• Reduction in the risk of stroke/systemic embolization associated with nonvalvular atrial fibrillation (AF).
• Treatment of venous thromboembolic events (VTE) (including deep vein thrombosis [DVT] or pulmonary embolism [PE]) in patients who have been treated with a parenteral anticoagulant for 5 days.
• Reduction in the risk of recurrence of VTE in patients who have been previously treated.
• Prevention of DVT and PE following hip replacement surgery.

Contraindicated in:

• Hypersensitivity
• Active pathologic bleeding
• Concurrent use of P-glycoprotein (P-gp) inducers
• Prosthetic heart valves (mechanical or bioprosthetic)
• Triple-positive antiphospholipid syndrome (↑ risk of thrombosis)
• OB: Pregnancy
• Lactation: Lactation.

Use Cautiously in:

• Neuroaxial spinal anesthesia or spinal puncture, especially if concurrent with an indwelling epidural catheter, drugs affecting hemostasis, history of traumatic/repeated spinal puncture or spinal deformity (↑ risk of spinal hematoma)
• Concurrent medications/pre-existing conditions that ↑ bleeding risk (other anticoagulants, antiplatelet agents, fibrinolytics, heparins, chronic NSAID use, labor and delivery)
• Renal impairment
• Surgical procedures (discontinue 1–2 days prior if CCr 50 mL/min or 3–4 days prior if CCr <50 mL/min
• Women of reproductive potential
• Pedi: Safety and effectiveness in children <3 mo (treatment and reduction in risk of VTE) and <18 yr (all other indications) not established
• Geri: Appears on Beers list. ↑ risk of bleeding in older adults. Use caution in selecting dabigatran over apixaban for long-term treatment of nonvalvular AF or VTE.

GI: abdominal pain, diarrhea, dyspepsia, gastritis, esophageal ulceration, nausea.

Hemat: bleeding, thrombocytopenia.
Misc: (INCLUDING ANAPHYLAXIS AND ANGIOEDEMA)HYPERSENSITIVITY REACTIONS .

Drug-Drug:

• Concurrent use of other anticoagulants, antiplatelet agents, fibrinolytics, heparins, prasugrel, clopidogrel, or chronic use of NSAIDs↑ risk of bleeding.
• Concurrent use of P-gp inducers including rifampin↓ levels and effectiveness; avoid concurrent use.
• P-gp inhibitors, including dronedarone, ketoconazole (systemic), verapamil, quinidine, and ticagrelor may ↑ levels and the risk of bleeding; concomitant use should be avoided in patients with CCr 15–30 mL/min.

(Generic available)

• Capsules: 75 mg; 110 mg; 150 mg;
• Oral pellets: 20 mg/pkt; 30 mg/pkt; 40 mg/pkt; 50 mg/pkt; 110 mg/pkt; 150 mg/pkt;

Reduction in Risk of Stroke/Systemic Embolism in Nonvalvular Atrial Fibrillation

• PO (Adults): Capsules: 150 mg twice daily.

Treatment of and Reduction in Risk of Recurrence of Deep Vein Thrombosis or Pulmonary Embolism

