DOSAGE AND ADMINISTRATION
Recommended Dose
|
Indication
|
Dosage
|
|
Reduction in Risk of Stroke and Systemic Embolism in Non-valvular
AF
|
CrCl >30 mL/min:
|
150 mg twice daily
|
CrCl 15 to 30 mL/min:
|
75 mg twice daily
|
CrCl <15 mL/min or on
dialysis:
|
Dosing recommendations
cannot be provided
|
CrCl 30 to 50 mL/min with concomitant
use of P-gp inhibitors:
|
Consider reducing dose
to 75 mg twice daily if given with P-gp inhibitors dronedarone or
ketoconazole. Dose adjustment is not necessary when co-administered
with other P-gp inhibitors
|
CrCl <30 mL/min with
concomitant use of P-gp inhibitors:
|
Avoid co-administration
|
Treatment of DVT and PE
Reduction in
the Risk of Recurrence of DVT and PE
|
CrCl >30 mL/min:
|
150 mg twice daily
|
CrCl <30 mL/min or on
dialysis:
|
Dosing recommendations
cannot be provided
|
CrCl <50 mL/min with
concomitant use of P-gp inhibitors:
|
Avoid co-administration
|
Reduction of Risk of Stroke and Systemic Embolism in Non-valvular
Atrial Fibrillation
For patients with creatinine clearance (CrCl)
>30 mL/min, the recommended dose of PRADAXA is 150 mg taken orally,
twice daily. For patients with severe renal impairment (CrCl 15-30
mL/min), the recommended dose of PRADAXA is 75 mg twice daily [see Use in Specific Populations and Clinical Pharmacology ]. Dosing recommendations for patients with a CrCl <15
mL/min or on dialysis cannot be provided.
Treatment
and Reduction in the Risk of Recurrence of Deep Venous Thrombosis
and Pulmonary Embolism
For patients
with CrCl >30 mL/min, the recommended dose of PRADAXA is 150 mg taken
orally, twice daily, after 5-10 days of parenteral anticoagulation.
Dosing recommendations for patients with a CrCl <30 mL/min or
on dialysis cannot be provided [see Use in Specific Populations and Clinical Pharmacology ].
Dosing Adjustments
Assess renal function prior to initiation
of treatment with PRADAXA. Periodically assess renal function as
clinically indicated (i.e., more frequently in clinical situations
that may be associated with a decline in renal function) and adjust
therapy accordingly. Discontinue PRADAXA in patients who develop
acute renal failure while on PRADAXA and consider alternative anticoagulant
therapy.
Generally, the extent
of anticoagulation does not need to be assessed. When necessary, use
aPTT or ECT, and not INR, to assess for anticoagulant activity in
patients on PRADAXA [see Warnings and Precautions and Clinical Pharmacology ].
Reduction of Risk
of Stroke and Systemic Embolism in Non-valvular Atrial Fibrillation
In patients with moderate renal impairment
(CrCl 30-50 mL/min), concomitant use of the P-gp inhibitor dronedarone
or systemic ketoconazole can be expected to produce dabigatran exposure
similar to that observed in severe renal impairment. Consider reducing
the dose of PRADAXA to 75 mg twice daily [see Warnings and
Precautions , Drug Interactions and Clinical Pharmacology ].
Treatment
and Reduction in the Risk of Recurrence of Deep Venous Thrombosis
and Pulmonary Embolism
Dosing recommendations
for patients with CrCl <30 mL/min cannot be provided. Avoid use
of concomitant P-gp inhibitors in patients with CrCl <50 mL/min [see Warnings and Precautions , Drug Interactions and Clinical
Pharmacology ].
Instructions toPatients
Instruct patients to swallow the capsules whole. PRADAXA should
be taken with a full glass of water. Breaking, chewing, or emptying
the contents of the capsule can result in increased exposure
[see Clinical Pharmacology ]
.
If a dose of PRADAXA is not taken at the scheduled time,
the dose should be taken as soon as possible on the same day; the
missed dose should be skipped if it cannot be taken at least 6 hours
before the next scheduled dose. The dose of PRADAXA should not be
doubled to make up for a missed dose.
Converting fromor to Warfarin
When converting
patients from warfarin therapy to PRADAXA, discontinue warfarin and
start PRADAXA when the INR is below 2.0.
When converting from PRADAXA to warfarin, adjust the
starting time of warfarin based on creatinine clearance as follows:
- For CrCl ≥50 mL/min, start warfarin 3 days before discontinuing
PRADAXA.
- For CrCl 30-50 mL/min, start warfarin 2 days before discontinuing
PRADAXA.
- For CrCl 15-30 mL/min, start warfarin 1 day before discontinuing
PRADAXA.
- For CrCl <15 mL/min, no recommendations can be made.
Because PRADAXA can increase INR,
the INR will better reflect warfarin’s effect only after PRADAXA has
been stopped for at least 2 days
[see Clinical Pharmacology ]
.
Converting fromor to Parenteral Anticoagulants
For patients currently receiving a parenteral anticoagulant,
start PRADAXA 0 to 2 hours before the time that the next dose of the
parenteral drug was to have been administered or at the time of discontinuation
of a continuously administered parenteral drug (e.g., intravenous
unfractionated heparin).
For patients
currently taking PRADAXA, wait 12 hours (CrCl ≥30 mL/min) or 24 hours
(CrCl <30 mL/min) after the last dose of PRADAXA before initiating
treatment with a parenteral anticoagulant
[see Clinical
Pharmacology ]
.
Discontinuation for Surgery and Other Interventions
If possible, discontinue PRADAXA 1 to 2
days (CrCl ≥50 mL/min) or 3 to 5 days (CrCl <50 mL/min) before
invasive or surgical procedures because of the increased risk of bleeding.
Consider longer times for patients undergoing major surgery, spinal
puncture, or placement of a spinal or epidural catheter or port, in
whom complete hemostasis may be required
[see Use
in Specific Populations and
Clinical Pharmacology ]
.
If surgery cannot
be delayed, there is an increased risk of bleeding
[see Warnings and Precautions ]
. This risk of bleeding should be weighed against
the urgency of intervention
[see Warnings and Precautions (5.1, 5.3) ]
.
DOSAGE FORMS ANDSTRENGTHS
150 mg capsules
with a light blue opaque cap imprinted in black with the Boehringer
Ingelheim company symbol and a cream-colored opaque body imprinted
in black with "R150".
75 mg capsules
with a cream-colored opaque cap imprinted in black with the Boehringer
Ingelheim company symbol and a cream-colored opaque body imprinted
in black with "R75".
|
