DRUGS & SUPPLEMENTS

Adenocard

Name: Adenocard drug & pharmaceuticals. Available Forms, Doses, Prices
Creator: sdrugs.com
Published: 2021-11-11T10:10:10+00:00

When are you taking this medicine?

Adenocard uses

Indications and usage
Dosage and administration
Dosage forms and strengths
Contraindications
Warnings and precautions
Adverse reactions
Drug interactions
Use in specific populations
Overdosage
Description
Clinical pharmacology
Nonclinical toxicology
Clinical studies
How supplied/storage and handling
Patient counseling information
Adenocard reviews

1 INDICATIONS AND USAGE

Adenocard Injection, USP is indicated as an adjunct to thallium-201 myocardial perfusion scintigraphy in patients unable to exercise adequately.

Adenocard 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 Adenocard injection dose is 0.14 mg/kg/min infused over six minutes (total dose of 0.84 mg/kg) (Table 1).

Administer Adenocard injection only as a continuous peripheral intravenous infusion
Inject Thallium-201 at the midpoint of the Adenocard injection infusion (i.e., after the first three minutes of Adenocard injection)
Thallium-201 is physically compatible with Adenocard injection and may be injected directly into the Adenocard injection infusion set
Inject Thallium-201 as close to the venous access as possible to prevent an inadvertent increase in the dose of Adenocard injection (the contents of the intravenous tubing) being administered

Visually inspect Adenocard injection for particulate matter and discoloration prior to administration. Do not administer Adenocard injection if it contains particulate matter or is discolored.

There are no data on the safety or efficacy of alternative Adenocard injection infusion protocols. The safety and efficacy of Adenocard injection administered by the intracoronary route have not been established.

Patient Weight *(kilograms)*	Infusion Rate *(mL per minute over 6 minutes for total dose of 0.84 mg/kg)*
45	2.1
50	2.3
55	2.6
60	2.8
65	3
70	3.3
75	3.5
80	3.8
85	4
90	4.2

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)

formula

3 DOSAGE FORMS AND STRENGTHS

Adenocard Injection, USP is supplied as 20 mL and 30 mL single-dose vials containing a sterile, nonpyrogenic, clear solution of Adenocard 3 mg per mL.

Adenocard Injection, USP: 3 mg per mL in single-dose vials (3)

4 CONTRAINDICATIONS

Adenocard is contraindicated in patients with:

Second- or third-degree AV block (except in patients with a functioning artificial pacemaker)
Sinus node disease, such as sick sinus syndrome or symptomatic bradycardia (except in patients with a functioning artificial pacemaker)
Known or suspected bronchoconstrictive or bronchospastic lung disease (e.g., asthma)
Known hypersensitivity to Adenocard

Second- or third-degree AV block (except in patients with a functioning artificial pacemaker) (4)
Sinus node disease, such as sick sinus syndrome or symptomatic bradycardia (except in patients with a functioning artificial pacemaker) (4)
Known or suspected bronchoconstrictive or bronchospastic lung disease (e.g., asthma) (4)
Known hypersensitivity to Adenocard (4)

5 WARNINGS AND PRECAUTIONS

Cardiac Arrest, Ventricular Arrhythmias, and Myocardial Infarction. Fatal cardiac events have occurred. Avoid use in patients with symptoms or signs of acute myocardial ischemia. Appropriate resuscitative measures should be available
Sinoatrial (SA) and Atrioventricular (AV) Nodal Block. First-, second-or third-degree AV block, or sinus bradycardia can occur. Discontinue Adenocard if patient develops persistent or symptomatic high-grade AV block (5.2)
Bronchoconstriction. Can induce dyspnea, bronchoconstriction, and respiratory compromise, especially in patients with obstructive pulmonary disease. Discontinue Adenocard if patient develops severe respiratory difficulties (5.3)
Hypotension. Significant hypotension can occur. Discontinue Adenocard if patient develops persistent or symptomatic hypotension (5.4)
Cerebrovascular Accidents. Hemorrhagic and ischemic cerebrovascular accidents have occurred (5.5)
Seizures. New onset or recurrence of convulsive seizures have occurred. Use of methylxanthines (e.g., caffeine, aminophylline and theophylline) is not recommended in patients who experience a seizures in association with Adenocard (5.6)
Hypersensitivity. Dyspnea, throat tightness, flushing, erythema, rash, and chest discomfort have occurred. Have personnel and resuscitative equipment immediately available (5.7)
Atrial Fibrillation. Reported in patients with or without a history of atrial fibrillation (5.8)
Hypertension. Clinically significant increases in systolic and diastolic pressure have been observed (5.9)

