ISOPROTERENOL HYDROCHLORIDE INJECTION USP 0.2 MG

What is ISOPROTERENOL HYDROCHLORIDE INJECTION USP?

ISOPROTERENOL HYDROCHLORIDE INJECTION USP 0.2 MG contains ISOPROTERENOL HYDROCHLORIDE : 0.2 MG. It is listed in the Health Canada Drug Product Database under DIN 02502615, held by MARCAN PHARMACEUTICALS INC, supplied as SOLUTION for SUBCUTANEOUS ; INTRAVENOUS ; INTRAMUSCULAR administration. Health Canada currently lists it as marketed, status dated 11-Dec-2020. Nexara Health is a licensed Canadian wholesale distributor (DEL 3-002896-A) and can source this product for hospitals, pharmacies and clinics. Availability and lead time are confirmed per order.

What is ISOPROTERENOL HYDROCHLORIDE INJECTION USP used for?

Symptomatic relief of bronchial asthma and in cases of emphysema, bronchitis and other chronic bronchopulmonary disorders in which bronchospasm is a complicating factor. Injectable form is particularly suitable for the treatment and prevention of (1) Adams-Stokes syndrome and other episodes of heart-block, except when caused by ventricular tachycardia of fibrillation (2) cardiac arrest (3) carotid sinus hypersensitivity (4) ventricular tachycardia and fibrillation (5) laryngobronchospasm during anesthesia (6) as adjunctive therapy in shock.

Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.

Product details and regulatory record

How is it administered?

Parenteral Cardiac Disorders: SC or IM injection of 200 mcg (1 mL of 1:5000 solution, IV injection of 20 mcg (0.1 mL of 1:5000 solution). IV infusion of solution containing 1 mg in 200 mL of 5% glucose at a rate of 1 mL (5 mcg) per minute. Intracardiac injection of 20 mcg (0.1 mL of 1:5000 solution). Laryngobronchospasm: IV injection from 10 to 20 mcg (0.5 to 1 mL of 1:50000 solution). To prepare 1:50000 solution dilute 1 mL of 1:5000 solution to 10 mL with 5% dextrose in water. Adjunctive Therapy in Shock: IV Infusion of 1 mg in 500 mL of 5% dextrose in water administered (after initial 5 mL dose of solution) at a rate of 0.5 mcg to 5 mcg/minute. Infusion rate (up to 30 mcg/minute in advanced shock) 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/minute, it may be advisable to decrease the infusion rate or temporarily discontinue the infusion.

Included because it drives pack selection and wastage. Consult the monograph.

How is it stored and handled?

Store between 15 and 30°C. Protect from light. Discard unused portion. Keep out of reach and sight of children. The injection is not to be used if the colour is pinkish or darker than slightly yellow or if it contains a precipitate.

How is it supplied?

Isoproterenol Hydrochloride Injection USP (0.2 mg/mL) is available in single use 1 mL and 5 mL vial, boxes of 10. 1 mL Isoproterenol Hydrochloride Injection USP available in 2 mL clear glass vial stoppered with 13 mm dark grey rubber stopper & sealed with 13 mm Green MT flip off seal. The 5 mL Isoproterenol Hydrochloride Injection USP available in 5 mL clear glass vial stoppered with 13 mm dark grey rubber stopper & sealed with 13 mm Green MT flip off seal.

Contraindications

Patients with tachyarrhythmias; tachycardia of heart-block caused by digitalis intoxication; ventricular arrhythmias which require inotropic therapy and angina pectoris. Do not administer concomitantly with epinephrine. May be used alternately with epinephrine if indicated, provided a 4-hour interval elapses.

Warnings and precautions

Isoproterenol 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 injection may produce beneficial hemodynamic and metabolic effects. In a few patients, presumably with organic disease of the AV node and its branches, isoproterenol injection has paradoxically been reported to worsen heart block or to precipitate Adams-Stokes attacks during normal sinus rhythm or transient heart block. Isoproterenol 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/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 injection may be given. In addition to the routine monitoring of systemic blood pressure, heart rate, urine flow, and the ECG, the response to therapy should also be monitored by frequent determination of the central venous pressure and blood gases. Patients in shock should be closely observed during isoproterenol hydrochloride injection administration. Determination of cardiac output and circulation time may also be helpful. Appropriate measures should be taken to ensure adequate ventilation. Careful attention should be paid to acid-base balance and to the correction of electrolyte disturbances. In cases of shock associated with bacteremia, suitable antimicrobial therapy is, of course, imperative.

What can be used instead?

Other Canadian products sharing ATC code C01CA02 ISOPRENALINE. 3 of 7 DINs in this group are currently marketed — marketed products are listed first, because that is what can actually be bought. These tables describe supply, not clinical equivalence: substitution rests with the prescriber or pharmacist, and interchangeability is determined provincially.

Who else supplies ISOPRENALINE worldwide?

Nexara tracks national medicine registries and published price lists across multiple markets. ISOPRENALINE appears in 7 registered pack listings across 3 markets, published on 2 different national price bases. Where a Canadian route is closed, that is where an alternative route of supply starts — subject to the import rules in both countries.

Registered listings are not stock. Ask us to confirm what can actually be sourced for your order.