DRUGS & SUPPLEMENTS
Active ingredient: Adenosine Monophosphate
Adenosine Monophosphate uses
1 INDICATIONS AND USAGE
Adenosine Monophosphate Injection, USP is indicated as an adjunct to thallium-201 myocardial perfusion scintigraphy in patients unable to exercise adequately.
Adenosine Monophosphate Injection, USP, a pharmacologic stress agent, is indicated as an adjunct to thallium-201 myocardial perfusion scintigraphy in patients unable to exercise adequately (1)
2 DOSAGE AND ADMINISTRATION
The recommended Adenosine Monophosphate injection dose is 0.14 mg/kg/min infused over six minutes (total dose of 0.84 mg/kg) (Table 1).
Visually inspect Adenosine Monophosphate injection for particulate matter and discoloration prior to administration. Do not administer Adenosine Monophosphate injection if it contains particulate matter or is discolored.
There are no data on the safety or efficacy of alternative Adenosine Monophosphate injection infusion protocols. The safety and efficacy of Adenosine Monophosphate injection administered by the intracoronary route have not been established.
The nomogram displayed in Table 1 was derived from the following general formula:
Recommended dose is 0.14 mg/kg/min infused over six minutes as a continuous peripheral intravenous infusion (total dose of 0.84 mg/kg) (2)
3 DOSAGE FORMS AND STRENGTHS
Adenosine Monophosphate Injection, USP is supplied as 20 mL and 30 mL single-dose vials containing a sterile, nonpyrogenic, clear solution of Adenosine Monophosphate 3 mg per mL.
Adenosine Monophosphate Injection, USP: 3 mg per mL in single-dose vials (3)
Adenosine Monophosphate is contraindicated in patients with:
5 WARNINGS AND PRECAUTIONS
5.1 Cardiac Arrest, Ventricular Arrhythmias, and Myocardial Infarction
Fatal and nonfatal cardiac arrest, sustained ventricular tachycardia (requiring resuscitation), and myocardial infarction have occurred following Adenosine Monophosphate infusion. Avoid use in patients with symptoms or signs of acute myocardial ischemia, for example, unstable angina or cardiovascular instability; these patients may be at greater risk of serious cardiovascular reactions to Adenosine Monophosphate. Appropriate resuscitative measures should be available .
5.2 Sinoatrial and Atrioventricular Nodal Block
Adenosine Monophosphate exerts a direct depressant effect on the SA and AV nodes and may cause first-, second- or third-degree AV block, or sinus bradycardia. In clinical trials, approximately 6% of patients developed AV block following Adenosine Monophosphate administration .
Use Adenosine Monophosphate with caution in patients with pre-existing first-degree AV block or bundle branch block. Do not use in patients with high-grade AV block or sinus node dysfunction (except in patients with a functioning artificial pacemaker). Discontinue Adenosine Monophosphate in any patient who develops persistent or symptomatic high-grade AV block.
Adenosine Monophosphate administration can cause dyspnea, bronchoconstriction, and respiratory compromise. Adenosine Monophosphate should be used with caution in patients with obstructive lung disease not associated with bronchoconstriction (e.g., emphysema, bronchitis). Do not use in patients with bronchoconstriction or bronchospasm (e.g., asthma). Discontinue Adenosine Monophosphate in any patient who develops severe respiratory difficulties. Resuscitative measures should be available prior to Adenosine Monophosphate administration .
Adenosine Monophosphate is a potent peripheral vasodilator and can induce significant hypotension. The risk of serious hypotension may be higher in patients with autonomic dysfunction, hypovolemia, stenotic valvular heart disease, pericarditis or pericardial effusions, or stenotic carotid artery disease with cerebrovascular insufficiency. Discontinue Adenosine Monophosphate in any patient who develops persistent or symptomatic hypotension.
5.5 Cerebrovascular Accident
Hemorrhagic and ischemic cerebrovascular accidents have occurred. Hemodynamic effects of Adenosine Monophosphate including hypotension or hypertension can be associated with these adverse reactions .