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 Adenocard 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 Adenocard. Appropriate resuscitative measures should be available .

5.2 Sinoatrial and Atrioventricular Nodal Block

Adenocard 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 Adenocard administration .

Use Adenocard 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 Adenocard in any patient who develops persistent or symptomatic high-grade AV block.

5.3 Bronchoconstriction

Adenocard administration can cause dyspnea, bronchoconstriction, and respiratory compromise. Adenocard 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 Adenocard in any patient who develops severe respiratory difficulties. Resuscitative measures should be available prior to Adenocard administration .

5.4 Hypotension

Adenocard 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 Adenocard in any patient who develops persistent or symptomatic hypotension.

5.5 Cerebrovascular Accident

Hemorrhagic and ischemic cerebrovascular accidents have occurred. Hemodynamic effects of Adenocard including hypotension or hypertension can be associated with these adverse reactions .

5.6 Seizures

New-onset or recurrence of convulsive seizures has occurred following Adenocard. Some seizures are prolonged and require emergent anticonvulsive management. Aminophylline may increase the risk of seizures associated with Adenocard. Methylxanthine use is not recommended in patients who experience seizures in association with Adenocard 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

Adenocard 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 Adenocard, lasted for 15 seconds to 6 hours, and spontaneously converted to normal sinus rhythm .

5.9 Hypertension

Adenocard 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:

Fatal Cardiac Arrest, Ventricular Arrhythmias, and Myocardial Infarction
Sinoatrial and Atrioventricular Nodal Block
Bronchoconstriction
Hypotension
Cerebrovascular Accident
Seizures
Hypersensitivity
Atrial fibrillation
Hypertension

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 Adenocard among 1,421 patients in clinical trials. 11% of the adverse reactions occurred several hours after Adenocard administration. 8% of the adverse reactions began with Adenocard infusion and persisted for up to 24 hours.

The most common (incidence ≥ 10%) adverse reactions to Adenocard are flushing, chest discomfort, shortness of breath, headache, throat, neck or jaw discomfort, gastrointestinal discomfort, and dizziness (Table 2).

Adverse Reactions	Adenocard N=1,421
Flushing	44%
Chest discomfort	40%
Dyspnea	28%
Headache	18%
Throat, neck or jaw discomfort	15%
Gastrointestinal discomfort	13%
Lightheadedness/dizziness	12%
Upper extremity discomfort	4%
ST segment depression	3%
First-degree AV block	3%
Second-degree AV block	3%
Paresthesia	2%
Hypotension	2%
Nervousness	2%
Arrhythmias	1%

Adverse reactions to Adenocard of any severity reported in less than 1% of patients include:

Body as a Whole:	back discomfort, lower extremity discomfort, weakness
Cardiovascular System:	myocardial infarction, ventricular arrhythmia, third-degree AV block, bradycardia, palpitation, sinus exit block, sinus pause, T-wave changes, hypertension (systolic blood pressure > 200 mm Hg)
Respiratory System:	cough
Central Nervous System:	drowsiness, emotional instability, tremors
Genital/Urinary System:	Vaginal pressure, urgency
Special Senses:	blurred vision, dry mouth, ear discomfort, metallic taste, nasal congestion, scotomas, tongue discomfort

6.2 Post-Marketing Experience

The following adverse reactions have been reported from marketing experience with Adenocard. 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.

