Enoxaparin Sodium (Claxine 40mg,60mg and 80mg): Complete Guide to Dosage, Indications & Precautions

Asghar Basdshah


DESCRIPTION

 

ACTIVE INGREDIENTS: Enoxaparin sodium

THERAPEUTIC CLASS: Antithrombotic Agents; Heparin group

PHARMACEUTICAL FORM(s): Sterile pyogen-free solution for injections

 

COMPOSITION

Clexane Injection 20mg/0.2ml:

Each 0.2ml contains ---- enoxaparin sodium 20mg

Clexane Injection 40mg/0.4ml:

Each 0.4ml contains ------ enoxaparin sodium 40mg.

Clexane Injection 60mg/0.6ml:

Each 0.6ml contains ----- enoxaparin sodium 60mg

Clexane Injection 80mg/0.8ml:

Each 0.8ml contains ------ enoxaparin sodium 80mg

 

INDICATIONS


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DOSAGE AND ADMINISTRATION

 

GENERAL

Prophylaxis of venous thrombosis in surgical patients:

The duration and dose of Enoxaparin therapy are based on the patient's risk. The thromboembolic risk for an individual patient can be estimated using validated risk stratification models.

In patients with a moderate risk of thrombo-embolism, the recommended dose of enoxaparin sodium is 20mg/0.2ml or 40mg/0.4ml once daily by subcutaneous injection. In general surgery, the first injection should be given 2 hours before the surgical procedure.

Enoxaparin sodium treatment is usually prescribed for an average of 7 to 10 days. A longer treatment duration may be appropriate in some patients, and enoxaparin sodium should be continued as long as there is a risk of venous thromboembolism and until the patient is ambulatory.

 

In patients with a high risk of thrombo-embolism, the recommended dose of enoxaparin sodium given by subcutaneous injection is 40mg/0.4ml once daily, initiated 12 hours before surgery. -For patients who undergo major orthopedic surgery with a high venous thromboembolism risk, athromboprophylaxis up to 5 weeks is recommended. For patients who undergo cancer surgery with a high venous thromboembolism risk, athromboprophylaxis up to 4 weeks is recommended.

 

For special recommendations concerning dosing intervals for Spinal/EpiduralAnesthesia and coronary revascularisation procedures: See Warnings •

 

Prophylaxis of venous thrombo-embolism in medical patients:

The recommended dose of enoxaparin sodium is 40mg once daily by subcutaneous injection. Treatment with enoxaparin sodium is prescribed for a minimum of 6 days and continued until the return to full ambulation, for a maximum of 14 days.

 

Treatment of deep vein thrombosis with or without pulmonary embolism:

 Enoxaparin sodium can be administered subcutaneously either as a single injection of 1.5mg/kg or as twice daily injections of 1mg/kg. In patients with complicated thrombo-embolic disorders, a dose of 1mg/kg administered twice daily is recommended.

Enoxaparin sodium treatment is usually prescribed for an average period of 10 days. Oral anticoagulant therapy should be initiated when appropriate and enoxaparin sodium treatment should be continued until a therapeutic anticoagulant effect has been achieved (International Normalisation Ratio 2 to 3)

 

Prevention of extra corporeal thrombus during hemodialysis:

The recommended dose is 1mg/kg of enoxaparin sodium. For patients with a high risk of hemorrhage, the dose should be reduced to 0.5mg/kg for double vascular access or 0.75 mg/kg for single vascular access

During hemodialysis, enoxaparin sodium should be introduced into the arterial line of the circuit at the beginning of the dialysis session. The effect of this dose is usually sufficient for a 4-hour session; however, if fibrin rings are found, for example, after a longer than regular session, a further dose of 0.5 to 1mg/kg may be given.

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Treatment of unstable angina and non-Q-wave myocardial infarction:

The recommended dose of enoxaparin sodium is 1mg/kg every 12 hours by subcutaneous injection, administered concurrently with oral aspirin (100 to 325 mg once daily). Treatment with enoxaparin sodium in these patients should be prescribed for a minimum of 2 days and continued until clinical stabilization. The usual duration of treatment is 2 to 8 days.

