Dabigat 150

Here is a detailed product description for DABIGAT 150:

DABIGAT 150

• Name:

  • Brand Name: DABIGAT 150
  • Common Name: Dabigatran etexilate

• Composition:

  • Each capsule contains Dabigatran etexilate 150 mg as the active ingredient.

• Uses: DABIGAT 150 is an anticoagulant (blood thinner) used to prevent and treat blood clots. It is prescribed for several medical conditions, including:

  • Reducing the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation (an irregular heartbeat).
  • Treatment and prevention of deep vein thrombosis (DVT - blood clots in leg veins) and pulmonary embolism (PE - blood clots in the lung).
  • Prevention of DVT and PE after hip replacement surgery.

• Dosage and Administration:

  • DABIGAT 150 capsules are typically taken orally twice daily (approximately every 12 hours).
  • For atrial fibrillation or the treatment/prevention of blood clots, the usual adult dose is 150 mg twice a day.
  • For prevention of blood clots after hip replacement surgery, an initial dose of 110 mg is usually taken 1 to 4 hours after surgery, followed by 220 mg once daily for 28 to 35 days.
  • The dose may be adjusted by a doctor based on individual patient factors, including kidney function and age.
  • DABIGAT 150 can be taken with or without food.
  • Capsules must be swallowed whole with a full glass of water. Do not crush, chew, or open the capsules, as this can increase the risk of side effects.

• Side Effects:

  • Common Side Effects: Stomach upset, nausea, heartburn, stomach pain, indigestion, diarrhea, belching, acid or sour stomach, and increased tendency to bleed (e.g., nosebleeds, gum bleeding, heavier periods, bruising).
  • Serious Side Effects (Seek immediate medical attention if you experience):
    • Severe or uncontrolled bleeding (including bloody or tarry stools, vomiting blood or material resembling coffee grounds, red or dark brown urine, severe headache, dizziness, weakness, unexplained joint pain or swelling, or bleeding from a cut that won't stop).
    • Allergic reactions (such as skin rash, itching, hives, or swelling of the face, lips, tongue, or throat).
    • Symptoms of a spinal or epidural blood clot (after spinal procedures), including midline back pain, loss of bladder or bowel control, or numbness, tingling, or weakness in the legs or feet.

• Precautions:

  • It is crucial to inform your doctor about any history of bleeding problems, kidney disease, stomach ulcers, recent surgery, or any severe injury before taking DABIGAT 150, as these conditions can increase the risk of bleeding.
  • DABIGAT 150 is not recommended for patients with mechanical prosthetic heart valves or antiphospholipid syndrome.
  • Always inform your healthcare provider and dentist that you are taking DABIGAT 150 before any surgery, dental work, or medical procedures.
  • Do not stop taking DABIGAT 150 suddenly without consulting your doctor, as this can increase the risk of blood clots and stroke.
  • Women who are pregnant or breastfeeding should discuss the risks and benefits with their doctor.
  • Concomitant use with other medications that affect bleeding, such as NSAIDs, warfarin, or heparin, may increase the risk of bleeding.

• Storage:

  • Store DABIGAT 150 in its original bottle or blister package to protect it from moisture.
  • Keep the medicine in a closed container at room temperature, between 20°C and 25°C (68°F and 77°F), away from heat, moisture, and direct light.
  • After opening a bottle, use all capsules within 4 months. Safely dispose of any unused medication after this period.
  • Do not store capsules in pill boxes or pill organizers.
  • Keep out of the reach of children.

Here are the most frequently asked questions about DABIGAT 150 by NATCO PHARMA LIMITED, along with their concise answers:

1. What is DABIGAT 150 used for?

DABIGAT 150, which contains Dabigatran etexilate, is an anticoagulant (blood thinner) used to prevent and treat blood clots. It is primarily prescribed to reduce the risk of stroke and systemic embolism in adults with non-valvular atrial fibrillation. It is also used to treat and prevent deep vein thrombosis (DVT) and pulmonary embolism (PE), and to prevent these conditions after hip replacement surgery.

