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.

* 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 Reaction		Proven Effective Treatment	Supportive Treatment
1.	Symptomatic hypotension requiring treatment	Dopamine intravenous Calcium chloride intravenous Norepinephrine bitartrate intravenous Metaraminol bitartrate intravenous Isoproterenol HCl intravenous	Intravenous fluids Trendelenburg position
2.	Bradycardia, AV block, Asystole	Isoproterenol 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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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.

* 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 Reaction		Proven Effective Treatment	Supportive Treatment
1.	Symptomatic hypotension requiring treatment	Dopamine intravenous Calcium chloride intravenous Norepinephrine bitartrate intravenous Metaraminol bitartrate intravenous Isoproterenol HCl intravenous	Intravenous fluids Trendelenburg position
2.	Bradycardia, AV block, Asystole	Isoproterenol 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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