pharmacopeia
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/api/v1/drug/calcitriol

Mechanism of action

Sourced from openFDA

Mechanism-of-action classes: Enzyme Interactions; Structural Macromolecules.

Indications

Sourced from openFDA
  • Predialysis Patients Calcitriol Oral Solution 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.

Contraindications

Sourced from openFDA
  • Calcitriol Oral Solution should not be given to patients with hypercalcemia or evidence of vitamin D toxicity. Use of Calcitriol Oral Solution in patients with known hypersensitivity to Calcitriol Oral Solution (or drugs of the same class) or any of the inactive ingredients is contraindicated.contraindicated

Dosage & administration

Sourced from openFDA

The optimal daily dose of Calcitriol Oral Solution must be carefully determined for each patient. Calcitriol Oral Solution can be administered as an oral solution (1 mcg/mL). Calcitriol Oral Solution 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 Oral Solution therapy is predicated on the assumption that each patient is receiving an adequate but not excessive daily intake of calcium. Patients are advised to have a dietary intake of calcium at a minimum of 600 mg daily. The U.S. RDA for calcium in adults is 800 mg to 1200 mg. To ensure that each patient receives an adequate daily intake of calcium, the physician should either prescribe a calcium supplement or instruct the patient in proper dietary measures. Because of improved calcium absorption from the gastrointestinal tract, some patients on Calcitriol Oral Solution may be maintained on a lower calcium intake. Patients who tend to develop hypercalcemia may require only low doses of calcium or no supplementation at all. During the titration period of treatment with Calcitriol Oral Solution, serum calcium levels should be checked at least twice weekly. When the optimal dosage of Calcitriol Oral Solution has been determined, serum calcium levels should be checked every month (or as given below for individual indications). Samples for serum calcium estimation should be taken without a tourniquet. Dialysis Patients The recommended initial dose of Calcitriol Oral Solution is 0.25 mcg/day.

Warnings & precautions

Sourced from openFDA

Overdosage of any form of vitamin D is dangerous (see OVERDOSAGE ). Progressive hypercalcemia due to overdosage of vitamin D and its metabolites may be so severe as to require emergency attention. Chronic hypercalcemia can lead to generalized vascular calcification, nephrocalcinosis and other soft-tissue calcification. The serum calcium times phosphate (Ca x P) product should not be allowed to exceed 70 mg 2 /dL 2 . Radiographic evaluation of suspect anatomical regions may be useful in the early detection of this condition. Calcitriol Oral Solution is the most potent metabolite of vitamin D available. The administration of Calcitriol Oral Solution to patients in excess of their daily requirements can cause hypercalcemia, hypercalciuria, and hyperphosphatemia. Therefore, pharmacologic doses of vitamin D and its derivatives should be withheld during Calcitriol Oral Solution treatment to avoid possible additive effects and hypercalcemia. If treatment is switched from ergocalciferol (vitamin D 2 ) to calcitriol, it may take several months for the ergocalciferol level in the blood to return to the baseline value (see OVERDOSAGE ). Calcitriol increases inorganic phosphate levels in serum. While this is desirable in patients with hypophosphatemia, caution is called for in patients with renal failure because of the danger of ectopic calcification. A nonaluminum phosphate-binding compound and a low-phosphate diet should be used to control serum phosphorus levels in patients undergoing dialysis.

Adverse reactions

Sourced from openFDA

Since Calcitriol Oral Solution 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, ie, 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 treatment withdrawal, ie, much faster than in treatment with vitamin D 3 preparations. The early and late signs and symptoms of vitamin D intoxication associated with hypercalcemia include: Early : weakness, headache, somnolence, nausea, vomiting, dry mouth, constipation, muscle pain, bone pain, metallic taste, and anorexia, abdominal pain or stomach ache. Late : polyuria, polydipsia, anorexia, weight loss, nocturia, conjunctivitis (calcific), pancreatitis, photophobia, rhinorrhea, pruritus, hyperthermia, decreased libido, elevated BUN, albuminuria, hypercholesterolemia, elevated SGOT (AST) and SGPT (ALT), ectopic calcification, nephrocalcinosis, hypertension, cardiac arrhythmias, dystrophy, sensory disturbances, dehydration, apathy, arrested growth, urinary tract infections, and, rarely, overt psychosis. In clinical studies on hypoparathyroidism and pseudohypoparathyroidism, hypercalcemia was noted on at least one occasion in about 1 in 3 patients and hypercalciuria in about 1 in 7 patients.