 

Treatment of acute ST-segment Elevation Myocardial Infarction

The recommended dose of enoxaparin sodium is a single IV bolus of 30 mg plus a 1 mg/kg SC dose followed by 1 mg/kg administered SC every 12 hours (max 100 mg for each of the first two SC doses only, followed by 1 mg/kg SC dosing for the remaining doses). For dosage in patients ≥75 years of age, see Special Populations - Elderly.

When administered in conjunction with a thrombolytic (fibrin-specific or non-fibrin-specific), enoxaparin sodium should be given between 15 minutes before and 30 minutes after the start of fibrinolytic therapy. All patients should receive acetylsalicylic acid (ASA) as soon as they are identified as having STEMI and maintained under (75 to 325 mg once daily) unless contraindicated.

 

The recommended duration of enoxaparin sodium treatment is 8 days or until hospital discharge, whichever comes first.

 

For patients managed with Percutaneous Coronary Intervention (PCI): If the last enoxaparin sodium SC administration was given less than 8 hours before balloon inflation, no additional dosing is needed. If the last SC administration was given more than 8 hours before balloon inflation, an IV bolus of 0.3 mg/kg of enoxaparin sodium should be administered.

 

Special Populations:

 

Children:

The safety and efficacy of enoxaparin sodium in children has not been established.

 

Elderly:

For treatment of acute ST-segment Elevation Myocardial Infarction in elderly patients ≥75 years of age, do not use an initial IV bolus. Initiate dosing with 0.75 mg/kg SC every 12 hours (maximum 75 mg for each of the first two SC doses only, followed by 0.75 mg/kg SC dosing for the remaining doses). For other indications: no dosage adjustment is necessary, unless kidney function is impaired (See Precautions and Dosage & Administration)

 

Hepatic impairment:

Caution should be used in hepatically impaired patients.

Renal impairment:

See Precautions.

 

Severe renal impairment:

A dosage adjustment is required for patients with severe renal impairment (creatinine clearance <30 ml/min), according to the following tables, since enoxaparin sodium exposure is significantly increased in this patient population.

 

The following dosage adjustments are recommended for therapeutic dosage ranges:

Enoxaparin Sodium (Claxine 40mg,60mg and 80mg) Complete Guide to Dosage, Indications & Precautions
Dosage adjustments of Enoxaparine sodium (claxine) are recommended for therapeutic dosage ranges


The recommended dosage adjustments do not apply to the hemodialysis indication.

Moderate and mild renal impairment Although no dose adjustment is recommended in patients with moderate (creatinine clearance 30-50ml/min) and mild (creatinine clearance 50-80ml/min) renal impairment, careful clinical monitoring is advised.

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Spinal/epidural anesthesia

For patients receiving spinal/epidural anesthesia see section Warnings, Spinal/epidural anesthesia.

 

Administration:

 

Subcutaneous Injection:

Enoxaparin sodium is administered by subcutaneous injection for the prevention of venous thromboembolic disease, treatment of deep vein thrombosis, treatment of unstable angina and non-Q-wave myocardial infarction and treatment of acute ST-segment Elevation Myocardial Infarction

 

IV bolus injection: For acute ST-segment Elevation Myocardial Infarction, treatment is to be initiated with a single IV bolus injection immediately followed by a subcutaneous injection.

 

Arterial line Injection:

It is administered through the arterial line of a dialysis circuit for the prevention of thrombus formation in the extra-corporeal circulation during hemodialysis. It must not be administered by the intramuscular route. The pre-filled disposable syringe is ready for immediate use.

 

Subcutaneous Injection Technique:

Injection should be made preferably when the patient is lying down.

Enoxaparin sodium is administered by deep subcutaneous injection. Do not expel the air bubble from the syringe before the injection to avoid the loss of drug when using the 20mg and 40mg pre-filled syringes. The administration should be alternated between the left and right anterolateral or posterolateral abdominal wall.

