Apixapil 5 Tablet (10 Tab)

APIXAPIL 5 TABLET (10 TAB) by ALKEM LABORATORIES LTD

Name

• Common Name: Apixapil
• Brand Name: APIXAPIL 5 TABLET (manufactured by Alkem Laboratories Ltd.)

Composition

• Active Ingredient: Apixaban 5mg

Uses

APIXAPIL 5 TABLET is an anticoagulant (blood thinner) used to prevent and treat blood clots in various parts of the body. It is prescribed for:

• Reducing the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation (irregular heartbeat).
• Treatment and prevention of deep vein thrombosis (DVT) (blood clots in the legs) and pulmonary embolism (PE) (blood clots in the lungs).
• Prevention of blood clots in patients who have undergone hip or knee replacement surgery.

Dosage and Administration

• APIXAPIL 5 TABLET should be taken orally, with or without food, as directed by your doctor.
• Swallow the tablet whole with a glass of water; do not chew, crush, or break it.
• It is recommended to take the medicine at the same time each day to maintain consistent levels in your body.
• If you have difficulty swallowing, the tablet can be crushed and mixed with water, apple puree, or juice and consumed immediately.
• Typical adult dosage for atrial fibrillation is one 5mg tablet twice a day. A lower dose of 2.5mg twice a day may be prescribed for patients over 80 years old, weighing less than 60kg, or with kidney disease and higher bleeding risk.
• For recent blood clots, the usual dose is two 5mg tablets twice a day for the first 7 days, followed by one 5mg tablet twice a day.
• For prevention after hip or knee replacement surgery, one 2.5mg tablet twice a day is common, usually starting 12 to 24 hours post-surgery.

Side Effects

• Common Side Effects: Bleeding (such as nosebleeds, gum bleeding, bruising, blood in urine or stools), anemia (leading to tiredness or paleness), nausea, swelling, low blood pressure, and a quickened heartbeat.
• Serious Side Effects (Seek immediate medical attention): Severe allergic reactions (e.g., swelling of the lips, mouth, tongue, and throat, with breathing difficulties), major internal bleeding (e.g., in the brain, spinal column, or gastrointestinal tract), and thrombocytopenia (low platelet count).

Precautions

• Inform your doctor if you have severe kidney or liver problems, active pathological bleeding, a history of stomach ulcers, recent bleeding in the brain, very high blood pressure, bleeding disorders, or antiphospholipid syndrome.
• APIXAPIL 5 TABLET is generally not recommended for children and adolescents under 18 years of age.
• Pregnancy and Breastfeeding: It is usually not recommended during pregnancy, and breastfeeding should be avoided as the medicine may pass into breast milk.
• Alcohol: Caution is advised with alcohol consumption as it may increase the risk of bleeding.
• Drug Interactions: Inform your doctor about all other medications you are taking, especially other anticoagulants (e.g., warfarin, heparin), antiplatelet medications (e.g., aspirin, clopidogrel), NSAIDs (e.g., ibuprofen, naproxen), certain antidepressants (SSRIs, SNRIs), epilepsy medications (e.g., phenytoin), St. John's Wort, and rifampicin.
• Do not stop taking APIXAPIL 5 TABLET or alter the dosage without consulting your doctor, as this can increase the risk of blood clot formation.
• Patients undergoing epidural or spinal anesthesia or spinal puncture may be at increased risk of spinal hematoma.

Storage

• Store APIXAPIL 5 TABLET in a cool and dry place, protected from direct sunlight, moisture, and heat.
• Keep the medicine out of sight and reach of children.
• The recommended storage temperature is below 30°C.

APIXAPIL 5 TABLET is a medication primarily used to prevent and treat blood clots. Its active ingredient is apixaban, an anticoagulant that helps reduce the risk of serious cardiovascular events.

What is APIXAPIL 5 TABLET used for?

APIXAPIL 5 TABLET (containing Apixaban) is used to prevent and treat deep vein thrombosis (DVT), which are blood clots that typically form in the leg veins, and pulmonary embolism (PE), where blood clots travel to the lungs. It is also prescribed to reduce the risk of stroke and systemic embolism in individuals with non-valvular atrial fibrillation (an irregular heartbeat not caused by a heart valve problem). Additionally, it is used to prevent DVT and PE in patients who have undergone hip or knee replacement surgery.