Pharmacokinetics

Sourced from openFDA
Metabolism
Absorption Calcitriol is rapidly absorbed from the intestine. Peak serum concentrations (above basal values) were reached within 3 to 6 hours following oral administration of single doses of 0.25 to 1.0 mcg of Calcitriol Oral Solution.

Overdosage

Sourced from openFDA

Administration of Calcitriol Oral Solution to patients in excess of their daily requirements can cause hypercalcemia, hypercalciuria, and hyperphosphatemia. Since calcitriol is a derivative of vitamin D, the signs and symptoms of overdose are the same as for an overdose of vitamin D (see ADVERSE REACTIONS ). High intake of calcium and phosphate concomitant with Calcitriol Oral Solution may lead to similar abnormalities. The serum calcium times phosphate (Ca x P) product should not be allowed to exceed 70 mg 2 /dL 2 . High levels of calcium in the dialysate bath may contribute to the hypercalcemia (see WARNINGS ). Treatment of Hypercalcemia and Overdosage in Dialysis Patients and Hypoparathyroidism Patients General treatment of hypercalcemia (greater than 1 mg/dL above the upper limit of the normal range) consists of immediate discontinuation of Calcitriol Oral Solution therapy, institution of a low-calcium diet and withdrawal of calcium supplements. Serum calcium levels should be determined daily until normocalcemia ensues. Hypercalcemia frequently resolves in 2 to 7 days.

Approval history

Sourced from openFDA
  • Aug 17, 1978NDANDA018044Esjay Pharma
  • Nov 20, 1998NDANDA021068Esjay Pharma
  • Oct 12, 2001ANDAANDA075765Teva
  • Jul 18, 2003ANDAANDA076242Hikma
  • Mar 27, 2006ANDAANDA076917Hikma
  • Jan 23, 2009NDANDA022087Galderma Labs Lp
  • May 24, 2013ANDAANDA091174Bionpharma
  • Dec 12, 2014ANDAANDA091356Onesource Specialty

FDA shortages

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Reference statistics from the openFDA drug-shortage dataset. For a live view, consult the FDA database directly. Not clinical guidance.

  • Calcitriol, Capsule, .25 ug (NDC 0093-7352-01)To be discontinued
    Sponsor: Teva Pharmaceuticals USA, Inc.
    Updated
  • Calcitriol, Capsule, .5 ug (NDC 0093-7353-01)To be discontinued
    Sponsor: Teva Pharmaceuticals USA, Inc.
    Updated

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
19,827 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Nausea1,4257.2%
  2. 2Diarrhoea1,1595.8%
  3. 3Off Label Use1,1075.6%
  4. 4Chronic Kidney Disease1,1045.6%
  5. 5Vomiting1,0655.4%
  6. 6Renal Failure1,0465.3%
  7. 7Dyspnoea1,0395.2%
  8. 8Fatigue1,0045.1%
  9. 9Acute Kidney Injury9554.8%
  10. 10Death8774.4%
  11. 11Drug Hypersensitivity8494.3%
  12. 12Drug Ineffective7733.9%
  13. 13Headache7473.8%
  14. 14Abdominal Pain7443.8%
  15. 15Asthenia7443.8%

Literature

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Recent PubMed references pinned to Calcitriol as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 184 ClinicalTrials.gov registrations naming Calcitriol as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Calcitriol work?
Mechanism-of-action classes: Enzyme Interactions; Structural Macromolecules.
What is Calcitriol used for?
According to FDA labeling, Calcitriol carries indications including: Predialysis Patients Calcitriol Oral Solution 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.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Calcitriol?
Calcitriol is classified as Other antipsoriatics for topical use, Vitamin D and analogues, Vitamin D3 Analog, Enzyme Interactions, Structural Macromolecules, Bone Resorption Inhibition, Decreased Distal Tubule PO4-- Excretion, Decreased Proximal Tubule PO4-- Excretion, Decreased PTH Secretion, Decreased Renal Ca++ Excretion, Stimulation Small Intestine Fluid/Electrolyte Absorption.
What are the brand names for Calcitriol?
Calcitriol is marketed under brand names including Rocaltrol, Vectical.
What are the contraindications for Calcitriol?
Calcitriol labeling lists contraindications including: Calcitriol Oral Solution should not be given to patients with hypercalcemia or evidence of vitamin D toxicity. Use of Calcitriol Oral Solution in patients with known hypersensitivity to Calcitriol Oral Solution (or drugs of the same class) or any of the inactive ingredients is contraindicated.. Always consult the full prescribing information and a clinician.
Note. Data for calcitriol is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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