"The US Food and Drug Administration (FDA) has approved calcifediol (Rayaldee, Opko Health, Inc) for the treatment of adults with secondary hyperparathyroidism (SHPT) associated with vitamin D insufficiency (serum total 25-hydroxyvitamin D "...
DOSAGE AND ADMINISTRATION
THE RANGE BETWEEN THERAPEUTIC AND TOXIC DOSES IS NARROW.
Vitamin D Resistant Rickets: 12,000 to 500,000 IU units daily.
Hypoparathyroidism: 50,000 to 200,000 IU units daily concomitantly with calcium lactate 4 g, six times per day.
DOSAGE MUST BE INDIVIDUALIZED UNDER CLOSE MEDICAL SUPERVISION.
Calcium intake should be adequate. Blood calcium and phosphorus determinations must be made every 2 weeks or more frequently if necessary.
X-rays of the bones should be taken every month until condition is corrected and stabilized.
Capsules of 1.25 mg (50,000 IU vitamin D) of ergocalciferol, USP are green and oval shaped, imprinted with a circled W on one side and "D 92" on the other.
Bottles of 50 capsules (NDC 0024-0392-02).
Store at 25° C (77° F); excursions permitted between 15° - 30° C (59° - 86°F) [see USP Controlled Room Temperature].
Manufactured for: sanofi-aventis U.S. LLC Bridgewater, NJ 08807. Revised March 2007This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 5/7/2009
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