Lipostabil Injections

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Lipostabil Injections uses

Lipostabil Injections consists of Adenosine Phosphate, Multivitamins, Phospholipids Essential.

Adenosine Phosphate:


1 INDICATIONS AND USAGE

Lipostabil Injections (Adenosine Phosphate) Injection, USP is indicated as an adjunct to thallium-201 myocardial perfusion scintigraphy in patients unable to exercise adequately.

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

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

Visually inspect Lipostabil Injections (Adenosine Phosphate) injection for particulate matter and discoloration prior to administration. Do not administer Lipostabil Injections (Adenosine Phosphate) injection if it contains particulate matter or is discolored.

There are no data on the safety or efficacy of alternative Lipostabil Injections (Adenosine Phosphate) injection infusion protocols. The safety and efficacy of Lipostabil Injections (Adenosine Phosphate) 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

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3 DOSAGE FORMS AND STRENGTHS

Lipostabil Injections (Adenosine Phosphate) Injection, USP is supplied as 20 mL and 30 mL single-dose vials containing a sterile, nonpyrogenic, clear solution of Lipostabil Injections (Adenosine Phosphate) 3 mg per mL.

Lipostabil Injections (Adenosine Phosphate) Injection, USP: 3 mg per mL in single-dose vials (3)

4 CONTRAINDICATIONS

Lipostabil Injections (Adenosine Phosphate) 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 Lipostabil Injections (Adenosine Phosphate)
  • 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 Lipostabil Injections (Adenosine Phosphate) (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 Lipostabil Injections (Adenosine Phosphate) 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 Lipostabil Injections (Adenosine Phosphate) if patient develops severe respiratory difficulties (5.3)
  • Hypotension. Significant hypotension can occur. Discontinue Lipostabil Injections (Adenosine Phosphate) 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 Lipostabil Injections (Adenosine Phosphate) (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 Lipostabil Injections (Adenosine Phosphate) 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 Lipostabil Injections (Adenosine Phosphate). Appropriate resuscitative measures should be available .

5.2 Sinoatrial and Atrioventricular Nodal Block

Lipostabil Injections 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 Lipostabil Injections (Adenosine Phosphate) administration (first-degree heart block developed in 3%, second-degree in 3%, and third-degree in 0.8% of patients) .

Use Lipostabil Injections (Adenosine Phosphate) 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 Lipostabil Injections (Adenosine Phosphate) in any patient who develops persistent or symptomatic high-grade AV block.

5.3 Bronchoconstriction

Lipostabil Injections (Adenosine Phosphate) administration can cause dyspnea, bronchoconstriction, and respiratory compromise. Lipostabil Injections (Adenosine Phosphate) 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 Lipostabil Injections (Adenosine Phosphate) in any patient who develops severe respiratory difficulties. Resuscitative measures should be available prior to Lipostabil Injections (Adenosine Phosphate) administration .

5.4 Hypotension

Lipostabil Injections 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 Lipostabil Injections (Adenosine Phosphate) in any patient who develops persistent or symptomatic hypotension.

5.5 Cerebrovascular Accident

Hemorrhagic and ischemic cerebrovascular accidents have occurred. Hemodynamic effects of Lipostabil Injections (Adenosine Phosphate) including hypotension or hypertension can be associated with these adverse reactions .

5.6 Seizures

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

Lipostabil Injections 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 Lipostabil Injections (Adenosine Phosphate), lasted for 15 seconds to 6 hours, and spontaneously converted to normal sinus rhythm .

5.9 Hypertension

Lipostabil Injections (Adenosine Phosphate) 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 .

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

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

Adverse Reactions Lipostabil Injections (Adenosine Phosphate)

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 Lipostabil Injections (Adenosine Phosphate) 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 Lipostabil Injections (Adenosine Phosphate). 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

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7 DRUG INTERACTIONS

  • Methylxanthines interfere with the activity of Lipostabil Injections (7.1, 10)
  • Nucleoside transport inhibitors such as dipyridamole can increase the activity of Lipostabil Injections (Adenosine Phosphate) (7.1)

7.1 Effects of Other Drugs on Lipostabil Injections (Adenosine Phosphate)

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

7.2 Effects of Lipostabil Injections on Other Drugs

Lipostabil Injections (Adenosine Phosphate) 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, Lipostabil Injections (Adenosine Phosphate) 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 Lipostabil Injections ; nor have studies been performed in pregnant women. Because it is not known whether Lipostabil Injections (Adenosine Phosphate) can cause fetal harm when administered to pregnant women, Lipostabil Injections (Adenosine Phosphate) should be used during pregnancy only if clearly needed.

