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RX ITEM-Argatroban N+ 100mg/ml Vial 2.5ml by Glaxosmithkline

NDC No.00007-4407-54 UPC/GTIN No.3-00074-40754-6 MPN 440754 Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical TherapiGlaxosmithkline/KdcOnly Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scopWant to do Research on this Med or need a large quantity? Email Details with quantity required to:sales@AmericanPharmaWholesale.comVisit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.

RX ITEM-Argatroban N+ 100mg/ml Vial 2.5ml by Glaxosmithkline

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NDC No.00007-4407-54 UPC/GTIN No.3-00074-40754-6 MPN 440754 Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scope of practice can order this RX item. Rx Item No.Rx071894 Argatroban N+ 100mg/ml Vial 2.5ml by Glaxosmithkline Item No.3071894 NDC No.00007440754 UPC No.300074407546 Other Name Acova Therapeutic Code 201204 Therapeutic Class Direct Thrombin

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ARGATROBAN argatroban injection, solution
Fresenius Kabi USA, LLC
DESCRIPTION
Argatroban is 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 asymmetric carbons. One of the asymmetric carbons has an configuration (stereoisomer Type I) and an configuration (stereoisomer Type II). Argatroban consists of mixture of and stereoisomers at ratio of approximately 65:35.
The molecular formula of argatroban is C23 H36 N6 O5 S?H2 O. Its molecular weight is 526.66 g/mol
Argatroban is 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 sterile clear, colorless to pale yellow, slightly viscous solution in single dose amber vial containing 250 mg per 2.5 mL of argatroban. It is supplied as solution intended for dilution prior to intravenous use. Each mL of sterile, nonpyrogenic solution contains 100 mg argatroban and 954 mg propylene glycol.
Mechanism of Action
Argatroban is direct thrombin inhibitor that reversibly binds to the thrombin active site. Argatroban does not require the co-factor antithrombin III for antithrombotic activity. Argatroban exerts its anticoagulant effects by inhibiting thrombin-catalyzed or -induced reactions, including fibrin formation; activation of coagulation factors V, VIII, and XIII; activation of protein C; and platelet aggregation.
HOW SUPPLIED/STORAGE AND HANDLING
NDC 63323-526-03, 250 mg per 2.5 mL (100 mg per mL) single dose vial, packaged individually.
Storage
Store the vial in original carton at 20? to 25?C (68? to 77?F) [see USP Controlled Room Temperature]. Protect from freezing. Protect from light (keep in outer carton). If the solution is cloudy, or if an insoluble precipitate is noted, the vial should be discarded.
The container closure is not made with natural rubber latex.
17 PATIENT COUNSELING info.
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:
the use of any other products known to affect bleeding.
any medical history that may increase the risk for bleeding, including history of severe hypertension; recent lumbar puncture or spinal anesthesia; major surgery, especially involving the brain, spinal cord, or eye; hematologic conditions associated with increased bleeding tendencies such as congenital or acquired bleeding disorders and gastrointestinal lesions such as ulcerations.
any bleeding signs or symptoms.
the occurrence of any signs or symptoms of allergic reactions (e.g., airway reactions, skin reactions and vasodilation reactions).

INDICATIONS AND USAGE
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 AND ADMINISTRATION
Argatroban injection 250 mg per 2.5 mL (100 mg per mL) must be diluted prior to infusion. If the solution is cloudy, or if an insoluble precipitate is noted, the vial should be discarded. Argatroban injection should not be mixed with other drugs prior to dilution.
DOSAGE FORMS AND STRENGTHS
Injection: 250 mg per 2.5 mL (100 mg per mL) in single dose vial.
4 CONTRAINDICATIONS
Argatroban is contraindicated in:
Patients with major bleeding


NDC No.00007-4407-54 UPC/GTIN No.3-00074-40754-6 MPN 440754 Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapi
Argatroban N+ 100mg/ml Vial 2.5ml by Gla
NDC No.00007-4407-54 UPC/GTIN No.3-00074-40754-6 MPN 440754 Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapi

Glaxosmithkline/Kdc
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Glaxosmithkline/Kdc

Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop
ARGATROBAN AL
Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop

Want to do Research on this Med or need a large quantity? Email Details with quantity required to:sales@AmericanPharmaWholesale.com
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Visit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.
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Visit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.