4 Ml Verapamil Hydrochloride 2.5 Mg/ml Prefilled Syringe
Protect from light.
Rx only
DESCRIPTION
Verapamil hydrochloride is a calcium antagonist or slow-channel inhibitor. Verapamil Hydrochloride Injection, USP is a sterile, nonpyrogenic solution containing verapamil hydrochloride 2.5 mg/mL and sodium chloride 8.5 mg/mL in water for injection. The solution contains no bacteriostat or antimicrobial agent and is intended for single-dose intravenous administration. May contain hydrochloric acid for pH adjustment; pH is 4.0 to 6.5.
The chemical name of Verapamil Hydrochloride, USP is benzeneacetonitrile, α-[3-[{2-(3,4-dimethoxyphenyl)ethyl} methylamino] propyl]-3,4-dimethoxy-α-(1-methylethyl) hydrochloride. Verapamil hydrochloride is a white or practically white crystalline powder. It is practically odorless and has a bitter taste. It is soluble in water; freely soluble in chloroform; sparingly soluble in alcohol; practically insoluble in ether. It has the following structural formula:
Molecular weight: 491.07
Molecular formula: C27H38N2O4 • HCl
Verapamil hydrochloride is not chemically related to other antiarrhythmic drugs.
CLINICAL PHARMACOLOGY
In the isolated rabbit heart, concentrations of verapamil that markedly affect SA nodal fibers or fibers in the upper and middle regions of the AV node have very little effect on fibers in the lower AV node (NH region) and no effect on atrial action potentials or His bundle fibers.
Electrical activity in the SA and AV nodes depends, to a large degree, upon calcium influx through the slow channel. By inhibiting this influx, verapamil slows AV conduction and prolongs the effective refractory period within the AV node in a rate-related manner. This effect results in a reduction of the ventricular rate in patients with atrial flutter and/or atrial fibrillation and a rapid ventricular response.
By interrupting reentry at the AV node, verapamil can restore normal sinus rhythm in patients with paroxysmal supraventricular tachycardias (PSVT), including PSVT associated with Wolff-Parkinson-White syndrome.
Verapamil does not induce peripheral arterial spasm.
Verapamil has a local anesthetic action that is 1.6 times that of procaine on an equimolar basis. It is not known whether this action is important at the doses used in man.
Verapamil does not alter total serum calcium levels.
Aging may affect the pharmacokinetics of verapamil given to hypertensive patients. Elimination half-life may be prolonged in the elderly.
INDICATIONS AND USAGE
Verapamil Hydrochloride Injection, USP is indicated for the following:
• Rapid conversion to sinus rhythm of paroxysmal supraventricular tachycardias, including those associated with accessory bypass tracts (Wolff-Parkinson-White [W-P-W] and Lown-Ganong- Levine [L-G-L] syndromes). When clinically advisable, appropriate vagal maneuvers (e.g., Valsalva maneuver) should be attempted prior to verapamil hydrochloride administration.
• Temporary control of rapid ventricular rate in atrial flutter or atrial fibrillation except when the atrial flutter and/or atrial fibrillation are associated with accessory bypass tracts (Wolff-Parkinson-White (W-P-W) and Lown-Ganong-Levine (L-G-L) syndromes).
In controlled studies in the United States, about 60% of patients with supraventricular tachycardia converted to normal sinus rhythm within 10 minutes after intravenous verapamil hydrochloride. Uncontrolled studies reported in the world literature describe a conversion rate of about 80%. About 70% of patients with atrial flutter and/or fibrillation with a faster ventricular rate respond with a decrease in ventricular rate of at least 20%. Conversion of atrial flutter or fibrillation to sinus rhythm is uncommon (about 10%) after verapamil hydrochloride and may reflect the spontaneous conversion rate, since the conversion rate after placebo was similar. Slowing of the ventricular rate in patients with atrial fibrillation/flutter lasts 30 to 60 minutes after a single injection.