8.3 Nursing Mothers

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

8.4 Pediatric Use

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

8.5 Geriatric Use

Clinical studies with Lipostabil Injections (Adenosine Phosphate) 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.

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10 OVERDOSAGE

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

11 DESCRIPTION

Lipostabil Injections (Adenosine Phosphate) is an endogenous nucleoside and is chemically described as 6-amino-9-beta-D-ribofuranosyl-9-H-purine. Lipostabil Injections (Adenosine Phosphate) has the following structural formula:

The molecular formula for Lipostabil Injections (Adenosine Phosphate) is C10H13N5O4 and its molecular weight is 267.24.

Lipostabil Injections (Adenosine Phosphate) 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 Lipostabil Injections (Adenosine Phosphate) Injection, USP vial contains a sterile, non-pyrogenic solution of Lipostabil Injections (Adenosine Phosphate) 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

Lipostabil Injections causes cardiac vasodilation which increases cardiac blood flow. Lipostabil Injections (Adenosine Phosphate) is thought to exert its pharmacological effects through activation of purine receptors (cell-surface A1 and A2 Lipostabil Injections (Adenosine Phosphate) receptors). Although the exact mechanism by which Lipostabil Injections (Adenosine Phosphate) 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. Lipostabil Injections (Adenosine Phosphate) may also lessen vascular tone by modulating sympathetic neurotransmission. The intracellular uptake of Lipostabil Injections (Adenosine Phosphate) is mediated by a specific transmembrane nucleoside transport system. Once inside the cell, Lipostabil Injections (Adenosine Phosphate) is rapidly phosphorylated by Lipostabil Injections (Adenosine Phosphate) kinase to Lipostabil Injections (Adenosine Phosphate) monophosphate, or deaminated by Lipostabil Injections (Adenosine Phosphate) deaminase to inosine. These intracellular metabolites of Lipostabil Injections (Adenosine Phosphate) are not vasoactive.

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

12.2 Pharmacodynamics

Hemodynamic Effects

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

Elimination

While extracellular Lipostabil Injections (Adenosine Phosphate) 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 Lipostabil Injections (Adenosine Phosphate) deaminase.

Specific Populations

Renal Impairment

As Lipostabil Injections (Adenosine Phosphate) 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 Lipostabil Injections (Adenosine Phosphate) 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. Lipostabil Injections (Adenosine Phosphate) was negative for genotoxic potential in the Salmonella (Ames Test) and Mammalian Microsome Assay.

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

Intracoronary Doppler flow catheter studies have demonstrated that a dose of intravenous Lipostabil Injections (Adenosine Phosphate) 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 Lipostabil Injections (Adenosine Phosphate) infusion.

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied

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

NDC Lipostabil Injections (Adenosine Phosphate) Injection, USP (3 mg per mL) 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 Lipostabil Injections (Adenosine Phosphate) .
  • Advise patients with COPD or asthma to discuss their respiratory history with their clinician before scheduling a myocardial perfusion imaging study with Lipostabil Injections (Adenosine Phosphate) .
  • Methylxanthines have the potential to impact the effects of Lipostabil Injections (Adenosine Phosphate). 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

©2014 Sagent Pharmaceuticals, Inc.

Revised: September 2014

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – Vial Label

NDC 25021-307-20

Rx only

Lipostabil Injections (Adenosine Phosphate) Injection, USP

60 mg per 20 mL (3 mg per mL)

For Intravenous Infusion Only

20 mL Single-Dose Vial

Lipostabil Injections pharmaceutical active ingredients containing related brand and generic drugs:

Active ingredient is the part of the drug or medicine which is biologically active. This portion of the drug is responsible for the main action of the drug which is intended to cure or reduce the symptom or disease. The other portions of the drug which are inactive are called excipients; there role is to act as vehicle or binder. In contrast to active ingredient, the inactive ingredient's role is not significant in the cure or treatment of the disease. There can be one or more active ingredients in a drug.


