Hyperstat Side Effects

Generic Name: diazoxide

Please note - some side effects for Hyperstat may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Hyperstat Side Effects - for the Professional

Hyperstat

It is reasonable to speculate that the currently recommended minibolus dosing regimen, which has replaced the 300-mg bolus dose in clinical practice, will result in adverse effects which are of similar character but of lesser frequency and severity.

In clinical experience with the rapid bolus administration of 300 mg, the most common adverse reactions reported were: hypotension (7%); nausea and vomiting (4%); dizziness and weakness (2%). Additional adverse reactions reported with bolus administration of 300 mg were as follows:

Cardiovascular: sodium and water retention after repeated injections, especially important in patients with impaired cardiac reserve; hypotension to shock levels; myocardial ischemia, usually transient and manifested by angina, atrial and ventricular arrhythmias, and marked electrocardiographic changes, but occasionally leading to myocardial infarction; optic nerve infarction following too rapid decrease in severely elevated blood pressure; supraventricular tachycardia and palpitation; bradycardia; chest discomfort or nonanginal "tightness in the chest."

Central Nervous System: cerebral ischemia, usually transient but occasionally leading to infarction and manifested by unconsciousness, convulsions, paralysis, confusion, or focal neurological deficit such as numbness of the hands; vasodilative phenomena, such as orthostatic hypotension, sweating, flushing, and generalized or localized sensations of warmth; various transient neurological findings secondary to alteration in regional blood flow to brain, such as headache (sometimes throbbing), dizziness, lightheadedness, sleepiness (also reported as lethargy, somnolence or drowsiness), euphoria or "funny feeling," ringing in the ears and momentary hearing loss, and weakness of short duration; apprehension or anxiety.

Gastrointestinal: rarely, acute pancreatitis; nausea, vomiting and/or abdominal discomfort; anorexia; alteration in taste; parotid swelling; salivation; dry mouth; lacrimation; ileus; constipation and diarrhea.

Other: hyperglycemia in diabetic patients, especially after repeated injections; hyperosmolar coma in an infant; transient hyperglycemia in nondiabetic patients; transient retention of nitrogenous wastes; various respiratory finding secondary to the relaxation of smooth muscle, such as dyspnea, cough and choking sensation; warmth or pain along the injected vein; cellulitis without sloughing and/or phlebitis at the injection site of extravasation; back pain and increased nocturia; hypersensitivity reactions, such as rash, leukopenia and fever; papilledema induced by plasma volume expansion secondary to the administration of diazoxide reported in a patient who had received eleven injections (300 mg/dose) over a 22-day period; malaise and blurred vision; transient cataract in an infant; hirsutism, and decreased libido.

Side Effects by Body System

General

The most common reactions reported following diazoxide administration include hypotension (7%), nausea and vomiting (4%), dizziness and weakness (2%).

Cardiovascular

Cardiovascular effects including sodium and water retention following repeated injections, hypotension, shock, myocardial ischemia, myocardial and cerebral infarction, angina, atrial and ventricular arrhythmias, marked electrocardiographic changes, optic nerve infarction, supraventricular tachycardia and palpitation, bradycardia, and chest discomfort have been reported.

Angina with myocardial and cerebral infarction have been associated with the use of a 300 mg intravenous dose of diazoxide.

One case of optic nerve infarction was reported following a single 300 mg bolus dose of diazoxide, as a result of a sudden reduction in diastolic pressure.

Results from one prospective trial conducted in patients with severe hypertension and coronary artery disease showed a 50% incidence of ischemic changes in the electrocardiogram following single 300 mg bolus injections of diazoxide.

Nervous system

Nervous system affects reported following diazoxide administration include cerebral ischemia, convulsions, paralysis, confusion, numbness of the hands, orthostatic hypotension, sweating, flushing, generalized or localized sensations of warmth, headache, dizziness, lightheadedness, sleepiness, lethargy, somnolence, drowsiness, euphoria, tinnitus, momentary loss of hearing, weakness and anxiety.

Gastrointestinal

Gastrointestinal side effects have been rarely reported and include acute pancreatitis, nausea, vomiting, abdominal discomfort, anorexia, alteration in taste, parotid swelling, salivation, dry mouth, lacrimation, ileus, constipation and diarrhea.

Metabolic

Metabolic effects including hyperglycemia have been reported in diabetic and nondiabetic patients, especially after repeated injections. Transient retention of nitrogenous wastes has also been reported.

Respiratory

Respiratory effects including dyspnea, cough and choking sensation have been reported.

Hypersensitivity

Hypersensitivity reactions characterized by rash, leukopenia, fever and papilledema induced by plasma volume expansion secondary to the administration of diazoxide have been reported.

Other

Other effects including warmth or pain along the injected vein, cellulitis and/or phlebitis at the injection site of extravasation, back pain, increased nocturia, malaise, blurred vision, hirsutism, and decreased libido have been reported.

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