Clexane40 Mg/0.4 Ml Injection

CLEXANE 40 MG/0.4 ML INJECTION by SANOFI INDIA LIMITED

• Name:

  • Common Name: Enoxaparin sodium
  • Brand Name: Clexane

• Composition:

  • Each 0.4 mL pre-filled syringe contains 40 mg of Enoxaparin sodium, equivalent to 4000 IU anti-Xa activity.

• Uses: Clexane is an anticoagulant prescribed to prevent and treat harmful blood clots throughout the body.

  • Prevention of Blood Clots:
    • Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE), particularly in patients undergoing surgery (e.g., hip or knee replacement, abdominal procedures).
    • In bedridden medical patients with restricted mobility due to acute illness.
    • Following a heart attack or unstable angina.
    • To prevent blood clot formation in the tubes of kidney dialysis machines.
  • Treatment of Blood Clots:
    • Existing DVT and PE.
  • Cardiac Conditions:
    • Treatment of unstable angina and certain types of heart attack (non-Q-wave myocardial infarction and acute ST-segment Elevation Myocardial Infarction (STEMI)), often in conjunction with aspirin.

• Dosage and Administration: Clexane 40 mg/0.4 mL is administered via subcutaneous injection, typically into the abdomen. It must not be injected into a muscle. The specific dose and duration of treatment are determined by a healthcare professional based on the patient's medical condition, response, age, and weight.

  • Typical Administration: Pinch a fold of skin (e.g., on the stomach) between your thumb and index finger, insert the entire needle at a 90° angle, and slowly inject the medicine.
  • Post-Injection: Do not rub the injection site after removing the needle to avoid bruising.
  • Prophylaxis: For prevention, a common dose is 40 mg once daily.
  • Therapeutic Dosing: For treatment, doses can vary, such as 1.5 mg/kg once daily or 1 mg/kg twice daily.

• Side Effects:

  • Common Side Effects: Pain, bruising, bleeding, swelling, itching, or rash at the injection site, headache, mild fever, diarrhea, and increased liver enzymes.
  • Serious Side Effects: Prompt medical attention is required for signs of significant bleeding such as prolonged bleeding from cuts, nosebleeds, bleeding gums, blood in urine or stool (black, tarry stools), or vomit. Other serious side effects include severe headache (indicating possible brain bleed), severe abdominal pain (indicating possible stomach bleed), allergic reactions (e.g., skin rash, hives, swelling of the face, lips, tongue, or throat), dizziness, and numbness, weakness, or paralysis, especially in the legs (potential spinal hematoma following spinal/epidural procedures).

• Precautions:

  • Increased Bleeding Risk: Clexane increases the risk of bleeding. Exercise caution with sharp objects and inform your doctor if you are taking other medications that may increase bleeding risk, such as aspirin, NSAIDs, or warfarin.
  • Medical History: Inform your doctor about any pre-existing medical conditions, including a history of high blood pressure, diabetes, gastric ulcer, heart valve issues, kidney or liver problems, recent stroke, or spinal/brain surgery.
  • Spinal/Epidural Anesthesia: Special caution is needed if you are scheduled for spinal or epidural anesthesia or a lumbar puncture due to the risk of spinal hematoma, which can cause paralysis. A specific time interval between Clexane administration and these procedures is usually necessary.
  • Pregnancy and Breastfeeding: Use during pregnancy should only be under strict medical guidance. Clexane is generally not recommended during breastfeeding.
  • Medication Interactions: Always inform your doctor or pharmacist about all other medications, including over-the-counter drugs, vitamins, and herbal supplements, to avoid potential interactions.
  • Self-Administration: Do not self-administer unless you have received proper training and instruction from a healthcare professional.

• Storage:

  • Store Clexane at or below 25°C (77°F), or below 30°C.
  • Do not refrigerate or freeze.
  • Keep the pre-filled syringe in its original packaging until ready to use.
  • Keep out of the sight and reach of children.
  • Discard the injection if you observe any particulate matter, abnormal color, or damage to the syringe.
  • Dispose of used syringes properly as instructed by your doctor or pharmacist; do not dispose of them in household rubbish.

What is Clexane 40 MG/0.4 ML Injection used for?

