Clexane Injections

Clexane Injections: contains Enoxaparin Sodium. Enoxaparin Sodium is an anticoagulant agent which has antithirombotic properties. Enoxaparin Sodium Injection a low molecular weight heparin fraction. It prepared commercially from bovine lung and porcine intestinal mucosa.

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Clexane Injections (Enoxaparin) Composition

Clexane Injections 20mg/0.2 ml: <———————> Each 0.2 ml contains enoxaparin sodium 20 mg

Injection Clexane 40 mg/0.4 ml <———————> Each 0.4 ml contains enoxaparin sodium 40 mg

Clexane Injections 60mg/0.6 ml <———————> Each 0.6 ml contains enoxaparin sodium 60 mg

Injection Clexane 80mg/0.8 ml <———————> Each 0.8 ml contains enoxaparin sodium 80 mg

Clexane (Enoxaparin) Injections Indications

Enoxaparin Sodium prophylaxis of venous thrombo embolic disease. Meanwhile, In particular those may be associated with orthopedic or general surgery.

prophylaxis of venous thrombo embolic disease. Meanwhile, In particular those may be associated with orthopedic or general surgery. Injection Enoxaparin Clexane prophylaxis of venous thrombo embolism in medical patients bedridden due to acute illness. Including cardiac insufficiency, respiratory failure, severe infections, rheumatic diseases.

Clexane prophylaxis of venous thrombo embolism in medical patients bedridden due to acute illness. Including cardiac insufficiency, respiratory failure, severe infections, rheumatic diseases. Clexane Enoxaparin Injection a treatment of deep vein thrombosis with or without pulmonary embolism.

a treatment of deep vein thrombosis with or without pulmonary embolism. Clexane Enoxaparin Sodium in prevention of thrombus formation in extra corporeal circulation during hemodialysis.

in prevention of thrombus formation in extra corporeal circulation during hemodialysis. Treatment of unstable angina and non-Q-wave myocardial infarction, administered concurrently with aspirin.

Treatment of accute ST-segment Elevation Myocardial Infarction (STEMI) including patients to managed medically or with subsequent Precutaneous Coronary Intervention (PCI).

Clexane (Enoxaparin) Injections Dosage And Administration

Clexane (Enoxaparin Sodium) injection dosage and administration details are as under.

General:

Prophylaxis of Venous Thrombosis In Surgical Patients :

However, In patients with a moderate risk of thrombo embolism. e.g abdominal surgery. So, The recommended dose of Clexane (enoxparin sodium) injections is 20mg/0.2 ml. Or 40mg/0.4 ml once daily by subcutaneous injection. Consequently, In general surgery the first injection should given 2 hours before the surgical procedure.

On the other hand, In patients with a high risk of thrombo embolism e.g. orthopedic surgery. Firstly, The recommended Clexane (enoxaparin sodium) injection dose given subcutaneous injection 40mg/0.4 ml once daily. Initiated 12 hours prior to surgery. Or 30 mg twice daily initiated 12 to 24 hours after surgery.

Clexane Enoxaparin sodium treatment is usually prescribed for an average period of 7 to 10 days. Longer treatment duration may be appropriate in some patients. And enoxaparin sodium should be continued for as long as there is a risk of venous thrombo emblism. And until the patient is ambulatory.

Continued therapy with Clexane 40mg/0.4 ml once daily for 3 weeks following the initial therapy has proven to be beneficial in orthopedic surgery.

For special recommendations concerning dosing intervals for spinal/epidural anesthesia and coronary revascularisation procedures.

Prophylaxis of Venous Thrombo Embolism in Medical Patients

Enoxaparin Sodium recommended dose is Clexane 40mg/0.4 ml 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 Injection Dose 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 recommended.

Enoxaparin Sodium Injection Dose treatment usually prescribed for an average period of 10 days. Oral anticoagulant therapy should initiated when appropriate. And Enoxaparin Sodium Injection Dose treatment should continued until a therapeutic anticoagulant effect has achieved. (International Normalisation Ratio 2 to 3)

Prevention Of Extra Corporeal Thrombus During Hemodialysis

Recommended Clexane Dose is 1mg/kg for patients with a high risk of hemorrhage. The Clexane Dose should be reduced to 0.5mg/kg for double vascular access or 0.75ml/kg for single vascular access.

During hemodialysis, Clexane Injections Dose should introduce into the arterial line of the circut at the beginning of the dialysis session. The effect of this dose is usually sufficient for a 4 hour session. However, if fibrin rings found for example after a longer than normal session a further dose of 0.5 to 1mg/kg may given.