2. How does DABIGAT 150 work?

DABIGAT 150 works by delivering Dabigatran etexilate, which is a prodrug. Once absorbed, it is converted into its active form, dabigatran. Dabigatran is a direct thrombin inhibitor, meaning it directly blocks the action of thrombin, a key protein in the blood clotting cascade. By inhibiting thrombin, it prevents the formation of new blood clots and stops existing clots from growing.

3. What is the usual dosage for DABIGAT 150?

For most adult patients, especially for conditions like atrial fibrillation or the treatment and prevention of blood clots, the usual dosage of Dabigatran is 150 milligrams (mg) twice a day. However, your doctor may prescribe a lower dose (e.g., 110 mg twice daily or 75 mg twice daily) if you are over 75 or 80 years old, have kidney problems, or are at a higher risk of bleeding. Dosing for prevention of blood clots after hip replacement surgery involves an initial dose followed by daily doses for a specific duration, as determined by your doctor. It should be taken with a full glass of water, with or without food.

4. What are the possible side effects of DABIGAT 150?

The most common side effects of DABIGAT 150 are related to stomach upset, such as indigestion, stomach pain, nausea, heartburn, and diarrhea. Bleeding is also a significant risk, and you may experience symptoms like easy bruising, nosebleeds, gum bleeding, and blood in urine or stools (which may appear black and tarry). More serious bleeding can occur. If you experience severe headache, unusual weakness, dizziness, or any signs of severe bleeding, seek immediate medical attention.

5. Is DABIGAT 150 safe during pregnancy or breastfeeding?

DABIGAT 150 is generally not recommended during pregnancy, as it may increase the risk of severe bleeding from the uterus. If you are pregnant or planning to become pregnant, inform your doctor immediately, as they will likely switch you to an alternative medication. Regarding breastfeeding, dabigatran is excreted into breast milk in small amounts. While infant side effects are not widely reported, it's advised to monitor the infant for any signs of bleeding. Your doctor may recommend a different medication with more established safety data during breastfeeding.

6. Can DABIGAT 150 be taken with other medications?

DABIGAT 150 can interact with other medications, especially those that also affect blood clotting, increasing the risk of bleeding. It is crucial to inform your doctor and pharmacist about all prescription, over-the-counter, vitamin, and herbal supplements you are taking. Medications such as aspirin, NSAIDs (e.g., ibuprofen, naproxen), clopidogrel, heparin, and warfarin can increase the risk of bleeding when taken with Dabigatran. While Dabigatran has fewer interactions with food or alcohol compared to some other anticoagulants, heavy or binge drinking is not recommended as alcohol can increase bleeding risk.

7. What precautions should be taken while on DABIGAT 150?

Do not stop taking DABIGAT 150 without consulting your doctor, as stopping it abruptly can increase your risk of blood clots and stroke. Due to the increased risk of bleeding, be extra careful to avoid injuries. This includes being gentle when brushing and flossing teeth, using caution with sharp objects like razors and nail clippers, and avoiding rough sports. Always inform any healthcare professional, including dentists, that you are taking this medicine before any procedure or surgery, as it may need to be temporarily stopped. Regular check-ups with your doctor are important to monitor your progress and kidney function. There is also a risk of spinal or epidural blood clots if you undergo spinal anesthesia or a spinal puncture while on this medication.

8. What happens if a dose of DABIGAT 150 is missed?

If you miss a dose of DABIGAT 150, 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.

9. How should DABIGAT 150 be stored?

DABIGAT 150 capsules should be stored in their original bottle or blister package to protect them from moisture and maintain potency. Keep them at room temperature, generally between 68°F to 77°F (20°C to 25°C), away from heat and direct light, and do not freeze. After opening a bottle, the capsules must be used within 4 months, and any unused medicine after this period should be safely discarded. Do not transfer the capsules to pill organizers or other containers. The bottle cap should be tightly closed immediately after each use.