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DOXORUBICIN (doxorubicin hydrochloride)
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DOXORUBICIN Quick Finder
WARNING: CARDIOMYOPATHY, SECONDARY MALIGNANCIES, EXTRAVASATION AND TISSUE NECROSIS, and SEVERE MYELOSUPPRESSION
- Cardiomyopathy: Myocardial damage, including acute left ventricular failure, can occur...
1 INDICATIONS AND USAGE
1.1 Adjuvant Breast Cancer
Doxorubicin Hydrochloride Injection/for Injection is indicated as a component of multi-agent adjuvant chemotherapy...
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...
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/...
4 CONTRAINDICATIONS
Doxorubicin Hydrochloride Injection/for Injection are contraindicated in patients with:
- Severe myocardial insufficiency [see Warnings and...
5 WARNINGS AND PRECAUTIONS
5.1 Cardiomyopathy and Arrhythmias
Cardiomyopathy
...
6 ADVERSE REACTIONS
The following clinically significant adverse reactions are described elsewhere in the labeling.
- Cardiomyopathy and Arrhythmias [see Warnings...
7 DRUG INTERACTIONS
7.1 Effect of Other Drugs on Doxorubicin Hydrochloride Injection/for Injection
...
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Risk Summary
Based on findings in...
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...
11 DESCRIPTION
Doxorubicin hydrochloride is an anthracycline topoisomerase inhibitor isolated from cultures of Streptomyces peucetius var. caesius. The chemical name...
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...
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
Doxorubicin hydrochloride treatment can increase the risk of secondary...
14 CLINICAL STUDIES
14.1 Adjuvant Breast Cancer
The efficacy of doxorubicin hydrochloride-containing regimens for the post-operative, adjuvant treatment of surgically...
15 REFERENCES
- "Hazardous Drugs". OSHA. http://www.osha.gov/SLTC/hazardousdrugs/index.html
16 HOW SUPPLIED/STORAGE AND HANDLING
Doxorubicin Hydrochloride Injection
Doxorubicin Hydrochloride Injection is a sterile, isotonic...
17 PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information).
...
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