Dabigat Capsule
Dabigatran etexilate
110 mg
Incepta Pharmaceuticals Ltd.
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| Retail Price | 95.00 AED |
Available as:
Indications
Dabigat Capsule is used for:
Prophylaxis of postoperative Venous Thromboembolism, Prevention of Stroke, Atrial fibrillation, Deep Venous Thrombosis (DVT), Pulmonary Embolism (PE)
Adult Dose
Oral
Prophylaxis of postoperative venous thromboembolism/Prophylaxis of DVT and PE following total Knee replacement surgery
Adult 18–74 years: Initially, 110 mg, to be taken 1–4 hours after surgery, followed by 220 mg once daily for 10 days, to be taken on the first day after surgery
Reduce dose to 150 mg once daily if given concurrently w/ amiodarone, verapamil or quinidine.
Prophylaxis of postoperative venous thromboembolism/Prophylaxis of DVT and PE following total Hip replacement surgery
Adult 18–74 years: Initially,110 mg, to be taken 1–4 hours after surgery, followed by 220 mg once daily for 28–35 days, to be taken on the first day after surgery.
Reduce dose to 150 mg once daily if given concurrently w/ amiodarone, verapamil or quinidine.
Treatment of DVT and PE in Adult Patients:
For patients with CrCl > 30 mL/min: 150 mg orally, twice daily after 5-10 days of parenteral anticoagulation
Atrial fibrillation
Adult: 150 mg bid, reduce dose to 110 mg bid if given concurrently w/ verapamil.
Non-Valvular Atrial Fibrillation in Adult Patients:
For patients with CrCl > 30 mL/min: 150 mg orally, twice daily
For patients with CrCl 15-30 mL/min: 75 mg orally, twice daily
Child Dose
Treatment of Pediatric VTE:
For pediatric patients: weight-based dosage, twice daily after at least 5 days of parenteral anticoagulant
Reduction in the Risk of Recurrence of Pediatric VTE:
For pediatric patients: weight-based dosage, twice daily after previous treatment
VTE Treatment or Prevention
Indicated for treatment of venous thromboembolic events (VTE) in pediatric patients aged 8 to <18 years who have been treated with a parenteral anticoagulant for at least 5 days
Also indicated to reduce risk of recurrent VTEs in pediatric patients aged 8 to <18 years who have been previously treated
Oral (Capsule)
8 to <18 years (Capsule)
May use for older children or adolescents who can swallow the capsule whole
Dosage based on actual weight
11 to <16 kg: 75 mg PO BID
16 to <26 kg: 110 mg PO BID
26 to <41 kg: 150 mg PO BID
41 to <61 kg: 185 mg PO BID
61 to <81 kg: 220 mg PO BID
>81 kg: 260 mg PO BID
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
Oral Administration
Oral capsules
For adults and children aged 8 years to <18 years
May be taken with or without food.
Swallow the capsule whole (do not chew, crush, or break); do not open the capsules and empty the pellets from the capsule
Contra Indications
Active pathological bleeding or patient at high risk for bleeding.
Patients with prosthetic heart valves.
Severe renal impairment.
Concomitant use with 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).
History of serious hypersensitivity reaction to Dabigatran
Precautions
Premature discontinuation of any oral anticoagulant, including Dabigatran, increases the risk of thrombotic events. To reduce this risk, consider coverage with another anticoagulant if Dabigatran is discontinued for a reason other than pathological bleeding or completion of a course of therapy
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.
Monitor patients frequently for signs and symptoms of neurological impairment and if observed, treat urgently. Consider the benefits and risks before neuraxial intervention in patients who are or who need to be anticoagulated
Bleeding: Dabigatran can cause serious and fatal bleeding
Bioprosthetic heart valves: Dabigatran use not recommended
Increased Risk of Thrombosis in Patients with Triple-Positive
Antiphospholipid Syndrome: Dabigatran use not recommended
MONITORING PARAMETERS
Patients should be monitored for signs of bleeding or anaemia; treatment should be stopped if severe bleeding occurs.
No routine anticoagulant monitoring required (INR tests are unreliable).
Assess renal function (Cockroft and Gault formula to calculate creatinine clearance) before treatment in all patients and at least annually in elderly.
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.
P-gp inducers: Avoid coadministration with Dabigatran
P-gp inhibitors in adult patients with CrCl 30-50 mL/min: Reduce dosage or avoid
P-gp inhibitors in adult patients with CrCl < 30 mL/min: Not recommended
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 thrombolytic.
Adverse Effects
Side effects of Dabigatran etexilate :
>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
Dabigat 110 mg Capsule manufactured by Incepta Pharmaceuticals Ltd.. Its generic name is Dabigatran etexilate. Dabigat is availble in Bangladesh.
Farmaco BD drug index information on Dabigat Capsule is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.