Pradaxa 110 Mg Capsule (10 Cap)

PRADAXA 110 MG CAPSULE

Pradaxa 110 mg Capsule is an oral anticoagulant, commonly known as a blood thinner, manufactured by Boehringer Ingelheim. It works by blocking a substance in the body called thrombin, which is crucial for blood clot formation, thereby helping to prevent and treat blood clots.

Composition

• Active Ingredient: Each hard capsule contains 110 mg of dabigatran etexilate (as dabigatran etexilate mesylate).
• Inactive Ingredients: Capsule fill typically includes acacia, dimeticone, hyprolose, hypromellose, purified talc, and tartaric acid. The capsule shell contains carrageenan, potassium chloride, titanium dioxide, and hypromellose.

Uses Pradaxa 110 mg Capsule is prescribed for various conditions requiring blood clot prevention and treatment:

• Reducing the risk of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (irregular heart rhythm).
• Prevention and treatment of deep vein thrombosis (DVT - blood clots in leg veins) and pulmonary embolism (PE - blood clots in the lungs).
• Reducing the risk of DVT and PE in adult patients who have undergone hip or knee replacement surgery.

Dosage and Administration The dosage of Pradaxa 110 mg varies based on the condition and patient factors.

• General Adult Dosing: Capsules are swallowed whole with a full glass of water, with or without food. It is recommended to take the medicine at approximately the same time each day. Do not chew, break, or open the capsules.
• Post-Hip/Knee Replacement Surgery: Typically, a single 110 mg capsule is taken 1-4 hours after surgery (once hemostasis is achieved), followed by 220 mg once daily (two 110 mg capsules) for 10-35 days, depending on the surgery.
• Patients 80 years or older or with increased bleeding risk: A lower dose of 220 mg daily, taken as one 110 mg capsule twice daily, may be recommended.
• Missed Dose: If a dose is missed, take it as soon as possible on the same day. If it cannot be taken at least 6 hours before the next scheduled dose, skip the missed dose. Do not double the dose.

Side Effects

• Common Side Effects: Bleeding (e.g., nosebleeds, bruising, heavy menstrual bleeding), indigestion, stomach pain, nausea, vomiting, and diarrhea.
• Serious Side Effects: Allergic reactions (rash, swelling), severe bleeding (bloody or tarry stools, vomiting blood, red or dark brown urine), bleeding in the brain (severe headache, confusion, numbness), and blood clots in or near the spinal column after spinal procedures, which can lead to paralysis.

Precautions

• Bleeding Risk: Pradaxa increases the risk of bleeding. Patients should report any unusual bleeding to their doctor.
• Discontinuation: Premature discontinuation of Pradaxa without adequate alternative anticoagulation increases the risk of thrombotic events (blood clots).
• Surgery/Dental Work: Inform healthcare providers about taking Pradaxa before any surgery or dental procedure, as it may need to be temporarily stopped.
• Kidney Function: Not recommended for patients with severely reduced kidney function due to increased dabigatran exposure.
• Other Conditions: Inform your doctor if you have antiphospholipid syndrome, active bleeding problems, or severe liver disease.
• Drug Interactions: Concomitant use with other blood thinners (e.g., warfarin, heparin, NSAIDs) or certain P-gp inhibitors (e.g., ketoconazole, dronedarone, cyclosporine) can increase the risk of bleeding.

Storage

• Store Pradaxa capsules in their original bottle or blister pack to protect from moisture.
• Keep in a cool, dry place where the temperature stays below 30°C.
• Do not store in pill boxes or pill organizers.
• Once a bottle is opened, the product must be used within 4 months (some sources say 30 or 60 days, defer to latest prescribing info for specific product). Close the bottle tightly immediately after removing a capsule.
• Keep out of the reach and sight of children.

PRADAXA 110 MG CAPSULE (10 CAP) by BOEHRINGER INGELHEIM INDIA PVT. LTD.: Frequently Asked Questions

What is PRADAXA 110 mg Capsule used for?

PRADAXA 110 mg Capsule is an anticoagulant, also known as a blood thinner, that is primarily used to prevent and treat blood clots. It is prescribed to reduce the risk of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (irregular heart rhythm). It also treats and prevents deep vein thrombosis (blood clots in the legs) and pulmonary embolism (blood clots in the lungs), and helps prevent clot formation in people who have undergone hip or knee replacement surgeries.

How does PRADAXA work?

