Apigat 5 Mg Tablet (30 Tab)

APIGAT 5 MG TABLET (30 TAB) by NATCO PHARMA LIMITED

Name

• Brand Name: APIGAT 5 MG TABLET
• Common Name: Apixaban (active ingredient)

Composition

• Active Ingredient: Apixaban 5 mg
• Apigat is a direct oral anticoagulant (DOAC) belonging to the Factor Xa Inhibitors class.

Uses APIGAT 5 MG TABLET is an anticoagulant (blood thinner) used to prevent and treat blood clots. 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 veins of the legs) and pulmonary embolism (PE) (blood clots in the blood vessels of the lungs).
• Preventing DVT and PE after hip or knee replacement surgery.
• Reducing the risk of DVT and PE recurrence after initial treatment.

Dosage and Administration

• The typical starting oral dose of apixaban is 2.5 mg taken twice daily.
• Swallow the tablet whole with a glass of water. Do not crush or chew it.
• It can be consumed with or without food.
• If swallowing is difficult, the tablet can be crushed and mixed with water, apple juice, or applesauce.
• Always follow your doctor's instructions regarding dosage and duration. Do not change the dosage or stop the medicine without consulting your doctor.

Side Effects Common side effects may include:

• Nausea.
• Bleeding events, such as nosebleeds, gum bleeding, or easy bruising.
• Anemia (a decrease in red blood cells or hemoglobin), leading to tiredness and weakness.
• Contusion (bruise).
• Hemorrhage (severe bleeding).
• Low blood pressure, which may cause fainting or a quickened heartbeat.

Serious side effects, though rare, can include severe allergic reactions (swelling of lips, mouth, tongue, throat, breathing difficulties) and abnormal liver function.

Precautions

• Bleeding Risk: Apigat increases the risk of bleeding. Inform your doctor if you experience unusual bleeding or bruising.
• Pregnancy and Breastfeeding: It may be unsafe during pregnancy and is probably unsafe during breastfeeding. Consult your doctor if pregnant, planning to conceive, or breastfeeding.
• Medical Conditions: Inform your doctor about pre-existing conditions such as liver or kidney disease, active bleeding issues, severe hypersensitivity to apixaban, or if you have prosthetic heart valves.
• Drug Interactions: Apigat can interact with other medications, including:
  • Combined P-gp and strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir).
  • Combined P-gp and strong CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin, St. John's wort).
  • Other anticoagulants, antiplatelet agents (e.g., aspirin), or nonsteroidal anti-inflammatory drugs (NSAIDs) due to an increased risk of bleeding.
  • Medicines for high blood pressure or heart problems (e.g., diltiazem) and certain antidepressants.
• Surgery and Procedures: Inform your doctor or dentist if you are taking Apigat before any surgery or dental treatment, as temporary cessation may be required. Spinal or epidural procedures carry a risk of spinal hematoma.
• Overdose: Taking more than the prescribed dose can increase the risk of bleeding. Symptoms of overdose include unusual bleeding or bruising, red/black/tarry stools, red/brown/pink urine, and coughing up or vomiting blood. Seek immediate medical attention if an overdose is suspected.

Storage

• Store Apigat 5 Tablet at room temperature, ideally between 20°C to 25°C, or below 30°C.
• Protect it from excessive heat and direct sunlight.
• Store in a dry place, avoiding damp areas.
• Keep this medicine out of the reach of children.

What is APIGAT 5 MG TABLET used for?

APIGAT 5 MG TABLET, containing Apixaban, is an anticoagulant or blood thinner primarily used to prevent and treat blood clots. It is prescribed to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation (an irregular heartbeat). It also treats and prevents 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. Additionally, it is used to prevent DVT and PE after hip or knee replacement surgery.

How does APIGAT 5 MG TABLET work?

APIGAT 5 MG TABLET works by inhibiting Factor Xa, a crucial protein involved in the blood clotting process. By blocking Factor Xa, Apixaban prevents the conversion of prothrombin to thrombin, an enzyme essential for the formation of fibrin, which forms the meshwork of a blood clot. This mechanism helps to stop the formation and growth of harmful blood clots in the body.

