CALCITRIOL injection

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CALCITRIOL (UNII: FXC9231JVH) (CALCITRIOL - UNII:FXC9231JVH)

Available from:

FOSUN PHARMA USA INC

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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. Calcitriol injection should not be given to patients with hypercalcemia or evidence of vitamin D toxicity. Calcitriol injection is contraindicated in patients with previous hypersensitivity to calcitriol or any of its excipients.

Product summary:

Calcitriol Injection, USP is supplied in 1 mL fill in 2 mL vials containing 1 mcg. NDC 72266-251-10 10 Single Dose Vials in one carton Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light. Distributed by: Fosun Pharma USA Inc. Princeton, NJ 08540 Made in India May 2023

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CALCITRIOL- CALCITRIOL INJECTION
FOSUN PHARMA USA INC
----------
CALCITRIOL INJECTION USP, 1 MCG/ML
RX ONLY
DESCRIPTION
Calcitriol injection 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 vials. Each 1 mL contains: Active:
Calcitriol, 1 mcg.
Inactives: Polysorbate 20, 4 mg; Dibasic Sodium Phosphate, Anhydrous
7.6 mg; Edetate
Disodium, Dihydrate 1.1 mg; Monobasic Sodium Phosphate, Monohydrate
1.8 mg;
Butylated hydroxyltoluene 0.02 mg; Butylated hydroxyl anisole 0.003
mg; Sodium
Chloride 1.5 mg; pH Range is from 6.5 to 8.0 and Water for Injection.
Calcitriol is a crystalline compound which occurs naturally in humans.
It is soluble in
organic solvents but relatively insoluble in water. Calcitriol is
chemically designated
(5Z,7E)-9,10 secocholesta-5,7,10(19)-triene-1α,3β,25-triol and has
the following
structural formula:
The other names frequently used for calcitriol are
1α,25-dihydroxycholecalciferol,1α,25-
dihydroxyvitamin D
,1,25-DHCC,1,25(OH)
D
and 1,25-diOHC.
CLINICAL PHARMACOLOGY
Calcitriol is the active form of vitamin D
(cholecalciferol). The natural or endogenous
supply of vitamin D in man mainly depends on ultraviolet light for
conversion of 7-
dehydrocholesterol to vitamin D
in the skin. Vitamin D
must be metabolically activated
3
2
3
3
3
3
in the liver and the kidney before it is fully active on its target
tissues. The initial
transformation is catalyzed by a vitamin D
-25-hydroxylase enzyme present in the liver,
and the product of this reaction is 25-(OH)D
(calcifediol). The latter undergoes
hydroxylation in the mitochondria of kidney tissue, and this reaction
is activated by the
renal 25-hydroxyvitamin D
-1-α-hydroxylase to produce 1,25-(OH)
D
(calcitriol), the
active form of vitamin D
.
The known sites of action of calcitriol are intestine, bone, kidney
and parathyroid gland.
Calcitriol is the most active known form of vitamin D3 in stimulating
i