Product Elements:
Isoproterenol isoproterenol hydrochloride isoproterenol hydrochloride isoproterenol sodium citrate citric acid acetate hydrochloric acid sodium hydroxide water nitrogen edetate disodium sodium chloride colourless liquid isoproterenol isoproterenol hydrochloride isoproterenol hydrochloride isoproterenol sodium citrate citric acid acetate hydrochloric acid sodium hydroxide water nitrogen edetate disodium sodium chloride colourless liquid
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.
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: * 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. 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
Read more...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 diluted 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) 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: â concentrations up to 10 times greater have been used when limitation of volume is essential. â â 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. route of administration preparation of dilution â infusion rate â â 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 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.
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-α-[(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 usp 0.2 mg edetate disodium usp (edta) 0.2 mg sodium chloride usp 7.0 mg sodium citrate, dihydrate usp 2.07 mg citric acid, anhydrous usp 2.5 mg hydrochloric acid nf q.s to adjust ph sodium hydroxide nf q.s to adjust ph water for injection usp q.s to 1.0 ml the ph is adjusted between 2.5 and 4.5 with hydrochloric acid nf or sodium hydroxide nf. the sterile solution is nonpyrogenic and can be administered by the intravenous, intramuscular, subcutaneous, or intracardiac routes. image
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
Read more...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.
How Supplied:
How supplied ndc container concentration fill quantity 69097-521-31 ampul 0.2 mg/ml 1 ml 25 ampuls per carton 69097-522-35 ampul 1 mg/5 ml (0.2 mg/ml) 5 ml 10 ampuls 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. manufactured by: gland pharma limited, india. manufactured for: cipla usa, inc. 10 independence boulevard, suite 300 warren, nj 07059 revised: 7/2020
Package Label Principal Display Panel:
Package label.principal display panel ndc 69097-521-31 rx only isoproterenol hydrochloride injection, usp 0.2 mg/ml intravenous, subcutaneous, intramuscular or intracardiac use only. 1 ml ampul x 25 ampuls per carton cipla 1 ml ndc 69097-521-31 rx only isoproterenol hydrochloride injection, usp 0.2 mg/ml intravenous, subcutaneous, intramuscular or intracardiac use only 1 ml cipla image ndc 69097-522-35 rx only isoproterenol hydrochloride injection, usp 1mg/5ml (0.2mg/ml) intravenous, subcutaneous, intramuscular or intracardiac use only. 5 ml ampul x 10 ampuls per carton cipla 5 ml ndc 69097-522-35 rx only isoproterenol hydrochloride injection, usp 1mg/5ml (0.2mg/ml) intravenous, subcutaneous, intramuscular or intracardiac use only 5 ml cipla image 1 ml ampul carton 1ml label 5 ml ampul carton 5ml label