Cardiac Disorders:	cardiac arrest, atrial fibrillation, cardiac failure, myocardial infarction, tachycardia, ventricular arrhythmia
Gastrointestinal Disorders:	nausea and vomiting
General Disorders and Administration Site Conditions:	chest pain, injection site reaction, infusion site pain
Immune System Disorders:	hypersensitivity
Nervous System Disorders:	cerebrovascular accident including intracranial hemorrhage, seizure activity including tonic-clonic (grand mal) seizures, loss of consciousness
Respiratory, Thoracic and Mediastinal Disorders:	bronchospasm, respiratory arrest, throat tightness

7 DRUG INTERACTIONS

Methylxanthines interfere with the activity of Adenocard
Nucleoside transport inhibitors such as dipyridamole can increase the activity of Adenocard (7.1)

7.1 Effects of Other Drugs on Adenocard

The vasoactive effects of Adenocard are inhibited by Adenocard receptor antagonists, (such as methylxanthines (e.g., caffeine, aminophylline, and theophylline). The safety and efficacy of Adenocard in the presence of these agents has not been systematically evaluated .
The vasoactive effects of Adenocard are potentiated by nucleoside transport inhibitors such as dipyridamole. The safety and efficacy of Adenocard in the presence of dipyridamole has not been systematically evaluated.
Whenever possible, drugs that might inhibit or augment the effects of Adenocard should be withheld for at least five half-lives prior to the use of Adenocard.

7.2 Effects of Adenocard on Other Drugs

Adenocard 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, Adenocard should be used with caution in the presence of these agents .

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Pregnancy Category C. Animal reproduction studies have not been conducted with Adenocard; nor have studies been performed in pregnant women. Because it is not known whether Adenocard can cause fetal harm when administered to pregnant women, Adenocard should be used during pregnancy only if clearly needed.

8.3 Nursing Mothers

It is not known whether Adenocard is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions from Adenocard in nursing infants, the decision to interrupt nursing after administration of Adenocard or not to administer Adenocard, should take into account the importance of the drug to the mother.

8.4 Pediatric Use

The safety and effectiveness of Adenocard in patients less than 18 years of age have not been established.

8.5 Geriatric Use

Clinical studies with Adenocard 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.

10 OVERDOSAGE

The half-life of Adenocard is less than 10 seconds and adverse reactions of Adenocard 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 Adenocard 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 Adenocard adverse reactions in approximately 2% of patients. Methylxanthine use is not recommended in patients who experience seizures in association with Adenocard .

11 DESCRIPTION

Adenocard is an endogenous nucleoside and is chemically described as 6-amino-9-beta-D-ribofuranosyl-9-H-purine. Adenocard has the following structural formula:

The molecular formula for Adenocard is C₁₀H₁₃N₅O₄ and its molecular weight is 267.24.

Adenocard 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 Adenocard Injection, USP vial contains a sterile, non-pyrogenic solution of Adenocard 3 mg/mL and sodium chloride 9 mg/mL in water for injection, with pH between 4.5 and 7.5.

Structural Formula

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

Adenocard causes cardiac vasodilation which increases cardiac blood flow. Adenocard is thought to exert its pharmacological effects through activation of purine receptors. Although the exact mechanism by which Adenocard 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. Adenocard may also lessen vascular tone by modulating sympathetic neurotransmission. The intracellular uptake of Adenocard is mediated by a specific transmembrane nucleoside transport system. Once inside the cell, Adenocard is rapidly phosphorylated by Adenocard kinase to Adenocard monophosphate, or deaminated by Adenocard deaminase to inosine. These intracellular metabolites of Adenocard are not vasoactive.

Myocardial uptake of thallium-201 is directly proportional to coronary blood flow. Since Adenocard significantly increases blood flow in normal coronary arteries with little or no increase in stenotic arteries, Adenocard causes relatively less thallium-201 uptake in vascular territories supplied by stenotic coronary arteries i.e., a greater difference is seen after Adenocard between areas served by normal and areas served by stenotic vessels than is seen prior to Adenocard.

12.2 Pharmacodynamics

Hemodynamic Effects

Adenocard 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 Adenocard 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 .