Clexane 40 MG/0.4 ML Injection, which contains enoxaparin sodium, is an anticoagulant medicine used to prevent and treat harmful blood clots. It is commonly prescribed to prevent deep vein thrombosis (DVT) and pulmonary embolism (PE), especially in hospitalized patients, those with limited mobility, or after surgeries such as hip or knee replacement. It also helps prevent blood clots in patients with conditions like unstable angina and after a heart attack. Additionally, it can be used to prevent clots from forming in the tubes of dialysis machines.

How does Clexane 40 MG/0.4 ML Injection work?

Clexane (enoxaparin) is a type of low molecular weight heparin (LMWH) that works by inactivating specific blood-clotting proteins, primarily Factor Xa. By blocking these substances, it prevents new blood clots from forming and stops existing ones from growing larger, allowing the body to break them down. This action helps ensure smooth blood flow throughout the body.

What is the usual dosage and how is it administered?

Clexane 40 MG/0.4 ML Injection is typically administered by a doctor or nurse as an injection under the skin (subcutaneous), usually into the stomach area, at least 2 inches from the belly button. It should not be injected into a muscle. The specific dose and duration of treatment depend on the medical condition being treated, the patient's weight, age, and response to the medicine. For prevention of venous thromboembolism in high-risk patients, a common prophylactic dose is 40 mg once daily. For the treatment of deep vein thrombosis, doses like 1.5 mg/kg once daily or 1 mg/kg twice daily subcutaneously are common.

What are the possible side effects of Clexane 40 MG/0.4 ML Injection?

Common side effects can include pain, bruising, irritation, redness, or swelling at the injection site. Other possible side effects include bleeding gums, increased menstrual flow, collection of blood under the skin, headache, nausea, diarrhea, and fever. More serious, but rare, side effects can include severe bleeding (which may manifest as dark urine, black stools, severe headache, confusion, or unusual dizziness) and allergic reactions. It's important to report any persistent or worsening side effects to your doctor immediately.

Is Clexane 40 MG/0.4 ML Injection safe during pregnancy or breastfeeding?

During pregnancy, Clexane should be used only if your doctor has determined a clear need, as there is limited information on its use. Enoxaparin (the active ingredient in Clexane) is generally considered safe in pregnancy because it does not cross the placenta to the baby in significant amounts. However, pregnant women with mechanical prosthetic heart valves may be at a higher risk of thromboembolism. For breastfeeding, Clexane is generally not recommended unless clearly necessary. While very small amounts may be secreted in breast milk, due to its large molecular weight and low oral bioavailability, it is unlikely to affect the baby significantly. It's crucial to discuss the risks and benefits with your doctor if you are pregnant or breastfeeding.

Can Clexane 40 MG/0.4 ML Injection be taken with other medications?

Clexane can interact with several other medications that affect blood clotting, increasing the risk of bleeding. It's important to inform your doctor about all medicines you are taking, including over-the-counter drugs, herbal supplements, and homeopathic medicines. Medications like aspirin, NSAIDs (e.g., ibuprofen), other anticoagulants (e.g., warfarin), thrombolytics, ticlopidine, dextran 40, and systemic glucocorticoids should be used with caution or discontinued before enoxaparin therapy unless strictly indicated.

What precautions should be taken?

Several precautions should be taken while using Clexane. Do not inject Clexane into a muscle. Avoid activities that increase your risk of bleeding or injury, and be careful when shaving or using sharp objects. Inform your doctor if you have high blood pressure, diabetes, kidney or liver disease, a history of peptic ulcers, a recent stroke, or if you have recently undergone brain, eye, or spinal surgery. Also, inform your doctor if you are planning to have spinal or epidural anesthesia, as this can increase the risk of spinal hematomas. Regular blood tests may be needed to monitor platelet counts due to the risk of heparin-induced thrombocytopenia (HIT).

What happens if a dose is missed?

If you miss a dose of Clexane, take 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 take a double dose to make up for the missed one, as this can increase the risk of side effects. If you miss two or more doses in a row, contact your doctor for advice.

How should it be stored?

Clexane 40 MG/0.4 ML Injection syringes should be stored below 25°C, away from moisture, heat, and direct sunlight. It is crucial not to freeze the medicine. Keep the syringes in their original packaging until it's time to use them and store them out of the reach of children. Used syringes should be disposed of safely in a sharps container.