Clexane 6000 Iu (60 Mg/0.6 Ml) Injection (2 Injection)

CLEXANE 6000 IU (60 MG/0.6 ML) INJECTION

Clexane 6000 IU (60 mg/0.6 mL) Injection, manufactured by Sanofi India Limited, is an anticoagulant medication designed to prevent and treat blood clots.

Name

• Brand Name: Clexane 6000 IU (60 MG/0.6 ML) Injection
• Common Name: Enoxaparin sodium

Composition

Each 0.6 ml pre-filled syringe contains 6000 anti-Xa IU, which is equivalent to 60 mg of enoxaparin sodium. The solution also contains water for injection as a solvent. Enoxaparin sodium is a low molecular weight heparin (LMWH).

Uses

Clexane is indicated for various conditions related to blood clot prevention and treatment:

• Prophylaxis of venous thromboembolic disease (prevention of blood clot formation in veins), particularly associated with orthopedic or general surgery.
• Prophylaxis of venous thromboembolic disease in medical patients who are bedridden due to acute illnesses like cardiac insufficiency, respiratory failure, severe infections, or rheumatic diseases.
• Treatment of established deep vein thrombosis (DVT), with or without pulmonary embolism.
• Treatment of unstable angina and non-Q-wave myocardial infarction, administered concurrently with aspirin.
• Treatment of acute ST-segment Elevation Myocardial Infarction (STEMI) in combination with a thrombolytic agent.
• Prevention of thrombus formation in extracorporeal circulation during hemodialysis.

Dosage and Administration

Clexane is administered by subcutaneous injection, meaning it is injected under the skin. It must not be administered by the intramuscular route. For specific conditions:

• Prophylaxis of DVT: Doses typically range from 2000 IU (20 mg) to 4000 IU (40 mg) once daily, depending on the risk level.
• Treatment of DVT: Can be administered subcutaneously as a single injection of 1.5 mg/kg once daily or as 1 mg/kg twice daily for about 10 days. Oral anticoagulant therapy should be initiated simultaneously.
• Unstable angina and non-Q-wave myocardial infarction: Typically 100 anti-Xa IU/kg (1 mg/kg) twice daily for 2-8 days, concurrently with aspirin.
• Prevention of thrombus in hemodialysis: A recommended dose is 100 anti-Xa IU/kg (1 mg/kg) administered into the arterial line at the start of the session. The dose and duration are determined by a healthcare professional based on the patient's condition and risk factors.

Side Effects

Common side effects may include:

• Bleeding (haemorrhage).
• Thrombocytopenia (low platelet count).
• Elevations of serum aminotransferase (liver enzymes).
• Pain, bruising, irritation, or rash at the injection site.
• Nausea, stomach discomfort, diarrhoea, or fever. Serious side effects, though rare, can include:
• Severe bleeding, indicated by black stools, blood in urine, prolonged bleeding from cuts or gums, or severe headaches.
• Neuraxial hematomas when used concurrently with spinal/epidural anesthesia, potentially leading to neurological injuries.
• Allergic reactions.

Precautions

• Bleeding Risk: Clexane should be used with extreme caution in conditions that increase the potential for bleeding, such as impaired hemostasis, active major bleeding, recent hemorrhagic stroke, history of peptic ulcer, uncontrolled severe arterial hypertension, or recent surgery (neuro- or ophthalmologic).
• Drug Interactions: It is recommended to discontinue other medications affecting hemostasis (e.g., aspirin, NSAIDs, clopidogrel, thrombolytics, other anticoagulants) prior to Clexane therapy unless strictly indicated, requiring careful monitoring.
• Platelet Monitoring: Platelet counts should be measured before and regularly during treatment.
• Spinal/Epidural Anesthesia: Use with caution, and discuss with your doctor if such procedures are planned, as it can increase the risk of spinal hematoma.
• Kidney/Liver Impairment: Caution is advised in patients with kidney or liver problems, as dosage adjustments may be necessary.
• Pregnancy and Breastfeeding: Clexane is Pregnancy Category B. It should be used during pregnancy only if clearly needed. It is unknown if enoxaparin is excreted in human milk.
• Hypersensitivity: Do not use if allergic to enoxaparin sodium, heparin, other low molecular weight heparins, or any other ingredients.

Storage

Store in a cool and dry place, protected from light and moisture. Do not store above 25°C or 30°C. Do not freeze or store in a refrigerator. Keep out of the sight and reach of children. The syringe should remain in its original pack until use.

Here are frequently asked questions about CLEXANE 6000 IU (60 MG/0.6 ML) INJECTION by SANOFI INDIA LIMITED:

What is Clexane used for?

