Verapamil Hydrochloride (Verapamil Hydrochloride)

Trade Name : Verapamil Hydrochloride

Amneal Biosciences LLC

INJECTION, SOLUTION

Strength 2.5 mg/mL

VERAPAMIL HYDROCHLORIDE P-Glycoprotein Inhibitors [MoA],Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Verapamil Hydrochloride (Verapamil Hydrochloride) which is also known as Verapamil Hydrochloride and Manufactured by Amneal Biosciences LLC. It is available in strength of 2.5 mg/mL per ml. Read more

Verapamil Hydrochloride (Verapamil Hydrochloride) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials. Click to know price. Read less

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No data

Verapamil hydrochloride is a calcium antagonist or slow-channel inhibitor. Verapamil hydrochloride injection, USP is a sterile, nonpyrogenic solution containing verapamil hydrochloride USP, 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 4.9 (4.0 to 6.5).
The chemical name of verapamil hydrochloride is benzeneacetonitrile, u03b1-[3-[{2-(3,4-dimethoxyphenyl)ethyl} methylamino] propyl]-3,4-dimethoxy-u03b1-(1-methylethyl) monohydrochloride (u00b1)-.
Verapamil hydrochloride, USP is white or practically white crystalline powder. It is practically odorless and has a bitter taste with a molecular formula CHNOu2022HCl, and a molecular weight of 491.06 g/mol. It is soluble in water; freely soluble in chloroform; sparingly soluble in alcohol; practically insoluble in ether.
It has the following structural formula:n
Verapamil hydrochloride is not chemically related to other antiarrhythmic drugs.

No data

Verapamil hydrochloride injection is indicated for the following:
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.
Because a small fraction (<1%) of patients treated with verapamil hydrochloride respond with life-threatening adverse responses (rapid ventricular rate in atrial flutter/fibrillation, and an accessory bypass tract, marked hypotension, or extreme bradycardia/asystole u2013 n- Arrayn- and n- Arrayn- ), the initial use of verapamil hydrochloride injection should, if possible, be in a treatment setting with monitoring and resuscitation facilities, including D.C.-cardioversion capability (n- Arrayn- , Suggested Treatment of Acute Cardiovascular Adverse Reactions). As familiarity with the patientu2019s response is gained, use in an office setting may be acceptable.
Cardioversion has been used safely and effectively after verapamil hydrochloride injection.

Verapamil hydrochloride 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 beta-adrenergic blocking drugs (e.g., propranolol). verapamil and beta-adrenergic blocking drugs should not be administered in close proximity to each other (within a few hours), since both may have a depressant effect on myocardial contractility and AV conduction.
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 u2265 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.

VERAPAMIL HYDROCHLORIDE SHOULD BE GIVEN AS A SLOW INTRAVENOUS n- INJECTION OVER AT LEAST A TWO-MINUTE PERIOD OF TIME (n- Arrayn- ).
Hypotension
Verapamil hydrochloride often produces a decrease in blood pressure below baseline levels that is usually transient and asymptomatic but may result in dizziness. Systolic pressure less than 90 mm Hg and/or diastolic pressure less than 60 mm Hg was seen in 5% to 10% of patients in controlled U.S. trials in supraventricular tachycardia and in about 10% of the patients with atrial flutter/fibrillation. The incidence of symptomatic hypotension observed in studies conducted in the U.S. was approximately 1.5%. Three of the five symptomatic patients required intravenous pharmacologic treatment (norepinephrine bitartrate, metaraminol bitartrate, or 10% calcium gluconate). All recovered without sequelae.
Extreme Bradycardia/Asystole
Verapamil hydrochloride affects the AV and SA nodes and rarely may produce second- or third-degree AV block, bradycardia, and, in extreme cases, asystole. This is more likely to occur in patients with a sick sinus syndrome (SA nodal disease), which is more common in older patients. Bradycardia associated with sick sinus syndrome was reported in 0.3% of the patients treated in controlled double-blind trials in the U.S. The total incidence of bradycardia (ventricular rate less than 60 beats/min) was 1.2% in these studies. Asystole in patients other than those with sick sinus syndrome is usually of short duration (few seconds or less), with spontaneous return to AV nodal or normal sinus rhythm. If this does not occur promptly, appropriate treatment should be initiated immediately (see and ).
Heart Failure
When heart failure is not severe or rate related, it should be controlled with digitalis glycosides and diuretics, as appropriate, before verapamil is used. In patients with moderately severe to severe cardiac dysfunction (pulmonary wedge pressure above 20 mm Hg, ejection fraction less than 30%), acute worsening of heart failure may be seen.
Concomitant Antiarrhythmic Therapy
Digitalis:
Procainamide:
Quinidine:
Beta-Adrenergic Blocking Drugs:n- intravenous n- intravenous n- Array
Disopyramide:
Flecainide:
Heart Block:n- Arrayn- Suggested Treatment of Acute Cardiovascular Adverse Reactions
Hepatic and Renal Failure:
Verapamil cannot be removed by hemodialysis.
Premature Ventricular Contractions:
Duchenneu2019s Muscular Dystrophy:
Increased Intracranial Pressure:

