Enoxaparin Sodium (Lovenox)

Trade Name : Lovenox

Sanofi-Aventis U.S. LLC

INJECTION

Strength 40 mg/.4mL

ENOXAPARIN SODIUM Heparin, Low-Molecular-Weight [CS],Low Molecular Weight Heparin [EPC]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Enoxaparin Sodium (Lovenox) which is also known as Lovenox and Manufactured by Sanofi-Aventis U.S. LLC. It is available in strength of 40 mg/.4mL per ml. Read more

Enoxaparin Sodium (Lovenox) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials. Click to know price. Read less

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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.
Consider the benefits and risks before neuraxial intervention in patients anticoagulated or to be anticoagulated for thromboprophylaxis n- [see and ]n- .
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. (, )

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 Lovenox and neuraxial procedures is not known

Lovenox is a low molecular weight heparin (LMWH) indicated for:

Prophylaxis of deep vein thrombosis (DVT) in abdominal surgery, hip replacement surgery, knee replacement surgery, or medical patients with severely restricted mobility during acute illness ()
Inpatient treatment of acute DVT with or without pulmonary embolism ()
Outpatient treatment of acute DVT without pulmonary embolism ()
Prophylaxis of ischemic complications of unstable angina and nonu2013Q-wave myocardial infarction (MI) ()
Treatment of acute ST-segment elevation myocardial infarction (STEMI) managed medically or with subsequent percutaneous coronary intervention (PCI) ()

See full prescribing information for dosing and administration information. ()

Lovenox is available in two concentrations.
100 mg/mL concentration ():
150 mg/mL concentration ():

Lovenox is contraindicated in patients with:

Active major bleeding ()
History of heparin-induced thrombocytopenia (HIT) within the past 100 days or in the presence of circulating antibodies ()
Hypersensitivity to enoxaparin sodium ()
Hypersensitivity to heparin or pork products ()
Hypersensitivity to benzyl alcohol (for multiple-dose formulation only) ()

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Increased Risk of Hemorrhage: Monitor for signs of bleeding. (, , )
Risk of Heparin-Induced Thrombocytopenia with or without Thrombosis. ()
Thrombocytopenia: Monitor platelet count closely. ()
Interchangeability with other heparins: Do not exchange with heparin or other LMWHs. ()
Increased Risk of Thrombosis in Pregnant Women with Mechanical Prosthetic Heart Valves: Women and their fetuses may be at increased risk. Monitor more frequently and adjust dosage as needed. ()

The following serious adverse reactions are also discussed in other sections of the labeling:
Most common adverse reactions (>1%) were bleeding, anemia, thrombocytopenia, elevation of serum aminotransferase, diarrhea, nausea, ecchymosis, fever, edema, peripheral edema, dyspnea, confusion, and injection site pain. ()

Whenever possible, agents which may enhance the risk of hemorrhage should be discontinued prior to initiation of Lovenox therapy. These agents include medications such as: anticoagulants, platelet inhibitors including acetylsalicylic acid, salicylates, NSAIDs (including ketorolac tromethamine), dipyridamole, or sulfinpyrazone. If coadministration is essential, conduct close clinical and laboratory monitoring.
Discontinue agents which may enhance hemorrhage risk prior to initiation of Lovenox or conduct close clinical and laboratory monitoring. (, )

No data

Severe Renal Impairment: Adjust dose for patients with creatinine clearance <30 mL/min. (, )
Geriatric Patients: Monitor for increased risk of bleeding. ()
Low-Weight Patients: Observe for signs of bleeding. ()

Accidental overdosage following administration of Lovenox may lead to hemorrhagic complications. Injected Lovenox may be largely neutralized by the slow intravenous injection of protamine sulfate (1% solution). The dose of protamine sulfate should be equal to the dose of Lovenox injected: 1 mg protamine sulfate should be administered to neutralize 1 mg Lovenox, if Lovenox was administered in the previous 8 hours. An infusion of 0.5 mg protamine per 1 mg of Lovenox may be administered if Lovenox was administered greater than 8 hours previous to the protamine administration, or if it has been determined that a second dose of protamine is required. The second infusion of 0.5 mg protamine sulfate per 1 mg of Lovenox may be administered if the aPTT measured 2 to 4 hours after the first infusion remains prolonged.
If at least 12 hours have elapsed since the last Lovenox injection, protamine administration may not be required; however, even with higher doses of protamine, the aPTT may remain more prolonged than following administration of heparin. In all cases, the anti-Factor Xa activity is never completely neutralized (maximum about 60%). Particular care should be taken to avoid overdosage with protamine sulfate. Administration of protamine sulfate can cause severe hypotensive and anaphylactoid reactions. Because fatal reactions, often resembling anaphylaxis, have been reported with protamine sulfate, it should be given only when resuscitation techniques and treatment of anaphylactic shock are readily available. For additional information consult the labeling of protamine sulfate injection products.