New-onset or recurrence of convulsive seizures has occurred following Adenosine Monophosphate. Some seizures are prolonged and require emergent anticonvulsive management. Aminophylline may increase the risk of seizures associated with Adenosine Monophosphate. Methylxanthine use is not recommended in patients who experience seizures in association with Adenosine Monophosphate administration .
5.7 Hypersensitivity, Including Anaphylaxis
Dyspnea, throat tightness, flushing, erythema, rash, and chest discomfort have occurred. Symptomatic treatment may be required. Have personnel and appropriate treatment available. Resuscitative measures may be necessary if symptoms progress .
5.8 Atrial Fibrillation
Adenosine Monophosphate can cause atrial fibrillation in patients with or without a history of atrial fibrillation. Atrial fibrillation typically began 1.5 to 3 minutes after initiation of Adenosine Monophosphate, lasted for 15 seconds to 6 hours, and spontaneously converted to normal sinus rhythm .
Adenosine Monophosphate can induce clinically significant increases in systolic and diastolic blood pressure. Most increases resolved spontaneously within several minutes, but in some cases, hypertension lasted for several hours .
6 ADVERSE REACTIONS
The following adverse reactions are discussed in more detail in other sections of the prescribing information:
Most common adverse reactions (incidence ≥ 10%) are: flushing; chest discomfort; shortness of breath; headache; throat, neck or jaw discomfort; gastrointestinal discomfort; and dizziness (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Sagent Pharmaceuticals, Inc. at 1-866-625-1618 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1 Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The following adverse reactions, with an incidence of at least 1%, were reported with Adenosine Monophosphate among 1,421 patients in clinical trials. 11% of the adverse reactions occurred several hours after Adenosine Monophosphate administration. 8% of the adverse reactions began with Adenosine Monophosphate infusion and persisted for up to 24 hours.
The most common (incidence ≥ 10%) adverse reactions to Adenosine Monophosphate are flushing, chest discomfort, shortness of breath, headache, throat, neck or jaw discomfort, gastrointestinal discomfort, and dizziness (Table 2).
Adverse reactions to Adenosine Monophosphate of any severity reported in less than 1% of patients include:
6.2 Post-Marketing Experience
The following adverse reactions have been reported from marketing experience with Adenosine Monophosphate. Because these reactions are reported voluntarily from a population of uncertain size, are associated with concomitant diseases and multiple drug therapies and surgical procedures, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
7 DRUG INTERACTIONS
7.1 Effects of Other Drugs on Adenosine Monophosphate
7.2 Effects of Adenosine Monophosphate on Other Drugs
Adenosine Monophosphate injection has been given with other cardioactive drugs (such as beta adrenergic blocking agents, cardiac glycosides, and calcium channel blockers) without apparent adverse interactions, but its effectiveness with these agents has not been systematically evaluated. Because of the potential for additive or synergistic depressant effects on the SA and AV nodes, however, Adenosine Monophosphate should be used with caution in the presence of these agents .
8 USE IN SPECIFIC POPULATIONS
Pregnancy Category C. Animal reproduction studies have not been conducted with Adenosine Monophosphate; nor have studies been performed in pregnant women. Because it is not known whether Adenosine Monophosphate can cause fetal harm when administered to pregnant women, Adenosine Monophosphate should be used during pregnancy only if clearly needed.
8.3 Nursing Mothers
It is not known whether Adenosine Monophosphate is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions from Adenosine Monophosphate in nursing infants, the decision to interrupt nursing after administration of Adenosine Monophosphate or not to administer Adenosine Monophosphate, should take into account the importance of the drug to the mother.
8.4 Pediatric Use
The safety and effectiveness of Adenosine Monophosphate in patients less than 18 years of age have not been established.
