Dabigatran exerts its anticoagulant effect by directly inhibiting thrombin (factor IIa), a key enzyme in the coagulation cascade. The mechanism of action involves:

1. Inhibition of Thrombin:
   • Thrombin plays a central role in the conversion of fibrinogen to fibrin, the final step in blood clot formation.
   • By directly inhibiting thrombin, dabigatran prevents the formation of fibrin clots.
2. Anticoagulant Effect:
   • Dabigatran’s action is specific to thrombin, making it a targeted anticoagulant with a lower risk of affecting other clotting factors.
   • It does not require antithrombin III (unlike heparin) for its activity.
3. Predictable Pharmacokinetics:
   • Dabigatran has a rapid onset of action, reaching peak plasma concentrations within 1–2 hours.

It has a half-life of approximately 12–14 hours in healthy individuals, allowing for twice-daily dosing

Dabigatran is approved for the following conditions:

1. Prevention of Stroke and Systemic Embolism in Atrial Fibrillation:
   • Used in patients with non-valvular atrial fibrillation (NVAF) to reduce the risk of stroke and systemic embolism.
2. Treatment and Prevention of Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE):
   • Used for the treatment of acute DVT and PE.
   • Also used for the prevention of recurrent DVT and PE.
3. Postoperative Thromboprophylaxis:
   • Used to prevent venous thromboembolism (VTE) in patients undergoing hip or knee replacement surgery.

The dosage of dabigatran varies depending on the indication and patient-specific factors. Below are general guidelines:

1. Atrial Fibrillation (Stroke Prevention):
   • Standard Dose: 150 mg taken orally twice daily.
   • Reduced Dose: 110 mg twice daily for patients with:
     • Moderate renal impairment (CrCl 30–50 mL/min)
     • High bleeding risk (e.g., elderly patients, those on antiplatelet therapy)
2. Treatment of DVT and PE:
   • Initial Dose: 150 mg taken orally twice daily.
   • Duration: Typically 3–6 months, depending on the clinical scenario.
3. Prevention of Recurrent DVT and PE:
   • Standard Dose: 150 mg taken orally twice daily.
4. Postoperative Thromboprophylaxis:
   • Standard Dose: 110 mg taken orally 1–4 hours after surgery, followed by 220 mg once daily for 28–35 days (hip replacement) or 10 days (knee replacement).
5. Administration:
   • Dabigatran should be taken with or without food.

Swallow the capsule whole; do not crush or chew

Dabigatran is generally well-tolerated, but some side effects may occur. These include:

1. Common Side Effects:
   • Bleeding (e.g., nosebleeds, gum bleeding, bruising)
   • Gastrointestinal symptoms (e.g., dyspepsia, abdominal pain, nausea)
2. Less Common Side Effects:
   • Headache
   • Rash
   • Elevated liver enzymes
3. Rare but Serious Side Effects:
   • Major Bleeding: Gastrointestinal bleeding, intracranial hemorrhage.
   • Hypersensitivity Reactions: Rare cases of anaphylaxis or angioedema.
   • Spinal/Epidural Hematoma: Especially in patients undergoing spinal procedures.

1. Contraindications:
   • Hypersensitivity to dabigatran or any component of the formulation.
   • Active clinically significant bleeding.
   • Severe renal impairment (CrCl < 30 mL/min).
2. Warnings:
   • Bleeding Risk: Dabigatran increases the risk of bleeding. Use with caution in patients with a history of bleeding disorders or conditions that predispose to bleeding.
   • Renal Impairment: Use with caution in patients with moderate renal impairment (CrCl 30–50 mL/min). Avoid use in severe renal impairment (CrCl < 30 mL/min).
   • Pregnancy and Lactation: Dabigatran is not recommended during pregnancy or breastfeeding unless the benefits outweigh the risks.
3. Monitoring:
   • Regular monitoring of renal function (serum creatinine).
   • Watch for signs of bleeding (e.g., unusual bruising, blood in stool or urine).

Dabigatran interacts with several medications, including:

1. Strong P-gp Inhibitors (e.g., ketoconazole, ritonavir): Increase dabigatran levels, increasing the risk of bleeding. Avoid concurrent use or reduce the dose of dabigatran.
2. Strong P-gp Inducers (e.g., rifampin, carbamazepine): Decrease dabigatran levels, reducing its efficacy. Avoid concurrent use.
3. Other Anticoagulants (e.g., warfarin, heparin): Increased risk of bleeding.
4. NSAIDs (e.g., ibuprofen): Increased risk of gastrointestinal bleeding.

Antiplatelet Agents (e.g., aspirin, clopidogrel): Increased risk of bleeding

Dabigatran is available under its generic name as well as brand names. Some common formulations include:

• Generic Name: Dabigatran etexilate

Brand Name: Pradaxa (commonly used worldwide