Dabigo 110 Mg Capsule (10 Cap)

DABIGO 110 MG CAPSULE (10 CAP) by SUN PHARMACEUTICAL IND.LTD.

Name

• Brand Name: DABIGO 110 mg Capsule
• Common Name: Dabigatran Etexilate
• Other Brand Name: Pradaxa (for Dabigatran etexilate)

Composition

• Active Ingredient: Dabigatran Etexilate (110 mg)

Uses DABIGO 110 mg Capsule is an anticoagulant (blood thinner) used to prevent and treat blood clots in various medical conditions.

• Prevention and Management of Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE): It helps manage and prevent the formation of blood clots in deep veins, typically in the legs, and in the blood vessels of the lungs. It also prevents the recurrence of DVT and PE in patients who have been previously treated for these conditions.
• Reduction of Stroke and Systemic Embolism: Prescribed to adult patients with non-valvular atrial fibrillation to lower the risk of stroke and systemic embolism.
• Post-Surgical Clot Prevention: Used as a preventative measure against DVT and PE following hip or knee replacement surgery.

Dosage and Administration

• DABIGO 110 mg Capsule should be taken exactly as prescribed by your doctor.
• It is typically taken twice daily, usually every 12 hours, at approximately the same time each day to maintain consistent medication levels.
• The capsule can be taken with or without food.
• Swallow the whole capsule with a glass of water. Do not break, chew, or open it.
• Do not discontinue or alter the dose without consulting your doctor, as this may increase the risk of serious cardiovascular events like heart attack or stroke.

Side Effects Common side effects may include:

• Dyspepsia (indigestion), stomach pain, nausea, and diarrhea.
• Increased bleeding tendency, such as nosebleeds (epistaxis), blood in urine (hematuria), bleeding into joint spaces (hemarthrosis), skin bleeding, or bruising.
• Anemia.
• Headaches and fatigue.

Serious side effects, though less common, can include severe bleeding (which can be fatal), allergic reactions, seizures, or changes in eyesight. Any signs of significant blood loss should be evaluated promptly by a healthcare professional.

Precautions

• Bleeding Risk: DABIGO increases the risk of bleeding. Patients should be cautious during activities that may cause injury or bleeding, such as shaving or using sharp objects. Notify your doctor immediately if you notice unusual bruising or bleeding, or blood in vomit, urine, or stool.
• Renal and Hepatic Impairment: Use with caution in patients with kidney or liver problems, as dose adjustments may be necessary. It is not recommended for those with severe kidney or liver impairment.
• Pregnancy and Breastfeeding: Caution is advised during pregnancy, and it should only be used if the doctor deems it safe. Women of childbearing age should avoid becoming pregnant while on this medication. Breastfeeding is not recommended.
• Alcohol: Avoid consuming alcohol, especially heavy drinking, as it can increase the risk of bleeding.
• Drug Interactions: Inform your doctor about all other medications you are taking, including over-the-counter drugs and herbal supplements, as some can interact with Dabigo and increase the risk of bleeding (e.g., other anticoagulants, antiplatelet agents) or affect its metabolism (e.g., certain antifungals, antivirals, or heart medications).
• Surgery and Procedures: Inform your doctor or dentist if you are scheduled for any surgery or dental treatment, as temporary discontinuation of DABIGO may be required.
• Contraindications: Do not take DABIGO if you have a known allergy to dabigatran etexilate, active pathological bleeding, a disease that increases the risk of serious bleeding (e.g., stomach ulcer, brain injury), severely reduced kidney or liver function, or if you have a mechanical heart valve.

Storage

• Store DABIGO 110 mg Capsules in their original package at room temperature, between 15°C and 30°C, and protect from moisture.
• Keep out of the reach and sight of children and pets.
• Always check the expiry date before use.
• If in a blister pack, use within 4 months of opening the blister.

Dabigo 110 mg Capsule contains Dabigatran etexilate, an anticoagulant (blood thinner) used to prevent and treat blood clots. Here are some frequently asked questions about this medication:

What is Dabigo 110 mg Capsule used for?

Dabigo 110 mg Capsule is primarily used to prevent and treat blood clots. This includes reducing the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation (irregular heartbeat). It is also used to treat and prevent deep vein thrombosis (blood clots in leg veins) and pulmonary embolism (blood clots in the lungs). Additionally, it's prescribed to prevent blood clots after hip or knee replacement surgeries.

How does Dabigo 110 mg Capsule work?

Dabigo 110 mg Capsule contains Dabigatran etexilate, which is a prodrug that is converted to its active form, dabigatran. Dabigatran works as a direct thrombin inhibitor. Thrombin is a key enzyme in the blood clotting cascade that converts fibrinogen to fibrin, a protein essential for clot formation. By inhibiting thrombin, dabigatran prevents the formation of blood clots, allowing blood to flow more easily through the veins.

