Isoproterenol Hydrochloride


Amphastar Pharmaceuticals, Inc.
Human Prescription Drug
NDC 0548-9501
Isoproterenol Hydrochloride is a human prescription drug labeled by 'Amphastar Pharmaceuticals, Inc.'. National Drug Code (NDC) number for Isoproterenol Hydrochloride is 0548-9501. This drug is available in dosage form of Injection, Solution. The names of the active, medicinal ingredients in Isoproterenol Hydrochloride drug includes Isoproterenol Hydrochloride - .2 mg/mL . The currest status of Isoproterenol Hydrochloride drug is Active.

Drug Information:

Drug NDC: 0548-9501
The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
Proprietary Name: Isoproterenol Hydrochloride
Also known as the trade name. It is the name of the product chosen by the labeler.
Product Type: Human Prescription Drug
Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing.
Non Proprietary Name: Isoproterenol Hydrochloride
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name: Amphastar Pharmaceuticals, Inc.
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form: Injection, Solution
The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources.
Status: Active
FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved.
Substance Name:ISOPROTERENOL HYDROCHLORIDE - .2 mg/mL
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:INTRACARDIAC
INTRAMUSCULAR
INTRAVENOUS
SUBCUTANEOUS
The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Marketing Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
Marketing Category: ANDA
Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
Marketing Start Date: 16 Jul, 2018
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date: 21 Dec, 2025
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
Application Number: ANDA210106
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
Listing Expiration Date: 31 Dec, 2023
This is the date when the listing record will expire if not updated or certified by the firm.

OpenFDA Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
Manufacturer Name:Amphastar Pharmaceuticals, Inc.
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:1667909
1667915
The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms.
Original Packager:Yes
Whether or not the drug has been repackaged for distribution.
UNII:DIA2A74855
Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information.
Pharmacologic Class:Adrenergic beta-Agonists [MoA]
beta-Adrenergic Agonist [EPC]
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

Packaging Information:

Package NDCDescriptionMarketing Start DateMarketing End DateSample Available
0548-9501-0010 VIAL in 1 CARTON (0548-9501-00) / 1 mL in 1 VIAL16 Jul, 2018N/ANo
Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together.

Product Elements:

Isoproterenol hydrochloride isoproterenol hydrochloride isoproterenol hydrochloride isoproterenol edetate disodium sodium chloride trisodium citrate dihydrate anhydrous citric acid water hydrochloric acid sodium hydroxide isoproterenol hydrochloride isoproterenol hydrochloride isoproterenol hydrochloride isoproterenol edetate disodium sodium chloride trisodium citrate dihydrate anhydrous citric acid water hydrochloric acid sodium hydroxide

Drug Interactions:

Drug interactions isoproterenol hydrochloride injection and epinephrine should not be administered simultaneously because both drugs are direct cardiac stimulants and their combined effects may induce serious arrhythmias. the drugs may, however, be administered alternately provided a proper interval has elapsed between doses. avoid isoproterenol hydrochloride injection when potent inhalational anesthetics such as halothane are employed because of potential to sensitize the myocardium to effects of sympathomimetic amines.

Indications and Usage:

Indications and usage isoproterenol hydrochloride injection is indicated: for mild or transient episodes of heart block that do not require electric shock or pacemaker therapy. for serious episodes of heart block and adams-stokes attacks (except when caused by ventricular tachycardia or fibrillation). (see contraindications.) for use in cardiac arrest until electric shock or pacemaker therapy, the treatments of choice, is available. (see contraindications.) for bronchospasm occurring during anesthesia. as an adjunct to fluid and electrolyte replacement therapy and the use of other drugs and procedures in the treatment of hypovolemic and septic shock, low cardiac output (hypoperfusion) states, congestive heart failure, and cardiogenic shock. (see warnings.)

Warnings:

Warnings isoproterenol hydrochloride injection, by increasing myocardial oxygen requirements while decreasing effective coronary perfusion, may have a deleterious effect on the injured or failing heart. most experts discourage its use as the initial agent in treating cardiogenic shock following myocardial infarction. however, when a low arterial pressure has been elevated by other means, isoproterenol hydrochloride injection may produce beneficial hemodynamic and metabolic effects. in a few patients, presumably with organic disease of the av node and its branches, isoproterenol hydrochloride injection has paradoxically been reported to worsen heart block or to precipitate adams-stokes attacks during normal sinus rhythm or transient heart block.

