ENOXAPARIN SODIUM injection

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

enoxaparin sodium (UNII: 8NZ41MIK1O) (enoxaparin - UNII:E47C0NF7LV)

Disponibil de la:

Cardinal Health

Calea de administrare:

SUBCUTANEOUS

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

Enoxaparin sodium is indicated for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE): Enoxaparin sodium is indicated for: Enoxaparin sodium is indicated for the prophylaxis of ischemic complications of unstable angina and non–Q-wave myocardial infarction, when concurrently administered with aspirin. Enoxaparin sodium, when administered concurrently with aspirin, has been shown to reduce the rate of the combined endpoint of recurrent myocardial infarction or death in patients with acute ST-segment elevation myocardial infarction (STEMI) receiving thrombolysis and being managed medically or with percutaneous coronary intervention (PCI). Enoxaparin sodium is contraindicated in patients with: Risk Summary Placental transfer of enoxaparin was observed in the animal studies. Human data from a retrospective cohort study, which included 693 live births, suggest that enoxaparin does not increase the risk of major developmental abnormalities (see Data) . Based on animal data, enox

Rezumat produs:

Enoxaparin sodium injection is available in two concentrations (see Tables 26 and 27). Graduated Prefilled Syringes ‡ 80 mg/0.8 mL 8000 IU Brown Overbagged with 5 syringes per bag NDC 55154-9579-5 Store at 25°C (77°F); excursions permitted to 15°C–30°C (59°F–86°F) [see USP Controlled Room Temperature]. Do not store the multiple-dose vials for more than 28 days after the first use.

Statutul autorizaţiei:

New Drug Application Authorized Generic

Caracteristicilor produsului

ENOXAPARIN SODIUM- ENOXAPARIN SODIUM INJECTION
CARDINAL HEALTH
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ENOXAPARIN SODIUM INJECTION SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ENOXAPARIN SODIUM
INJECTION.
ENOXAPARIN SODIUM INJECTION, FOR SUBCUTANEOUS AND INTRAVENOUS USE
INITIAL U.S. APPROVAL: 1993
WARNING: SPINAL/EPIDURAL HEMATOMAS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
EPIDURAL OR SPINAL HEMATOMAS MAY OCCUR IN PATIENTS WHO ARE
ANTICOAGULATED WITH LOW MOLECULAR WEIGHT
HEPARINS (LMWH) OR HEPARINOIDS 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:
•
•
•
•
•
MONITOR PATIENTS FREQUENTLY FOR SIGNS AND SYMPTOMS OF NEUROLOGICAL
IMPAIRMENT. IF NEUROLOGICAL
COMPROMISE IS NOTED, URGENT TREATMENT IS NECESSARY. (5.1, 7)
INDICATIONS AND USAGE
Enoxaparin sodium is a low molecular weight heparin (LMWH) indicated
for:
•
•
•
•
•
DOSAGE AND ADMINISTRATION
See full prescribing information for dosing and administration
information. (2)
DOSAGE FORMS AND STRENGTHS
100 mg/mL concentration (3):
•
•
•
150 mg/mL concentration (3):
•
CONTRAINDICATIONS
•
•
USE OF INDWELLING EPIDURAL CATHETERS
CONCOMITANT USE OF OTHER DRUGS THAT AFFECT HEMOSTASIS, SUCH AS
NON-STEROIDAL ANTI-INFLAMMATORY
DRUGS (NSAIDS), PLATELET INHIBITORS, AND OTHER ANTICOAGULANTS
A HISTORY OF TRAUMATIC OR REPEATED EPIDURAL OR SPINAL PUNCTURES
A HISTORY OF SPINAL DEFORMITY OR SPINAL SURGERY
OPTIMAL TIMING BETWEEN THE ADMINISTRATION OF ENOXAPARIN SODIUM AND
NEURAXIAL PROCEDURES IS NOT
KNO WN
Prophylaxis of deep vein thrombosis (DVT) in abdominal surgery, hip
replacement surgery, knee replacement
surgery, or medical patients with severely restricted mobility during
acute illnes