12.3 Pharmacokinetics

Distribution

Intravenously administered Adenocard 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.

Metabolism

Intracellular Adenocard is metabolized either via phosphorylation to Adenocard monophosphate by Adenocard kinase, or via deamination to inosine by Adenocard deaminase in the cytosol. Since Adenocard kinase has a lower K_m and V_max than Adenocard deaminase, deamination plays a significant role only when cytosolic Adenocard saturates the phosphorylation pathway. Inosine formed by deamination of Adenocard can leave the cell intact or can be degraded to hypoxanthine, xanthine, and ultimately uric acid. Adenocard monophosphate formed by phosphorylation of Adenocard is incorporated into the high-energy phosphate pool.

Elimination

While extracellular Adenocard 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 Adenocard deaminase.

Specific Populations

Renal Impairment

As Adenocard does not require renal function for its activation or inactivation, renal impairment would not be expected to alter its effectiveness or tolerability.

Hepatic Impairment

As Adenocard 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. Adenocard was negative for genotoxic potential in the Salmonella (Ames Test) and Mammalian Microsome Assay.

Adenocard, 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), Adenocard 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 Adenocard and 64% for exercise testing. The specificity was 54% for Adenocard and 65% for exercise testing. The 95% confidence limits for Adenocard sensitivity were 56% to 78% and for specificity were 37% to 71%.

Intracoronary Doppler flow catheter studies have demonstrated that a dose of intravenous Adenocard 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 Adenocard infusion.

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied

Adenocard Injection, USP is supplied as 20 mL and 30 mL single-dose vials of sterile, nonpyrogenic solution in normal saline as follows:

NDC	Adenocard Injection, USP	Package Factor
25021-307-20	60 mg per 20 mL Single-Dose Vial	1 vial per carton
25021-307-21	60 mg per 20 mL Single-Dose Vial	10 vials per carton
25021-307-30	90 mg per 30 mL Single-Dose Vial	1 vial per carton
25021-307-31	90 mg per 30 mL Single-Dose Vial	10 vials per carton

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

Advise patients that they may be at increased risk of fatal and nonfatal heart attacks, abnormal heart rhythms, cardiac arrest, heart block, significant increase or decrease in blood pressure, bronchoconstriction, hypersensitivity reactions, seizures, or cerebrovascular accidents with the use of Adenocard .
Advise patients with COPD or asthma to discuss their respiratory history with their clinician before scheduling a myocardial perfusion imaging study with Adenocard .
Methylxanthines have the potential to impact the effects of Adenocard. Instruct patients to avoid consumption of any products containing methylxanthines, including caffeinated coffee, tea or other caffeinated beverages, caffeine-containing drug products, aminophylline, and theophylline prior to the myocardial perfusion imaging study. Question patients about a history of seizures .

SAGENT

Mfd. for SAGENT Pharmaceuticals

Schaumburg, IL 60195 (USA)

Made in India

Revised: September 2014

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – Vial Label

NDC 25021-307-20

Rx only

Adenocard Injection, USP

60 mg per 20 mL (3 mg per mL)

For Intravenous Infusion Only

20 mL Single-Dose Vial

Adenocard pharmaceutical active ingredients containing related brand and generic drugs:

Adenosine

Adenocard available forms, composition, doses:

Injectable; Injection; Adenosine 3 mg / ml

Adenocard destination | category:

Human:
Cardiac drugs
Class IV antiarrythmics

Adenocard Anatomical Therapeutic Chemical codes:

C01EB10 - Adenosine

Adenocard pharmaceutical companies:

References

Dailymed."ADENOSINE INJECTION, SOLUTION [SAGENT PHARMACEUTICALS]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
Dailymed."ADENOSINE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
"adenosine". https://pubchem.ncbi.nlm.nih.gov/co... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming Adenocard?

Depending on the reaction of the Adenocard after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Adenocard 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 Adenocard 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.

Review

sdrugs.com conducted a study on Adenocard, 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 Adenocard 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.