Principal Display Panel - 5 mL Carton Label

NDC 14789-015-05

NEXUS

PHARMACEUTICALS

Isoproterenol Hydrochloride
** Injection, USP**

1 mg/5 mL (0.2 mg/mL)

Intravenous, Subcutaneous
** Intramuscular or Intracardiac Use Only**

5 mLSingle Dose Vial x 10 vials per carton

Rx Only

1. INDICATIONS AND USAGE

Isoproterenol hydrochloride is indicated:

• To improve hemodynamic status in patients in distributive shock and shock due to reduced cardiac output
• For bronchospasm occurring during anesthesia

4. CONTRAINDICATIONS

Isoproterenol hydrochloride is contraindicated in patients with:

• tachycardia
• ventricular arrhythmias
• angina pectoris

5. WARNINGS AND PRECAUTIONS

5.1 Cardiac Arrhythmias and Ischemia

Isoproterenol may induce cardiac arrhythmias and myocardial ischemia in patients, especially patients with coronary artery disease, or cardiomyopathy.

5.2 Allergic Reactions associated with Sulfite

Isoproterenol hydrochloride contains sodium metabisulfite, which may cause mild to severe allergic reactions including anaphylaxis or asthmatic episodes, particularly in patients with a history of allergies. However, the presence of metabisulfite in this product should not preclude its use for treatment in emergency situations, even if the patient is sulfite-sensitive, as the alternatives to using isoproterenol in a life-threatening situation may not be satisfactory.

6. ADVERSE REACTIONS

The following adverse reactions have been associated with use of isoproterenol. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency reliably or to establish a causal relationship to drug exposure.

Nervous system disorders:Nervousness, headache, dizziness, visual blurring

Cardiovascular:Tachycardia, tachyarrhythmias, palpitations, angina, ventricular arrhythmias, Adams-Stokes attacks, pulmonary edema

Respiratory:Dyspnea

Other:Flushing of the skin, sweating, mild tremors, pallor, nausea

7. DRUG INTERACTIONS

Table 1. Clinically Relevant Interactions with Isoproterenol

Epinephrine
Clinical Impact	Both drugs are direct cardiac stimulants, and their combined effects may induce serious arrhythmias upon simultaneous administration.
Intervention	Isoproterenol hydrochloride injection and epinephrine should not be administered simultaneously.
Drugs that may potentiate clinical response of Isoproterenol
Clinical Impact	The effects of isoproterenol may be potentiated by tricyclic antidepressants, monoamine oxidase inhibitors, levothyroxine sodium, and certain antihistamines, notably chlorpheniramine, tripelennamine, and diphenhydramine.
Intervention	Monitor hemodynamic parameters in patients who concurrently are taking tricyclic antidepressants, monoamine oxidase inhibitors, levothyroxine sodium and certain antihistamines. Adjust doses appropriately.
Drugs that may reduce clinical response of Isoproterenol
Clinical Impact	The cardiostimulating and bronchodilating effects of isoproterenol are antagonized by beta-adrenergic blocking drugs, such as propranolol.
Intervention	Monitor for hemodynamic response and relief of bronchospasm and adjust dose appropriately

3. DOSAGE FORMS AND STRENGTHS

Injection solution: single dose, clear glass vials containing isoproterenol in a clear, colorless solution;

• 1 mL containing 0.2 mg/1 mL (0.2 mg/mL)
• 5 mL containing 1 mg/5 mL (0.2 mg/mL)

2. DOSAGE AND ADMINISTRATION

2.1 General Considerations

Inspect visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use if the injection is pinkish or darker than slightly yellow or contains a precipitate. Discard any unused portion.

Diluted solution should be used immediately. Unused material should be discarded.

2.2 Recommended Dosage

Dosage should generally be started at the lowest recommended dose and increased gradually based on patient response.

Recommended dosage for adults with shock and hypoperfusion states:

†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. Adjust the rate of infusion based on heart rate, central venous pressure, systemic blood pressure, and urine flow. If the heart rate exceeds 110 beats per minute, consider decreasing or temporarily discontinuing the infusion.
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)

Recommended dosage for adults with shock and hypoperfusion states:

Route of Administration	Preparation of Dilution	Initial Dose	Subsequent Dose
Bolus Intravenous injection	Dilute 1 mL (0.2 mg) to 10 mL with Sodium Chloride Injection, USP, or 5% Dextrose Injection, USP	10 mcg to 20 mcg per minute (0.5 mL to 1 mL of diluted solution)	The initial dose may be repeated when necessary

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 mcg/kg/min to 1 mcg/kg/min.

11. DESCRIPTION

Isoproterenol hydrochloride is 3,4-Dihydroxy-α-[(isopropylamino)methyl] benzyl alcohol hydrochloride, a beta-adrenergic agonist and a synthetic sympathomimetic amine that is structur ally related to epinephrine. The molecular formula is C 11H 17NO 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, USP	0.2 mg
Edetate Disodium (EDTA) mg	0.2
Sodium Citrate Dihydrate mg	2.07
Citric Acid, Anhydrous mg	2.5
Sodium Chloride	7.0 mg
Water for Injection	qs 1.0 mL

The pH is adjusted between 3.5 and 4.5 with hydrochloric acid and/or sodium hydroxide. The sterile solution is nonpyrogenic and can be administered by the intravenous route.

16. HOW SUPPLIED/STORAGE AND HANDLING

NDC Number	Container	Concentration	Fill	Quantity
14789-011-01	Single-dose vial	0.2 mg/mL	1 mL	10 vials per carton
14789-015-05	Single-dose vial	1 mg/5 mL (0.2 mg/mL)	5 mL	10 vials per carton

Protect from light.

Keep in opaque container until used. Store at 20º to 25ºC (68º to 77ºF). [See USP Controlled Room Temperature.] Do not use if the injection is pinkish or darker than slightly yellow or contains a precipitate.

Discard unused portion.

The container closure is not made with natural rubber latex.

Manufactured in the USA for:
Nexus Pharmaceuticals, Inc.
Lincolnshire, IL 60069, USA

ISPPI01R03
Revised: 03/2023

NEXUS
PHARMACEUTICALS