What is the usual dosage of APIGAT 5 MG TABLET?

The usual adult dosage for APIGAT 5 MG TABLET is often 5 mg taken orally twice daily, but the exact dose and duration are determined by your doctor based on your specific medical condition and response to treatment. It is important to take the tablet at the same time each day, with or without food. The tablet should be swallowed whole; do not chew, crush, or break it. If you have difficulty swallowing, your doctor may advise crushing the tablet and mixing it with water, apple juice, or applesauce for immediate consumption.

What are the possible side effects of APIGAT 5 MG TABLET?

The most common side effect of APIGAT 5 MG TABLET is an increased tendency to bleed, which can manifest as nosebleeds, bleeding gums, easy bruising, or blood in the urine or stool. Other common side effects include nausea, anemia (which can cause tiredness or paleness), and hematoma (a collection of blood outside blood vessels). Rarely, more severe side effects like low blood pressure, a quickened heartbeat, or severe allergic reactions (e.g., swelling of the lips, mouth, tongue, or throat, and breathing difficulties) may occur, requiring immediate medical attention.

Is APIGAT 5 MG TABLET safe during pregnancy or breastfeeding?

APIGAT 5 MG TABLET is generally not recommended during pregnancy as it may cause harm to the unborn baby. It is classified as a Category B pregnancy drug, meaning it should only be used if the potential benefits outweigh the risks as determined by a doctor. Similarly, taking APIGAT 5 MG TABLET is not recommended while breastfeeding, as it may pass into breast milk and potentially cause adverse effects in the infant. Always consult your doctor if you are pregnant, planning to conceive, or breastfeeding before taking this medication.

Can APIGAT 5 MG TABLET be taken with other medications?

APIGAT 5 MG TABLET can interact with several other medications, which may increase the risk of bleeding or alter its effectiveness. It is crucial to inform your doctor about all medicines, supplements, and herbal remedies you are taking.

• Increased Bleeding Risk: Concomitant use with other anticoagulants (e.g., warfarin, heparin), antiplatelet agents (e.g., aspirin, clopidogrel), nonsteroidal anti-inflammatory drugs (NSAIDs), and certain antidepressants (e.g., SSRIs, SNRIs) can significantly increase the risk of bleeding.
• Reduced Effectiveness: Medications like rifampin (for tuberculosis), carbamazepine, phenytoin (for epilepsy), and the herbal supplement St. John's wort can decrease the effectiveness of APIGAT 5 MG TABLET.
• Increased Apixaban Levels: Strong CYP3A4 inhibitors such as ketoconazole, itraconazole (antifungals), and ritonavir (anti-HIV medication) can increase the blood levels of apixaban, potentially raising the risk of side effects.

What precautions should be taken while using APIGAT 5 MG TABLET?

Do not stop or change the dosage of APIGAT 5 MG TABLET without consulting your doctor, as abrupt discontinuation can significantly increase your risk of blood clots, stroke, or heart attack. Inform your doctor about any pre-existing medical conditions, especially liver or kidney problems, stomach ulcers, recent bleeding in the brain, high blood pressure, or bleeding disorders, as dose adjustments or extra precautions may be necessary. You should also notify your doctor before undergoing any surgery, dental treatment, or spinal procedures, as this medication may need to be temporarily stopped to reduce bleeding risk. While there's no known interaction with alcohol, excessive consumption should be avoided as a general precaution.

What happens if a dose of APIGAT 5 MG TABLET is missed?

If you forget to take a dose of APIGAT 5 MG TABLET, 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 a missed one.

How should APIGAT 5 MG TABLET be stored?

APIGAT 5 MG TABLET should be stored at room temperature, ideally between 20°C and 25°C, or below 30°C. Keep the medicine protected from excessive heat, direct sunlight, and moisture, avoiding damp areas like bathrooms. Always keep APIGAT 5 MG TABLET out of the sight and reach of children.