A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Rocaltrol Side Effects, and Drug Interactions - Vitamin D/ Calcitriol
Rocaltrol Side Effects, and Drug Interactions - Vitamin D/ Calcitriol
SIDE EFFECTS
Since Rocaltrol 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. 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
and metallic taste.
Late: polyuria,
polydipsia, anorexia,
weight loss, nocturia,
conjunctivitis (calcific), pancreatitis,
photophobia, rhinorrhea,
pruritus, hyperthermia, decreased libido,
elevated BUN, albuminuria,
hypercholesterolemia, elevated SGOT
and SGPT, ectopic calcification,
nephrocalcinosis, hypertension, cardiac arrhythmias 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. Elevated serum
creatinine levels were observed in about 1 in 6 patients (approximately
one half of whom had normal
levels at baseline).
One case of erythema
multiforme and one case
of allergic reaction
(swelling of lips and hives
all over the body) were confirmed by rechallenge.
DRUG INTERACTIONS
Cholestyramine has been reported to reduce
intestinal absorption
of fat-soluble vitamins; as such
it may impair intestinal
absorption of Rocaltrol
(see WARNINGS and PRECAUTIONS:
General).
The coadministration
of phenytoin or phenobarbital
will not affect
plasma concentrations of calcitriol, but may reduce
endogenous plasma
levels of 25(OH) D3 by inhibiting 25-hydroxylase in liver.
Since endogenous synthesis of calcitriol
will be inhibited, higher
doses of Rocaltrol may be necessary if these drugs are administered
simultaneously.
Thiazides are known to induce hypercalcemia
by the reduction of
calcium excretion in urine. Some reports have shown that the concomitant
administration of thiazides with Rocaltrol causes hypercalcemia.
Therefore, precaution should be taken when coadministration
is necessary.
Ketoconazole may inhibit both synthetic
and catabolic enzymes of calcitriol. Reductions in serum
endogenous calcitriol
concentrations have been observed following the administration
of 300 mg/day to 1200 mg/day ketoconazole for a week to healthy
men. However, in vivo drug
interaction studies of ketoconazole with Rocaltrol have not been
investigated.
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