Verapamil Hydrochloride 240 mg Capsule, Extended Release, 100-count — NDC 0378-6440-01 (Billing 00378-6440-01)
This is a package of 100 capsules of Verapamil Hydrochloride 240 mg Capsule, Extended Release from Mylan Pharmaceuticals Inc., marketed since May 1999 and currently FDA-listed; retail pharmacies pay about $3.15 per capsule (NADAC). It is this product's only package size.
Other active recalls for Verapamil Hydrochloride (different manufacturers) — 2 · tap to view
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 015067
- GCN: 03002
- GPI-14 (Medi-Span): 34000030107035
- HICL (First Databank): 000180
- AHFS class code: 24:04.04.24
- RxCUI (RxNorm): 897612
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
RxNorm drug class
This medicine belongs to the Calcium Channel Blocker class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
Verapamil is used to treat high blood pressure and to control angina (chest pain). The immediate-release tablets are also used alone or with other medications to prevent and treat irregular heartbeats. Verapamil is in a class of medications called calcium-channel blockers. It works by relaxing the blood vessels so the heart does not have to pump as hard. It also increases the supply of blood and oxygen to the heart and slows electrical activity in the heart to control the heart rate. High blood pressure is a common condition and when not treated, can cause damage to the brain, heart, blood ves...
Read the full MedlinePlus article ↗- It depends on the product. Verapamil tablets treat angina, certain fast heart rhythms and high blood pressure. Extended-release forms are used for high blood pressure. The injectio...
- Extended-release tablets are taken with food in the morning. The PM capsules are taken at bedtime. Swallow capsules whole, or sprinkle the entire contents on applesauce. Never crus...
- How should I take my extended-release verapamil?
- Constipation is the most common, along with headache, dizziness and ankle swelling. Tell your doctor if they bother you. Call right away for fainting, a very slow heartbeat, shortn...
Patient education
Supplement & herbal interactions
Verapamil may be associated with lower levels of 2 nutrients — worth a chat with your pharmacist, not a cause for alarm.
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
Ask a licensed pharmacist directly — free, answered by our team.
Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $3.148 | $314.76 / 100 capsules |
| Medicaid paysCMS SDUD · 12 mo | $1.21 | $120.75 / 100 capsules |
| Medicare drug plans payPart D · Q2 2026 | $1.29 | $128.60 / 100 capsules |
Where does this data come from?
- CMS NADAC weekly file · file of Sep 30, 2026
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · through Q1 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 00378-6440-01 You're viewing this Main listing | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC | 1999-05-20 | — | Active |
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Verapamil Hydrochloride 240 mg 00591-2884-01 | Teva | 100 capsules | $1.540 | AB | Discontinued | save 51% |
| Verapamil Hydrochloride 240 mgthis 00378-6440-01 | Mylan | 100 capsules | $3.148 | AB | Availability likely | — |
| Verapamil Hydrochloride 240 mg 52536-0884-01 | Wilshire | 100 capsules | $3.148 | AB | Availability likely | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Sep 3, 2026
- CMS NADAC weekly file · file of Sep 30, 2026
Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
- FDA Orange Book · refreshed Sep 3, 2026
What it looks like
Where does this data come from?
- FDA label on DailyMed · label index refreshed Oct 1, 2026
Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII 5138Q19F1X
Ammonia is a colorless gas made from nitrogen and hydrogen. It's used in medicines as a pH buffer to maintain the correct acidity level and help keep the product stable.
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UNII 35SW5USQ3G
A synthetic yellow dye used to color medicines. It helps make tablets, capsules, and liquids visually distinct so patients can easily identify their medication.
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UNII 4W5IH7FLNY
A clear, oily liquid derived from sebacic acid and butanol. It works as a plasticizer and solvent in pharmaceutical coatings and films, helping them stay flexible and smooth.
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UNII UF064M00AF
Diethyl phthalate is a clear, colorless liquid made from phthalic acid. It's used in medicines as a plasticizer to make tablet coatings flexible and as a solvent to help dissolve and distribute active ingredients evenly throughout the product.
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UNII 7Z8S9VYZ4B
Ethylcellulose is a plant-derived thickener and film-former made by chemically modifying cellulose. It's used as a binder to hold tablet ingredients together, a coating to control how quickly medicine is released, or a thickener in liquid formulations.
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UNII H3R47K3TBD
FD&C Blue No. 1 is a synthetic blue dye approved for use in foods and medicines. It serves as a colorant to give the medication its distinctive appearance and help with product identification.
