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deferoxamine mesylate for injection, USP

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deferoxamine mesylate for injection, USP Quick Finder

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the...
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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...

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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...

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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...

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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...

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5 WARNINGS AND PRECAUTIONS

5.1 Hypersensitivity Reactions

Hypersensitivity reactions, including anaphylaxis, have occurred in deferoxamine mesylate-treated...

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6 ADVERSE REACTIONS

The following clinically significant adverse reactions are described elsewhere in the labeling:

Hypersensitivity Reactions [see...
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7 DRUG INTERACTIONS

7.1 Prochlorperazine

Concurrent treatment with deferoxamine mesylate and prochlorperazine, a phenothiazine derivative, may lead to temporary...

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8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Risk Summary

There are no available data on Deferoxamine mesylate use in pregnant...

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10 OVERDOSAGE

Acute Toxicity

Intravenous LD50s (mg/kg): mice, 287; rats, 329.

Inadvertent administration of an overdose or inadvertent intravenous bolus administration/rapid intravenous...

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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...

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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...

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13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term carcinogenicity studies in animals have not been performed with...

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16 HOW SUPPLIED/STORAGE AND HANDLING

How Supplied

...
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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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