Cardioversion has been used safely and effectively after verapamil hydrochloride injection.
CONTRAINDICATIONS
Verapamil hydrochloride injection is contraindicated in:
1. Severe hypotension or cardiogenic shock.
2. Second- or third-degree AV block (except in patients with a functioning artificial ventricular pacemaker).
3. Sick sinus syndrome (except in patients with a functioning artificial ventricular pacemaker).
4. Severe congestive heart failure (unless secondary to a supraventricular tachycardia amenable to verapamil therapy).
5. Patients receiving
6. Patients with atrial flutter or atrial fibrillation and an accessory bypass tract (e.g., Wolff-Parkinson-White, Lown-Ganong-Levine syndromes) are at risk to develop ventricular tachyarrhythmia including ventricular fibrillation if verapamil is administered. Therefore, the use of verapamil in these patients is contraindicated.
7. Ventricular tachycardia: Administration of intravenous verapamil to patients with wide-complex ventricular tachycardia (QRS ≥ 0.12 sec) can result in marked hemodynamic deterioration and ventricular fibrillation. Proper pretherapy diagnosis and differentiation from wide-complex supraventricular tachycardia is imperative in the emergency room setting.
8. Known hypersensitivity to verapamil hydrochloride.
WARNINGS
Verapamil cannot be removed by hemodialysis.
PREGNANCY
Drug Interactions:
(See
Ivabradine: Concurrent use of verapamil increases exposure to ivabradine and may exacerbate bradycardia and conduction disturbances. Avoid coadministration of verapamil and ivabradine.
Pregnancy:
Labor and Delivery:
There have been few controlled studies to determine whether the use of verapamil during labor or delivery has immediate or delayed adverse effects on the fetus, or whether it prolongs the duration of labor or increases the need for forceps delivery or other obstetric intervention. Such adverse experiences have not been reported in the literature, despite a long history of use of verapamil hydrochloride injection in Europe in the treatment of cardiac side effects of beta-adrenergic agonist agents used to treat premature labor.
Nursing Mothers:
Verapamil crosses the placental barrier and can be detected in umbilical vein blood at delivery. Also, verapamil is excreted in human milk. Because of the potential for adverse reactions in nursing infants from verapamil, nursing should be discontinued while verapamil is administered.
Pediatric Use:
Controlled studies with verapamil have not been conducted in pediatric patients, but uncontrolled experience with intravenous administration in more than 250 patients, about half under 12 months of age and about 25% newborn, indicates that results of treatment are similar to those in adults.
ADVERSE REACTIONS
The following reactions were reported with verapamil hydrochloride injection used in controlled U.S. clinical trials involving 324 patients:
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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The frequency of these adverse reactions was quite low, and experience with their treatment has been limited. |
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Adverse Reaction |
Proven Effective Treatment |
Supportive Treatment |
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|
1. |
Symptomatic hypotension requiring treatment |
Dopamine intravenous |
Intravenous fluids |
|
2. |
Bradycardia, AV block, Asystole |
Isoproterenol HCl intravenous |
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) |
Intravenous fluids (slow drip) |
OVERDOSAGE
Treatment of overdosage should be supportive and individualized. Beta-adrenergic stimulation and/or parenteral administration of calcium injections may increase calcium ion flux across the slow channel, and have been effectively used in treatment of deliberate overdosage with oral verapamil hydrochloride. Verapamil cannot be removed by hemodialysis.
Clinically significant hypotensive reactions or high-degree AV block should be treated with vasopressor agents or cardiac pacing, respectively. Asystole should be handled by the usual measures including isoproterenol hydrochloride, other vasopressor agents, or cardiopulmonary resuscitation (see
DOSAGE AND ADMINISTRATION
For stability reasons this product is not recommended for dilution with Sodium Lactate Injection, USP in polyvinyl chloride bags. Verapamil is physically compatible and chemically stable for at least 24 hours at 25°C protected from light in most common large volume parenteral solutions. Admixing verapamil hydrochloride injection with albumin, amphotericin B, hydralazine hydrochloride and trimethoprim with sulfamethoxazole should be avoided. Verapamil hydrochloride injection will precipitate in any solution with a pH above 6.0.