General Precautions:

General isoproterenol hydrochloride injection should generally be started at the lowest recommended dose. this may be gradually increased if necessary while carefully monitoring the patient. doses sufficient to increase the heart rate to more than 130 beats per minute may increase the likelihood of inducing ventricular arrhythmias. such increases in heart rate will also tend to increase cardiac work and oxygen requirements which may adversely affect the failing heart or the heart with a significant degree of arteriosclerosis. adequate filling of the intravascular compartment by suitable volume expanders is of primary importance in most cases of shock and should precede the administration of vasoactive drugs. in patients with normal cardiac function, determination of central venous pressure is a reliable guide during volume replacement. if evidence of hypoperfusion persists after adequate volume replacement, isoproterenol hydrochloride injection may be given. in addition to the routine
monitoring of systemic blood pressure, heart rate, urine flow, and the electrocardiograph, monitor the response to therapy by frequent determination of the central venous pressure and blood gases. closely observe patients in shock during isoproterenol hydrochloride injection administration. if the heart rate exceeds 110 beats per minute, it may be advisable to decrease the infusion rate or temporarily discontinue the infusion. determinations of cardiac output and circulation time may also be helpful. take appropriate measures to ensure adequate ventilation. pay attention to acid-base balance and to the correction of electrolyte disturbances.

Dosage and Administration:

Dosage and administration start isoproterenol hydrochloride injection at the lowest recommended dose and increase the rate of administration gradually if necessary while carefully monitoring the patient. the usual route of administration is by intravenous infusion or bolus intravenous injection. in dire emergencies, the drug may be administered by intracardiac injection. if time is not of the utmost importance, initial therapy by intramuscular or subcutaneous injection is preferred. recommended dosage for adults with heart block, adams-stokes attacks, and cardiac arrest : route of administration preparation of dilution initial dose subsequent dose range* bolus intravenous injection dilute 1 ml (0.2 mg) in 9 ml of sodium chloride injection, usp, or 5% dextrose injection, usp 0.02 mg to 0.06 mg (1 ml to 3 ml of diluted solution) 0.01 mg to 0.2 mg (0.5 ml to 10 ml of diluted solution) intravenous infusion dilute 10 ml (2 mg) in 500 ml of 5% dextrose injection, usp 5 mcg/min. (1.25 ml of d
iluted solution per minute) intramuscular use solution undiluted 0.2 mg (1 ml) 0.02 mg to 1 mg (0.1 ml to 5 ml) subcutaneous use solution undiluted 0.2 mg (1 ml) 0.15 mg to 0.2 mg (0.75 ml to 1 ml) intracardiac use solution undiluted 0.02 mg (0.1 ml) * subsequent dosage and method of administration depend on the ventricular rate and the rapidity with which the cardiac pacemaker can take over when the drug is gradually withdrawn. there are no well-controlled studies in children to establish appropriate dosing; however, the american heart association recommends an initial infusion rate of 0.1 mcg/kg/min, with the usual range being 0.1 mcg/kg/min to 1 mcg/kg/min. recommended dosage for adults with shock and hypoperfusion states: route of administration preparation of dilution † infusion rate †† intravenous infusion dilute 5 ml (1 mg) in 500 ml of 5% dextrose injection, usp 0.5 mcg to 5 mcg per minute(0.25 ml to 2.5 ml of diluted solution) † concentrations up to 10 times greater have been used when limitation of volume is essential. †† rates over 30 mcg per minute have been used in advanced stages of shock. the rate of infusion should be adjusted on the basis of heart rate, central venous pressure, systemic blood pressure, and urine flow. if the heart rate exceeds 110 beats per minute, it may be advisable to decrease or temporarily discontinue the infusion. recommended dosage for adults with bronchospasm occurring during anesthesia: route of administration preparation of dilution initial dose subsequent dose bolus intravenous injection dilute 1 ml (0.2 mg) in 9 ml of sodium chloride injection, usp, or 5% dextrose injection, usp 0.01 mg to 0.02 mg (0.5 ml to 1 ml of diluted solution) the initial dose may be repeated when necessary parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. such solution should not be used.

