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Pradaxa

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Overview

What is Pradaxa?

The chemical name for dabigatran etexilate mesylate, a direct thrombin inhibitor, is β-Alanine, N-[[2-[[[4-[[[(hexyloxy)carbonyl]amino]iminomethyl]phenyl]amino]methyl]-1-methyl-1H-benzimidazol-5-yl]carbonyl]-N-2-pyridinyl-,ethyl ester, methanesulfonate. The empirical formula is CHNO⋅ CHOS and the molecular weight is 723.86 (mesylate salt), 627.75 (free base). The structural formula is:

Dabigatran etexilate mesylate is a yellow-white to yellow powder. A saturated solution in pure water has a solubility of 1.8 mg/mL. It is freely soluble in methanol, slightly soluble in ethanol, and sparingly soluble in isopropanol.

PRADAXA capsules are supplied in 75, 110, and 150 mg strengths for oral administration. Each capsule contains dabigatran etexilate mesylate as the active ingredient: 172.95 mg dabigatran etexilate mesylate (equivalent to 150 mg dabigatran etexilate), 126.83 mg dabigatran etexilate mesylate (equivalent to 110 mg dabigatran etexilate), or 86.48 mg dabigatran etexilate mesylate (equivalent to 75 mg dabigatran etexilate) along with the following inactive ingredients: acacia, dimethicone, hypromellose, hydroxypropyl cellulose, talc, and tartaric acid. The capsule shell is composed of carrageenan, hypromellose, potassium chloride, titanium dioxide, black edible ink, and FD&C Blue No. 2 (150 mg and 110 mg capsules only).



What does Pradaxa look like?



What are the available doses of Pradaxa?

Capsules: 75 mg, 110 mg and 150 mg

What should I talk to my health care provider before I take Pradaxa?

Lactation: Breastfeeding not recommended. ()Geriatric use: Risk of bleeding increases with age ()

How should I use Pradaxa?

PRADAXA is indicated to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation.

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 Dosing recommendations for patients with a CrCl <15 mL/min or on dialysis cannot be provided.

Treatment 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

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 previous treatment. Dosing recommendations for patients with a CrCl ≤30 mL/min or on dialysis cannot be provided

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

For patients with CrCl >30 mL/min, the recommended dose of PRADAXA is 110 mg taken orally 1-4 hours after surgery and after hemostasis has been achieved, then 220 mg taken once daily for 28-35 days. If PRADAXA is not started on the day of surgery, after hemostasis has been achieved initiate treatment with 220 mg once daily. Dosing recommendations for patients with a CrCl ≤30 mL/min or on dialysis cannot be provided .


What interacts with Pradaxa?

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What are the warnings of Pradaxa?

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What are the precautions of Pradaxa?

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What are the side effects of Pradaxa?

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What should I look out for while using Pradaxa?

PRADAXA is contraindicated in patients with:

(A) PREMATURE DISCONTINUATION OF PRADAXA INCREASES THE RISK OF THROMBOTIC EVENTSPremature discontinuation of any oral anticoagulant, including PRADAXA, increases the risk of thrombotic events. If anticoagulation with PRADAXA is discontinued for a reason other than pathological bleeding or completion of a course of therapy, consider coverage with another anticoagulant .

(B) SPINAL/EPIDURAL HEMATOMAEpidural or spinal hematomas may occur in patients treated with PRADAXA who are receiving neuraxial anesthesia or undergoing spinal puncture. These hematomas may result in long-term or permanent paralysis. Consider these risks when scheduling patients for spinal procedures. Factors that can increase the risk of developing epidural or spinal hematomas in these patients include:

 • use of indwelling epidural catheters • concomitant use of other drugs that affect hemostasis, such as non-steroidal anti-inflammatory drugs (NSAIDs), platelet inhibitors, other anticoagulants • a history of traumatic or repeated epidural or spinal punctures • a history of spinal deformity or spinal surgery • optimal timing between the administration of PRADAXA and neuraxial procedures is not known .

Monitor patients frequently for signs and symptoms of neurological impairment. If neurological compromise is noted, urgent treatment is necessary . Consider the benefits and risks before neuraxial intervention in patients anticoagulated or to be anticoagulated .


What might happen if I take too much Pradaxa?

Accidental overdose may lead to hemorrhagic complications. In the event of hemorrhagic complications, initiate appropriate clinical support, discontinue treatment with PRADAXA, and investigate the source of bleeding. A specific reversal agent (idarucizumab) is available.