8.5 Geriatric Use
Clinical studies with Adenosine Monophosphate did not include sufficient numbers of subjects aged younger than 65 years to determine whether they respond differently. Other reported experience has not revealed clinically relevant differences of the response of elderly in comparison to younger patients.
The half-life of Adenosine Monophosphate is less than 10 seconds and adverse reactions of Adenosine Monophosphate usually resolve quickly when the infusion is discontinued, although delayed or persistent reactions have been observed. Methylxanthines, such as caffeine, aminophylline, and theophylline, are competitive Adenosine Monophosphate receptor antagonists and theophylline has been used to terminate persistent adverse reactions. In clinical trials, theophylline (50 to 125 mg slow intravenous injection) was used to attenuate Adenosine Monophosphate adverse reactions in approximately 2% of patients. Methylxanthine use is not recommended in patients who experience seizures in association with Adenosine Monophosphate .
Adenosine Monophosphate is an endogenous nucleoside and is chemically described as 6-amino-9-beta-D-ribofuranosyl-9-H-purine. Adenosine Monophosphate has the following structural formula:
The molecular formula for Adenosine Monophosphate is C10H13N5O4 and its molecular weight is 267.24.
Adenosine Monophosphate is a white crystalline powder. It is soluble in water and practically insoluble in alcohol. Solubility increases by warming and lowering the pH of the solution.
Each Adenosine Monophosphate Injection, USP vial contains a sterile, non-pyrogenic solution of Adenosine Monophosphate 3 mg/mL and sodium chloride 9 mg/mL in water for injection, with pH between 4.5 and 7.5.
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
Adenosine Monophosphate causes cardiac vasodilation which increases cardiac blood flow. Adenosine Monophosphate is thought to exert its pharmacological effects through activation of purine receptors. Although the exact mechanism by which Adenosine Monophosphate receptor activation relaxes vascular smooth muscle is not known, there is evidence to support both inhibition of the slow inward calcium current reducing calcium uptake, and activation of adenylate cyclase through A2 receptors in smooth muscle cells. Adenosine Monophosphate may also lessen vascular tone by modulating sympathetic neurotransmission. The intracellular uptake of Adenosine Monophosphate is mediated by a specific transmembrane nucleoside transport system. Once inside the cell, Adenosine Monophosphate is rapidly phosphorylated by Adenosine Monophosphate kinase to Adenosine Monophosphate monophosphate, or deaminated by Adenosine Monophosphate deaminase to inosine. These intracellular metabolites of Adenosine Monophosphate are not vasoactive.
Myocardial uptake of thallium-201 is directly proportional to coronary blood flow. Since Adenosine Monophosphate significantly increases blood flow in normal coronary arteries with little or no increase in stenotic arteries, Adenosine Monophosphate causes relatively less thallium-201 uptake in vascular territories supplied by stenotic coronary arteries i.e., a greater difference is seen after Adenosine Monophosphate between areas served by normal and areas served by stenotic vessels than is seen prior to Adenosine Monophosphate.
Adenosine Monophosphate produces a direct negative chronotropic, dromotropic and inotropic effect on the heart, presumably due to A1-receptor agonism, and produces peripheral vasodilation, presumably due to A2-receptor agonism. The net effect of Adenosine Monophosphate in humans is typically a mild to moderate reduction in systolic, diastolic and mean arterial blood pressure associated with a reflex increase in heart rate. Rarely, significant hypotension and tachycardia have been observed .
Intravenously administered Adenosine Monophosphate distributes 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 Monophosphate is metabolized either via phosphorylation to Adenosine Monophosphate monophosphate by Adenosine Monophosphate kinase, or via deamination to inosine by Adenosine Monophosphate deaminase in the cytosol. Since Adenosine Monophosphate kinase has a lower Km and Vmax than Adenosine Monophosphate deaminase, deamination plays a significant role only when cytosolic Adenosine Monophosphate saturates the phosphorylation pathway. Inosine formed by deamination of Adenosine Monophosphate can leave the cell intact or can be degraded to hypoxanthine, xanthine, and ultimately uric acid. Adenosine Monophosphate monophosphate formed by phosphorylation of Adenosine Monophosphate is incorporated into the high-energy phosphate pool.
