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verapamil hydrochloride injection, USP Adverse Reactions

ADVERSE REACTIONS

The following reactions were reported with verapamil hydrochloride injection used in controlled U.S. clinical trials involving 324 patients:

Cardiovascular: Symptomatic hypotension (1.5%); bradycardia (1.2%); severe tachycardia (1.0%). The worldwide experience in open clinical trials in more than 7,900 patients was similar.

Central Nervous System Effects: Dizziness (1.2%); headache (1.2%). Occasional cases of seizures during verapamil injection have been reported.

Gastrointestinal: Nausea (0.9%); abdominal discomfort (0.6%).

In rare cases of hypersensitive patients, broncho/laryngeal spasm accompanied by itch and urticaria has been reported.

The following reactions have been reported at low frequency: emotional depression, rotary nystagmus, sleepiness, vertigo, muscle fatigue, diaphoresis, and respiratory failure.

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Actual treatment and dosage should depend on the severity of the clinical situation and the judgment and experience of the treating physician.
Suggested Treatment of Acute Cardiovascular Adverse Reactions*
The frequency of these adverse reactions was quite low, and experience with their treatment has been limited.
Adverse ReactionProven Effective TreatmentSupportive Treatment
1.Symptomatic hypotension requiring treatmentDopamine intravenous
Calcium chloride intravenous
Norepinephrine bitartrate intravenous
Metaraminol bitartrate intravenous
Isoproterenol HCl intravenous
Intravenous fluids
Trendelenburg position
2.Bradycardia, AV block, AsystoleIsoproterenol HCl intravenous
Calcium chloride intravenous
Norepinephrine bitartrate intravenous
Atropine intravenous
Cardiac pacing
Intravenous fluids (slow drip)
3.Rapid ventricular rate (due to antegrade conduction in flutter/fibrillation with W-P-W or L-G-L syndromes)DC-cardioversion (high energy may be required)
Procainamide intravenous
Lidocaine intravenous
Intravenous fluids (slow drip)
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