HOW SUPPLIED/STORAGE AND HANDLING
Verapamil Hydrochloride Injection, USP 2.5 mg/mL is supplied in single-dose containers as follows:
| Unit of Sale | Concentration | Each |
|---|---|---|
|
NDC 0409-4011-01
|
5 mg/2 mL |
NDC 0409-4011-61 |
|
NDC 0409-1144-02
|
10 mg/4 mL |
NDC 0409-1144-62 |
|
NDC 0409-1144-05
|
5 mg/2 mL |
NDC 0409-1144-65 |
Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.]
Protect from light by retaining in package until ready to use.
Distributed by Hospira, Inc., Lake Forest, IL 60045 USA
LAB-0885-5.0
Revised: 07/2026
PRINCIPAL DISPLAY PANEL - 4 mL Vial Label
4 mL Single-dose
NDC 0409-1144-62
Rx only
Verapamil HCl
Injection, USP
10 mg/4 mL (2.5 mg/mL)
Distributed by Hospira, Inc., Lake Forest, IL 60045 USA
Protect from light.
For I.V. use only.
RL–7066
PRINCIPAL DISPLAY PANEL - 4 mL Vial Carton
4 mL Single-dose Fliptop Vial
NDC 0409-1144-02
Contains 5 of NDC 0409-1144-62
Verapamil Hydrochloride Injection, USP
10 mg/4 mL (2.5 mg/mL)
Protect from light. For Intravenous use only.
Rx only
MADE IN ITALY
Distributed by Hospira, Inc., Lake Forest, IL 60045 USA
Hospira
PRINCIPAL DISPLAY PANEL - 2 mL Vial Label
2 mL Single-dose
NDC 0409-1144-65
Rx only
Verapamil HCl
Injection, USP
5 mg/2 mL (2.5 mg/mL)
Protect from light. For Intravenous use only.
Dist. by Hospira, Inc., Lake Forest, IL 60045 USA
RL–7063
PRINCIPAL DISPLAY PANEL - 2 mL Vial Carton
25 x 2 mL Single-dose Fliptop Vial
NDC 0409-1144-05
Contains 25 of NDC 0409-1144-65
Verapamil Hydrochloride
Injection, USP
5 mg/2 mL (2.5 mg/mL)
Protect from light.
For Intravenous use only.
Rx only
Hospira
PRINCIPAL DISPLAY PANEL - 2 mL Ampul Label
2 mL
NDC 0409-4011-61
Verapamil HCl
Injection, USP
5 mg/2 mL (2.5 mg/mL)
Protect from light.
For Intravenous use only.
Rx only
RL–7064
Distributed by Hospira, Inc.
Lake Forest, IL 60045 USA
Hospira
PRINCIPAL DISPLAY PANEL - 2 mL Ampul Container Label
2 mL Single-dose 5 Ampuls
NDC 0409-4011-01
Contains 5 of NDC 0409-4011-61
Verapamil Hydrochloride
Injection, USP
5 mg/2 mL (2.5 mg/mL)
Rx only
Protect from light. Keep ampuls in tray until time of use.
For Intravenous use only.
Each mL contains verapamil hydrochloride 2.5 mg (equivalent to
2.3 mg verapamil); sodium chloride 8.5 mg. May contain
hydrochloric acid for pH adjustment. 0.301 mOsmol/mL (calc.)
pH 4.0 to 6.5
Verapamil Hydrochloride Inj., USP should be given as a slow
intravenous injection over at least a two minute period of time.
Discard unused portion. Usual dosage: See insert. Store at 20 to
25°C (68 to 77°F). [See USP Controlled Room Temperature.]
MADE IN ITALY
Distributed by
Hospira, Inc.,
Lake Forest, IL 60045 USA
Hospira
RL - 6999