Clexane (enoxaparin sodium) is an anticoagulant medication used to treat and prevent blood clots. Specifically, it is used to prevent and treat deep vein thrombosis (DVT) and pulmonary embolism (PE), including during pregnancy and following certain surgeries. It also helps prevent blood clot formation in patients with limited mobility due to acute illness, and in the tubes of dialysis machines. Additionally, it is used in the treatment of unstable angina and certain types of heart attacks (non-Q-wave myocardial infarction and acute ST-segment Elevation Myocardial Infarction).

How does Clexane work?

Clexane is a type of low molecular weight heparin (LMWH). It works by binding to and activating a natural anticoagulant in the body called antithrombin. This complex then primarily inactivates Factor Xa and, to a lesser extent, Factor IIa (thrombin), which are key components in the blood clotting process. This action prevents new blood clots from forming and stops existing clots from growing larger, though it does not break down clots that have already formed.

What is the usual dosage of Clexane 6000 IU (60 mg/0.6 ml)?

Clexane 6000 IU (60 mg/0.6 ml) refers to the concentration of the pre-filled syringe. The specific dosage depends on the condition being treated and your body weight, and will be determined by your doctor. For instance, in some treatment regimens for conditions like deep vein thrombosis or unstable angina, doses of 1 mg per kilogram of body weight are administered, sometimes every 12 hours. For prophylaxis (prevention), doses can range from 20 mg to 40 mg once daily, but specific treatment doses are often weight-based and could include 60 mg. Clexane is typically administered via subcutaneous injection (under the skin) and should not be injected into a muscle.

What are the possible side effects of Clexane?

Common side effects include pain, bruising, swelling, itching, or rash at the injection site. The most significant potential side effect is bleeding, which can range from minor (e.g., nosebleeds, gum bleeding) to serious (e.g., blood in urine or stool, severe internal bleeding). Less common but serious side effects can include allergic reactions (such as rash, difficulty swallowing or breathing, swelling of the face or tongue), low platelet count (thrombocytopenia), and skin necrosis. Long-term use may rarely be associated with a decrease in bone density (osteoporosis). If you experience any severe or concerning side effects, contact your doctor immediately.

Is Clexane safe during pregnancy or breastfeeding?

Pregnancy: Clexane is generally considered safe for use during pregnancy as it is a low molecular weight heparin that does not cross the placenta to the baby. However, it is crucial to discuss the timing of injections with your doctor, especially if labor is anticipated or if you are considering spinal or epidural anesthesia.

Breastfeeding: Enoxaparin is considered safe for use during breastfeeding. Very little of the medication passes into breast milk, and if it does, it has poor oral bioavailability, meaning it is unlikely to have a significant effect on the infant.

Can Clexane be taken with other medications?

Clexane should be used with caution, or avoided, with other medications that can increase the risk of bleeding. These include other anticoagulants (like warfarin, dabigatran, rivaroxaban), antiplatelet agents (like aspirin or clopidogrel), non-steroidal anti-inflammatory drugs (NSAIDs like ibuprofen or naproxen), and thrombolytics. Always inform your doctor or pharmacist about all prescription, over-the-counter, and herbal medications you are taking to check for potential interactions.

What precautions should be taken when using Clexane?

• Do not inject Clexane into a muscle; it is administered subcutaneously (under the skin) or intravenously (by a healthcare professional).
• Do not rub the injection site after administration to prevent bruising.
• Do not mix Clexane with other injections or fluids.
• Inform all healthcare providers, including doctors, dentists, and pharmacists, that you are using Clexane.
• If you have kidney impairment, are elderly, underweight, or obese, your doctor may monitor you more closely, as these factors can affect the risk of bleeding or the medication's effectiveness.
• Avoid activities that could increase your risk of bleeding or injury, such as contact sports, new tattoos, or piercings, without consulting your doctor.
• If you are scheduled for spinal or epidural anesthesia, inform your doctor well in advance, as specific timing guidelines for Clexane administration must be followed.

What happens if a dose of Clexane is missed?

If you miss a dose of Clexane, inject it as soon as you remember. However, if it is almost time for your next scheduled dose, skip the missed dose and continue with your regular dosing schedule. Do not inject a double dose to make up for a missed one. If you are unsure, contact your doctor or pharmacist for advice.

How should Clexane be stored?

Clexane syringes should be stored below 25°C or 30°C (depending on the specific product information) and must not be frozen. Keep the syringes in their original packaging, away from moisture, heat, and direct sunlight, and out of the reach of children.