ZEMPLAR paricalcitol capsule liquid filled

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

paricalcitol (UNII: 6702D36OG5) (paricalcitol - UNII:6702D36OG5)

Disponible des:

Cardinal Health

Designació comuna internacional (DCI):

paricalcitol

Composición:

paricalcitol 1 ug

tipo de receta:

PRESCRIPTION DRUG

Estat d'Autorització:

New Drug Application

Fitxa tècnica

ZEMPLAR- PARICALCITOL CAPSULE, LIQUID FILLED
CARDINAL HEALTH
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ZEMPLAR SAFELY AND EFFECTIVELY.
SEE FULL PRESCRIBING INFORMATION FOR ZEMPLAR.
ZEMPLAR (PARICALCITOL) CAPSULES
INITIAL U.S. APPROVAL: 1998
INDICATIONS AND USAGE
Zemplar is a vitamin D analog indicated for the prevention and
treatment of secondary hyperparathyroidism associated
with
Chronic kidney disease (CKD) Stages 3 and 4 (1.1).
CKD Stage 5 in patients on hemodialysis (HD) or peritoneal dialysis
(PD) (1.2).
DOSAGE AND ADMINISTRATION
CKD Stages 3 and 4: Zemplar Capsules may be administered once daily or
every other day, three times a week (2.1).
CKD Stage 5: Zemplar Capsules are dosed every other day, three times a
week (2.2). To minimize the risk of
hypercalcemia patients should be treated only after their baseline
serum calcium has been reduced to 9.5 mg/dL or
lowe r.
Initial Dosage
CKD Stages 3, 4
CKD Stage 5
Baseline intact parathyroid (iPTH)
Le ve l
Starting Dose
Dose in micrograms is based on
baseline iPTH level (pg/mL)/80.
Dose three times a week (e.g. every
other day).
≤ 500 pg/mL
1 mcg daily or 2 mcg three times a week (e.g.
every other day)
> 500 pg/mL
2 mcg daily or 4 mcg three times a week (e.g.
every other day)
Dose Titration
CKD Stages 3, 4
CKD Stage 5
iPTH Level Relative to Baseline
Dosing Recommendation
Dose in micrograms is based on most
recent iPTH level (pg/mL)/80 with
adjustments based on serum calcium and
phosphorous levels.
Dose three times a week (e.g. every other
day).
Decreased by < 30%
Increase dose by 1 mcg daily or 2 mcg
three times a week (e.g. every other
day)
Decreased by ≥ 30% and ≤ 60%
Maintain dose
Decreased by > 60% or iPTH < 60
pg/mL
Decrease dose by 1 mcg daily or 2
mcg three times a week (e.g. every
other day)
DOSAGE FORMS AND STRENGTHS
Capsules: 1 mcg, 2 mcg, and 4 mcg (3).
CONTRAINDICATIONS
Evidence of hypercalcemia or vitamin D toxicity (4).
WARNINGS AND PRECAUTIONS
Hypercalcemia: Excessive ad