Contraindications:

Contraindications use of isoproterenol hydrochloride injection is contraindicated in patients with tachyarrhythmias; tachycardia or heart block caused by digitalis intoxication; ventricular arrhythmias which require inotropic therapy; and angina pectoris.

Adverse Reactions:

Adverse reactions the following reactions to isoproterenol hydrochloride injection have been reported: cns : nervousness, headache, dizziness, nausea, visual blurring. cardiovascular : tachycardia, palpitations, angina, adams-stokes attacks, pulmonary edema, hypertension, hypotension, ventricular arrhythmias, tachyarrhythmias. in a few patients, presumably with organic disease of the av node and its branches, isoproterenol hydrochloride injection has been reported to precipitate adams-stokes seizures during normal sinus rhythm or transient heart block. respiratory : dyspnea. other : flushing of the skin, sweating, mild tremors, weakness, pallor

Drug Interactions:

Drug interactions isoproterenol hydrochloride injection and epinephrine should not be administered simultaneously because both drugs are direct cardiac stimulants and their combined effects may induce serious arrhythmias. the drugs may, however, be administered alternately provided a proper interval has elapsed between doses. avoid isoproterenol hydrochloride injection when potent inhalational anesthetics such as halothane are employed because of potential to sensitize the myocardium to effects of sympathomimetic amines.

Use in Pregnancy:

Pregnancy category c animal reproduction studies have not been conducted with isoproterenol hydrochloride. it is also not known whether isoproterenol hydrochloride can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. isoproterenol hydrochloride should be given to a pregnant woman only if clearly needed.

Pediatric Use:

Pediatric use safety and efficacy of isoproterenol in pediatric patients have not been established. intravenous infusions of isoproterenol in refractory asthmatic children at rates of 0.05 to 2.7 mcg/kg/min have caused clinical deterioration, myocardial necrosis, congestive heart failure and death. the risks of cardiac toxicity appear to be increased by some factors [acidosis, hypoxemia, coadministration of corticosteroids, coadministration of methylxanthines (theophylline, theobromine) or aminophylline] that are especially likely to be present in these patients. if intravenous isoproterenol is used in children with refractory asthma, patient monitoring must include continuous assessment of vital signs, frequent electrocardiography, and daily measurements of cardiac enzymes, including cpk-mb.

Geriatric Use:

Geriatric use clinical studies of isoproterenol hydrochloride injection did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects in clinical circumstances. there are, however, some data that suggest that elderly healthy or hypertensive patients are less responsive to beta-adrenergic stimulation than are younger subjects. in general, dose selection for elderly patients should usually start at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function and of concomitant diseases or other drug therapy.

Overdosage:

Overdosage the acute toxicity of isoproterenol hydrochloride in animals is much less than that of epinephrine. excessive doses in animals or man can cause a striking drop in blood pressure, and repeated large doses in animals may result in cardiac enlargement and focal myocarditis. in case of accidental overdosage as evidenced mainly by tachycardia or other arrhythmias, palpitations, angina, hypotension, or hypertension, reduce rate of administration or discontinue isoproterenol hydrochloride injection until patient’s condition stabilizes. blood pressure, pulse, respiration, and ecg should be monitored. it is not known whether isoproterenol hydrochloride is dialyzable. the oral ld 50 of isoproterenol hydrochloride in mice is 3,850 mg/kg ± 1,190 mg/kg of pure drug in solution.

Description:

Description isoproterenol hydrochloride is 3,4-dihydroxy--[(isopropylamino)methyl] benzyl alcohol hydrochloride, a synthetic sympathomimetic amine that is structurally related to epinephrine but acts almost exclusively on beta receptors. the molecular formula is c 11 h 17 no 3 hcl. it has a molecular weight of 247.72 and the following structural formula: isoproterenol hydrochloride is a racemic compound. each milliliter of the sterile solution contains: isoproterenol hydrochloride injection, usp 0.2 mg edetate disodium (edta) 0.2 mg sodium chloride 7.0 mg sodium citrate, dihydrate 2.07 mg citric acid, anhydrous 2.5 mg water for injection 1.0 ml the ph is adjusted between 2.5 and 4.5 with hydrochloric acid or sodium hydroxide. the sterile solution is nonpyrogenic and can be administered by the intravenous, intramuscular, subcutaneous, or intracardiac routes. structure

