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Argatroban Injection, USP
If you provide additional keywords, you may be able to browse through our database of Scientific Response Documents.
Our scientific content is evidence-based, scientifically balanced and non-promotional. It undergoes rigorous internal medical review and is updated regularly to reflect new information.
Argatroban Injection, USP Quick Finder
Highlights
Indications and Usage
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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Dosage and Administration
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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Dosage Forms and Strengths
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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Contraindications
4 CONTRAINDICATIONS
Argatroban is contraindicated in
- •
- Patients with major bleeding [see Warnings and...
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Warnings and Precautions
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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Adverse Reactions
6 ADVERSE REACTIONS
The following adverse reaction is also discussed in other sections of the labeling:
- Risk of Hemorrhage [see ...
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Drug Interactions
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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Use in Specific Populations
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Risk Summary
Limited data from...
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Overdosage
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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Description
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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Clinical Pharmacology
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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Nonclinical Toxicology
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
Carcinogenicity studies with argatroban have not been performed.
Argatroban...
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Clinical Studies
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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How Supplied/Storage and Handling
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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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Medication Guide
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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Report Adverse Event
To report an adverse event related to Pfizer-BioNTech COVID-19 Vaccine (also known as COMIRNATY®, COVID-19 mRNA, Vaccine BNT162b2 or BNT162) or Pfizer COVID-19 Treatment (also known as PAXLOVID™ (nirmatrelvir tablets; ritonavir tablets)), and you are not part of a clinical trial* for this product, click the link below to submit your information:
*If you are involved in a clinical trial for either product, adverse events should be reported to your coordinating study site.
If you cannot use the above website or would like to report an adverse event related to a different Pfizer product, please call Pfizer Safety at(800) 438-1985.
You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at www.fda.gov/medwatchor by calling
(800)-332-1088.
(800)-332-1088.