ZOLEDRONIC ACID injection, solution

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

Zoledronic Acid (UNII: 6XC1PAD3KF) (Zoledronic Acid Anhydrous - UNII:70HZ18PH24)

Disponível em:

Dr. Reddy's Laboratories Inc

Via de administração:

INTRAVENOUS

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

Zoledronic acid injection is indicated for the treatment of hypercalcemia of malignancy defined as an albumin­-corrected calcium (cCa) of greater than or equal to 12 mg/dL [3 mmol/L] using the formula: cCa in mg/dL=Ca in mg/dL + 0.8 (4 g/dL - patient albumin [g/dL]). Zoledronic acid injection is indicated for the treatment of patients with multiple myeloma and patients with documented bone metastases from solid tumors, in conjunction with standard antineoplastic therapy. Prostate cancer should have progressed after treatment with at least one hormonal therapy. Limitation of Use The safety and efficacy of zoledronic acid injection in the treatment of hypercalcemia associated with hyperparathyroidism or with other non-tumor-related conditions have not been established. Hypersensitivity to Zoledronic Acid or Any Components of Zoledronic Acid Injection Hypersensitivity reactions including rare cases of urticaria and angioedema, and very rare casesof anaphylactic reaction/shock have been reported [see Adverse Re

Resumo do produto:

Zoledronic acid injection 4 mg/100 mL single-use ready-to-use bottle is available as follows:  Carton of 1 bottle……………………………………NDC 43598-255-52 Store at 20° - 25°C (68° - 77°F); [see USP Controlled Room Temperature].

Status de autorização:

Abbreviated New Drug Application

Características técnicas

ZOLEDRONIC ACID- ZOLEDRONIC ACID INJECTION, SOLUTION
DR. REDDY'S LABORATORIES INC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ZOLEDRONIC ACID INJECTIONSAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ZOLEDRONIC ACID
INJECTION.
ZOLEDRONIC ACID INJECTIONREADY-TO-USE SOLUTION FOR INTRAVENOUS
INFUSION (FOR SINGLE USE)
INITIAL U.S. APPROVAL: 2001
INDICATIONS AND USAGE
Zoledronic acid injection is a bisphosphonate indicated for the
treatment of:
Hypercalcemia of malignancy. (1.1)
Patients with multiple myeloma and patients with documented bone
metastases from solid tumors, in conjunction with
standard antineoplastic therapy. Prostate cancer should have
progressed after treatment with at least one hormonal
therapy. (1.2).
Limitation of use: The safety and efficacy of zoledronic acid
injection has not been established for use in
hyperparathyroidism or nontumor-related-hypercalcemia .
DOSAGE AND ADMINISTRATION
Hypercalcemia of malignancy (2.1)
4 mg as a single-use intravenous infusion over no less than 15
minutes.
4 mg as retreatment after a minimum of 7 days
Multiple myeloma and bone metastasis from solid tumors. (2.2)
4 mg as a single-use intravenous infusion over no less than 15 minutes
every 3 to 4 weeks for patients with creatinine
clearance of greater than 60 mL/min.
Reduce the dose for patients with renal impairment.
Coadminister oral calcium supplements of 500 mg and a multiple vitamin
containing 400 international units of vitamin D
daily.
Administer through a separate vented infusion line and do not allow to
come in contact with any calcium or divalent
cation-containing solutions. (2.3)
DOSAGE FORMS AND STRENGTHS
4 mg/100 mL single-use- ready-to-use bottle (3)
CONTRAINDICATIONS
Hypersensitivity to any component of zoledronic acid injection (4)
WARNINGS AND PRECAUTIONS
Patients being treated with zoledronic acid injection should not be
treated with Reclast
.(5.1)
Adequately rehydrate patients with hypercalcemia of malignancy prior
t