Calcitriol is the generic equivalent of the brand-name drug CALCITRIOL. Licensed pharmacies, clinics, doctor's offices, and veterinary practices can source wholesale Calcitriol through Premier Pharma with same-day fulfillment on in-stock SKUs.
FDA Drug Information
Indications & Usage
INDICATIONS AND USAGE Predialysis Patients Calcitriol is indicated in the management of secondary hyperparathyroidism and resultant metabolic bone disease in patients with moderate to severe chronic renal failure (Ccr 15 to 55 mL/min) not yet on dialysis. In children, the creatinine clearance value must be corrected for a surface area of 1.73 square meters. A serum iPTH level of ≥ 100 pg/mL is strongly suggestive of secondary hyperparathyroidism. Dialysis Patients Calcitriol is indicated in the management of hypocalcemia and the resultant metabolic bone disease in patients undergoing chronic renal dialysis. In these patients, calcitriol administration enhances calcium absorption, reduces ser…
Clinical Pharmacology
CLINICAL PHARMACOLOGY Man’s natural supply of vitamin D depends mainly on exposure to the ultraviolet rays of the sun for conversion of 7-dehydrocholesterol in the skin to vitamin D 3 (cholecalciferol). Vitamin D 3 must be metabolically activated in the liver and the kidney before it is fully active as a regulator of calcium and phosphorus metabolism at target tissues. The initial transformation of vitamin D 3 is catalyzed by a vitamin D 3 -25-hydroxylase enzyme (25-OHase) present in the liver, and the product of this reaction is 25-hydroxyvitamin D 3 [25-(OH)D 3 ]. Hydroxylation of 25-(OH)D 3 occurs in the mitochondria of kidney tissue, activated by the renal 25-hydroxyvitamin D 3 -1 alpha-…
Contraindications & Precautions
CONTRAINDICATIONS Calcitriol should not be given to patients with hypercalcemia or evidence of vitamin D toxicity. Use of calcitriol in patients with known hypersensitivity to calcitriol (or drugs of the same class) or any of the inactive ingredients is contraindicated.
Adverse Reactions
ADVERSE REACTIONS Since calcitriol is believed to be the active hormone which exerts vitamin D activity in the body, adverse effects are, in general, similar to those encountered with excessive vitamin D intake, i.e., hypercalcemia syndrome or calcium intoxication, depending on the severity and duration of hypercalcemia (see WARNINGS ). Because of the short biological half-life of calcitriol, pharmacokinetic investigations have shown normalization of elevated serum calcium within a few days of t…
Drug Interactions
Drug Interactions Cholestyramine Cholestyramine has been reported to reduce intestinal absorption of fat-soluble vitamins; as such it may impair intestinal absorption of calcitriol (see WARNINGS and PRECAUTIONS : General ). Phenytoin/Phenobarbital The coadministration of phenytoin or phenobarbital will not affect plasma concentrations of calcitriol, but may reduce endogenous plasma levels of 25(OH)D 3 by accelerating metabolism. Since blood level of calcitriol will be reduced, higher doses of ca…
Dosage & Administration
DOSAGE AND ADMINISTRATION The optimal daily dose of calcitriol must be carefully determined for each patient. Calcitriol can be administered orally either as a capsule (0.25 mcg or 0.50 mcg) or as an oral solution (1 mcg/mL). Calcitriol therapy should always be started at the lowest possible dose and should not be increased without careful monitoring of serum calcium. The effectiveness of calcitriol therapy is predicated on the assumption that each patient is receiving an adequate but not excess…
Patient Counseling Information
Information for Patients The patient and his or her caregivers should be informed about compliance with dosage instructions, adherence to instructions about diet and calcium supplementation, and avoidance of the use of unapproved nonprescription drugs. Patients and their caregivers should also be carefully informed about the symptoms of hypercalcemia (see ADVERSE REACTIONS ). The effectiveness of calcitriol therapy is predicated on the assumption that each patient is receiving an adequate daily intake of calcium. Patients are advised to have a dietary intake of calcium at a minimum of 600 mg d…
Source: FDA. For professional use only. Not a substitute for prescribing information.
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