What is the usual dosage of Dabigo 110 mg Capsule?

The dosage of Dabigo (dabigatran) varies depending on the condition being treated and individual patient factors, including kidney function. For the prevention of stroke and blood clots in nonvalvular atrial fibrillation, a common adult dose is 150 mg twice a day, although a lower dose of 110 mg twice daily may be considered for patients over 75, those on certain medications like verapamil, or with an increased risk of bleeding. For the prevention of blood clots after hip replacement surgery, an initial dose of 110 mg is typically given 1 to 4 hours post-surgery, followed by 220 mg once daily for 28 to 35 days. It is crucial to take this medicine exactly as prescribed by your doctor and not to stop or change the dose without medical guidance.

What are the possible side effects of Dabigo 110 mg Capsule?

The most common side effect of Dabigo 110 mg Capsule is bleeding, as it is a blood thinner. Less serious bleeding may include heavier or longer menstrual periods, prolonged bleeding from cuts, occasional nosebleeds lasting less than 10 minutes, bleeding gums, and easier bruising. Other common side effects can include stomach upset, indigestion, nausea, vomiting, diarrhea, and stomach pain.

More serious side effects, though less common, require immediate medical attention and may include severe headache, dizziness, weakness, blood in urine or stools (which may appear black and tarry), coughing up blood, vomiting material that looks like coffee grounds, or unusual bruising or bleeding that won't stop. Dabigatran may also increase the risk of spinal or epidural blood clots if you have an epidural catheter, take NSAIDs, or have a history of spinal problems, which can lead to numbness, tingling, or weakness in the legs or feet.

Is Dabigo 110 mg Capsule safe during pregnancy or breastfeeding?

Dabigatran should generally be avoided during pregnancy due to an increased risk of severe bleeding from the uterus. If you are pregnant, planning to become pregnant, or become pregnant while taking Dabigo, you should consult your doctor immediately, as they will likely switch you to a different medication.

Regarding breastfeeding, dabigatran is excreted into breast milk in tiny amounts, and while it's unlikely to cause side effects in the infant, there is limited information available. Therefore, its use is generally not recommended unless clearly needed, and your doctor may suggest an alternative. If you do take it while breastfeeding, monitor your baby for any signs of bleeding or feeding difficulties.

Can it be taken with other medications?

Dabigo 110 mg Capsule can interact with several other medications, increasing the risk of bleeding. It's crucial to inform your doctor about all medications you are taking, including over-the-counter drugs, herbal supplements, and vitamins. Medications that may increase the risk of bleeding when taken with dabigatran include:

• Other anticoagulants (blood thinners) such as warfarin, heparin, rivaroxaban, apixaban, and enoxaparin.
• Antiplatelet medications like aspirin, clopidogrel, prasugrel, and ticagrelor.
• Nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen and naproxen.
• Certain medications that affect P-glycoprotein (P-gp) transporters, which can increase dabigatran levels (e.g., dronedarone, ketoconazole, amiodarone) or decrease them (e.g., rifampin, carbamazepine).

Your doctor may adjust your dosage or take other precautions if you need to take these medications together.

What precautions should be taken?

It is very important for your doctor to monitor your progress regularly. Blood tests may be needed to check for unwanted effects, though routine coagulation monitoring like INR (International Normalized Ratio) is not typically required for dabigatran, unlike warfarin. Key precautions include:

• Bleeding Risk: Dabigo can make you bleed or bruise more easily. Be careful to avoid injuries, especially from rough sports or sharp objects. Report any unusual bleeding or bruising to your doctor immediately.
• Kidney Function: Dabigatran is primarily excreted by the kidneys. Patients with kidney problems may require a lower dose, and caution is advised.
• Surgery and Procedures: Inform any doctor or dentist treating you that you are taking Dabigo. You may need to stop taking it for a few days before surgery or dental procedures to reduce bleeding risk.
• Spinal Procedures: There is an increased risk of spinal or epidural blood clots if you have epidural anesthesia or spinal puncture while on this medication.
• Do Not Stop Abruptly: Do not suddenly stop taking Dabigo without consulting your doctor, as this can increase your risk of blood clots and stroke.

What happens if a dose is missed?

If you miss a dose of Dabigo 110 mg Capsule, take it as soon as you remember. However, if your next scheduled dose is less than 6 hours away, 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 it be stored?

Dabigo 110 mg Capsules should be stored at room temperature, typically between 20°C to 25°C (68°F to 77°F). It is crucial to keep the medication in its original container (bottle or blister package) to protect it from moisture. Do not store Dabigo capsules in pill boxes or pill organizers. If you have a bottle, close the cap tightly immediately after taking your dose. Once a bottle is opened, any unused capsules should typically be discarded after 4 months (or 60 days in some regions/guidelines). Keep the medication out of the reach and sight of children and pets.