Argatroban Injection

Name: Argatroban Injection

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-piperidinecarboxylic acid, monohydrate. Argatroban has 4 asymmetric carbons. One of the asymmetric carbons has an R configuration (stereoisomer Type I) and an S configuration (stereoisomer Type II). Argatroban consists of a mixture of R and S stereoisomers at a ratio of approximately 65:35.

The molecular formula of argatroban is C23H36N6O5S•H2O. Its molecular weight is 526.66 g/mol. The structural formula is:

Argatroban is a white, odorless crystalline powder that is freely soluble in glacial acetic acid, slightly soluble in ethanol, and insoluble in acetone, ethyl acetate, and ether.

Argatroban Injection is a sterile clear, colorless to pale yellow, slightly viscous solution in a single-use amber vial containing 250 mg/2.5 mL of argatroban. Each mL of sterile, nonpyrogenic solution contains 100 mg argatroban, 300 mg D-sorbitol, and 400 mg dehydrated alcohol in water for injection.

How supplied

Dosage Forms And Strengths

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

Storage And Handling

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

NDC 0007-4407-01     (Package of 1)

Storage

Store the vials in original cartons at room temperature [25° C (77°F), with excursions permitted to 15°-30° C (59°-86°F)]. Do not freeze. Retain in the original carton to protect from light. If the solution is cloudy, or if an insoluble precipitate is noted, the vial should be discarded.

Manufactured by : GlaxoSmithKline Research Triangle Park, NC 27709. Revised: May 2016.

Warnings

Included as part of the "PRECAUTIONS" Section

What is argatroban (acova)?

Argatroban keeps the platelets in your blood from coagulating (clotting) to prevent unwanted blood clots that can occur while receiving heparin

Argatroban is used to treat or prevent blood clots in people who have thrombocytopenia (low levels of platelets in the blood) caused by using heparin. Argatroban is sometimes used in people who are undergoing a procedure called angioplasty (to open blocked arteries).

Argatroban may also be used for purposes not listed in this medication guide.

What is the most important information i should know about argatroban (acova)?

You should not use this medication if you are allergic to argatroban, or if you have any major bleeding from a surgery, injury, or other medical trauma.

Argatroban is not expected to be harmful to an unborn baby. However, aspirin is sometimes given with argatroban, and aspirin can cause bleeding when it is taken during the last 3 months of pregnancy. Aspirin can also cause side effects in a newborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

Before receiving argatroban, tell your doctor if you have liver disease, a stomach ulcer or bleeding, a bleeding or blood clotting disorder, untreated or uncontrolled high blood pressure, if you have recently had a spinal tap or epidural anesthesia, or if you have recently had major surgery (especially on your eyes, brain, or spinal cord).

Tell your doctor if you are using or receiving blood thinners or any other medications used to treat or prevent blood clots.

Because argatroban keeps your blood from coagulating (clotting) to prevent unwanted blood clots, it can also make it easier for you to bleed, even from a minor injury. Contact your doctor or seek emergency medical attention if you have bleeding that will not stop.

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Read the Argatroban User Reviews »

© Argatroban Patient Information is supplied by Cerner Multum, Inc. and Argatroban Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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