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Praxbind

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Overview

What is Praxbind?

Idarucizumab is a humanized monoclonal antibody fragment (Fab) derived from an IgG1 isotype molecule, whose target is the direct thrombin inhibitor dabigatran. Using recombinant expression technology, idarucizumab is produced in a well characterized recombinant (mammalian) CHO cell line and is purified using standard technology. Idarucizumab is composed of a light chain of 219 amino acids and a heavy chain fragment of 225 amino acids, covalently linked together by one disulfide bond between cysteine 225 of the heavy chain fragment and cysteine 219 of the light chain, and has an estimated molecular mass of approximately 47,766 Daltons.

PRAXBIND (idarucizumab) is a sterile, preservative-free, colorless to slightly yellow, clear to slightly opalescent solution for intravenous administration. PRAXBIND (idarucizumab) is supplied in 2 single-dose vials, each containing 2.5 g of idarucizumab in 50 mL formulated as a buffered, isotonic, solution containing acetic acid glacial (10.05 mg), polysorbate 20 (10 mg), sodium acetate trihydrate (147.35 mg), sorbitol (2004.20 mg), and water for injection with an osmolality of 270-330 mOsm/kg and a pH of 5.3-5.7.



What does Praxbind look like?



What are the available doses of Praxbind?

Injection: 2.5 g/50 mL solution in a single-dose vial ()

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

How should I use Praxbind?

PRAXBIND is indicated in patients treated with Pradaxa when reversal of the anticoagulant effects of dabigatran is needed:

The recommended dose of PRAXBIND is 5 g, provided as two separate vials each containing 2.5 g/50 mL idarucizumab (see Figure 1).

For intravenous use only.

There is limited data to support administration of an additional 5 g of PRAXBIND


What interacts with Praxbind?

Sorry No Records found


What are the warnings of Praxbind?

Sorry No Records found


What are the precautions of Praxbind?

Sorry No Records found


What are the side effects of Praxbind?

Sorry No records found


What should I look out for while using Praxbind?

None.


What might happen if I take too much Praxbind?

Sorry No Records found


How should I store and handle Praxbind?