While extracellular Adenosine Monophosphate is primarily cleared from plasma by cellular uptake with a half-life of less than 10 seconds in whole blood, excessive amounts may be deaminated by an ecto-form of Adenosine Monophosphate deaminase.
As Adenosine Monophosphate does not require renal function for its activation or inactivation, renal impairment would not be expected to alter its effectiveness or tolerability.
As Adenosine Monophosphate does not require hepatic function for its activation or inactivation, hepatic impairment would not be expected to alter its effectiveness or tolerability.
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
Studies in animals have not been performed to evaluate adenosine's carcinogenic potential or potential effects on fertility. Adenosine Monophosphate was negative for genotoxic potential in the Salmonella (Ames Test) and Mammalian Microsome Assay.
Adenosine Monophosphate, however, like other nucleosides at millimolar concentrations present for several doubling times of cells in culture, is known to produce a variety of chromosomal alterations.
14 CLINICAL STUDIES
In two crossover comparative studies involving 319 subjects who could exercise (including 106 healthy volunteers and 213 patients with known or suspected coronary disease), Adenosine Monophosphate and exercise thallium images were compared by blinded observers. The images were concordant for the presence of perfusion defects in 85.5% of cases by global analysis (patient by patient) and up to 93% of cases based on vascular territories.
In the two studies, 193 patients also had recent coronary arteriography for comparison (healthy volunteers were not catheterized). The sensitivity for detecting angiographically significant disease (≥ 50% reduction in the luminal diameter of at least one major vessel) was 64% for Adenosine Monophosphate and 64% for exercise testing. The specificity was 54% for Adenosine Monophosphate and 65% for exercise testing. The 95% confidence limits for Adenosine Monophosphate sensitivity were 56% to 78% and for specificity were 37% to 71%.
Intracoronary Doppler flow catheter studies have demonstrated that a dose of intravenous Adenosine Monophosphate of 0.14 mg/kg/min produces maximum coronary hyperemia (relative to intracoronary papaverine) in approximately 95% of cases within two to three minutes of the onset of the infusion. Coronary blood flow velocity returns to basal levels within one to two minutes of discontinuing the Adenosine Monophosphate infusion.
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1 How Supplied
Adenosine Monophosphate Injection, USP is supplied as 20 mL and 30 mL single-dose vials of sterile, nonpyrogenic solution in normal saline as follows:
16.2 Storage and Handling
Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F).
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.
Discard unused portion.
Sterile, Nonpyrogenic, Preservative-free.
The container closure is not made with natural rubber latex.
17 PATIENT COUNSELING INFORMATION
Mfd. for SAGENT Pharmaceuticals
Schaumburg, IL 60195 (USA)
Made in India
©2014 Sagent Pharmaceuticals, Inc.
Revised: September 2014
PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – Vial Label
Adenosine Monophosphate Injection, USP
60 mg per 20 mL (3 mg per mL)
For Intravenous Infusion Only
20 mL Single-Dose Vial
Adenosine Monophosphate available forms, composition, doses:
Indications and Usages:
Adenosine Monophosphate destination | category:
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Frequently asked QuestionsCan i drive or operate heavy machine after consuming Adenosine Monophosphate?
Depending on the reaction of the Adenosine Monophosphate after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Adenosine Monophosphate not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.Is Adenosine Monophosphate addictive or habit forming?
Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.
Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.
ReviewsDrugs.com conducted a study on Adenosine Monophosphate, and the result of the survey is set out below. It is noteworthy that the product of the survey is based on the perception and impressions of the visitors of the website as well as the views of Adenosine Monophosphate consumers. We, as a result of this, advice that you do not base your therapeutic or medical decisions on this result, but rather consult your certified medical experts for their recommendations.
The information was verified by Dr. Arunabha Ray, MD Pharmacology