DOXERCALCIFEROL capsule

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

DOXERCALCIFEROL (UNII: 3DIZ9LF5Y9) (DOXERCALCIFEROL - UNII:3DIZ9LF5Y9)

Tilgjengelig fra:

West-Ward Pharmaceuticals Corp.

INN (International Name):

DOXERCALCIFEROL

Sammensetning:

DOXERCALCIFEROL 0.5 ug

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Doxercalciferol Capsules is contraindicated in patients with: Risk Summary: The limited available data with doxercalciferol in pregnant women are insufficient to identify a drug-associated risk for major birth defects, miscarriage or adverse maternal or fetal outcomes. There are risks to the mother and fetus associated with chronic kidney disease in pregnancy [see Clinical Considerations ]. In reproduction studies in rats and rabbits administered doxercalciferol during organogenesis at up to 20 mcg/kg/day and 0.1 mcg/kg/day, respectively (approximately 25 times (rats) and less than (rabbits) the maximum recommended human oral dose of 60 mcg/week based on mcg/m2 body surface area), no adverse developmental effects were observed [see Data ]. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20

Produkt oppsummering:

Doxercalciferol Capsules are supplied as a clear, oily solution encapsulated in oval shaped, soft gelatin capsules. The 0.5 mcg capsules are orange, opaque with "r" imprinted in black ink along one side of the capsule. The 1 mcg capsules are light peach, opaque with "r" imprinted in black ink along one side of the capsule. The 2.5 mcg capsules are yellow, opaque with "r" imprinted in black ink along one side of the capsule. 0054-0338-19 0.5 mcg, orange capsules, bottle of 50 0054-0388-19 1 mcg, light peach capsules, bottle of 50 0054-0339-19 2.5 mcg, yellow capsules, bottle of 50 Storage Store at 25ºC (77ºF), with excursions permitted between 15º to 30ºC (59º to 86ºF). [See USP Controlled Room Temperature.]

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

DOXERCALCIFEROL- DOXERCALCIFEROL CAPSULE
WEST-WARD PHARMACEUTICALS CORP.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DOXERCALCIFEROL CAPSULES SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR DOXERCALCIFEROL
CAPSULES.
DOXERCALCIFEROL CAPSULES, FOR ORAL USE
INITIAL U.S. APPROVAL: 1999
INDICATIONS AND USAGE
Doxercalciferol is a synthetic vitamin D2 analog:
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DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
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CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
The most common adverse reactions in patients with Stage 3 or 4 CKD
(incidence >5%) were infection, urinary tract
infection, chest pain, angina pectoris, constipation, dyspepsia,
anemia, leucopenia, dehydration, edema, depression,
hypertonia, insomnia, asthenia, paresthesia, cough increased, dyspnea,
pruritus, sinusitis, and rhinitis. (6.1)
The most common adverse reactions in patients with CKD on dialysis
(incidence >5%) were headache, malaise, edema,
nausea/vomiting, dyspnea, dizziness, pruritus, and bradycardia. (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT WEST-WARD
PHARMACEUTICALS CORP. AT 1-800-962-8364
Doxercalciferol capsules are indicated for the treatment of secondary
hyperparathyroidism in adult patients with
Stage 3 or Stage 4 chronic kidney disease (CKD) and adult patients
with CKD on dialysis. (1)
Before initiating treatment, ensure serum calcium is not above the
upper limit of normal. (2.1)
Dosage for doxercalciferol capsules in patients with:
Stage 3 or 4 CKD: Initiate dosing at 1 mcg orally once daily. Maximum
dose is 3.5 mcg once daily. (2.2)
CKD on dialysis: Initiate dosing at 10 mcg orally three times weekly
at dialysis (no more frequently than every other
day). Maximum dose is 20 mcg three times weekly for a total of 60 mcg
weekly. (2.3)
Target the maintenance dose of doxercalciferol to intact parathyroid
hormone (PTH) levels within the desired
therapeutic range and serum calcium within n