Store between 2-8°C (36°-46°F).Cyproheptadine Hydrochloride Tablets USP, 4 mg are available as white to off white, round, flat faced, bevelled edged tablets debossed "C4" on  one side and score on the other side, containing 4 mg of cyproheptadine HCl packaged in Bottles of 100 tablets with NDC code - NDC 64380-795-06, Bottles of 1000 tablets with NDC code - NDC 64380-795-08PHARMACIST: Dispense in a well-closed container as defined in the USP, with a child-resistant closure (as required).Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Manufactured By:Strides Shasun LimitedBengaluru, India.Distributed by: Strides Pharma Inc. East Brunswick, NJ 08816Issued: 01/2017Cyproheptadine Hydrochloride Tablets USP, 4 mg are available as white to off white, round, flat faced, bevelled edged tablets debossed "C4" on  one side and score on the other side, containing 4 mg of cyproheptadine HCl packaged in Bottles of 100 tablets with NDC code - NDC 64380-795-06, Bottles of 1000 tablets with NDC code - NDC 64380-795-08PHARMACIST: Dispense in a well-closed container as defined in the USP, with a child-resistant closure (as required).Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Manufactured By:Strides Shasun LimitedBengaluru, India.Distributed by: Strides Pharma Inc. East Brunswick, NJ 08816Issued: 01/2017Cyproheptadine Hydrochloride Tablets USP, 4 mg are available as white to off white, round, flat faced, bevelled edged tablets debossed "C4" on  one side and score on the other side, containing 4 mg of cyproheptadine HCl packaged in Bottles of 100 tablets with NDC code - NDC 64380-795-06, Bottles of 1000 tablets with NDC code - NDC 64380-795-08PHARMACIST: Dispense in a well-closed container as defined in the USP, with a child-resistant closure (as required).Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Manufactured By:Strides Shasun LimitedBengaluru, India.Distributed by: Strides Pharma Inc. East Brunswick, NJ 08816Issued: 01/2017Cyproheptadine Hydrochloride Tablets USP, 4 mg are available as white to off white, round, flat faced, bevelled edged tablets debossed "C4" on  one side and score on the other side, containing 4 mg of cyproheptadine HCl packaged in Bottles of 100 tablets with NDC code - NDC 64380-795-06, Bottles of 1000 tablets with NDC code - NDC 64380-795-08PHARMACIST: Dispense in a well-closed container as defined in the USP, with a child-resistant closure (as required).Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Manufactured By:Strides Shasun LimitedBengaluru, India.Distributed by: Strides Pharma Inc. East Brunswick, NJ 08816Issued: 01/2017Cyproheptadine Hydrochloride Tablets USP, 4 mg are available as white to off white, round, flat faced, bevelled edged tablets debossed "C4" on  one side and score on the other side, containing 4 mg of cyproheptadine HCl packaged in Bottles of 100 tablets with NDC code - NDC 64380-795-06, Bottles of 1000 tablets with NDC code - NDC 64380-795-08PHARMACIST: Dispense in a well-closed container as defined in the USP, with a child-resistant closure (as required).Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Manufactured By:Strides Shasun LimitedBengaluru, India.Distributed by: Strides Pharma Inc. East Brunswick, NJ 08816Issued: 01/2017Cyproheptadine Hydrochloride Tablets USP, 4 mg are available as white to off white, round, flat faced, bevelled edged tablets debossed "C4" on  one side and score on the other side, containing 4 mg of cyproheptadine HCl packaged in Bottles of 100 tablets with NDC code - NDC 64380-795-06, Bottles of 1000 tablets with NDC code - NDC 64380-795-08PHARMACIST: Dispense in a well-closed container as defined in the USP, with a child-resistant closure (as required).Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Manufactured By:Strides Shasun LimitedBengaluru, India.Distributed by: Strides Pharma Inc. East Brunswick, NJ 08816Issued: 01/2017Cyproheptadine Hydrochloride Tablets USP, 4 mg are available as white to off white, round, flat faced, bevelled edged tablets debossed "C4" on  one side and score on the other side, containing 4 mg of cyproheptadine HCl packaged in Bottles of 100 tablets with NDC code - NDC 64380-795-06, Bottles of 1000 tablets with NDC code - NDC 64380-795-08PHARMACIST: Dispense in a well-closed container as defined in the USP, with a child-resistant closure (as required).Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Manufactured By:Strides Shasun LimitedBengaluru, India.Distributed by: Strides Pharma Inc. East Brunswick, NJ 08816Issued: 01/2017Cyproheptadine Hydrochloride Tablets USP, 4 mg are available as white to off white, round, flat faced, bevelled edged tablets debossed "C4" on  one side and score on the other side, containing 4 mg of cyproheptadine HCl packaged in Bottles of 100 tablets with NDC code - NDC 64380-795-06, Bottles of 1000 tablets with NDC code - NDC 64380-795-08PHARMACIST: Dispense in a well-closed container as defined in the USP, with a child-resistant closure (as required).Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Manufactured By:Strides Shasun LimitedBengaluru, India.Distributed by: Strides Pharma Inc. East Brunswick, NJ 08816Issued: 01/2017Cyproheptadine Hydrochloride Tablets USP, 4 mg are available as white to off white, round, flat faced, bevelled edged tablets debossed "C4" on  one side and score on the other side, containing 4 mg of cyproheptadine HCl packaged in Bottles of 100 tablets with NDC code - NDC 64380-795-06, Bottles of 1000 tablets with NDC code - NDC 64380-795-08PHARMACIST: Dispense in a well-closed container as defined in the USP, with a child-resistant closure (as required).Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Manufactured By:Strides Shasun LimitedBengaluru, India.Distributed by: Strides Pharma Inc. East Brunswick, NJ 08816Issued: 01/2017Cyproheptadine Hydrochloride Tablets USP, 4 mg are available as white to off white, round, flat faced, bevelled edged tablets debossed "C4" on  one side and score on the other side, containing 4 mg of cyproheptadine HCl packaged in Bottles of 100 tablets with NDC code - NDC 64380-795-06, Bottles of 1000 tablets with NDC code - NDC 64380-795-08PHARMACIST: Dispense in a well-closed container as defined in the USP, with a child-resistant closure (as required).Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Manufactured By:Strides Shasun LimitedBengaluru, India.Distributed by: Strides Pharma Inc. East Brunswick, NJ 08816Issued: 01/2017Cyproheptadine Hydrochloride Tablets USP, 4 mg are available as white to off white, round, flat faced, bevelled edged tablets debossed "C4" on  one side and score on the other side, containing 4 mg of cyproheptadine HCl packaged in Bottles of 100 tablets with NDC code - NDC 64380-795-06, Bottles of 1000 tablets with NDC code - NDC 64380-795-08PHARMACIST: Dispense in a well-closed container as defined in the USP, with a child-resistant closure (as required).Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Manufactured By:Strides Shasun LimitedBengaluru, India.Distributed by: Strides Pharma Inc. East Brunswick, NJ 08816Issued: 01/2017Cyproheptadine Hydrochloride Tablets USP, 4 mg are available as white to off white, round, flat faced, bevelled edged tablets debossed "C4" on  one side and score on the other side, containing 4 mg of cyproheptadine HCl packaged in Bottles of 100 tablets with NDC code - NDC 64380-795-06, Bottles of 1000 tablets with NDC code - NDC 64380-795-08PHARMACIST: Dispense in a well-closed container as defined in the USP, with a child-resistant closure (as required).Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Manufactured By:Strides Shasun LimitedBengaluru, India.Distributed by: Strides Pharma Inc. East Brunswick, NJ 08816Issued: 01/2017


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Clinical Information

Chemical Structure

No Image found
Clinical Pharmacology

Idarucizumab is a specific reversal agent for dabigatran. It is a humanized monoclonal antibody fragment (Fab) that binds to dabigatran and its acylglucuronide metabolites with higher affinity than the binding affinity of dabigatran to thrombin, neutralizing their anticoagulant effect.

Non-Clinical Toxicology
None.

Increased nephrotoxicity has been reported following concomitant administration of cephalosporins and aminoglycoside antibiotics.

Patients being treated with dabigatran therapy have underlying disease states that predispose them to thromboembolic events. Reversing dabigatran therapy exposes patients to the thrombotic risk of their underlying disease. To reduce this risk, resumption of anticoagulant therapy should be considered as soon as medically appropriate

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

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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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Professional

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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