Krajina: Spojené štáty
Jazyk: angličtina
Zdroj: NLM (National Library of Medicine)
Adenosine (UNII: K72T3FS567) (Adenosine - UNII:K72T3FS567)
Gland Pharma Limited
Adenosine
Adenosine 3 mg in 1 mL
INTRAVENOUS
PRESCRIPTION DRUG
Adenosine Injection, USP is indicated for the following: Conversion to sinus rhythm of paroxysmal supraventricular tachycardia (PSVT), including that associated with accessory bypass tracts (Wolff-Parkinson-White Syndrome). When clinically advisable, appropriate vagal maneuvers (e.g., Valsalva maneuver), should be attempted prior to adenosine administration. It is important to be sure the adenosine solution actually reaches the systemic circulation (see DOSAGE AND ADMINISTRATION ). Adenosine does not convert atrial flutter, atrial fibrillation, or ventricular tachycardia to normal sinus rhythm. In the presence of atrial flutter or atrial fibrillation, a transient modest slowing of ventricular response may occur immediately following adenosine administration. Adenosine injection is contraindicated in: 1. Second- or third-degree A-V block (except in patients with a functioning artificial pacemaker). 2. Sinus node disease, such as sick sinus syndrome or symptomatic bradycardia (except in patien
Adenosine Injection, USP is supplied as a sterile solution in normal saline as follows: Storage Conditions Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Do not freeze. DO NOT REFRIGERATE as crystallization may occur. If crystallization has occurred, dissolve crystals by warming to room temperature. The solution must be clear at the time of use. Sterile, Nonpyrogenic, Preservative-free, DEHP-free, PVC-free. The container closure is not made with natural rubber latex. Discard unused portion. May require needle or blunt. To prevent needle-stick injuries, needles should not be recapped, purposely bent or broken by hand.
Abbreviated New Drug Application
ADENOSINE - ADENOSINE INJECTION GLAND PHARMA LIMITED ---------- RX ONLY DESCRIPTION Adenosine is an endogenous nucleoside occurring in all cells of the body. It is chemically 6-amino-9- β-D-ribofuranosyl-9-H-purine and has the following structural formula: Adenosine is a white crystalline powder. It is soluble in water and practically insoluble in alcohol. Solubility increases by warming and lowering the pH. Adenosine is not chemically related to other antiarrhythmic drugs. Adenosine Injection, USP is a sterile solution for rapid bolus intravenous injection. Each mL contains 3 mg adenosine, USP and 9 mg sodium chloride, USP in water for injection, USP. The pH of the solution is between 4.5 and 7.5. CLINICAL PHARMACOLOGY MECHANISM OF ACTION Adenosine slows conduction time through the A-V node, can interrupt the reentry pathways through the A-V node, and can restore normal sinus rhythm in patients with paroxysmal supraventricular tachycardia (PSVT), including PSVT associated with Wolff-Parkinson-White Syndrome. Adenosine is antagonized competitively by methylxanthines such as caffeine and theophylline, and potentiated by blockers of nucleoside transport such as dipyridamole. Adenosine is not blocked by atropine. HEMODYNAMICS The intravenous bolus dose of 6 or 12 mg adenosine usually has no systemic hemodynamic effects. When larger doses are given by infusion, adenosine decreases blood pressure by decreasing peripheral resistance. PHARMACOKINETICS Intravenously administered adenosine is rapidly cleared from the circulation via cellular uptake, primarily by erythrocytes and vascular endothelial cells. This process involves a specific transmembrane nucleoside carrier system that is reversible, nonconcentrative, and bidirectionally symmetrical. Intracellular adenosine is rapidly metabolized either via phosphorylation to adenosine monophosphate by adenosine kinase, or via deamination to inosine by adenosine deaminase in the cytosol. Since adenosine kinase has a lower K and V than adenosine deaminase, deamination plays Prečítajte si celý dokument