No data

The following reactions were reported with verapamil hydrochloride used in controlled U.S. clinical trials involving 324 patients:
Cardiovascular:
Central Nervous System Effects:
Gastrointestinal:
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.
To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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 n ).

FOR INTRAVENOUS USE ONLY. VERAPAMIL HYDROCHLORIDE INJECTION SHOULD BE GIVEN AS A SLOW INTRAVENOUS INJECTION OVER AT LEAST A TWO-MINUTE PERIOD OF TIME UNDER CONTINUOUS ELECTROCARDIOGRAPHIC (ECG) AND BLOOD PRESSURE MONITORING.
Adult
Arrayn- Initial dose
Arrayn- Repeat dose
Arrayn- Older patients
Pediatric
Arrayn- Initial dose
0 to 1 year: n- under continuous ECG monitoring
1 to 15 years: n- Do not exceed 5 mg
Arrayn- Repeat dose
0 to 1 year: n- under continuous ECG monitoring
1 to 15 years:n- Do not exceed 10 mg as a single dose.
Note
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Use only if solution is clear and vial seal is intact. Unused amount of solution should be discarded immediately following withdrawal of any portion of contents.
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 25u00b0C 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.

Verapamil Hydrochloride Injection, USP is a clear, colorless solution and supplied in and single-dose clear glass vial. Each mL contains verapamil hydrochloride, USP 2.5 mg.
It is available as follows:
5 mg/2 mL (2.5 mg/mL)
2 mL Single-Dose Vial:u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 NDC 70121-1585-1
25 Vials in a Carton:u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 NDC 70121-1585-5
10 mg/4 mL (2.5 mg/mL)
4 mL Single-Dose Vial:u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 NDC 70121-1586-1
5 Vials in a Carton:u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 NDC 70121-1586-3
Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F) [see USP Controlled Room Temperature].
Protect from light by retaining in carton until ready to use.
Discard unused portion.
Manufactured by:
Amneal Pharmaceuticals Pvt. Ltd.
Parenteral Unit
Ahmedabad 382213, INDIA
Distributed by:
Amneal Pharmaceuticalsn- LLC
Bridgewater, NJ 08807
Rev. 02-2020-02

NDC 70121-1585-1
Verapamil Hydrochloride injection USP
Strength: 5 mg/2 mL (2.5 mg/mL)
R only
Vial Label
Amneal Pharmaceuticals LLC
NDC 70121-1585-5
Verapamil Hydrochloride injection USP
Strength: 5 mg/2 mL n
R only
Carton Labeln
Amneal PharmaceuticalsLLC
NDC 70121-1586-1
Verapamil Hydrochloride injection USP
Strength: 10 mg/4 mL (2.5 mg/mL)
R only
Vial Label
Amneal PharmaceuticalsLLC
NDC 70121-1586-3
Verapamil Hydrochloride injection USP
Strength: 10 mg/4 mL (2.5 mg/mL)
R only
Carton Labeln
Amneal PharmaceuticalsLLC
Arrayn- Array

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Verapamil Hydrochloride (Verapamil Hydrochloride)

Trade Name : Verapamil Hydrochloride

INJECTION, SOLUTION

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

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Verapamil Hydrochloride (Verapamil Hydrochloride)

Trade Name : Verapamil Hydrochloride

INJECTION, SOLUTION

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

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