Dabigatran is primarily eliminated by the kidneys with a low plasma protein binding of approximately 35%. Hemodialysis can remove dabigatran; however, data supporting this approach are limited. Using a high-flux dialyzer, blood flow rate of 200 mL/min, and dialysate flow rate of 700 mL/min, approximately 49% of total dabigatran can be cleared from plasma over 4 hours. At the same dialysate flow rate, approximately 57% can be cleared using a dialyzer blood flow rate of 300 mL/min, with no appreciable increase in clearance observed at higher blood flow rates. Upon cessation of hemodialysis, a redistribution effect of approximately 7% to 15% is seen. The effect of dialysis on dabigatran’s plasma concentration would be expected to vary based on patient specific characteristics. Measurement of aPTT or ECT may help guide therapy


How should I store and handle Pradaxa?

Store at 20º to 25ºC (68º to 77ºF); excursions permitted to 15º to 30ºC (59º to 86ºF) [see USP Controlled Room Temperature].PRADAXA 75 mg capsules have a white opaque cap imprinted with the Boehringer Ingelheim company symbol and a white opaque body imprinted with “R75”. The color of the imprinting is black. The capsules are supplied in the packages listed:PRADAXA 110 mg capsules have a light blue opaque cap imprinted with the Boehringer Ingelheim company symbol and a light blue opaque body imprinted with “R110”. The color of the imprinting is black. The capsules are supplied in the packages listed:PRADAXA 150 mg capsules have a light blue opaque cap imprinted with the Boehringer Ingelheim company symbol and a white opaque body imprinted with “R150”. The color of the imprinting is black. The capsules are supplied in the packages listed:Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Once opened, the product must be used within 4 months. Keep the bottle tightly closed. Store in the original package to protect from moisture.BlistersStore at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Store in the original package to protect from moisture.Keep out of the reach of children.PRADAXA 75 mg capsules have a white opaque cap imprinted with the Boehringer Ingelheim company symbol and a white opaque body imprinted with “R75”. The color of the imprinting is black. The capsules are supplied in the packages listed:PRADAXA 110 mg capsules have a light blue opaque cap imprinted with the Boehringer Ingelheim company symbol and a light blue opaque body imprinted with “R110”. The color of the imprinting is black. The capsules are supplied in the packages listed:PRADAXA 150 mg capsules have a light blue opaque cap imprinted with the Boehringer Ingelheim company symbol and a white opaque body imprinted with “R150”. The color of the imprinting is black. The capsules are supplied in the packages listed:Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Once opened, the product must be used within 4 months. Keep the bottle tightly closed. Store in the original package to protect from moisture.BlistersStore at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Store in the original package to protect from moisture.Keep out of the reach of children.PRADAXA 75 mg capsules have a white opaque cap imprinted with the Boehringer Ingelheim company symbol and a white opaque body imprinted with “R75”. The color of the imprinting is black. The capsules are supplied in the packages listed:PRADAXA 110 mg capsules have a light blue opaque cap imprinted with the Boehringer Ingelheim company symbol and a light blue opaque body imprinted with “R110”. The color of the imprinting is black. The capsules are supplied in the packages listed:PRADAXA 150 mg capsules have a light blue opaque cap imprinted with the Boehringer Ingelheim company symbol and a white opaque body imprinted with “R150”. The color of the imprinting is black. The capsules are supplied in the packages listed:Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Once opened, the product must be used within 4 months. Keep the bottle tightly closed. Store in the original package to protect from moisture.BlistersStore at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Store in the original package to protect from moisture.Keep out of the reach of children.PRADAXA 75 mg capsules have a white opaque cap imprinted with the Boehringer Ingelheim company symbol and a white opaque body imprinted with “R75”. The color of the imprinting is black. The capsules are supplied in the packages listed:PRADAXA 110 mg capsules have a light blue opaque cap imprinted with the Boehringer Ingelheim company symbol and a light blue opaque body imprinted with “R110”. The color of the imprinting is black. The capsules are supplied in the packages listed:PRADAXA 150 mg capsules have a light blue opaque cap imprinted with the Boehringer Ingelheim company symbol and a white opaque body imprinted with “R150”. The color of the imprinting is black. The capsules are supplied in the packages listed:Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Once opened, the product must be used within 4 months. Keep the bottle tightly closed. Store in the original package to protect from moisture.BlistersStore at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Store in the original package to protect from moisture.Keep out of the reach of children.PRADAXA 75 mg capsules have a white opaque cap imprinted with the Boehringer Ingelheim company symbol and a white opaque body imprinted with “R75”. The color of the imprinting is black. The capsules are supplied in the packages listed:PRADAXA 110 mg capsules have a light blue opaque cap imprinted with the Boehringer Ingelheim company symbol and a light blue opaque body imprinted with “R110”. The color of the imprinting is black. The capsules are supplied in the packages listed:PRADAXA 150 mg capsules have a light blue opaque cap imprinted with the Boehringer Ingelheim company symbol and a white opaque body imprinted with “R150”. The color of the imprinting is black. The capsules are supplied in the packages listed:Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Once opened, the product must be used within 4 months. Keep the bottle tightly closed. Store in the original package to protect from moisture.BlistersStore at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Store in the original package to protect from moisture.Keep out of the reach of children.PRADAXA 75 mg capsules have a white opaque cap imprinted with the Boehringer Ingelheim company symbol and a white opaque body imprinted with “R75”. The color of the imprinting is black. The capsules are supplied in the packages listed:PRADAXA 110 mg capsules have a light blue opaque cap imprinted with the Boehringer Ingelheim company symbol and a light blue opaque body imprinted with “R110”. The color of the imprinting is black. The capsules are supplied in the packages listed:PRADAXA 150 mg capsules have a light blue opaque cap imprinted with the Boehringer Ingelheim company symbol and a white opaque body imprinted with “R150”. The color of the imprinting is black. The capsules are supplied in the packages listed:Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Once opened, the product must be used within 4 months. Keep the bottle tightly closed. Store in the original package to protect from moisture.BlistersStore at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Store in the original package to protect from moisture.Keep out of the reach of children.PRADAXA 75 mg capsules have a white opaque cap imprinted with the Boehringer Ingelheim company symbol and a white opaque body imprinted with “R75”. The color of the imprinting is black. The capsules are supplied in the packages listed:PRADAXA 110 mg capsules have a light blue opaque cap imprinted with the Boehringer Ingelheim company symbol and a light blue opaque body imprinted with “R110”. The color of the imprinting is black. The capsules are supplied in the packages listed:PRADAXA 150 mg capsules have a light blue opaque cap imprinted with the Boehringer Ingelheim company symbol and a white opaque body imprinted with “R150”. The color of the imprinting is black. The capsules are supplied in the packages listed:Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Once opened, the product must be used within 4 months. Keep the bottle tightly closed. Store in the original package to protect from moisture.BlistersStore at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Store in the original package to protect from moisture.Keep out of the reach of children.


