Bivalirudin in 0.9% Sodium Chloride

×

Overview

What is Bivalirudin in 0.9% Sodium Chloride?

Bivalirudin Injection contains bivalirudin which is a specific and reversible direct thrombin inhibitor. Bivalirudin is a synthetic, 20 amino acid peptide, with the chemical name of D-phenylalanyl-L-prolyl-L-arginyl-L-prolyl-glycyl-glycyl-glycyl-glycyl-L-asparagyl-glycyl-L-aspartyl-L-phenylalanyl-L-glutamyl-L-glutamyl-L-isoleucyl-L-prolyl-L-glutamyl-L-glutamyl-L-tyrosyl-L-leucine (Figure 1). The molecular weight of bivalirudin is 2180 daltons (anhydrous free base peptide). The active pharmaceutical ingredient is in the form of bivalirudin trifluoroacetate as a white to off-white powder.

Bivalirudin Injection is supplied as a frozen, premixed, iso-osmotic, sterile, nonpyrogenic 50 mL or 100 mL solution containing 250 mg or 500 mg respectively as bivalirudin (equivalent to an average of 275 or 550 mg bivalirudin trifluoroacetate*) in the GALAXY single-dose container (PL 2040 Plastic). Sodium Chloride, USP has been added to adjust osmolality (0.9 g/100 mL).

The approximate osmolality for Bivalirudin Injection is 300 mOsmol/kg.

The pH of Bivalirudin Injection may have been adjusted with sodium hydroxide and/or hydrochloric acid to 5.2 to 6.0. The solution is intended for intravenous use at room temperature.

*The range of bivalirudin trifluoroacetate is 270 to 280 mg (250 mg strength) or 540 to 560 mg (500 mg strength) based on a range of trifluoroacetic acid composition of 1.7 to 2.6 equivalents.

What does Bivalirudin in 0.9% Sodium Chloride look like?

What are the available doses of Bivalirudin in 0.9% Sodium Chloride?

Injection, clear and colorless solution:

What should I talk to my health care provider before I take Bivalirudin in 0.9% Sodium Chloride?

Geriatric patients

Renal impairment

How should I use Bivalirudin in 0.9% Sodium Chloride?

Bivalirudin Injection is an anticoagulant for use in patients undergoing percutaneous coronary intervention (PCI).

The recommended dose of Bivalirudin Injection is an intravenous bolus dose of 0.75 mg/kg, followed immediately by a maintenance infusion of 1.75 mg/kg/h for the duration of the procedure. Five minutes after the bolus dose has been administered, an activated clotting time (ACT) should be performed and an additional bolus of 0.3 mg/kg should be given if needed.

Consider extending duration of infusion following PCI at 1.75 mg/kg/h for up to 4 hours post-procedure in patients with ST segment elevation MI (STEMI).

What interacts with Bivalirudin in 0.9% Sodium Chloride?

Sorry No Records found

What are the warnings of Bivalirudin in 0.9% Sodium Chloride?

Sorry No Records found

What are the precautions of Bivalirudin in 0.9% Sodium Chloride?

Sorry No Records found

What are the side effects of Bivalirudin in 0.9% Sodium Chloride?

Sorry No records found

What should I look out for while using Bivalirudin in 0.9% Sodium Chloride?

Bivalirudin Injection is contraindicated in patients with:

What might happen if I take too much Bivalirudin in 0.9% Sodium Chloride?

Cases of overdose of up to 10 times the recommended bolus or continuous infusion dose of Bivalirudin Injection have been reported in clinical trials and in postmarketing reports. A number of the reported overdoses were due to failure to adjust the infusion dose of bivalirudin in persons with renal dysfunction including persons on hemodialysis . Bleeding, as well as deaths due to hemorrhage, have been observed in some reports of overdose. In cases of suspected overdosage, discontinue Bivalirudin Injection immediately and monitor the patient closely for signs of bleeding. There is no known antidote to bivalirudin. Bivalirudin is hemodialyzable .

How should I store and handle Bivalirudin in 0.9% Sodium Chloride?

