Drug reference

Dabigatran

Direct thrombin inhibitor (anticoagulant) · Antithrombotic

Also known as dabigatran etexilate

START

Verify indication, renal function (CrCl essential for dosing), check for active bleeding, review interacting drugs (P-gp inhibitors/inducers). Baseline CBC, creatinine. Capsules must be swallowed whole—do NOT open, crush, or chew.

TYPICAL MAX

150mg BID (AF/DVT). Dyspepsia can be reduced by taking with food. Do not open capsules (80% bioavailability increase if contents exposed).

STOP IF

Major bleeding, need for urgent surgery (stop 1-2 days before if CrCl ≥50; 3-5 days if CrCl <50), CrCl <15, severe hepatic impairment.

WATCH

Renal function at least annually (more frequently if elderly or CrCl <60). Bleeding signs. Idarucizumab (Praxbind) is the specific reversal agent—keep in mind for emergencies. P-gp inhibitors (ketoconazole, dronedarone, verapamil) increase levels. Dyspepsia is common—take with food or use PPI.

CDSCO approvedSchedule HATC B01AE07

Dose laddermg/d

Renal dose adjustmenteGFR mL/min/1.73m²

KDIGO 2024 + manufacturer label

Pharmacokineticsplasma · t hours

ONSET: 1h · Onset ~1 hour
PEAK: 2h · Tmax 1-3 hours
t½: 14h · t½ ~12-17h (normal); up to 28h (renal impairment)
DURATION: 12h · 12 hours (BID)

EXCRETION

Renal unchanged (~80%)

route + CYP

INTERACTIONS

6 major

incl. contraindicated

PREGNANCY

Limited data; avoid in pregnancy unless benefit clearly outweighs risk. Prodrug etexilate is teratogenic in animals.

FDA category + note

Top interactionssee all 12 →

Other AnticoagulantsContraindicatedDatabaseKimi deep-research + Cla
ItraconazoleSevereTextbookG&G 14e · p1592
Antiplatelets + NsaidsSevereDatabaseKimi deep-research + Cla
P Gp InducersSevereDatabaseKimi deep-research + Cla

Available in India

70 branded formulations. Look up specific brands in the Drugs workspace.

Mechanism

Reversibly binds to the active site of both free and clot-bound thrombin, inhibiting thrombin-catalyzed reactions including fibrin formation, activation of factors V, VIII, and XI, and platelet aggregation. Direct inhibition of the final common pathway of coagulation.

Indications

Stroke prevention in non-valvular atrial fibrillationTreatment and secondary prevention of DVT and PEPrimary prevention of VTE after hip or knee replacement surgeryPrevention of recurrent VTE

Dosing

Adult: AF: 150mg PO BID (CrCl >30); 75mg BID (CrCl 15-30—US only; not approved in EU). DVT/PE treatment: 150mg BID after 5-10 days of parenteral anticoagulation. VTE prophylaxis (hip/knee): 110mg 1-4h post-surgery then 220mg daily x 28-35 days (EU dosing); OR 75mg BID (US dosing).
Pediatric: ≥8 years (EU): weight-based dosing for VTE treatment and prevention.
Renal adjustment: AF: CrCl >30: 150mg BID; CrCl 15-30: 75mg BID (US); CrCl <15: avoid. DVT/PE: CrCl >30: 150mg BID; CrCl ≤30: avoid or use 75mg BID (US).
Hepatic adjustment: Severe: contraindicated. Moderate: use caution.
Geriatric: No specific adjustment; increased bleeding risk with age and renal decline.
Max dose: 300mg/day (150mg BID); 220mg/day (VTE prophylaxis)

Pharmacokinetics

Onset

Peak anticoagulant effect within 2-3 hours

Peak effect

Tmax 1-3 hours (fasted); 2-4 hours (with food); steady-state in 2-3 days

Duration

12-24 hours (BID or daily dosing)

Half-life

~12-17 hours (CrCl >50); up to 28 hours (CrCl 15-30)

Bioavailability

~6.5% (dabigatran etexilate is a prodrug; converted by esterases in liver/plasma to active dabigatran)

Protein binding

~35%

Metabolism

Dabigatran etexilate (prodrug) converted by plasma/carboxylesterases to active dabigatran; minimal further metabolism (conjugation only)

Excretion

~80% renal (unchanged); remainder fecal

Contraindications

Active major bleeding
Severe hepatic impairment (Child-Pugh C) or hepatic disease expected to affect survival
Lesion or condition with significant bleeding risk (e.g., recent GI ulcer, intracranial hemorrhage)
Concomitant strong P-gp inhibitors in patients with renal impairment (CrCl <30)
Mechanical prosthetic heart valves (RE-ALIGN trial showed harm)
Hypersensitivity to dabigatran

Side effects

Common

Bleeding (any site—most common)Dyspepsia / abdominal pain (~10-15%)NauseaDiarrheaUpper respiratory infection

Serious

Major bleeding (GI, intracranial)
Life-threatening bleeding
Epidural/spinal hematoma (with neuraxial anesthesia)
Anaphylaxis
Angioedema (rare)
Drug-induced hepatitis (rare)

Pregnancy & lactation

Pregnancy

Limited data; avoid in pregnancy unless benefit clearly outweighs risk. Prodrug etexilate is teratogenic in animals.

Lactation

Excretion in breast milk unknown; not recommended during breastfeeding.

Drug interactions

Other Anticoagulants

Contraindicated

Database

No additional benefit; substantially increased bleeding risk.

Do not combine. Transition with appropriate overlap.

Source: Kimi deep-research + Cla

Itraconazole

Severe

Textbook

dabigatran AUC increased 6.9-fold.

coadministration generally contraindicate[d] or at least require[s] dosage adjustment.

Source: G&G 14e · p1592

Antiplatelets + Nsaids

Severe

Database

Additive bleeding risk; triple therapy markedly increases GI and intracranial bleeding.

Avoid triple therapy if possible; use PPI gastroprotection; minimize NSAID use.

Source: Kimi deep-research + Cla

P Gp Inducers

Severe

Database

Reduces dabigatran exposure by 50-70%, increasing thrombosis risk.

Avoid combination; use alternative anticoagulant if these drugs are essential.

Source: Kimi deep-research + Cla

P Gp Inhibitors

Severe

Database

Increases dabigatran levels by 50-150%, significantly increasing bleeding risk.

Avoid dronedarone. Reduce dabigatran dose if verapamil used. Monitor for bleeding.

Source: Kimi deep-research + Cla

Verapamil

Severe

Database

Increased plasma dabigatran concentrations.