Drug information of Dabigatran

Dabigatran

فارسی

Anticoagulant ; a synthetic reversible direct thrombin inhibitor .

Mechanism of effect

Inhibits coagulation by preventing thrombin-mediated effects, including cleavage of fibrinogen to fibrin monomers, activation of factors V, VIII, XI, and XIII, and inhibition of thrombin-induced platelet aggregation.

Pharmacodynamic

dabigatran is a specific, reversible, direct thrombin inhibitor that inhibits both free and fibrin-bound thrombin.

Pharmacokinetics

Absorption is Rapid; initially slow postoperatively.
Metabolism is Hepatic; dabigatran etexilate is rapidly and completely hydrolyzed to dabigatran (active form) by plasma and hepatic esterases; dabigatran undergoes hepatic glucuronidation to active acylglucuronide isomers .
Excretion is in Urine (80%). Time to Peak of Dabigatran in Plasma is 1 hour; delayed 2 hours by food (no effect on bioavailability).
Half-Life Elimination is 12-17 hours; Elderly: 14-17 hours; Mild-to-moderate renal impairment: 15-18 hours; Severe renal impairment: 28 hours an. Protein Bindian is 35%.

Dosage

Usual Adult Dose for Deep Vein Thrombosis – Prophylaxis
Recommended doses: 150 mg orally twice a day
Usual Adult Dose for Prevention of Thromboembolism in Atrial Fibrillation
- Recommended doses: 150 mg orally twice a day
- Comments: Generally, the extent of anticoagulation does not need to be assessed with this drug; however, when necessary, use aPTT or ECT, and not INR to assess anticoagulant activity.
Usual Adult Dose for Deep Vein Thrombosis/Pulmonary Embolism Prophylaxis Following Hip Replacement Surgery
110 mg orally 1 to 4 hours after surgery and after hemostasis has been achieved, then 220 mg orally once a day for 28 to 35 days
Comments: If this drug is not started on the day of surgery, initiate treatment with 220 mg orally once a day after hemostasis has been achieved.

Alerts

Thrombotic events: Premature discontinuation of dabigatran increases the risk of thrombotic events. If anticoagulation with dabigatran is discontinued for a reason other than pathological bleeding or completion of a course of therapy, consider coverage with another anticoagulant.
Spinal/Epidural hematoma: Epidural or spinal hematomas may occur in patients treated with dabigatran who are receiving neuraxial anesthesia or undergoing spinal puncture. These hematomas may result in long-term or permanent paralysis.
Consider these risks when scheduling patients for spinal procedures. Factors that can increase the risk of developing epidural or spinal hematomas in these patients include use of indwelling epidural catheters; concomitant use of other drugs that affect hemostasis, such as nonsteroidal anti-inflammatory drugs (NSAIDs), platelet inhibitors, or other anticoagulants; a history of traumatic or repeated epidural or spinal punctures; a history of spinal deformity or spinal surgery; optimal timing between the administration of dabigatran and neuraxial procedures is not known.
Monitor patients frequently for signs and symptoms of neurological impairment. If neurological compromise is noted, urgent treatment is necessary.
Consider the benefits and risks before neuraxial intervention in patients anticoagulated or to be anticoagulated.
Bleeding: The most common complication is bleeding, sometimes fatal bleeding. Risk factors for bleeding include concurrent use of drugs that increase the risk of bleeding (eg, antiplatelet agents, heparin), renal impairment, and elderly patients (especially if low body weight).
Monitor for signs and symptoms of bleeding; discontinue in patients with active pathological bleeding. Important: Idarucizumab is commercially available for dabigatran reversal; protamine and vitamin K do not reverse or impact anticoagulant effects of dabigatran.

Points of recommendation

To make sure this medicine is safe for you, tell your doctor if you have :
• If you have an allergy to dabigatran or any other part of it.
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you have bleeding problems.
• If you have had a heart valve replaced.
• If you have kidney problems.
• If you are taking any of these drugs: Dronedarone or ketoconazole.
• If you are taking or will be taking another drug like this one.
• If you are breast-feeding or plan to breast-feed.
This medicine may need to be stopped before certain types of surgery as your doctor has told you. If this medicine is stopped, your doctor will tell you when to start taking dabigatran etexilate again after your surgery or procedure.
You may bleed more easily. Be careful and avoid injury. Use a soft toothbrush and an electric razor.
If you are 65 or older, use this medicine with care. You could have more side effects.
Take with or without food. Swallow whole. Do not chew, open, or crush. Take with a full glass of water.
Take a missed dose as soon as you think about it. If it is less than 6 hours until the next dose, skip the missed dose and go back to the normal time. Do not take 2 doses at the same time or extra doses.

Pregnancy level

C

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