The whole length of the needle should be introduced vertically into a skin fold gently held between the thumb and index finger. The skin fold should not be released until the injection is complete. Do not rub the injection site after administration

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Intravenous (Bolus) Injection Technique (for acute STEMI indication only):

Enoxaparin sodium should be administered through an intravenous line. It should not be mixed or coadministered with other medications. To avoid the possible mixture of enoxaparin sodium with other drugs, the intravenous access chosen should be flushed with a sufficient amount of saline or dextrose solution prior to and following the intravenous bolus administration of enoxaparin sodium to clear the port of drug. Enoxaparin sodium may be safely administered with normal saline solution (0.9%) or 5% dextrose in water.

 

Initial 30-mg bolus

For the initial 30-mg bolus, using an enoxaparin sodium graduated pre-filled syringe, expel the excessive volume to retain only 30 mg (0.3 ml) in the syringe. The 30-mg dose can then be directly injected into the intravenous line.

 

 Additional bolus for PCI when last SC administration was given more than 8 hours before balloon inflation.

For patients being managed with Percutaneous Coronary Intervention (PCI), an additional IV bolus of 0.3 mg/kg is to be administered if last SC administration was given more than 8 hours before balloon inflation (see Dosage and Administration: Treatment of acute STEMI).

 

How to make Dilution of enoxaparin sodium injection:

In order to assure the accuracy of the small volume to be injected, it is recommended to dilute the drug to 3 mg/ml.

To obtain a 3-mg/ml solution, using a 60-mg enoxaparin sodium pre-filled syringe, it is recommended to use a 50-ml infusion bag (ie, using either normal saline solution (0.9%) or 5% dextrose in water) as follows:

Withdraw 30 ml from the infusion bag with a syringe and discard the liquid. Inject the complete contents of the 60-mg enoxaparin sodium pre-filled syringe into the 20 ml remaining in the bag. Gently mix the contents of the bag. Withdraw the required volume of diluted solution with a syringe for administration into the intravenous line.

 

After dilution is completed, the volume to be injected can be calculated using the following formula:

dosage adjustments are recommended for therapeutic dosage ranges
The volume of Enoraparine injection to be injected can be calculated using the given formula.


CONTRAINDICATIONS

Hypersensitivity to enoxaparin sodium, heparin or its derivatives including other Low Molecular Weight Heparins,

History of immune mediated heparin induced thrombocytopenia (HIT) within the past 100 days or in the presence of circulating antibodies (see Precautions)

Active major bleeding and conditions with a high risk of uncontrolled hemorrhage, including recent hemorrhagic stroke.

 

WARNINGS

 

General

Low Molecular Weight Heparins should not be used interchangeably since they differ in their manufacturing process, molecular weights, specific anti Na activities, units and dosage. This results in differences in pharmacokinetics and associated biological activities leg anti-thrombin activity, and platelet interactions) Special attention and compliance with the instructions for use specific to each proprietary medicinal product are therefore required.

 

Spinal/Epidural Anesthesia

There have been cases of neuraxial haematomas reported with the concurrent use of enoxaparin sodium and spinal/epidural anaesthesia resulting in long term or permanent paralysis. These events are rare with enoxaparin sodium dosage regimens 40 mg once daily or lower. The risk is greater with higher enoxaparin sodium dosage regimens, use of post-operative indwelling catheters or the concomitant use of additional drugs affecting haemostasis such as NSAIDs (ser Interactions with other medicinal products or other forms of interactions. The risk also appears to be increased by traumatic or repeated neuraxial puncture or in patients with a history of spinal surgery or spinal deformity

 

To reduce the potential risk of bleeding associated with the concurrent use of enoxaparin sodium and epidural or spinal anaesthesia/analgesia, the pharmacokinetic profile of the drug should be considered. Placement and removal of the catheter is best performed when the anticoagulant effect of enoxaparin is low, however, the exact timing to reach a sufficiently low anticoagulant effect in each patient is not known