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Clinical Information

Chemical Structure

No Image found
Clinical Pharmacology

Dabigatran and its acyl glucuronides are competitive, direct thrombin inhibitors. Because thrombin (serine protease) enables the conversion of fibrinogen into fibrin during the coagulation cascade, its inhibition prevents the development of a thrombus. Both free and clot-bound thrombin, and thrombin-induced platelet aggregation are inhibited by the active moieties.

Non-Clinical Toxicology
PRADAXA is contraindicated in patients with:

(A) PREMATURE DISCONTINUATION OF PRADAXA INCREASES THE RISK OF THROMBOTIC EVENTSPremature discontinuation of any oral anticoagulant, including PRADAXA, increases the risk of thrombotic events. If anticoagulation with PRADAXA is discontinued for a reason other than pathological bleeding or completion of a course of therapy, consider coverage with another anticoagulant .

(B) SPINAL/EPIDURAL HEMATOMAEpidural or spinal hematomas may occur in patients treated with PRADAXA who are receiving neuraxial anesthesia or undergoing spinal puncture. These hematomas may result in long-term or permanent paralysis. Consider these risks when scheduling patients for spinal procedures. Factors that can increase the risk of developing epidural or spinal hematomas in these patients include:

 • use of indwelling epidural catheters • concomitant use of other drugs that affect hemostasis, such as non-steroidal anti-inflammatory drugs (NSAIDs), platelet inhibitors, other anticoagulants • a history of traumatic or repeated epidural or spinal punctures • a history of spinal deformity or spinal surgery • optimal timing between the administration of PRADAXA and neuraxial procedures is not known .

Monitor patients frequently for signs and symptoms of neurological impairment. If neurological compromise is noted, urgent treatment is necessary . Consider the benefits and risks before neuraxial intervention in patients anticoagulated or to be anticoagulated .

The sedative effects of metaxalone and other CNS depressants (e.g., alcohol, alcohol, benzodiazepines, opioids, tricyclic antidepressants) may be additive. Therefore, caution should be exercised with patients who take more than one of these CNS depressants simultaneously.

Premature discontinuation of any oral anticoagulant, including PRADAXA, in the absence of adequate alternative anticoagulation increases the risk of thrombotic events. If PRADAXA is discontinued for a reason other than pathological bleeding or completion of a course of therapy, consider coverage with another anticoagulant and restart PRADAXA as soon as medically appropriate

The following serious adverse reactions are described elsewhere in the labeling:

The most serious adverse reactions reported with PRADAXA were related to bleeding .

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Interactions

Interactions

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