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deferoxamine mesylate for injection, USP
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deferoxamine mesylate for injection, USP Quick Finder
1 INDICATIONS AND USAGE
1.1 Acute Iron Intoxication
Deferoxamine Mesylate for injection is indicated as an adjunct to standard measures for the treatment of acute...
2 DOSAGE AND ADMINISTRATION
The dosage (based on body weight in mg/kg/day), rates of administration, and mode of administration for both adults and pediatric patients are individually determined and adapted during the...
3 DOSAGE FORMS AND STRENGTHS
For injection: 500 mg of deferoxamine mesylate (corresponding to 426.82 mg of deferoxamine as free base) as a white to off-white lyophilized powder in single-dose fliptop vial for reconstitution...
4 CONTRAINDICATIONS
Deferoxamine Mesylate for injection is contraindicated in patients with:
A history of a hypersensitivity reaction to deferoxamine or any of its inactive ingredients [see...
5 WARNINGS AND PRECAUTIONS
5.1 Hypersensitivity Reactions
Hypersensitivity reactions, including anaphylaxis, have occurred in deferoxamine mesylate-treated...
6 ADVERSE REACTIONS
The following clinically significant adverse reactions are described elsewhere in the labeling:
- •
- Hypersensitivity Reactions [see...
7 DRUG INTERACTIONS
7.1 Prochlorperazine
Concurrent treatment with deferoxamine mesylate and prochlorperazine, a phenothiazine derivative, may lead to temporary...
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Risk Summary
There are no available data on Deferoxamine mesylate use in pregnant...
10 OVERDOSAGE
Acute Toxicity
Intravenous LD50s (mg/kg): mice, 287; rats, 329.
Inadvertent administration of an overdose or inadvertent intravenous bolus administration/rapid intravenous...
11 DESCRIPTION
Deferoxamine Mesylate for Injection, USP, is an iron-chelating agent, available in vials for injection via intramuscular, subcutaneous, and intravenous administration. Deferoxamine mesylate is supplied as...
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
Deferoxamine mesylate chelates iron by forming a stable complex that prevents the iron from entering into further...
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
Long-term carcinogenicity studies in animals have not been performed with...
16 HOW SUPPLIED/STORAGE AND HANDLING
How Supplied
17 PATIENT COUNSELING INFORMATION
Caution patients about the potential allergic reactions associated with rapid intravenous administration of Deferoxamine Mesylate for injection and the need for monitoring allergic...
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