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Pronunciation |
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(kal
si TRYE
ole) |
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U.S. Brand
Names |
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Calcijex™;
Rocaltrol® |
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Generic
Available |
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No |
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Synonyms |
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1,25 Dihydroxycholecalciferol |
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Pharmacological Index |
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Vitamin D Analog |
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Use |
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Management of hypocalcemia in patients on chronic renal dialysis; reduce
elevated parathyroid hormone levels |
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Pregnancy Risk
Factor |
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C (per manufacturer); A/D (if dose exceeds RDA recommendation)(per expert
analysis) |
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Contraindications |
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Hypercalcemia; vitamin D toxicity; abnormal sensitivity to the effects of
vitamin D; malabsorption syndrome |
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Warnings/Precautions |
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Adequate dietary (supplemental) calcium is necessary for clinical response to
vitamin D; maintain adequate fluid intake; calcium-phosphate product (serum
calcium times phosphorus) must not exceed 70; avoid hypercalcemia or use with
renal function impairment and secondary hyperparathyroidism |
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Adverse
Reactions |
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Percentage unknown: Hypotension, cardiac arrhythmias, hypertension,
irritability, headache, somnolence, seizures (rare), pruritus, polydipsia,
hypermagnesemia, nausea, vomiting, constipation, anorexia, pancreatitis,
metallic taste, xerostomia, polyuria, elevated LFTs, myalgia, bone pain,
conjunctivitis, photophobia
>10%: Endocrine & metabolic: Hypercalcemia (33%) |
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Overdosage/Toxicology |
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Rarely toxicity occurs from acute overdose. Symptoms of chronic overdose
include hypercalcemia, hypercalciuria with weakness, altered mental status, GI
upset, renal tubular injury, and occasionally cardiac arrhythmias.
Following withdrawal of the drug, treatment consists of bed rest, liberal
intake of fluids, reduced calcium intake, and cathartic administration. Severe
hypercalcemia requires I.V. hydration and forced diuresis. I.V. saline may
increase excretion of calcium. Calcitonin, cholestyramine, prednisone, sodium
EDTA, biphosphonates, and mithramycin have all been used successfully to treat
the more resistant cases of vitamin D-induced hypercalcemia.
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Drug
Interactions |
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Decreased effect/absorption: Cholestyramine, colestipol
Increased effect: Thiazide diuretics
Additive effect: Magnesium-containing antacids |
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Stability |
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Store in tight, light-resistant container; calcitriol degrades upon prolonged
exposure to light |
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Mechanism of
Action |
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Promotes absorption of calcium in the intestines and retention at the kidneys
thereby increasing calcium levels in the serum; decreases excessive serum
phosphatase levels, parathyroid hormone levels, and decreases bone resorption;
increases renal tubule phosphate resorption |
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Pharmacodynamics/Kinetics |
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Onset of action: ~2-6 hours
Duration: 3-5 days
Absorption: Oral: Rapid
Metabolism: Primarily to 1,24,25-trihydroxycholecalciferol and
1,24,25-trihydroxy ergocalciferol
Half-life: 3-8 hours
Elimination: Principally in bile and feces with 4% to 6% excreted in urine
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Usual Dosage |
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Individualize dosage to maintain calcium levels of 9-10 mg/dL
Children:
Oral: 0.25-2 mcg/day have been used (with hemodialysis); 0.014-0.041
mcg/kg/day (not receiving hemodialysis); increases should be made at 4- to
8-week intervals
I.V.: 0.01-0.05 mcg/kg 3 times/week if undergoing hemodialysis
Adults:
Oral: 0.25 mcg/day or every other day (may require 0.5-1 mcg/day); increases
should be made at 4- to 8-week intervals
I.V.: 0.5 mcg/day 3 times/week (may require from 0.5-3 mcg/day given 3
times/week) if undergoing hemodialysis
Hypoparathyroidism/pseudohypoparathyroidism: Oral (evaluate dosage at 2- to
4-week intervals):
Children:
<1 year: 0.04-0.08 mcg/kg once daily
1-5 years: 0.25-0.75 mcg once daily
Children >6 years and Adults: 0.5-2 mcg once daily
Vitamin D-dependent rickets: Children and Adults: Oral: 1 mcg once daily
Vitamin D-resistant rickets (familial hypophosphatemia): Children and Adults:
Oral: Initial: 0.015-0.02 mcg/kg once daily; maintenance: 0.03-0.06 mcg/kg once
daily; maximum dose: 2 mcg once daily
Hypocalcemia in premature infants: Oral: 1 mcg once daily for 5 days
Hypocalcemic tetany in premature infants: I.V.: 0.05 mcg/kg once daily for
5-12 days |
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Monitoring
Parameters |
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Monitor symptoms of hypercalcemia (weakness, fatigue, somnolence, headache,
anorexia, dry mouth, metallic taste, nausea, vomiting, cramps, diarrhea, muscle
pain, bone pain and irritability) |
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Reference Range |
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Calcium (serum) 9-10 mg/dL (4.5-5 mEq/L) but do not include the I.V. dosages;
phosphate: 2.5-5 mg/dL |
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Test
Interactions |
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calcium, cholesterol,
magnesium, BUN, AST, ALT,
calcium (S), cholesterol (S);
alkaline
phosphatase |
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Mental Health: Effects
on Mental Status |
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May cause sedation or irritability |
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Mental Health:
Effects on Psychiatric
Treatment |
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None reported |
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Dental Health: Local
Anesthetic/Vasoconstrictor
Precautions |
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No information available to require special precautions |
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Dental Health:
Effects on Dental Treatment |
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No effects or complications reported |
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Patient
Information |
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Take exact dose as prescribed; do not increase dose. Maintain recommended
diet and calcium supplementation. Avoid taking magnesium-containing antacids.
You may experience nausea, vomiting, loss of appetite, or metallic taste
(frequent small meals, frequent mouth care, chewing gum, or sucking lozenges may
help); or hypotension (use caution when rising from sitting or lying position or
when climbing stairs or bending over). Report chest pain or palpitations; acute
headache; skin rash; change in vision or eye irritation; CNS changes; unusual
weakness or fatigue; persistent nausea, vomiting, cramps, or diarrhea; or muscle
or bone pain. |
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Nursing
Implications |
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May be administered as a bolus dose I.V. through the catheter at the end of
hemodialysis
Monitor serum calcium and phosphate levels during therapy
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Dosage Forms |
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Capsule: 0.25 mcg, 0.5 mcg
Injection: 1 mcg/mL (1 mL); 2 mcg/mL (1 mL)
Solution, oral: 1 mcg/mL |
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References |
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Letsou AP and Price LS, "Health Aging and Nutrition: An Overview," Clin
Geriatr Med, 1987, 3(2):253-60.
Myrianthopoulos M, "Dietary Treatment of Hyperlipidemia in the Elderly,"
Clin Geriatr Med, 1987, 3(2):343-59.
Riggs BL and Melton LJ, "The Prevention and Treatment of Osteoporosis," N
Engl J Med, 1992, 327(9):620-7.
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