Lovenox is a sterile aqueous solution containing enoxaparin sodium, a low molecular weight heparin. The pH of the injection is 5.5 to 7.5.
Enoxaparin sodium is obtained by alkaline depolymerization of heparin benzyl ester derived from porcine intestinal mucosa. Its structure is characterized by a 2-O-sulfo-4-enepyranosuronic acid group at the non-reducing end and a 2-N,6-O-disulfo-D-glucosamine at the reducing end of the chain. About 20% (ranging between 15% and 25%) of the enoxaparin structure contains a 1,6 anhydro derivative on the reducing end of the polysaccharide chain. The drug substance is the sodium salt. The average molecular weight is about 4500 daltons. The molecular weight distribution is:
STRUCTURAL FORMULA
Lovenox 100 mg/mL Concentration
Lovenox 150 mg/mL Concentration
The Lovenox prefilled syringes and graduated prefilled syringes are preservative-free and intended for use only as a single-dose injection. The multiple-dose vial contains 15 mg benzyl alcohol per 1 mL as a preservative .

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Lovenox is available in two concentrations (see and ).
Store at 25u00b0C (77u00b0F); excursions permitted to 15u00b0Cu201330u00b0C (59u00b0Fu201386u00b0F) [see USP Controlled Room Temperature].
Do not store the multiple-dose vials for more than 28 days after the first use.

If patients have had neuraxial anesthesia or spinal puncture, and particularly, if they are taking concomitant NSAIDs, platelet inhibitors, or other anticoagulants, advise them to watch for signs and symptoms of spinal or epidural hematoma, such as tingling, numbness (especially in the lower limbs) and muscular weakness. Instruct the patient to seek immediate medical attention if any of these symptoms occur.
Inform patients:

sanofi-aventis U.S. LLCBridgewater, NJ 08807A SANOFI COMPANY
u00a9 2018 sanofi-aventis U.S. LLC

NDC 0075-0624-30
LOVENOXn (enoxaparin sodium injection)
30mg/0.3mL
Rx ONLY
SINGLE DOSE SYRINGES WITH AUTOMATIC SAFETY DEVICE FOR SUBCUTANEOUS INJECTION
Ten 0.3mL Syringes
SANOFI

NDC 0075-0620-40
LOVENOXn (enoxaparin sodium injection)
40mg/0.4mL
Rx ONLY
SINGLE DOSE SYRINGES WITH AUTOMATIC SAFETY DEVICE FOR SUBCUTANEOUS INJECTION
Ten 0.4mL Syringes
SANOFI

NDC 0075-0621-60
LOVENOXn (enoxaparin sodium injection)
60mg/0.6mL
Rx ONLY
SINGLE DOSE SYRINGES WITH AUTOMATIC SAFETY DEVICE FOR SUBCUTANEOUS INJECTION
Ten 0.6mL Syringes
SANOFI

NDC 0075-0622-80
LOVENOXn (enoxaparin sodium injection)
80mg/0.8mL
Rx ONLY
SINGLE DOSE SYRINGES WITH AUTOMATIC SAFETY DEVICE FOR SUBCUTANEOUS INJECTION
Ten 0.8mL Syringes
SANOFI

NDC 0075-0623-00
LOVENOXn (enoxaparin sodium injection)
100mg/1 mL
Rx ONLY
SINGLE DOSE SYRINGES WITH AUTOMATIC SAFETY DEVICE FOR SUBCUTANEOUS INJECTION
Ten 1mL Syringes
SANOFI

NDC 0075-0626-03
LOVENOXn (enoxaparin sodium injection)
300mg/3mL (100mg/1mL)
R ONLY
For Subcutaneous or Intravenous Injection
Multiple Dose Vial
One 3mL Vial
SANOFI

NDC 0075-2912-01
LOVENOXn (enoxaparin sodium injection)
120mg/0.8mL
Rx ONLY
SINGLE DOSE SYRINGES WITH AUTOMATIC SAFETY DEVICE FOR SUBCUTANEOUS INJECTION
Ten 0.8mL Syringes
SANOFI

NDC 0075-2915-01
LOVENOXn (enoxaparin sodium injection)
150mg/1 mL
Rx ONLY
SINGLE DOSE SYRINGES WITH AUTOMATIC SAFETY DEVICE FOR SUBCUTANEOUS INJECTION
Ten 1mL Syringes
SANOFI

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Enoxaparin Sodium (Lovenox)

Trade Name : Lovenox

INJECTION

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

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Enoxaparin Sodium (Lovenox)

Trade Name : Lovenox

INJECTION

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

Browse Our Services And Processes

Disclaimer

Browse from other international pharmaceuticals

General

US NDC

Canadian DIN

Swiss Drugs

NZ Drugs

FAQ

Can’t find what you’re looking for?

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QUICK LINKS

CONTACT US

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you’re looking for?