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UNII L06K8R7DQK
A synthetic blue dye approved by the FDA for use in medications and foods. It serves as a colorant to make pills and liquids visually distinct and easier to identify.
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UNII 3P3ONR6O1S
A synthetic green dye approved by the FDA for use in medicines and foods. It serves as a colorant to make the pill or liquid visually distinctive and help with product identification.
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UNII WZB9127XOA
A synthetic red dye used to color medications and make them easier to identify. It serves as a colorant in tablets, capsules, and liquid formulations.
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UNII XM0M87F357
A dark iron oxide compound that gives medicines their black or dark color. It's used as a colorant in tablets and capsules to help identify the product and make it visually distinctive.
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UNII 2G86QN327L
Gelatin is a protein derived from animal collagen, commonly used in medicines as a gelling agent and capsule material. It helps create soft or hard capsule shells that hold and release medication, and can also thicken liquid formulations.
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UNII 3NXW29V3WO
Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
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UNII 7CVR7L4A2D
A starch-derived carbohydrate produced by breaking down corn, potato, or tapioca starch. It functions as a filler and binder to give the medicine bulk and texture, and sometimes as a mild sweetener or texture enhancer in powders and tablets.
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UNII 5KY68S2577
A synthetic plastic polymer made from two chemical compounds combined in a specific ratio. It forms a coating on tablets and capsules to control how and where the medication dissolves in the digestive tract.
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UNII NX76LV5T8J
A synthetic plastic polymer made from methacrylic acid and ethyl acrylate. It's used as a coating or binder to control how and where the medicine dissolves in your digestive system.
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UNII 2UMI9U37CP
Oleic acid is a naturally occurring fatty acid derived from plant or animal oils. It functions as an emulsifier and solvent in medicines, helping blend water and oil-based ingredients together and dissolving other components.
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UNII 3WJQ0SDW1A
Polyethylene glycol is a synthetic liquid or solid polymer used in medicines as a solvent, lubricant, and humectant. It helps dissolve active ingredients, reduces friction during manufacturing, and retains moisture in the final product.
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UNII FZ989GH94E
Povidone is a synthetic polymer made from a plastic-like material. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in your stomach so the medicine can be absorbed.
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UNII 6DC9Q167V3
Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
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UNII 46N107B71O
Shellac is a natural resin secreted by the lac beetle. It's used as a coating on tablets and capsules to control how quickly the medicine dissolves and to improve appearance and stability.
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UNII ETJ7Z6XBU4
Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
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UNII 368GB5141J
A detergent and foaming agent derived from coconut or palm oil. In medications, it helps break down and mix oil and water-based ingredients, aids in tablet disintegration, and improves how the drug dissolves and spreads in the mouth or digestive system.
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UNII O8232NY3SJ
A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
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UNII 96K6UQ3ZD4
Sucralose is a synthetic sweetener made from sugar. It's added to medicines to improve taste without adding calories, helping make bitter or unpleasant-tasting drugs easier to take.
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UNII 7SEV7J4R1U
A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.
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UNII 15FIX9V2JP
Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
26 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.- FDA label on DailyMed · label index refreshed Oct 1, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
Inactive ingredient FAQ
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Manufacturer & labeler
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Verapamil hydrochloride extended-release capsules are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including this drug.
Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC).
Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly.
Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal.
Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION Essential Hypertension The dose of verapamil hydrochloride extended-release capsules should be individualized by titration. The usual daily dose of extended-release, verapamil hydrochloride capsules, in clinical trials has been 240 mg given by mouth once daily in the morning. However, initial doses of 120 mg a day may be warranted in patients who may have an increased response to verapamil (e.g., elderly, small people, etc.).
Upward titration should be based on therapeutic efficacy and safety evaluated approximately 24 hours after dosing. The antihypertensive effects of verapamil hydrochloride extended-release capsules are evident within the first week of therapy. If adequate response is not obtained with 120 mg of verapamil hydrochloride extended-release capsules, the dose may be titrated upward in the following manner: (a) 180 mg in the morning.
(b) 240 mg in the morning. (c) 360 mg in the morning. (d) 480 mg in the morning.
Verapamil extended-release capsules are for once-a-day administration. When switching from immediate-release verapamil to verapamil hydrochloride extended-release capsules, the same total daily dose of verapamil hydrochloride extended-release capsules can be used. As with immediate-release verapamil, dosages of verapamil hydrochloride extended-release capsules should be individualized and titration may be needed in some patients.