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Placement or removal of a catheter should be delayed for at least 12 hours after administration of lower doses (20 mg once daily, 30 mg once or twice daily or 40 mg once daily of enoxaparin, and at least 24 hours after the administration of higher doses (0.75 mg/kg twice daily, 1 mg/kg twice daily, or 1.5 mg/kg once daily) of enoxaparin. Anti-Xa levels are still detectable at these time points, and these delays are not a guarantee that neurasial haematoma will be avoided. Patients receiving the 0.75 mg/kg twice daily dose or the 1 mg/kg twice daily dose should not receive the second enoxaparin dose in the twice daily regimen to allow a longer delay before catheter placement or removal. Likewise, although a specific recommendation for timing of a subsequent enoxaparin dose after catheter removal cannot be made, consider delaying this next dose for at least four hours, based on a benefit-risk assessment considering both the risk for thrombosis and the risk for bleeding in the context of the procedure and patient risk factors. For patients with creatinine clearance <30ml/minute, additional considerations are necessary because elimination of enoxaparin is mare prolonged; consider doubling the timing of removal of a catheter, at least 24 hours for the lower prescribed dose of enoxaparin 30 mg once daily) and at least 48 hours for the higher dose (1 mg/kg/day)

 

Should the physician decide to administer anticoagulation in the context of epidural/spinal anesthesia or lumbar puncture, frequent monitoring must be exercised to detect any signs and symptoms of neurological impairment such as midline back pain, sensory and motor deficits (numbness or weakness in lower limbs), bowel and/or bladder dysfunction. Patients should be instructed to inform their physician immediately if they experience any of the above signs or symptoms. If signs or symptoms of spinal haematoma are suspected, urgent diagnosis and treatment including spinal cord decompression should be initiated.

 

Heparin-induced thrombocytopenia

Use of enoxaparin sodium in patients with a history of immune mediated HIT within the past 100 days or in the presence of circulating antibodies is contraindicated (see Contraindication) Circulating antibodies may persist several years

Enoxaparin sodium is to be used with extreme caution in patients with a history (more than 100 days of heparin induced thrombocytopenia without circulating antibodies. The decision to use enoxaparin sodium in such a case must be made only after a careful benefit risk assessment and after non-hepann alternative treatments are considered

 

Percutaneous coronary revascularisation procedures:

To minimize the risk of bleeding following the vascular instrumentation during the treatment of unstable angina, non Q wave myocardial infarction and acute St-segment elevation myocardial infraction, adhere precisely to the interval recommended between enoxaparin injection doses. It is important to achieve hemostasis at the puncture site after PC, in case a closure device is used, the sheath can he removed immediately, if a manual compression method is used, sheath should be removed 6 hours after the last IV/SC enoxaparin sodium injection. If the treatment with enoxaparin sodium is to be continued, the next scheduled dose should be given no sooner than 6 to 8 hours after sheath removal. The site of the procedure should be observed for signs of bleeding or hematoma formation.

 

 Pregnant women with mechanical prosthetic heart valves:

The use of enoxaparin Injection for thromboprophylaxis in pregnant women with mechanical prosthetic heart valves has not been adequately studied. In a clinical study of pregnant women with mechanical prosthetic heart valves given enoxaparin (1 mg/kg bid) to reduce the risk of thrombo-embolism, 2 of 8 women developed clots resulting in blockage of the valve and leading to maternal and fetal death

 

There have been isolated postmarketing reports of valve thrombosis in pregnant women with mechanical prosthetic heart valves while receiving enoxaparin for thromboprophylaxis, Pregnant women with mechanical prosthetic heart valves may be at higher risk for thrombo-embolism (see Section Precautions: Mechanical prosthetic heart valves).

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Laboratory tests

At doses used for prophylaxis of venous thrombo-embolism, enoxaparin sodium does not influence bleeding time and global blood coagulation tests significantly, nor does it affect platelet aggregation or binding of fibrinogen to platelets.

At higher doses, increases in aPTT (activated partial thromboplastin time), and ACT (activated clotting time) may occur. Increases in aPTT and ACT are not linearly correlated with increasing enoxaparin sodium antithrombotic activity and therefore are unsuitable and unreliable for monitoring enoxaparin sodium activity

 

PRECAUTIONS

 

Do not administer by the intramuscular route.

 

Hemorrhage

As with other anticoagulants, bleeding may occur at any site (see Section Adverse Reactions).

