ENOXAPARIN SODIUM injection

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

ENOXAPARIN SODIUM (UNII: 8NZ41MIK1O) (ENOXAPARIN - UNII:E47C0NF7LV)

Disponível em:

Cardinal Health

DCI (Denominação Comum Internacional):

ENOXAPARIN SODIUM

Composição:

ENOXAPARIN SODIUM 100 mg in 1 mL

Via de administração:

SUBCUTANEOUS

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

Enoxaparin sodium injection, USP is indicated for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE): Enoxaparin sodium injection, USP is indicated for: Enoxaparin sodium injection, USP is indicated for the prophylaxis of ischemic complications of unstable angina and non-Q-wave myocardial infarction, when concurrently administered with aspirin. Enoxaparin sodium injection, USP, 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 injection 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 maj

Resumo do produto:

Enoxaparin sodium injection, USP is available in two concentrations (see Tables 26 and 27 ): Prefilled Syringes ‡ 30 mg / 0.3 mL 3000 IU 10 syringes Medium Blue 0781-3133-63 40 mg / 0.4 mL 4000 IU 10 syringes Yellow 0781-3224-64 Graduated Prefilled Syringes ‡ 60 mg / 0.6 mL 6000 IU 10 syringes Orange 0781-3356-66 80 mg / 0.8 mL 8000 IU 10 syringes Brown 0781-3428-68 100 mg / mL 10,000 IU 10 syringes Black 0781-3500-69 Multiple-Dose Vial § 300 mg/3 mL 30,000 IU 1 vial Red 0781-3122-93 Graduated Prefilled Syringes ‡   120 mg / 0.8 mL 12,000 IU 10 syringes Purple 0781-3612-68   150 mg / mL 15,000 IU 10 syringes Navy Blue 0781-3655-69 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Do not store the multiple-dose vials for more than 28 days after the first use.

Status de autorização:

Abbreviated New Drug Application

Características técnicas

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 SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ENOXAPARIN SODIUM.
ENOXAPARIN SODIUM INJECTION, USP 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 injection, USP is a low molecular weight heparin
[LMWH] indicated for:
•
•
•
•
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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):
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CONTRAINDICATIONS
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•
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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
INJECTION AND NEURAXIAL
PROCEDURES IS NOT KNOWN.
Prophylaxis of deep vein thrombosis (DVT) in abdominal surgery, hip
replacement surgery, knee replacement
surgery, or medical patients with severely restricted mobility d