Storage and HandlingStore at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) (see USP Controlled Room Temperature).Storage and HandlingStore at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) (see USP Controlled Room Temperature).Each Dextroamphetamine Sulfate Tablet USP (5 mg) contains dextroamphetamine sulfate 5 mg. It is available as triangle shaped, white to off white tablet debossed with a number “5” and a bisect on one side and an “M” in a box on the other. Bottles of 100 ........................NDC 0406-8958-01Each Dextroamphetamine Sulfate Tablet USP (10 mg) contains dextroamphetamine sulfate 10 mg. It is available as diamond shaped, white to off white tablet debossed with a number “10” and a partial quadrisect on one side and an “M” in a box on the other. Bottles of 100 ........................NDC 0406-8959-01Each Dextroamphetamine Sulfate Tablet USP (5 mg) contains dextroamphetamine sulfate 5 mg. It is available as triangle shaped, white to off white tablet debossed with a number “5” and a bisect on one side and an “M” in a box on the other. Bottles of 100 ........................NDC 0406-8958-01Each Dextroamphetamine Sulfate Tablet USP (10 mg) contains dextroamphetamine sulfate 10 mg. It is available as diamond shaped, white to off white tablet debossed with a number “10” and a partial quadrisect on one side and an “M” in a box on the other. Bottles of 100 ........................NDC 0406-8959-01Each Dextroamphetamine Sulfate Tablet USP (5 mg) contains dextroamphetamine sulfate 5 mg. It is available as triangle shaped, white to off white tablet debossed with a number “5” and a bisect on one side and an “M” in a box on the other. Bottles of 100 ........................NDC 0406-8958-01Each Dextroamphetamine Sulfate Tablet USP (10 mg) contains dextroamphetamine sulfate 10 mg. It is available as diamond shaped, white to off white tablet debossed with a number “10” and a partial quadrisect on one side and an “M” in a box on the other. Bottles of 100 ........................NDC 0406-8959-01Each Dextroamphetamine Sulfate Tablet USP (5 mg) contains dextroamphetamine sulfate 5 mg. It is available as triangle shaped, white to off white tablet debossed with a number “5” and a bisect on one side and an “M” in a box on the other. Bottles of 100 ........................NDC 0406-8958-01Each Dextroamphetamine Sulfate Tablet USP (10 mg) contains dextroamphetamine sulfate 10 mg. It is available as diamond shaped, white to off white tablet debossed with a number “10” and a partial quadrisect on one side and an “M” in a box on the other. Bottles of 100 ........................NDC 0406-8959-01

×

Clinical Information

Chemical Structure

No Image found

Clinical Pharmacology

Bivalirudin directly inhibits thrombin by specifically binding both to the catalytic site and to the anion-binding exosite of circulating and clot-bound thrombin. Thrombin is a serine proteinase that plays a central role in the thrombotic process, acting to cleave fibrinogen into fibrin monomers and to activate Factor XIII to Factor XIIIa, allowing fibrin to develop a covalently cross-linked framework which stabilizes the thrombus; thrombin also activates Factors V and VIII, promoting further thrombin generation, and activates platelets, stimulating aggregation and granule release. The binding of bivalirudin to thrombin is reversible as thrombin slowly cleaves the bivalirudin-Arg3-Pro4 bond, resulting in recovery of thrombin active site functions.

Non-Clinical Toxicology

Bivalirudin Injection is contraindicated in patients with:

Drug Interactions

Acidifying Agents

Adrenergic Blockers

Alkalinizing Agents

MAO Inhibitors

Antihistamines

Antihypertensives

Chlorpromazine

Ethosuximide

Haloperidol

Lithium Carbonate

Meperidine

Methenamine Therapy

Norepinephrine

Phenobarbital

Phenytoin

Propoxyphene

Veratrum Alkaloids

Bivalirudin increases the risk of bleeding . Bivalirudin’s anticoagulant effect subsides approximately one hour after discontinuation .

×

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.

×

Review

×

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

×

Tips

×

Interactions

A total of 440 drugs (1549 brand and generic names) are known to interact with Imbruvica (ibrutinib). 228 major drug interactions (854 brand and generic names) 210 moderate drug interactions (691 brand and generic names) 2 minor drug interactions (4 brand and generic names) Show all medications in the database that may interact with Imbruvica (ibrutinib).

Disclaimer: