Rx Item-Arixtra fondaparinux sodium 2.5mg 0.5 Syg 10X0.5ml by Mylan

Clinical Information
Gen. Code and Des.
49808 fondaparinux sodium SUBCUT SYRINGE 2.5 MG/0.5
GCN and Des.
15494 fondaparinux sodium SUBCUT SYRINGE 2.5 MG/0.5
Strength
2.5MG
Dose Form
SYRINGE (ML)
Product Category
RX Pharmaceuticals
Fine Line Class
850085008510 All Rx Products
DEA Class
NC
OMP Family

AHFS Class
20120492 ANTICOAGULANTS, MISCELLANEOUS
Active Ingredients
9550 fondaparinux sodium 114870030
Inactive Ingredients
8921 latex






ARIXTRA- fondaparinux sodium injection, solution
Mylan Institutional LLC
WARNING: SPINAL/EPIDURAL HEMATOMAS
Epidural or spinal hematomas may occur in patients who are anticoagulated with low molecular weight heparins (LMWH), heparinoids, or fondaparinux sodium and are receiving neuraxial anesthesia or undergoing spinal puncture. These hematomas may result in long-term or permanent paralysis. Consider these risks when scheduling patients for spinal procedures. Factors that can increase the risk of developing epidural or spinal hematomas in these patients include:
Use of indwelling epidural catheters
concomitant use of other drugs that affect hemostasis, such as non-steroidal anti-inflammatory drugs (NSAIDs), platelet inhibitors, or other anticoagulants
a history of traumatic or repeated epidural or spinal puncture
a history of spinal deformity or spinal surgery
Optimal timing between the administration of ARIXTRA and neuraxial procedures is not known.
Monitor patients frequently for signs and symptoms of neurologic impairment. If neurologic compromise is noted, urgent treatment is necessary.
Consider the benefit and risks before neuraxial intervention in patients anticoagulated or to be anticoagulated for thromboprophylaxis
INDICATIONS AND USAGE
1.1 Prophylaxis of Deep Vein Thrombosis
ARIXTRA? is indicated for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE):
in patients undergoing hip fracture surgery, including extended prophylaxis;
in patients undergoing hip replacement surgery;
in patients undergoing knee replacement surgery;
in patients undergoing abdominal surgery who are at risk for thromboembolic complications.
1.2 Treatment of Acute Deep Vein Thrombosis
ARIXTRA is indicated for the treatment of acute deep vein thrombosis when administered in conjunction with warfarin sodium.
1.3 Treatment of Acute Pulmonary Embolism
ARIXTRA is indicated for the treatment of acute pulmonary embolism when administered in conjunction with warfarin sodium when initial therapy is administered in the hospital.
2 DOSAGE AND ADMINISTRATION
Do not mix other medications or solutions with ARIXTRA. Administer ARIXTRA only subcutaneously.
2.1 Deep Vein Thrombosis Prophylaxis Following Hip Fracture, Hip Replacement, and Knee Replacement Surgery
In patients undergoing hip fracture, hip replacement, or knee replacement surgery, the recommended dose of ARIXTRA is 2.5 mg administered by subcutaneous injection once daily after hemostasis has been established. Administer the initial dose no earlier than to hours after surgery. Administration of ARIXTRA earlier than hours after surgery increases the risk of major bleeding. The usual duration of therapy is to days; up to 11 days of therapy was administered in clinical trials.
In patients undergoing hip fracture surgery, an extended prophylaxis course of up to 24 additional days is recommended. In patients undergoing hip fracture surgery, total of 32 days (peri-operative and extended prophylaxis) was administered in clinical trials.
2.2 Deep Vein Thrombosis Prophylaxis Following Abdominal Surgery
In patients undergoing abdominal surgery, the recommended dose of ARIXTRA is 2.5 mg administered by subcutaneous injection once daily after hemostasis has been established. Administer the initial dose no earlier than to hours after surgery. Administration of ARIXTRA earlier than hours after surgery increases the risk of major bleeding. The usual duration of administration is to days, and up to 10 days of ARIXTRA was administered in clinical trials.
2.3 Deep Vein Thrombosis and Pulmonary Embolism Treatment
In patients with acute symptomatic DVT and in patients with acute symptomatic PE, the recommended dose of ARIXTRA is mg (body weight <50 kg), 7.5 mg (body weight 50 to 100 kg), or 10 mg (body weight >100 kg) by subcutaneous injection once daily (ARIXTRA treatment regimen). Initiate concomitant treatment with warfarin sodium as soon as possible, usually within 72 hours. Continue treatment with ARIXTRA for at least days and until therapeutic oral anticoagulant effect is established (INR to 3). The usual duration of administration of ARIXTRA is to days; up to 26 days of ARIXTRA injection was administered in clinical trials.
2.4 Hepatic Impairment
No dose adjustment is recommended in patients with mild to moderate hepatic impairment, based upon single-dose pharmacokinetic data. Pharmacokinetic data are not available for patients with severe hepatic impairment. Patients with hepatic impairment may be particularly vulnerable to bleeding during ARIXTRA therapy. Observe these patients closely for signs and symptoms of bleeding.
DOSAGE FORMS AND STRENGTHS
Single-dose, prefilled syringes containing either 2.5 mg, mg, 7.5 mg, or 10 mg of fondaparinux.

Arixtra 2.5mg 0.5 Syg 10X0.5ml
Mylan Institutional/Gen RX399194 399194 NDC No.NEW 67457-0592-10 67457-592-10 OLD 00007-3230-11 UPC/GTIN No.3-67457-59210-7 MPN 5210

Arixtra 2.5mg 0.5 Syg 10X0.5ml
RX399194 399194 NDC No.NEW 67457-0592-10 67457-592-10 OLD 00007-3230-11 UPC/GTIN No.3-67457-59210-7 MPN 5210

Arixtra 2.5mg 0.5 Syg 10X0.5ml
RX399194 399194 NDC No.NEW 67457-0592-10 67457-592-10 OLD 00007-3230-11 UPC/GTIN No.3-67457-59210-7 MPN 5210

Arixtra 2.5mg 0.5 Syg 10X0.5ml by Mylan
NDC No.NEW 67457-0592-10 67457-592-10 OLD 00007-3230-11 UPC/GTIN No.3-67457-59210-7 MPN 5210 Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optomet

FONDAPARINUX SODIUM SUB-Q
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

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