If bleeding occurs, the origin of the hemorrhage should be investigated and appropriate treatment instituted.

 

Enoxaparin sodium, as with any other anticoagulant therapy, should be used with caution in conditions with increased potential for bleeding, such as;

Impaired hemostasis,

History of peptic ulcer,

Recent ischemic stroke,

Uncontrolled severe arterial hypertension,

Diabeticretinopathy,

Recent neuro- or ophthalmologic surgery,

Concomitant use of medications affecting hemostasis (see Section

Interaction)

 

Mechanical prosthetic heart valves:

The use of Clexane Injection has not been adequately studied for thromboprophylaxis in patients with mechanical prosthetic heart valves.

Isolated cases of prosthetic heart valve thrombosis have been reported in patients with mechanical prosthetic heart valves who have received enoxaparin for thromboprophylaxis. Confounding factors, including underlying disease and insufficient clinical data, limit the evaluation of these cases. Some of these cases were pregnant women in whom thrombosis led to maternal and fetal death. Pregnant women with prosthetic heart valves may be at higher risk for thrombo-embolism (see Section Warnings: Pregnant women with mechanical prosthetic heart).

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Hemorrhage in the elderly

No increased bleeding tendency is observed in the elderly with the prophylactic dosage ranges. Elderly patients (especially patients eighty years of age and older) may be at an increased risk for bleeding complications with the therapeutic dosage ranges. Careful clinical monitoring is advised (see Section Dosage and Administration)

 

Renal impairment

In patients with renal impairment, there is an increase in exposure of enoxaparin sodium which increases the risk of bleeding. Since exposure of enoxaparin sodium is significantly increased in patients with severe renal impairment (creatinine clearance <30 ml/min), a dosage adjustment is recommended for therapeutic and prophylactic dosage ranges. Although no dose adjustment is recommended in patients with moderate (creatinine clearance 30-50 ml/min) and mild (creatinine clearance 50-80 ml/min) renal impairment, careful clinical monitoring is advised (see Section Dosage & Administration: Renal impairment)

 

 Low weight

An increase in exposure of enoxaparin sodium with prophylactic dosages (non-weight adjusted) has been observed in low-weight women (<45 kg) and low-weight men (<57 kg), Therefore, careful clinical monitoring is advised in these patients.

 

Obese Patients

Obese patients are at higher risk for thromboembolism. The safety and efficacy of prophylactic doses in obese patients (BMI>30 kg/m2) has not been fully determined and there is no consensus for dose adjustment these patients should be observed carefully for signs and symptoms of thromboembolism

 

Monitoring of platelet counts

The risk of antibody mediated heparin-induced thrombocytopenia also exists with Low Molecular Weight Heparins. Should thrombocytopenia occur, it usually appears between the 5th and the 21st day following the beginning of enoxaparin sodium treatment. Therefore, it is recommended that the platelet counts be measured before the initiation of therapy with enoxaparin sodium and then regularly thereafter during the treatment In practice, if a confirmed significant decrease of the platelet count is observed (30 to 50% of the initial value), enoxaparin sodium treatment must be immediately discontinued and the patient switched to another therapy.

 

INTERACTIONS

It is recommended that agents which affect hemostasis should be discontinued prior to enoxaparin sodium therapy unless strictly indicated. These agents include medications such as:

Dextran 40, ticlopidine and clopidogrel,

Systemic salicylates, acetylsalicylic acid, and NSAIDs including ketorolac, Systemic glucocorticoids

Thrombolytics and anticoagulants,

Other anti-platelet agents including glycoprotein IIb/Illa antagonists

 

If the combination is indicated, enoxaparin sodium should be used with careful clinical and laboratory monitoring when appropriate

 

PREGNANCY

In humans, there is no evidence that enoxaparin sodium crosses the placental barrier during the second trimester of pregnancy There is no information available concerning the first and the third trimesters.

As there are no adequate and well-controlled studies in pregnant women and because animal studies are not always predictive of human response, this drug should be used during pregnancy only if the physician has established a clear need (See Warnings and Precautions).

