FDA Clears First Generic of Isoproterenol (Isuprel)

Megan Brooks

August 11, 2017

The US Food and Drug Administration (FDA) has approved the first generic version of isoproterenol hydrochloride injection (Isuprel, Hospira).

Nexus Pharmaceuticals' version of isoproterenol hydrochloride is available as a single-dose vial containing 0.2 mg per 1 mL or 1 mg per 5 mL and is an AP-rated (therapeutically equivalent) generic equivalent of Isuprel, the company said in a news release[1].

"FDA prioritizes the review of potential first generics, which can open the market to competition and drive down prices, in recognition of the fact that drug prices can interfere with patient access to lifesaving medications," the agency said in a statement.

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); for use in cardiac arrest until electric shock or pacemaker therapy is available; for bronchospasm occurring during anesthesia; and 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.

In clinical trials, the most common side effects reported with isoproterenol hydrochloride injection were nervousness, headache, dizziness, nausea, and visual blurring. Cardiovascular side effects included tachycardia, palpitations, angina, Adams-Stokes attacks, pulmonary edema, hypertension, hypotension, ventricular arrhythmias, and tachyarrhythmias.

Isoproterenol hydrochloride injection is contraindicated in patients with tachyarrhythmias; tachycardia or heart block caused by digitalis intoxication; ventricular arrhythmias that require inotropic therapy; and angina pectoris. Respiratory side effects include shortness of breath. Other reported side effects include flushing of the skin, sweating, mild tremors, weakness, and pallor.

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