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zoledronic acid for injection 4 MG VIAL
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Our scientific content is evidence-based, scientifically balanced and non-promotional. It undergoes rigorous internal medical review and is updated regularly to reflect new information.
zoledronic acid for injection 4 MG VIAL Quick Finder
Highlights
Indications and Usage
1 INDICATIONS AND USAGE
1.1 Hypercalcemia of Malignancy
Zoledronic acid injection is indicated for the treatment of hypercalcemia of malignancy defined as an albumin-...
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Dosage and Administration
2 DOSAGE AND ADMINISTRATION
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
...
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Dosage Forms and Strengths
3 DOSAGE FORMS AND STRENGTHS
Injection: 4 mg/5 mL (0.8 mg/mL) single-dose vial for dilution prior to intravenous infusion.
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Contraindications
4 CONTRAINDICATIONS
Hypersensitivity to Zoledronic Acid or Any Components of Zoledronic Acid Injection
Hypersensitivity reactions including...
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Warnings and Precautions
5 WARNINGS AND PRECAUTIONS
5.1 Drugs With Same Active Ingredient or in the Same Drug Class
Zoledronic Acid Injection contains the same active ingredient as found in...
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Adverse Reactions
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the...
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Drug Interactions
7 DRUG INTERACTIONS
In vitro studies indicate that the plasma protein binding of zoledronic acid is low, with the unbound fraction ranging from 60% to 77%. In vitro...
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Use in Specific Populations
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Risk Summary
Based on findings from...
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Overdosage
10 OVERDOSAGE
Clinical experience with acute overdosage of zoledronic acid is limited. Two patients received zoledronic acid 32 mg over 5 minutes in clinical trials. Neither patient experienced any clinical or laboratory...
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Description
11 DESCRIPTION
Zoledronic acid is a bisphosphonic acid which is an inhibitor of osteoclastic bone resorption. Zoledronic acid is designated chemically as (1-Hydroxy-2-imidazol-1-yl-phosphonoethyl) phosphonic acid monohydrate...
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Clinical Pharmacology
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
The principal pharmacologic action of zoledronic acid is inhibition of bone resorption. Although the antiresorptive...
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Nonclinical Toxicology
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
Standard lifetime carcinogenicity bioassays were conducted in mice and rats. Mice...
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Clinical Studies
14 CLINICAL STUDIES
14.1 Hypercalcemia of Malignancy
Two identical multicenter, randomized, double-blind, double-dummy studies of zoledronic acid 4 mg given as a 5-...
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How Supplied/Storage and Handling
16 HOW SUPPLIED/STORAGE AND HANDLING
4 mg/5 mL (0.8 mg/mL) single-dose vial for dilution prior to intravenous infusion
...
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Medication Guide
17 PATIENT COUNSELING INFORMATION
Drugs With Same Active Ingredient or in the Same Drug Class
Inform patients not to take Reclast or other...
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Report Adverse Event
To report an adverse event related to Pfizer-BioNTech COVID-19 Vaccine (also known as COMIRNATY®, COVID-19 mRNA, Vaccine BNT162b2 or BNT162) or Pfizer COVID-19 Treatment (also known as PAXLOVID™ (nirmatrelvir tablets; ritonavir tablets)), and you are not part of a clinical trial* for this product, click the link below to submit your information:
*If you are involved in a clinical trial for either product, adverse events should be reported to your coordinating study site.
If you cannot use the above website or would like to report an adverse event related to a different Pfizer product, please call Pfizer Safety at(800) 438-1985.
You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at www.fda.gov/medwatchor by calling
(800)-332-1088.
(800)-332-1088.