Verapamil Hydrochloride (Verapamil Hydrochloride)

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Trade Name: Verapamil Hydrochloride

Following information is meant for : Wholesalers, Suppliers, Exporters, Doctors, CROs, Comparator Supplies, Hospitals, MOH Tender Supplies, Generic, Brand, Cooperate Sourcing, India, Institutional Buyers.

Manufacturer: Somerset Therapeutics, LLC

Presentation: INJECTION, SOLUTION, HUMAN PRESCRIPTION DRUG

Strength: 2.5 mg/mL

Storage and handling

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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These products are NOT FOR SALE in US territories. We offer them for Exports outside of US Territories to Trade Professionals or patients with a valid prescription.
Trademark shown are property of their respective owners and GNH India does not lay any claim on them.

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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 and/or sodium hydroxide for pH adjustment; pH is 4.0 to 6.5.u00a0
The chemical name of Verapamil Hydrochloride, USP is benzeneacetonitrile, u03b1-[3-[{2-(3,4-dimethoxyphenyl)ethyl} methylamino] propyl]-3,4-dimethoxy-u03b1-(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: CHNO u2022 HCl
Verapamil hydrochloride is not chemically related to other antiarrhythmic drugs.

Mechanism of Action:
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.
Hemodynamics:
Pharmacokinetics:
Approximately 70% of an administered dose is excreted in the urine and 16% more in the feces within 5 days. About 3% to 4% is excreted as unchanged drug.
Aging may affect the pharmacokinetics of verapamil given to hypertensive patients. Elimination half-life may be prolonged in the elderly.

Verapamil Hydrochloride Injection, USP 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 - see and), the initial use of verapamil hydrochloride injection should, if possible, be in a treatment setting with monitoring and resuscitationn- facilities , including D.C.-cardioversion capability (see , Suggested Treatment of Acute Cardiovascular Adverse Reactions). As familiarity with the patient's response is gained, use in an office setting may be acceptable.
Cardioversion has been used safely and effectively after verapamil hydrochloride injection.

Verapamil hydrochloride injection is contraindicated in:

VERAPAMIL HYDROCHLORIDE SHOULD BE GIVEN AS A SLOW INTRAVENOUS INJECTION OVER AT LEAST A TWO-MINUTE PERIOD OF TIME (see ).
Hypotension:
Extreme Bradycardia/Asystole:n- Arrayn- Suggested Treatment of Acute Cardiovascular Adverse Reactions
Heart Failure:
Concomitant Antiarrhythmic Therapy:
Digitalis:
Procainamide:
Quinidine:
Beta-Adrenergic Blocking Drugs:n- intravenousn- intravenousn- Array
Disopyramide:
Flecainide:
Heart Block:n- Array
Hepatic and Renal Failure:
Verapamil cannot be removed by hemodialysis.
Premature Ventricular Contractions:
Duchenne's Muscular Dystrophy:
Increased Intracranial Pressure:

Drug Interactions:
(See u00a0) Verapamil hydrochloride injection has been used concomitantly with other cardioactive drugs (especially digitalis) without evidence of serious negative drug interactions. In rare instances, including when patients with severe cardiomyopathy, congestive heart failure, or recent myocardial infarction were given beta-adrenergic blocking agents or disopyramide concomitantly with verapamil, serious adverse effects have occurred. Concomitant use of verapamil hydrochloride with u03b2-adrenergic blockers may result in an exaggerated hypotensive response. Such an effect was observed in one study, following the concomitant administration of verapamil and prazosin. It may be necessary to decrease the dose of verapamil and/or dose of the neuromuscular blocking agent when the drugs are used concomitantly. As verapamil is highly bound to plasma proteins, it should be administered with caution to patients receiving other highly protein-bound drugs.

The following reactions were reported with verapamil hydrochloride injection 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.
*Actual treatment and dosage should depend on the severity of the clinical situation and the judgment and experience of the treating physician.

Treatment of overdosage should be supportive and individualized. Beta-adrenergic stimulation and/or parenteral administration of calcium solutions 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 u00a0n

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- -
Arrayn- Repeat dose
Arrayn- Older patients
Pediatric:
Arrayn- Initial dose:
0 to 1 year:n- under continuous ECG monitoring.
1 to 15 yearsn- 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:
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, amphoteric in 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 2.5 mg/mL is supplied in single-dose containers as follows:
Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F) [See USP Controlled Room Temperature].
Protect from light by retaining in package until ready to use.
For Product Inquiry call +1-800-417-9175
Manufactured for:
Somerset Therapeutics, LLC
Hollywood, FL 33024
Made in India
Code No.: KR/DRUGS/KTK/28/289/97
ST-VRP/P/01
Revised:

2 mL Container Vial Label
2 mL Carton Label u2013 Pack of 25
2 mL Carton Label u2013 Pack of 5
4 mL Container Vial Label
4 mL Carton Label u2013 Pack of 5
4 mL Carton Label u2013 Pack of 25
2 mL Container Ampule Label
Ampule Tray Label u2013 Pack of 5

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler, Supplier, Exporters from India of Verapamil Hydrochloride (Verapamil Hydrochloride) which is also known as Verapamil Hydrochloride and Manufactured by Somerset Therapeutics, LLC. It is available in strength of 2.5 mg/mL.

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.