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Argatroban Injection, USP

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Argatroban 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 Heparin-Induced Thrombocytopenia

Argatroban Injection is indicated for prophylaxis or treatment of thrombosis in adult patients with...

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2 DOSAGE AND ADMINISTRATION

Argatroban Injection must be diluted 100-fold prior to infusion. Argatroban Injection should not be mixed with other drugs prior to dilution.

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3 DOSAGE FORMS AND STRENGTHS

250 mg of argatroban in 2.5 ml of sterile solution for injection in a single-dose vial.

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4 CONTRAINDICATIONS

Argatroban is contraindicated in

Patients with major bleeding [see Warnings and...
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5 WARNINGS AND PRECAUTIONS

5.1 Risk of Hemorrhage

Hemorrhage can occur at any site in the body in patients receiving argatroban. Unexplained fall in hematocrit or...

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6 ADVERSE REACTIONS

The following adverse reaction is also discussed in other sections of the labeling:

  • Risk of Hemorrhage [see

    6.1 Clinical Trials...

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7 DRUG INTERACTIONS

7.1 Heparin

If argatroban is to be initiated after cessation of heparin therapy, allow sufficient time for heparin's effect on the aPTT to...

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8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Risk Summary

Limited data from...

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10 OVERDOSAGE

Excessive anticoagulation, with or without bleeding, may be controlled by discontinuing argatroban or by decreasing the argatroban dose. In clinical studies, anticoagulation parameters generally returned from...

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11 DESCRIPTION

Argatroban is a synthetic direct thrombin inhibitor and the chemical name is 1-[5-[(aminoiminomethyl)amino] 1-oxo-2-[[(1,2,3,4-tetrahydro-3-methyl-8-quinolinyl)sulfonyl]amino]pentyl]-4-methyl-2-...

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12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

Argatroban is a direct thrombin inhibitor that reversibly binds to the thrombin active site. Argatroban does not...

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13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenicity studies with argatroban have not been performed.

Argatroban...

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14 CLINICAL STUDIES

14.1 Heparin-Induced Thrombocytopenia

The safety and efficacy of argatroban were evaluated in a historically controlled efficacy and safety study...

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16 HOW SUPPLIED/STORAGE AND HANDLING

Argatroban Injection is supplied in 2.5 mL solution in single-dose vials at the concentration of 100 mg/mL. Each vial contains 250 mg of argatroban.

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17 PATIENT COUNSELING INFORMATION

Inform patients of the risks associated with Argatroban Injection as well as the plan for regular monitoring during administration of the drug. Specifically, inform patients to report:

...
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