Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/419
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| rdf:type | |
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ZEMPLAR (Capsule, Liquid Filled)
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| dailymed-instance:dosage |
Zemplar Capsules may be administered daily or three
times a week. When dosing three times weekly, the dose should be administered
no more frequently than every other day. The average weekly doses for both
daily and three times a week dosage regimens are similar (see CLINICAL
STUDIES). Zemplar Capsules may be taken
without regard to food. No dosing adjustment is required in patients with
mild and moderate hepatic impairment.<br/>Initial Dose: The initial dose of Zemplar Capsules is based on
baseline intact parathyroid hormone (iPTH) levels.<br/>Dose Titration: Dosing must be individualized and based on serum
or plasma iPTH levels, with monitoring of serum calcium and serum phosphorus.
The following is a suggested approach in titration. If a patient is taking the lowest dose
on the daily regimen and a dose reduction is needed, the dose can be decreased
to 1 mcg three times a week. If a further dose reduction is required, the
drug should be withheld as needed and can be restarted at a lower dose. If
a patient is on a calcium-based phosphate binder, the binder dose may be decreased
or withheld, or the patient may be switched to a non-calcium-based phosphate
binder. If hypercalcemia or an elevated Ca x P is observed, the dose of Zemplar
should be reduced or interrupted until these parameters are normalized. Serum calcium and phosphorus levels should be closely monitored
after initiation of Zemplar Capsules and during dose titration periods and
coadministration with strong P450 3A inhibitors (see CLINICAL
PHARMACOLOGY and PRECAUTIONS).
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| dailymed-instance:descripti... |
Paricalcitol, USP, the active ingredient in Zemplar
Capsules, is a synthetically manufactured analog of calcitriol, the metabolically
active form of vitamin D indicated for the prevention and treatment of secondary
hyperparathyroidism in chronic kidney disease. Zemplar is available as soft
gelatin capsules for oral administration containing 1 microgram, 2 micrograms
or 4 micrograms of paricalcitol. Each capsule also contains medium chain
triglycerides, alcohol, and butylated hydroxytoluene. The medium chain triglycerides
are fractionated from coconut oil or palm kernel oil. The capsule shell is
composed of gelatin, glycerin, titanium dioxide, iron oxide red (2 microgram
capsules only), iron oxide yellow (2 microgram and 4 microgram capsules),
iron oxide black (1 microgram capsules only), and water. Paricalcitol is a white, crystalline powder with the empirical
formula of CHO, which corresponds to
a molecular weight of 416.64. Paricalcitol is chemically designated as 19-nor-1��,3��,25-trihydroxy-9,10-secoergosta-5(Z),7(E),22(E)-triene
and has the following structural formula:
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| dailymed-instance:genericMe... |
paricalcitol
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| dailymed-instance:fullName |
ZEMPLAR (Capsule, Liquid Filled)
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| dailymed-instance:adverseRe... |
The safety of Zemplar Capsules has been evaluated
in three 24-week (approximately six-month), double-blind, placebo-controlled,
multicenter clinical studies involving 220 CKD Stage 3 and 4 patients.
Six percent (6%) of Zemplar Capsules treated patients and 4% of placebo treated
patients discontinued from clinical studies due to an adverse event. All
reported adverse events occurring in at least 2% in either treatment group
are presented in Table 3. Potential adverse effects of Zemplar Capsules are,
in general, similar to those encountered with excessive vitamin D intake.
The early and late signs and symptoms of hypercalcemia associated with vitamin
D overdoses include:<br/>Early: Weakness, headache, somnolence, nausea, vomiting,
dry mouth, constipation, muscle pain, bone pain, and metallic taste.<br/>Late: Anorexia, weight loss, conjunctivitis (calcific),
pancreatitis, photophobia, rhinorrhea, pruritus, hyperthermia, decreased libido,
elevated BUN, hypercholesterolemia, elevated AST and ALT, ectopic calcification,
hypertension, cardiac arrhythmias, somnolence, death, and, rarely, overt psychosis.
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ZEMPLAR
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