• PO (Adults): 150 mg twice daily.
• PO (Children 8–<18 yr and 81 kg actual body weight): 260 mg (one 150-mg capsule + one 110-mg capsule or one 110-mg capsule + two 75-mg capsules) twice daily.
• PO (Children 8–<18 yr and 61–<81 kg actual body weight): 220 mg (two 110-mg capsules) twice daily.
• PO (Children 8–<18 yr and 41–<61 kg actual body weight): 185 mg (one 110-mg capsule + one 75-mg capsule) twice daily.
• PO (Children 8–<18 yr and 26–<41 kg actual body weight): 150 mg (one 150-mg capsule or two 75-mg capsules) twice daily.
• PO (Children 8–<18 yr and 16–<26 kg actual body weight): 110 mg (one 110-mg capsule) twice daily.
• PO (Children 8–<18 yr and 11–<16 kg actual body weight): 75 mg (one 75-mg capsule) twice daily.
Oral Pellets
• PO (Children 2–<12 yr and 41 kg actual body weight): 260 mg (one 110-mg pkt + one 150-mg pkt) twice daily.
• PO (Children 2–<12 yr and 21–<41 kg actual body weight): 220 mg (two 110-mg pkts) twice daily.
• PO (Children 2–<12 yr and 16–<21 kg actual body weight): 170 mg (one 20-mg pkt + one 150-mg pkt) twice daily.
• PO (Children 2–<12 yr and 13–<16 kg actual body weight): 140 mg (one 30-mg pkt + one 110-mg pkt) twice daily.
• PO (Children 2–<12 yr and 11–<13 kg actual body weight): 110 mg (one 110-mg pkt) twice daily.
• PO (Children 2–<12 yr and 9–<11 kg actual body weight): 90 mg (one 40-mg pkt + one 50-mg pkt) twice daily.
• PO (Children 2–<12 yr and 7–<9 kg actual body weight): 70 mg (one 30-mg pkt + one 40-mg pkt) twice daily.
• PO (Children 18 mo-<2 yr and 21–<26 kg actual body weight): 180 mg (one 30-mg pkt + one 150-mg pkt) twice daily.
• PO (Children 12 mo-<2 yr and 16–<21 kg actual body weight): 140 mg (one 30-mg pkt + one 110-mg pkt) twice daily.
• PO (Children 11 mo-<2 yr and 13–<16 kg actual body weight): 140 mg (one 30-mg pkt + one 110-mg pkt) twice daily.
• PO (Children 10 mo-<11 mo and 13–<16 kg actual body weight): 100 mg (two 50-mg pkts) twice daily.
• PO (Children 18 mo-<2 yr and 11–<13 kg actual body weight): 110 mg (one 110-mg pkt) twice daily.
• PO (Children 8 mo-<18 mo and 11–<13 kg actual body weight): 100 mg (two 50-mg pkts) twice daily.
• PO (Children 11 mo–<2 yr and 9–<11 kg actual body weight): 90 mg (one 40-mg pkt + one 50-mg pkt) twice daily.
• PO (Children 6–<11 mo and 9–<11 kg actual body weight): 80 mg (two 40-mg pkts) twice daily.
• PO (Children 5–<6 mo and 9–<11 kg actual body weight): 60 mg (two 30-mg pkts) twice daily.
• PO (Children 9 mo-<2 yr and 7–<9 kg actual body weight): 70 mg (one 30-mg pkt + one 40-mg pkt) twice daily.
• PO (Children 4–<9 mo and 7–<9 kg actual body weight): 60 mg (two 30-mg pkts) twice daily.
• PO (Children 3–<4 mo and 7–<9 kg actual body weight): 50 mg (one 50-mg pkt) twice daily.
• PO (Children 5 mo–<2 yr and 5–<7 kg actual body weight): 50 mg (one 50-mg pkt) twice daily.
• PO (Children 3–<5 mo and 5–<7 kg actual body weight): 40 mg (one 40-mg pkt) twice daily.
• PO (Children 3–<10 mo and 4–<5 kg actual body weight): 40 mg (one 40-mg pkt) twice daily.
• PO (Children 3–<6 mo and 3–<4 kg actual body weight): 30 mg (one 30-mg pkt) twice daily.

Prevention of Deep Vein Thrombosis and Pulmonary Embolism Following Hip Replacement Surgery

• PO (Adults): Capsules: 110 mg taken 1–4 hr after surgery and once hemostasis achieved, then 220 mg once daily for 28–35 days; if unable to start on day of surgery, once hemostasis achieved, start with 220 mg once daily.

Pradaxa

• Acts as a direct inhibitor of thrombin.

• Reduced risk of thrombotic sequelae (stroke and systemic embolism) in nonvalvular AF.
• Reduced risk of recurrent PE and DVT.
• Resolution of DVT and PE.

Therapeutic Classification: anticoagulants

Pharmacologic Classification: thrombin inhibitors

Absorption: 3–7% absorbed following oral administration. Bioavailability of oral pellets higher than that of capsules in adults.

Distribution: Unknown.

Metabolism/Excretion: Of the amount absorbed, mostly excreted by kidneys (80%); 86% of ingested dose is eliminated in feces due to poor bioavailability.

Half-life: 12–17 hr.

(effects on coagulation)

†Following discontinuation, 3–5 days in renal impairment.

• Instruct patient to take dabigatran as directed. Take missed doses as soon as remembered within 6 hr. If <6 hr until next dose, skip dose and take next dose when scheduled; do not double doses. Do not discontinue without consulting health care professional. If temporarily discontinued, restart as soon as possible. Store dabigatran at room temperature. After opening bottle, use within 4 mo; discard unused dabigatran after 4 mo. Advise patient to read Medication Guide before starting therapy and with each Rx refill in case of changes.
• Inform patient that they may bleed more easily or longer than usual. Advise patient to notify health care professional immediately if signs of bleeding (unusual bruising; pink or brown urine; red or black, tarry stools; coughing up blood; vomiting blood; pain or swelling in a joint; headache; dizziness; weakness; recurring nose bleeds; unusual bleeding from gums; heavier than normal menstrual bleeding; dyspepsia; abdominal pain; epigastric pain) occur.
• Advise patient to notify health care professional of medication regimen prior to treatment or surgery.
• Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and consult health care professional before taking any new medications.
• May cause fetal harm. Advise females of reproductive potential to notify health care professional if pregnancy is planned or suspected and to avoid breastfeeding during therapy. May increase risk of bleeding in the fetus and neonate. Monitor neonates for bleeding. May increase risk of uterine bleeding; advise patient to notify health care professional if significant uterine bleeding occurs.

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