How does APIXAPIL 5 TABLET work?

APIXAPIL 5 TABLET works as an anticoagulant, specifically a direct factor Xa inhibitor. It functions by blocking the action of factor Xa, an enzyme that plays a crucial role in the blood clotting cascade. By inhibiting factor Xa, apixaban disrupts the process of thrombin generation, which is essential for fibrin clot formation, thereby preventing new blood clots from forming and keeping existing ones from growing larger.

What is the usual dosage of APIXAPIL 5 TABLET?

The dosage of APIXAPIL 5 TABLET varies depending on the condition being treated. For preventing stroke in non-valvular atrial fibrillation, the typical adult dose is 5 mg twice a day, though a lower dose of 2.5 mg twice a day may be prescribed for patients who are 80 years or older, weigh 60 kg or less, or have kidney problems. For the initial treatment of DVT and PE, the dose is often 10 mg twice daily for the first 7 days, followed by 5 mg twice daily. To prevent DVT/PE after hip or knee replacement surgery, the usual dose is 2.5 mg twice a day, with the first dose typically taken 12 to 24 hours after surgery.

What are the possible side effects of APIXAPIL 5 TABLET?

The most common and serious side effect of APIXAPIL 5 TABLET is bleeding, which can range from minor issues like nosebleeds, bleeding gums, or easy bruising to more severe and potentially life-threatening internal bleeding. Other possible side effects include nausea, headache, and allergic reactions such as skin rash, itching, hives, or swelling of the face, lips, tongue, or throat. Patients should immediately report any unusual or severe bleeding, blood in urine or stools, coughing up blood, severe headache, or symptoms like tingling, numbness, or muscle weakness, especially in the legs and feet, as these could indicate serious bleeding or spinal blood clots.

Is it safe during pregnancy or breastfeeding?

APIXAPIL 5 TABLET (Apixaban) is generally not recommended during pregnancy due to potential risks to the fetus, including an increased risk of bleeding in the mother and unborn baby, and a lack of sufficient safety data. For breastfeeding, it is also not usually recommended as it is unknown if apixaban passes into breast milk, and there's a potential risk of bleeding complications in the infant. Alternative anticoagulants, such as low molecular weight heparins, are often preferred for pregnant and breastfeeding women.

Can it be taken with other medications?

APIXAPIL 5 TABLET can interact with several other medications, which can increase the risk of bleeding. It is important to inform your doctor about all prescription, non-prescription medications, vitamins, nutritional supplements, and herbal products you are taking. Medications that can increase bleeding risk when taken with apixaban include aspirin, NSAIDs (e.g., ibuprofen, naproxen), other anticoagulants (e.g., warfarin, heparin, clopidogrel), selective serotonin reuptake inhibitors (SSRIs), and serotonin norepinephrine reuptake inhibitors (SNRIs). Certain medications for fungal infections (e.g., ketoconazole), bacterial infections (e.g., clarithromycin, rifampicin), abnormal heart rhythm (e.g., dronedarone), and epilepsy (e.g., carbamazepine) can also interact with apixaban. Do not take St. John's wort while on apixaban as it can increase side effects.

What precautions should be taken?

It is crucial to take APIXAPIL 5 TABLET exactly as prescribed and not to stop taking it without consulting your doctor, as discontinuing it prematurely can significantly increase your risk of blood clots and stroke. Regular check-ups, including blood and urine tests, may be needed to monitor its effects. Before any surgery, including dental procedures, inform your healthcare team that you are taking apixaban, as you may need to temporarily stop the medication. Avoid activities that may cause injury and be careful with sharp objects. Patients should also carry an anticoagulant alert card.

What happens if a dose is missed?

If you miss a dose of APIXAPIL 5 TABLET, take it as soon as you remember on the same day. However, if it is almost time for your next scheduled dose (e.g., less than 6 hours until the next dose for a twice-daily regimen), skip the missed dose and continue with your regular dosing schedule. Do not take a double or extra dose to make up for a missed one.

How should it be stored?

APIXAPIL 5 TABLET should be stored in its original container at room temperature, typically between 20°C to 25°C (68°F to 77°F), away from heat, moisture, and direct light. It is important to keep the medicine in a dry place, avoiding areas like the bathroom, and to keep it out of the reach of children. Do not take the medication if the expiry date has passed.