Clinical Pharmacology:

Clinical pharmacology isoproterenol is a potent nonselective beta-adrenergic agonist with very low affinity for alpha-adrenergic receptors. intravenous infusion of isoproterenol in man lowers peripheral vascular resistance, primarily in skeletal muscle but also in renal and mesenteric vascular beds. diastolic pressure falls. renal blood flow is decreased in normotensive subjects but is increased markedly in shock. systolic blood pressure may remain unchanged or rise, although mean arterial pressure typically falls. cardiac output is increased because of the positive inotropic and chronotropic effects of the drug in the face of diminished peripheral vascular resistance. the cardiac effects of isoproterenol may lead to palpitations, sinus tachycardia, and more serious arrhythmias; large doses of isoproterenol may cause myocardial necrosis in animals. isoproterenol relaxes almost all varieties of smooth muscle when the tone is high, but this action is most pronounced on bronchial and gast
rointestinal smooth muscle. it prevents or relieves bronchoconstriction, but tolerance to this effect develops with overuse of the drug. in man, isoproterenol causes less hyperglycemia than does epinephrine. isoproterenol and epinephrine are equally effective in stimulating the release of free fatty acids and energy production. absorption, fate, and excretion. isoproterenol is metabolized primarily in the liver and other tissues by comt. isoproterenol is a relatively poor substrate for mao and is not taken up by sympathetic neurons to the same extent as are epinephrine and norepinephrine. the duration of action of isoproterenol may therefore be longer than that of epinephrine, but is still brief.

Carcinogenesis and Mutagenesis and Impairment of Fertility:

Carcinogenesis, mutagenesis, impairment of fertility long-term studies in animals to evaluate the carcinogenic potential of isoproterenol hydrochloride have not been done. mutagenic potential and effect on fertility have not been determined. there is no evidence from human experience that isoproterenol hydrochloride injection may be carcinogenic or mutagenic or that it impairs fertility.

How Supplied:

How supplied ndc container concentration fill quantity 0548-9501-00 single-dose vial 0.2 mg/ml 1 ml 10 × 1 ml single dose vials 0548-9502-00 single-dose vial 1 mg/5 ml (0.2 mg/ml) 5 ml 10 × 5 ml single dose vials protect from light. keep in opaque container until used. store at 20° to 25°c (68° to 77°f). [see usp controlled room temperature.] do not use if the injection is pinkish or darker than slightly yellow or contains a precipitate.

Package Label Principal Display Panel:

Principle display panel: vial label (1 ml) ndc 0548- 9501 -00 rx only isoproterenol hcl injection, usp 0.2 mg/ml intravenous, subcutaneous, intramuscular or intracardiac use only. 1 ml single-dose vial protect from light amphastar pharmaceuticals, inc. rancho cucamonga, ca 91730 u.s.a. 7395016c/6-17 0548-9051-00 vial label (1 ml)

Principle display panel: carton (1 ml) 10 x 1 ml single-dose vials ndc 0548- 9501 -00 rx only isoproterenol hydrochloride injection, usp 0.2 mg/ml intravenous, subcutaneous, intramuscular or intracardiac use only. sterile injection amphastar pharmaceuticals, inc. rancho cucamonga, ca 91730 u.s.a. carton (1 ml)

Principle display panel: vial label (5 ml) ndc 0548- 9502 -00 rx only isoproterenol hcl injection, usp 1 mg/ml (0.2 mg/ml) intravenous, subcutaneous, intramuscular or intracardiac use only. 5 ml single-dose vial protect from light amphastar pharmaceuticals, inc. rancho cucamonga, ca 91730 u.s.a. 7395026c/6-17 0548-9052-00 vial label (5 ml)

Principle display panel: carton (5 ml) 10 x 5 ml single-dose vials ndc 0548- 9502 -00 rx only isoproterenol hydrochloride injection, usp 1 mg/5 ml (0.2 mg/ml) intravenous, subcutaneous, intramuscular or intracardiac use only. do not use if the injection is pinkish or darker than slightly yellow or contains a precipitate. amphastar pharmaceuticals, inc. rancho cucamonga, ca 91730 u.s.a. carton (5 ml)


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