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 Indications, Dosage, Storage, Stability - Vitamin D/ Calcitriol
Rocaltrol Indications, Dosage, Storage, Stability - Vitamin D/ Calcitriol
INDICATIONS
Predialysis Patients: Rocaltrol 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
³100 pg/mL is strongly suggestive
of secondary hyperparathyroidism.
Dialysis Patients: Rocaltrol is indicated in the
management of hypocalcemia
and the resultant metabolic bone
disease in patients
undergoing chronic renal
dialysis. In these patients,
Rocaltrol administration
enhances calcium absorption,
reduces serum alkaline
phosphatase levels
and may reduce elevated parathyroid
hormone levels and the
histological manifestations of osteitis
fibrosa cystica and defective
mineralization.
Hypoparathyroidism Patients: Rocaltrol is also indicated
in the management of hypocalcemia
and its clinical manifestations
in patients with postsurgical hypoparathyroidism, idiopathic
hypoparathyroidism, and pseudohypoparathyroidism.
DOSAGE AND ADMINISTRATION
The optimal daily dose
of Rocaltrol must be carefully determined for each patient. Rocaltrol
can be administered orally either as a capsule (0.25 mcg
or 0.50 mcg) or as an oral
solution (1 mcg/mL).
The effectiveness
of Rocaltrol 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 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.
Dialysis Patients: The recommended initial
dose of Rocaltrol is 0.25
mcg/day. If a satisfactory response
in the biochemical
parameters and clinical
manifestations of the disease
state is not observed,
dosage may be increased by 0.25 mcg/day at 4- to 8-week intervals.
During this titration period, serum
calcium levels should
be obtained at least twice weekly, and if hypercalcemia
is noted, the drug should
be immediately discontinued until normocalcemia
ensues.
Patients with normal
or only slightly reduced serum
calcium levels may respond
to Rocaltrol doses of 0.25 mcg
every other day. Most patients undergoing hemodialysis respond to
doses between 0.5 and 1 mcg/day.
Oral Rocaltrol may normalize plasma
ionized calcium in some
uremic patients, yet
fail to suppress parathyroid
hyperfunction. In these individuals
with autonomous parathyroid
hyperfunction, oral Rocaltrol
may be useful to maintain normocalcemia, but has not been shown
to be adequate treatment
for hyperparathyroidism.
Hypoparathyroidism: The recommended initial
dosage of Rocaltrol is
0.25 mcg/day given in the morning. If a satisfactory response in
the biochemical
parameters and clinical
manifestations of the disease is not observed, the dose
may be increased at 2- to 4- week intervals. During the dosage
titration period,
serum calcium
levels should be obtained at least twice weekly and
if hypercalcemia
is noted, Rocaltrol should be immediately discontinued until normocalcemia
ensues. Careful consideration should also be given to lowering the
dietary calcium
intake.
Most adult patients and
pediatric patients
age 6 years and older have
responded to dosages in the range
of 0.5 mcg to 2 mcg
daily. Pediatric patients in the 1 to 5 year age
group with hypoparathyroidism
have usually been given 0.25 mcg
to 0.75 mcg daily. The number
of treated patients with pseudohypoparathyroidism less than 6 years
of age is too small to make
dosage recommendations.
Predialysis Patients: The recommended initial
dosage of Rocaltrol is
0.25 mcg/day in adults and pediatric
patients 3 years of age and older. This dosage
may be increased if necessary to 0.5 mcg/day.
For pediatric patients
less than 3 years of age, the recommended initial dosage of Rocaltrol
is 10 to 15 ng/kg/day.
HOW SUPPLIED
Capsules
0.25 mcg calcitriol
in soft gelatin, light
orange, oval capsules,
imprinted with ROCALTROL 0.25 ROCHE;
- bottles of 30 (NDC 0004-0143-23), and
- bottles of 100 (NDC 0004-0143-01).
0.5 mcg calcitriol
in soft gelatin, dark orange,
oblong capsules, imprinted with ROCALTROL 0.5 ROCHE;
Oral Solution
A clear, colorless to pale yellow
oral solution
containing 1 mcg/mL of calcitriol;
each amber glass bottle
of 15 mL of oral solution
supplied with 20 single-use, graduated oral
dispensers (NDC 0004-9115-00).
Rocaltrol Capsules and Oral Solution should be protected from
light.
Store at 59° to 86° F (15° to 30° C).
REFERENCE:
1. Jones CL, et al. Comparisons between oral
and intraperitoneal 1,25-dihydroxyvitamin D3 therapy
in children treated with peritoneal dialysis. Clin Nephrol.
1994; 42: 44-49.
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