PRADAXA 110 mg Capsule contains dabigatran etexilate, which is a direct thrombin inhibitor. It works by directly blocking thrombin, a substance in the body that plays a crucial role in blood clot formation. By inhibiting thrombin, PRADAXA prevents the conversion of fibrinogen to fibrin, thereby hindering the development of blood clots and helping blood flow smoothly.

What is the usual dosage of PRADAXA 110 mg Capsule?

PRADAXA capsules are typically taken twice daily, once in the morning and once in the evening, at approximately the same time each day, with the dosing interval being as close to 12 hours as possible. The specific dosage can vary based on the condition being treated, the patient's age, weight, and kidney function. For example, for the prevention of stroke and systemic embolism in non-valvular atrial fibrillation, a common adult dose is 150 mg twice daily, but a 110 mg twice daily dose may be recommended for patients aged 80 years or older, or those on concomitant verapamil, or with a higher bleeding risk. For preventing blood clots after hip replacement surgery, treatment may start with a 110 mg capsule 1-4 hours after surgery, followed by 220 mg (two 110 mg capsules) once daily for 28-35 days. It can be taken with or without food; however, if stomach upset occurs, taking it with food may help. It is crucial to swallow the capsules whole and not to cut, crush, chew, or open them, as this can increase dabigatran exposure.

What are the possible side effects of PRADAXA?

The most common side effects of PRADAXA include stomach pain, upset stomach, heartburn, nausea, vomiting, diarrhea, and minor bleeding such as nosebleeds or bruising. More serious side effects can include severe bleeding (e.g., bloody or tarry stools, vomiting blood, red/dark brown urine, unusual bruising), allergic reactions (skin rash, itching, hives, swelling), and in rare cases, bleeding in the brain (severe headache, confusion, weakness, vision changes). PRADAXA carries a boxed warning about an increased risk of blood clots if prematurely discontinued.

Is PRADAXA safe during pregnancy or breastfeeding?

PRADAXA is generally not recommended during pregnancy unless clearly necessary, as studies in animals have shown reproductive toxicity, and the potential risk for humans is unknown. Serious fetal side effects, such as bleeding, may occur. It is also probably unsafe to use during breastfeeding, and it is not known if dabigatran is excreted in human milk. Women of childbearing potential should avoid pregnancy while undergoing treatment with Pradaxa. Your doctor will weigh the benefits and potential risks before prescribing it if you are pregnant or breastfeeding.

Can PRADAXA be taken with other medications?

PRADAXA can interact with several other medications, especially those that also affect blood clotting, increasing the risk of bleeding. These include aspirin and aspirin-like medications, other anticoagulants (e.g., warfarin, heparin, enoxaparin, apixaban, rivaroxaban), antiplatelet drugs (e.g., clopidogrel, prasugrel), and NSAIDs (ibuprofen, naproxen). Certain other medications like dronedarone, systemic ketoconazole, and cyclosporine can also interact with PRADAXA, potentially increasing its levels in the body. Always inform your doctor and pharmacist about all prescription, over-the-counter, and herbal products you are taking to avoid potential drug interactions.

What precautions should be taken?

Several precautions should be taken while on PRADAXA. Due to the increased risk of bleeding, be careful with activities that may cause injury and report any unusual bruising or bleeding to your doctor. Inform your care team before any surgery, dental work, or spinal procedures, as PRADAXA may need to be temporarily stopped. Patients with severe kidney or liver disease, bleeding problems, stomach ulcers, or those with artificial heart valves should generally avoid PRADAXA or use it with extreme caution and under strict medical supervision. Alcohol consumption should be avoided as it may increase the risk of stomach bleeding. Do not stop taking PRADAXA without consulting your doctor, as this can significantly increase your risk of blood clots, stroke, or heart attack.

What happens if a dose is missed?

If you miss a dose of PRADAXA, take it as soon as you remember on the same day. However, if your next scheduled dose is less than 6 hours away, skip the missed dose. Do not take a double dose or an extra dose to make up for a missed one.

How should PRADAXA be stored?

PRADAXA capsules should be stored at room temperature, typically between 20-25°C (68-77°F), protected from moisture. Keep the capsules in their original bottle or blister package. After opening the bottle, the capsules must be used within 4 months; any unused capsules after this period should be safely discarded. Keep PRADAXA out of the sight and reach of children. Do not put PRADAXA capsules into pill boxes or organizers, as this can expose them to moisture.