mcg administered intravenously three times weekly, approximately every other day. The doses as small as 0.5 mcg and as large as 4 mcg three times weekly have been used as an initial dose. 

CALCILEAP (Calcitriol) injection is for intravenous injection only.

CONTRAINDICATIONS

CALCILEAP (Calcitriol) injection should not be given to patients with hypercalcemia or evidence of vitamin D toxicity.

CALCILEAP (Calcitriol) injection is contraindicated in patients with previous hypersensitivity to calcitriol or any of its excipients.