Pradaxa Capsules (Vegetable)
Dabigatran
110mg
Boehringer Ingelheim Pharma GmbH & Co. KG
| Pack size | 60's (10's Blister x 6) |
|---|---|
| Dispensing mode | POM |
| Source | GERMANY |
| Agent | GULF DRUG EST. |
| Retail Price | 416.50 AED |
Available as:
Indications
Pradaxa Capsules (Vegetable) is used for:
Prophylaxis of postoperative venous thromboembolism, Atrial fibrillation
Adult Dose
Oral
Prophylaxis of postoperative venous thromboembolism
Adult: Initially, 110 mg given w/in 1-4 hr after surgery followed by 220 mg once daily for a total of 10 days after (knee replacement) or 28-35 after (hip replacement). Reduce dose to 150 mg once daily if given concurrently w/ amiodarone, verapamil or quinidine.
Elderly: >75 yr Initially, 75 mg given w/in 1-4 hr after surgery followed by 150 mg once daily for a total of 10 days after (knee replacement) or 28-35 after (hip replacement).
Atrial fibrillation
Adult: 150 mg bid, reduce dose to 110 mg bid if given concurrently w/ verapamil.
Elderly: >75 yr 110 mg bid.
Child Dose
Renal Dose
Prophylaxis of postoperative venous thromboembolism
Renal impairment:
CrCl (ml/min) Dosage Recommendation
<30 Contraindicated.
30-50 Initial: 75 mg w/in 1-4 hr after surgery followed by 150 mg once daily for a total of 10 days after (knee replacement) or 28-35 days after (hip replacement). Max: 75 in patients taking w/ verapamil.
Atrial fibrillation
Renal impairment:
CrCl (ml/min) Dosage Recommendation
<30 Contraindicated.
30-50 110 mg bid.
Administration
May be taken with or without food. Swallow whole, do not chew/crush.
Contra Indications
Active pathological bleeding or patient at high risk for bleeding. Patients w/ prosthetic heart valve. Severe renal impairment. Concomitant use w/ antiplatelets, other anticoagulants, thrombolytics, dronedarone, P-glycoprotein inducers (e.g. carbamazepine, rifampicin, phenytoin and St John's wort) and P-glycoprotein strong inhibitors (e.g. ciclosporin, systemic ketoconazole, itraconazole, and tacrolimus).
Precautions
Increased risk of haemorrhage and stroke. Renal and hepatic impairment. Pregnancy, lactation, elderly, childn. Monitoring Parameters Monitor renal function prior to initiation and periodically thereafter.
Pregnancy-Lactation
Risk Summery
Limited available data on use in pregnant women are insufficient to determine drug-associated risks for adverse developmental outcomes; there are risks to mother associated with untreated venous thromboembolism in pregnancy and a risk of hemorrhage in mother and fetus associated with use of anticoagulants
Pregnancy confers an increased risk for thromboembolism that is higher for women with underlying thromboembolic disease and certain high-risk pregnancy conditions; published data describe that women with previous history of venous thrombosis are at high risk for recurrence during pregnancy
Use of anticoagulants, may increase risk of bleeding in fetus and neonate; monitor neonates for bleeding.
Labor or delivery
All patients receiving anticoagulants, including pregnant women, are at risk for bleeding; use during labor or delivery in women who are receiving neuraxial anesthesia may result in epidural or spinal hematomas; consider discontinuation or use of shorter acting anticoagulant as delivery approache.
Lactation
There are no data on presence of dabigatran in human milk, effects on breastfed child, or on milk production; drug and/or its metabolites were present in rat milk; breastfeeding is not recommended during therapy.
Interactions
May increase risk of bleeding w/ NSAIDs. Clarithromycin may increase the serum levels of dabigatran.
Potentially Fatal: P-glycoprotein inducers (e.g. carbamazepine, rifampicin, and phenytoin) decreases systemic exposure of dabigatran. P-glycoprotein strong inhibitors (e.g. ciclosporin, systemic ketoconazole, itraconazole, and tacrolimus) and dronedarone increases systemic exposure of dabigatran. Increased bleeding risk w/ antiplatelets, other anticoagulants and thrombolytics.
Adverse Effects
Side effects of Dabigatran :
>10%
Dyspepsia and gastritis (35%; compared with warfarin [24%])
Any bleed (16.6%; compared with warfarin [18.4%])
1-10%
Major bleed (3.3%; compared with warfarin [3.6%])
Life-threatening bleed (1.5%; compared with warfarin [1.9%])
<1%
Intracranial hemorrhage (0.3%; compared with warfarin [0.8%])
Hypersensitivity, including urticaria, rash, pruritus (<0.1%)
Mechanism of Action
Dabigatran is a competitive, selective, reversible direct inhibitor of thrombin. It inhibits thrombin-induced platelet aggregation and the conversion of fibrinogen to fibrin thus preventing thrombus formation.
Note
Pradaxa 110mg Capsules (Vegetable) manufactured by Boehringer Ingelheim Pharma GmbH & Co. KG. Its generic name is Dabigatran. Pradaxa is availble in United Arab Emirates.
Farmaco UAE drug index information on Pradaxa Capsules (Vegetable) is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.
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