 

Lactation: It is not known whether unchanged enoxaparin sodium is excreted in human breast milk. The oral absorption of enoxaparin sodium is unlikely. However, as a precaution, lactating mothers receiving enoxaparin sodium should be advised to avoid breast-feeding

 

DRIVING A VEHICLE OR PERFORMING OTHER HAZARDOUS TASKS:

Enoxaparin sodium has no effect on the ability to drive and operate machines

 

ADVERSE REACTIONS

Enoxaparin has been evaluated in more than 15 000 patients who received enoxaparin in clinical trials. These included 1776 for prophylaxis of deep vein thrombosis following orthopaedic or abdominal surgery in patients at risk for thromboembolic complications, 1169 for prophylaxis of deep vein thrombosis in acutely ill medical patients with severely restricted mobility, 559 for treatment of deep vein thrombosis with or without pulmonary embolism, 1578 for treatment of unstable angina and non-Q-wave myocardial infarction and 10 176 for treatment of acute ST-elevation myocardial infarction

Enoxaparin sodium regimen administered during these clinical trials varies depending on indications. The enoxaparin sodium dose was 40 mg SC once daily for prophylaxis of deep vein thrombosis following surgery or in acutely ill medical patients with severely restricted mobility. In treatment of deep vein thrombosis (DVI) with or without pulmonary embolism (PE), patients receiving enoxaparin were treated with either a 1 mg/kg SC dose every 12 hours or a 1.5 mg/kg SC dose once a day. In the clinical studies for treatment of unstable angina and non-Q-wave myocardial infarction, doses were 1 mg/kg SC every 12 hours and in the dinical study for treatment of acute ST-segment elevation myocardial infarction enoxaparin sodium regimen was a 30 mg iv bolus followed by 1 mg/kg SC every 12 hours

The adverse reactions observed in these clinical studies and reported in post marketing experience are detailed below. Frequencies are defined as follows: very common (21/10), common (2 1/100 το 1/10); uncommon 2 1/1000 to 1/100), rare ( 1/10,000 to <1/1,000), very rare (<1/10,000) or not known (Cannot be estimated from available data) Post-marketing adverse reactions are designated with a frequency "not known".

 

Haemorrhages:

In clinical studies, haemorrhages were the most commonly reported reaction. These included major haemorrhages, reported at most in 4.2% of the patients burgical patients). Some of these caves have been fatal As with other anticoagulants, haemorrhage may occur in the presence of associated ink factors such as organic lessons liable to bleed, invasive procedures or the concomitant use of medication afflicting haemostasis see Precautions and Interactions).

 

Vascular disorders:

Prophylaxis in surgical patients

Very common: Haemorrhage"

Rare: Retroperitoneal haemorrhage

Prophylaxis in medical patients

Common: Haemorrhage

Treatment in patients with DVT with or without PE

Very common: Haemorrhage

Uncommon: Intracranial haemorrhage, Retroperitoneal haemorrhage

Treatment in patients with unstable angina and non-Q-wave MI

Common: Haemorrhage

Rare: Retroperitoneal haemorrhage

Treatment in patients with acute STEMI

Common: Haemorrhage

Uncommon. Intracranial haemorrhage, Retroperitoneal haemorrhage

Such as haematoma, ecchymosis other than at injection site, wound haematoma, haematuria, epistaxis and gastro-intestinal haemorrhage.

 

Thrombocytopenia and thrombocytosis:

 

Blood and lymphatic system disorders:

 

Prophylaxis in surgical patients

Very common: Thrombocytosis"

Common: Thrombocytopenia

Prophylaxis in medical patients

Uncommon: Thrombocytopenia

Treatment in patients with DVT with or without PE

Very common: Thrombocytosis

Common: Thrombocytopenia

Treatment in patients with unstable angina and non-Q-wave MI

Uncommon: Thrombocytopenia

Treatment in patients with acute STEMI

Common: Thrombocytosis Thrombocytopenia Very rare: Immuno-allergic thrombocytopenia

Platelet increased > 400 G/L

 

Other clinically relevant adverse reactions

 

Immune system disorders:

Common: Allergic reaction

 