Treatment Of Unstable Angina And Non-Q-Wave Myocardial Infarction:

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

Treatment Of Accute ST-Segment Elevation Myocardial Infarction :

The recommended Clexane (Enoxaparin Sodium) Dose is a single IV bolus of 30 mg plus a 1 mg/kg SC dose followed by 1mg/kg administered SC every 12 hours.

When administered in conjunction with a thrombolytic, Enoxaparin sodium should given between 15 minutes before and 30 minutes after the start of fibrinolytic therapy. All patients should receive acetylsalicylic acid 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 precauaneous coronary intervention. If the last enoxaparin sodium SC administration given less than 8 hours before balloon inflation. No additional dosing need if the last SC administration given more than 8 hours. Before balloon inflation an IV bolus of 0.3mg/kg of enoxaparin sodium should administered.

Clexane Injections Contradictions

Clexane Contradiction: Hypertensitivity to enoxaparin sodium heparin or its derivatives including other low molecular weight heparins. History of immune mediated heparin induced thrombocytopenia within the past 100 days or in the presence of circulating antibodies.

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

Clexane Injections Warnings

General:

Low molecular weight heparins should not used interchangeably since they differ in their manufacturing process. Molecular weights, specific anti-Xa activities, units and dosage. This results in difference in pharmacokinetics and associated biological activities. And platelet specific to each proprietary medicinal product there required. There are some other conditions listed below.

Spinal/ Epidural Anesthesia

Heparin Induced Thrombocytopenia

Percutaneous Coronary Revascularisation Procedures

Pregnant Women With Medical Prosthetic Heart Valves

The Clexane Use in Pregnancy for thromboprophylaxis in pregnant women with mechanical prosthetic heart valves has not adequately studied. In a clinical study of pregnant women with mechanical prosthetic heart valves given Enoxaparin In Pregnancy (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 at higher risk for thrombo embolism.

Clexane (Enoxaparin) Tablets/Injections Precautions

Do not administer by the intramuscular route.

Hemorrhage

Enoxaparin Sodium, as with any other anticoagulant therapy. Should be used with caution in conditions with increased potential for bleeding.

Mechanical Prosthetic Heart Valves

Haemorrhage in the Elderly

Clexane Renal Impairment.

Low Weight

Obese Patients

Monitoring of Platelet Counts.

Enoxaparin Interactions

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

Systemic salicylates, acetylsalicylic acid and NSAIDs including ketorolac.

Dextran 40 ticlopidine and clopidogrel

Systemic glucocorticoids

Thrombolytics and anticoagulants

Other anti platelet agents including glycoprotein.

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

Clexane (Enoxaparin) In Pregnancy

Clexane (Enoxaparin) In Pregnancy with animal studies not shown any evidence of fetotoxicity or teratogenicity. The pregnant rat the transfer of S-Enoxaparin Sodium in pregnancy across the maternal placenta to the fetus is minimal. In humans no evidence that enoxaparin sodium crosses the placental barrier during the second trimester of pregnancy. No information available concerning the first and the third trimesters.

No adequated and well controlled studies in pregnant women and because animal studies not always predictive of human response. This drug should used during pregnancy only if the physician established a clear need.

Clexane (Enoxaparin) In Lactation

In lactating rats the concentration of S-Enoxaparin Sodium or its labelled metabolites in milk very low. It is not known whether unchanged enoxaparin sodium excreted in human breast mil. The oral absorption of enoxaparin sodium unlikely However as a precaution lactating mothers receiving enoxaparin sodium should advised to avoid breast feeding.

Clexane (Enoxaparin) Side Effects

Haemorrhages :

In clinical studies of Enoxaparin Side Effects, Haemorrhages are the most common Clexane Side Effects. It included major haemorrhages, reported at most in 4.2% of the patients. Some the cases have fatal.

As with other anticoagulants haemorrhage may occur in the presence of associated risk factors such as. Organic lesions liable to bleed, invasive procedures or the concomitant use of medications affecting haemostasis.

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

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 . 400G/L

Other Clinically Relevant Clexane Side Effects :

Immune System Disorders:

Common <—————————-> Allergic Reaction

Rare <———————————> Anaphylactic / anaphylactoid reaction

Hepatobilary Disorders:

Very Common <———————> Hepatic enzymes increase

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 and other reactions

Uncommon <————————> Local irritation, skin necrosis at injection site

Clexane (Enoxaparin Sodium) Over Dose

Signs, Symptoms And Severity:

Accidental Clexane (Enoxaparin Sodium) Over Dose after intravenous, extracorporeal or subcutaneous administration may lead to hemorrhagic complications. Following oral administration of even large dose. It unlikely that enoxaparin sodium will absorbed.

Clexane Injections Storage Instructions

Clexane Storage temperature must not exceed over 30 C. Do not freeze pre filled syringes.

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Clexane Injections (Enoxaparin)

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