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DOXORUBICIN (doxorubicin hydrochloride)
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DOXORUBICIN Quick Finder
Highlights
Boxed Warning
WARNING: CARDIOMYOPATHY, SECONDARY MALIGNANCIES, EXTRAVASATION AND TISSUE NECROSIS, and SEVERE MYELOSUPPRESSION
- Cardiomyopathy: Myocardial damage, including acute left ventricular failure, can occur...
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Indications and Usage
1 INDICATIONS AND USAGE
1.1 Adjuvant Breast Cancer
Doxorubicin Hydrochloride Injection/for Injection is indicated as a component of multi-agent adjuvant chemotherapy...
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Dosage and Administration
2 DOSAGE AND ADMINISTRATION
2.1 Recommended Dosage for Adjuvant Breast Cancer
The recommended dosage of Doxorubicin Hydrochloride Injection/for Injection is 60 mg/m...
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Dosage Forms and Strengths
3 DOSAGE FORMS AND STRENGTHS
- Doxorubicin Hydrochloride Injection:
- 10 mg/5 mL, 20 mg/10 mL and 50 mg/25 mL (2 mg/mL) clear red solution in a single-dose vial
- 150 mg/75 mL and 200 mg/...
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Contraindications
4 CONTRAINDICATIONS
Doxorubicin Hydrochloride Injection/for Injection are contraindicated in patients with:
- Severe myocardial insufficiency [see Warnings and...
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Warnings and Precautions
5 WARNINGS AND PRECAUTIONS
5.1 Cardiomyopathy and Arrhythmias
Cardiomyopathy
...
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Adverse Reactions
6 ADVERSE REACTIONS
The following clinically significant adverse reactions are described elsewhere in the labeling.
- Cardiomyopathy and Arrhythmias [see Warnings...
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Drug Interactions
7 DRUG INTERACTIONS
7.1 Effect of Other Drugs on Doxorubicin Hydrochloride Injection/for Injection
...
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Use in Specific Populations
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Risk Summary
Based on findings in...
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Overdosage
10 OVERDOSAGE
Few cases of overdose have been described.
A 58-year-old man with acute lymphoblastic leukemia received 10-fold overdose of doxorubicin hydrochloride (300 mg/m2) in one day. He...
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Description
11 DESCRIPTION
Doxorubicin hydrochloride is an anthracycline topoisomerase inhibitor isolated from cultures of Streptomyces peucetius var. caesius. The chemical name...
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Clinical Pharmacology
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
The cytotoxic effect of doxorubicin hydrochloride on malignant cells and its toxic effects on various organs are...
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Nonclinical Toxicology
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
Doxorubicin hydrochloride treatment can increase the risk of secondary...
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Clinical Studies
14 CLINICAL STUDIES
14.1 Adjuvant Breast Cancer
The efficacy of doxorubicin hydrochloride-containing regimens for the post-operative, adjuvant treatment of surgically...
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References
15 REFERENCES
- "Hazardous Drugs". OSHA. http://www.osha.gov/SLTC/hazardousdrugs/index.html
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How Supplied/Storage and Handling
16 HOW SUPPLIED/STORAGE AND HANDLING
Doxorubicin Hydrochloride Injection
Doxorubicin Hydrochloride Injection is a sterile, isotonic...
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Medication Guide
17 PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information).
...
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