Medicine Overview
Adult Dose
| Clinical Information | Administration Information |
|---|---|
|
Indication: Prophylaxis of postoperative venous thromboembolism/Prophylaxis of DVT and PE following total Knee replacement surgery Age: Adult 18–74 years |
Dose: Oral – Initially, 110 mg, followed by 220 mg Frequency: once daily Duration: 10 days Note: Initial dose to be taken 1–4 hours after surgery, followed by 220 mg once daily starting on the first day after surgery. Reduce dose to 150 mg once daily if given concurrently with amiodarone, verapamil or quinidine. |
|
Indication: Prophylaxis of postoperative venous thromboembolism/Prophylaxis of DVT and PE following total Hip replacement surgery Age: Adult 18–74 years |
Dose: Oral – Initially, 110 mg, followed by 220 mg Frequency: once daily Duration: 28–35 days Note: Initial dose to be taken 1–4 hours after surgery, followed by 220 mg once daily starting on the first day after surgery. Reduce dose to 150 mg once daily if given concurrently with amiodarone, verapamil or quinidine. |
Child Dose
| Clinical Information | Administration Information |
|---|---|
|
Indication: Treatment of venous thromboembolic events (VTE) Age: 8 to less than 18 years Condition: after at least 5 days of parenteral anticoagulant |
Dose: Capsule – 75 mg Frequency: twice daily Note: by mouth (oral), swallow the capsule whole |
|
Indication: Treatment of venous thromboembolic events (VTE) Age: 8 to less than 18 years Condition: after at least 5 days of parenteral anticoagulant |
Dose: Capsule – 110 mg Frequency: twice daily Note: by mouth (oral), swallow the capsule whole |
Renal Dose
| Clinical Information | Administration Information |
|---|---|
|
Indication: Prophylaxis of postoperative venous thromboembolism Condition: Renal impairment with Creatinine Clearance less than 30 ml/minute |
Dose: Tablet – Dosage not specified Note: Contraindicated |
|
Indication: Prophylaxis of postoperative venous thromboembolism Condition: Renal impairment with Creatinine Clearance 30-50 ml/minute (Knee replacement) |
Dose: Tablet – Initial: 75 mg followed by 150 mg Frequency: Initial dose within 1-4 hours after surgery followed by once daily Duration: Total of 10 days Note: Maximum 75 mg in patients taking with verapamil |
Administration
- Take with or without food
- Swallow capsule whole
Side Effect
- Dyspepsia and gastritis (35%, compared with warfarin [24%])
- Any bleed (16.6%, compared with warfarin [18.4%])
- Major bleed (3.3%
- compared with warfarin [3.6%])
- Life-threatening bleed (1.5%, compared with warfarin [1.9%])
- Intracranial hemorrhage (0.3%
- compared with warfarin [0.8%])
- Hypersensitivity including urticaria, rash, pruritus (Less than 0.1%)
Drug Interaction
Drug Interaction
| Drug Name | Risk Factors |
|---|---|
|
NSAIDs (Ibuprofen, Naproxen, Diclofenac, Celecoxib, Meloxicam, Indomethacin, Piroxicam, Ketorolac)
|
May increase risk of bleeding
|
|
Clarithromycin
|
May increase serum levels of dabigatran
|
Disease Interaction
Disease Interaction
| Disease Name | Risk Factors |
|---|---|
|
Active bleeding
|
Risk of severe hemorrhage
|
|
Prosthetic heart valve
|
Risk of valve thrombosis
|
Pregnancy
Pregnancy
Lactation
Special Use
Precaution
Overdose
Pharmacology
Storage
Store Dabigatran Etexilate at room temperature 20°C to 25°C. After opening the bottle, use Dabigatran Etexilate within 4 months. Safely throw away any unused Dabigatran Etexilate after 4 months. Keep Dabigatran Etexilate in the original bottle or blister package to keep it dry (protect the capsules from moisture). Do not put Dabigatran Etexilate in pill boxes or pill organizers. Tightly close your bottle of Dabigatran Etexilate right away after you take your dose. Keep Dabigatran Etexilate and all medicines out of the reach of children.
Data Sources
Clinical & regulatory information on this page is compiled from the following government sources:
DISCLAIMER: This drug information content is provided for informational purposes only and is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Patients should always consult their physician with any questions regarding a medical condition and to obtain medical advice and treatment.