Lipostabil Injections available forms, composition, doses:

Form of the medicine is the form in which the medicine is marketed in the market, for example, a medicine X can be in the form of capsule or the form of chewable tablet or the form of tablet. Sometimes same medicine can be available as injection form. Each medicine cannot be in all forms but can be marketed in 1, 2, or 3 forms which the pharmaceutical company decided based on various background research results.
Composition is the list of ingredients which combinedly form a medicine. Both active ingredients and inactive ingredients form the composition. The active ingredient gives the desired therapeutic effect whereas the inactive ingredient helps in making the medicine stable.
Doses are various strengths of the medicine like 10mg, 20mg, 30mg and so on. Each medicine comes in various doses which is decided by the manufacturer, that is, pharmaceutical company. The dose is decided on the severity of the symptom or disease.


Lipostabil Injections destination | category:

Destination is defined as the organism to which the drug or medicine is targeted. For most of the drugs what we discuss, human is the drug destination.
Drug category can be defined as major classification of the drug. For example, an antihistaminic or an antipyretic or anti anginal or pain killer, anti-inflammatory or so.


Lipostabil Injections Anatomical Therapeutic Chemical codes:

A medicine is classified depending on the organ or system it acts [Anatomical], based on what result it gives on what disease, symptom [Therapeutical], based on chemical composition [Chemical]. It is called as ATC code. The code is based on Active ingredients of the medicine. A medicine can have different codes as sometimes it acts on different organs for different indications. Same way, different brands with same active ingredients and same indications can have same ATC code.


Lipostabil Injections pharmaceutical companies:

Pharmaceutical companies are drug manufacturing companies that help in complete development of the drug from the background research to formation, clinical trials, release of the drug into the market and marketing of the drug.
Researchers are the persons who are responsible for the scientific research and is responsible for all the background clinical trials that resulted in the development of the drug.


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References

  1. 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).
  2. "adenosine". https://pubchem.ncbi.nlm.nih.gov/co... (accessed August 28, 2018).
  3. "adenosine". http://www.drugbank.ca/drugs/DB0064... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming Lipostabil Injections?

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

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Review

sdrugs.com conducted a study on Lipostabil Injections, 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 Lipostabil Injections 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.

Visitor reports

Visitor reported useful

No survey data has been collected yet

One visitor reported side effects

Did you get side effects while taking the Lipostabil Injections drug, or were there no side effects?
According to the survey conducted by website sdrugs.com users, the below-mentioned percentages indicate the number of people experiencing the side effects and the number of people not experiencing the side effects when taking Lipostabil Injections medicine. Every drug produces minimal side effects, and they are negligible most times, when compared to the desired effect [use] of the medicine. Side effects depend on the dose you are taking, any drug interactions that happen when you are on other medications, if the patient is sensitive, and other associated conditions. If you cannot tolerate the side effects, consult your doctor immediately, so he can either adjust the dose or change the medication.
Visitors%
No side effects1
100.0%

Visitor reported price estimates

No survey data has been collected yet

Visitor reported frequency of use

No survey data has been collected yet

One visitor reported doses

What is the dose of Lipostabil Injections drug you are taking?
According to the survey conducted among sdrugs.com website users, the maximum number of people are using the following dose 11-50mg. Few medications come in only one or two doses. Few are specific for adult dose and child dose. The dose of the medicine given to the patient depends on the severity of the symptom/disease. There can be dose adjustments made by the doctor, based on the progression of the disease. Follow-up is important.
Visitors%
11-50mg1
100.0%

One visitor reported time for results

What is the time duration Lipostabil Injections drug must be taken for it to be effective or for it to reduce the symptoms?
Most chronic conditions need at least some time so the dose and the drug action gets adjusted to the body to get the desired effect. The stastistics say sdrugs.com website users needed 1 day to notice the result from using Lipostabil Injections drug. The time needed to show improvement in health condition after using the medicine Lipostabil Injections need not be same for all the users. It varies based on other factors.
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The information was verified by Dr. Arunabha Ray, MD Pharmacology

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