Argatroban 100 mg/mL
Argatroban · INJECTION, SOLUTION · Amneal Pharmaceuticals LLC
Argatroban is a injection, solution containing argatroban at 100 mg/mL, taken intravenous. Manufactured by Amneal Pharmaceuticals LLC.
Key Facts
- Brand Name
- Argatroban
- Generic Name
- Argatroban
- NDC Code (Product)
70121-1037- Manufacturer
- Amneal Pharmaceuticals LLC
- Strength
- 100 mg/mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- ANDA206698
- Drug Class
- Anti-coagulant [EPC]; Direct Thrombin Inhibitor [EPC]
- Marketing Start
- 01/26/2018
Recall History
Teva North America
CGMP Deviations
Hospira Inc., A Pfizer Company
Failed Impurities/Degradation Specifications; out of specification result for denitroquinoline-related impurity during three month time point
Pfizer Inc.
Failed Impurities/Degradation Specifications; Out of specification stability testing results at the 18 month time point
Eagle Pharmaceuticals Inc.
A complaint was received from a hospital pharmacy on 11/10/11 for crystalline particulates in a single vial from Lot V10194. Additional small visible particles consisting of fibers were identified.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Argatroban is a direct thrombin inhibitor indicated: For prophylaxis or treatment of thrombosis in adult patients with heparin-induced thrombocytopenia (HIT) ( 1.1 ) As an anticoagulant in adult patients with or at risk for HIT undergoing percutaneous coronary intervention (PCI) ( 1.2 ) 1.1 Heparin-Induced Thrombocytopenia Argatroban Injection is indicated for prophylaxis or treatment of thrombosis in adult patients with heparin-induced thrombocytopenia (HIT). 1.2 Percutaneous Coronary Intervention Argatroban Injection is indicated as an anticoagulant in adult patients with or at risk for HIT undergoing percutaneous coronary intervention (PCI).
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Argatroban Injection 250 mg/2.5 mL (100 mg/mL) must be diluted 100-fold by mixing with 0.9% Sodium Chloride Injection, 5% Dextrose Injection, or Lactated Ringer’s Injection to a final concentration of 1 mg/mL. ( 2.1 ) Argatroban Injection 50 mg/50 mL (1 mg/mL) is ready for intravenous infusion. Dilution is not required. ( 2.1 ) Heparin-Induced Thrombocytopenia The dose for heparin-induced thrombocytopenia without hepatic impairment is 2 mcg/kg/min administered as a continuous infusion. ( 2.2 ) Percutaneous Coronary Intervention The dose for patients with or at risk for heparin-induced thrombocytopenia undergoing percutaneous coronary intervention is started at 25 mcg/kg/min and a bolus of 350 mcg/kg administered via a large bore intravenous line over 3 to 5 minutes. ( 2.3 ) 2.1 Preparation for Intravenous Administration Argatroban Injection 250 mg/2.5 mL (100 mg/mL) must be diluted 100-fold prior to infusion. Argatroban should not be mixed with other drugs prior to dilution. Dilution is not required for Argatroban Injection 50 mg/50 mL (1 mg/mL). Argatroban Injection 250 mg/2.5 mL (100 mg/mL) Argatroban 250 mg/2.5 mL (100 mg/mL) should be diluted in 0.9%…
Contraindications
4 CONTRAINDICATIONS Argatroban is contraindicated in: Patients with major bleeding, [see Warnings and Precautions (5.1) ] Patients with a history of hypersensitivity to argatroban. Airway, skin, and generalized hypersensitivity reactions have been reported [see Adverse Reactions (6.1) ] Major bleeding (4) History of hypersensitivity to this product (4)
Drug Interactions
7 DRUG INTERACTIONS Heparin: Allow sufficient time for heparin’s effect on activated partial thromboplastin time (aPTT) to decrease before initiating Argatroban Injection therapy. ( 7.1 ) Warfarin: Concomitant use results in increased prolongation of PT and INR. ( 7.2 ) Thrombolytic agents or glycoprotein IIb/IIIa antagonists: Safety and effectiveness of concomitant use with argatroban have not been established. ( 7.4 , 7.5 ) 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 decrease prior to initiation of argatroban therapy. 7.2 Oral Anticoagulant Agents Pharmacokinetic drug-drug interactions between argatroban and warfarin (7.5 mg single oral dose) have not been demonstrated. However, the concomitant use of argatroban and warfarin (5 to 7.5 mg initial oral dose, followed by 2.5 to 6 mg/day orally for 6 to 10 days) results in prolongation of the prothrombin time (PT) and International Normalized Ratio (INR) [see Dosage and Administration (2.5 ) and Clinical Pharmacology (12.2) ]. 7.3 Aspirin/Acetaminophen No drug-drug interactions have been demonstrated between argatroban and concomitantly adm…
Adverse Reactions
6 ADVERSE REACTIONS The following adverse reaction is also discussed in other sections of the labeling: Risk of Hemorrhage [see Warnings and Precautions (5.1) ] . HIT patients: The most common (>5%) adverse reactions were dyspnea, hypotension, fever, diarrhea, sepsis, and cardiac arrest. (6.1) PCI patients: The most common (>5%) adverse reactions were chest pain, hypotension, back pain, nausea, vomiting and headache. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Hikma Pharmaceuticals USA Inc. at 1-877-233-2001 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Adverse Reactions in Patients with HIT (With or Without Thrombosis) Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The following safety information is based on all 568 patients treated with argatroban in Study 1 and Study 2. The safety profile of the patients from these studies is compared with that of 193 historical controls in which the adverse reactions were collected retr…
Frequently Asked Questions
What is Argatroban used for?
Argatroban contains Argatroban. It is a injection, solution taken intravenous. Consult your doctor for specific uses.
Is Argatroban a controlled substance?
Argatroban is not classified as a controlled substance by the DEA.
What is the generic name for Argatroban?
The generic name for Argatroban is Argatroban. There are no other listed brand versions of Argatroban.
What is the NDC code for Argatroban 100 mg/mL?
The NDC (National Drug Code) for Argatroban 100 mg/mL is 70121-1037, listed by Amneal Pharmaceuticals LLC.
Other Argatroban Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)