Rare: Anaphylactic / anaphylactoid reaction (see also Post marketing experience)

Hepatobilary disorders:

Very common: Hepatic enzymes increase (mainly transaminases **)

Skin and subcutaneous tissue disorders:

Common: Urticaria, pruritus, erythema

Uncommon: Bullous dermatitis

General disorders and administration site conditions:

Common: Injection site haematoma, injection site pain, other injection site reaction

Uncommon: Local irritation; skin necrosis at injection site Investigations:

Rare: Hyperkaliemia

Such as injection site oedema, haemorrhage, hypersensitivity, inflammation, mass, pain, or reaction (NOS)

**transaminases levels > 3 times the upper limit of normality

 

Post marketing experience

The following adverse reactions have been identified during post-approval use of Clexane. The adverse reactions are derived from spontaneous reports and therefore, the frequency is "not known" (cannot be estimated from the available data).

Immune Systern Disorders

Anaphylactic/anaphylactoid reaction including shock

Nervous System Disorders

Headache

 

Vascular Disorders

Cases of spinal haematoma (or neuraxial haematoma) have been reported with the concurrent use of enoxaparin sodium as well as spinal/epidural anaesthesia or spinal puncture. These reactions have resulted in varying degrees of neurologic injuries including long-term or permanent paralysis (see Section Warnings: Spinal/epidural anesthesia)

 

Blood and Lymphatic System Disorders:

Haemorrhagic anemia

Cases of immuno-allergic thrombocytopenia with thrombosis, in some of them thrombosis was complicated by organ infarction or limb ischaemia (see Section Precautions: Monitoring of platelet counts).

Eosinophilia

 

Skin and subcutaneous disorders

- Cutaneous vasculitis, skin necrosis usually occurring at the injection site (these phenomena have been usually preceded by purpura or erythematous plaques, infiltrated and painful)

Treatment with enoxaparin sodium must be discontinued.

Injection site nodules (inflammatory nodules, which were not cystic enclosure of enoxaparin)

They resolve after a few days and should not cause treatment discontinuation.

 

OVERDOSAGE

 

Signs and Symptoms:

 

Symptoms and Severity

Accidental overdosage with enoxaparin sodium after intravenous, extracorporeal or subcutaneous administration may lead to hemorrhagic complications. Following oral administration of even large doses, it is unlikely that enoxaparin sodium will be absorbed.

 

Management:

Antidote and Treatment

The anticoagulant effects can be largely neutralized by the slow intravenous injection of protamine. The dose of protamine depends on the dose of enoxaparin sodium injected, 1 mg protamine neutralizes the anticoagulant effect of 1 mg of enoxaparin sodium, if enoxaparin sodium was administered in the previous 8 hours. An infusion of 0.5 mg protamine per 1 mg of enoxaparin sodium may be administered if enoxaparin sodium 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. After 12 hours of the enoxaparin sodium injection, protamine administration may not be required. However, even with high doses of protamine, the anti-Xa activity of enoxaparin sodium is never completely neutralized (maximum about 60%).

 

STORAGE

 

Do not store above 25°C. Do not freeze pre-filled syringes. Keep medicine out of the reach of children.

 

Expiry Date:

Do not uses after the expiry date indicated on outer packaging.

 

PRESENTATION

Clexane Injection 20mg/0.2ml: 2 Pre-filled syringes

Clexane Injection 40mg/0.4ml: 2 Pre-filled syringes

Clexane Injection 60mg/0.6ml: 2 Pre-filled syringes

Clexane Injection 80mg/0.8ml: 2 Pre-filled syringes

Manufactured by:

Sanofi Winthrop industrie

180 rue Jeans Jaures - BP 40 94702 Maisons-Alfort Cedex, France

For:

Sanofi-aventis Pakistan limited

Plot No. 23, Sector No. 22, Korangi Industrial Area,

Karachi Pakistan. (Enoxaparin-CCDS-v14


References : 

1.  Enoxaparin (Lovenox) - Uses, Side Effects, and More
2. Enoxaparin sodium . Wikipedia 
3. Protamine - StatPearls - NCBI bookshelf . Sandeep Krishnan 

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