Sprinkling the Capsule Contents on Food Verapamil hydrochloride extended-release bead filled capsules may also be administered by carefully opening the capsule and sprinkling the beads on a spoonful of applesauce. The applesauce should be swallowed immediately without chewing and followed with a glass of cool water to ensure complete swallowing of the beads. The applesauce used should not be hot, and it should be soft enough to be swallowed without chewing.
Any bead/applesauce mixture should be used immediately and not stored for future use. Subdividing the contents of a verapamil hydrochloride extended-release capsule is not recommended.
⛔ Contraindications ▾
CONTRAINDICATIONS Verapamil HCl is contraindicated in: 1. Severe left ventricular dysfunction. (See WARNINGS .) 2.
Hypotension (less than 90 mmHg systolic pressure) or cardiogenic shock. 3. Sick sinus syndrome (except in patients with a functioning artificial ventricular pacemaker).
4. Second- or third-degree AV block (except in patients with a functioning artificial ventricular pacemaker). 5.
Patients with atrial flutter or atrial fibrillation and an accessory bypass tract (e.g., Wolff-Parkinson-White, Lown-Ganong-Levine syndromes). (See WARNINGS .) 6. Patients with known hypersensitivity to verapamil hydrochloride.
⚠️ Warnings ▾
WARNINGS Heart Failure Verapamil has a negative inotropic effect which, in most patients, is compensated by its afterload reduction (decreased systemic vascular resistance) properties without a net impairment of ventricular performance. In clinical experience with 4,954 patients, 87 (1.8%) developed congestive heart failure or pulmonary edema. Verapamil should be avoided in patients with severe left ventricular dysfunction (e.g., ejection fraction less than 30% or moderate to severe symptoms of cardiac failure) and in patients with any degree of ventricular dysfunction if they are receiving a beta-adrenergic blocker.
(See PRECAUTIONS: Drug Interactions .) Patients with milder ventricular dysfunction should, if possible, be controlled with optimum doses of digitalis and/or diuretics before verapamil treatment (note interactions with digoxin under: PRECAUTIONS ). Hypotension Occasionally, the pharmacologic action of verapamil may produce a decrease in blood pressure below normal levels which may result in dizziness or symptomatic hypotension. The incidence of hypotension observed in 4,954 patients enrolled in clinical trials was 2.5%.
In hypertensive patients, decreases in blood pressure below normal are unusual. Tilt table testing (60 degrees) was not able to induce orthostatic hypotension. Elevated Liver Enzymes Elevations of transaminases with and without concomitant elevations in alkaline phosphatase and bilirubin have been reported.
Such elevations have sometimes been transient and may disappear even in the face of continued verapamil treatment. Several cases of hepatocellular injury related to verapamil have been proven by rechallenge; half of these had clinical symptoms (malaise, fever, and/or right upper quadrant pain) in addition to elevations of SGOT, SGPT and alkaline phosphatase. Periodic monitoring of liver function in patients receiving verapamil is therefore prudent.
Accessory Bypass Tract (Wolff-Parkinson-White or Lown-Ganong-Levine) Some patients with paroxysmal and/or chronic atrial flutter or atrial fibrillation and a coexisting accessory AV pathway have developed increased antegrade conduction across the accessory pathway bypassing the AV node, producing a very rapid ventricular response or ventricular fibrillation after receiving intravenous verapamil (or digitalis). Although a risk of this occurring with oral verapamil has not been established, such patients receiving oral verapamil may be at risk and its use in these patients is contraindicated.
(See CONTRAINDICATIONS .) Treatment is usually DC-cardioversion. Cardioversion has been used safely and effectively after oral verapamil. Atrioventricular Block The effect of verapamil on AV conduction and the SA node may lead to asymptomatic first-degree AV block and transient bradycardia, sometimes accompanied by nodal escape rhythms.
PR interval prolongation is correlated with verapamil plasma concentrations, especially during the early titration phase of therapy. Higher degrees of AV block, however, were infrequently (0.8%) observed. Marked first-degree block or progressive development to second- or third-degree AV block requires a reduction in dosage or, in rare instances, discontinuation of verapamil HCl and institution of appropriate therapy depending upon the clinical situation.
Patients with Hypertrophic Cardiomyopathy (IHSS) In 120 patients with hypertrophic cardiomyopathy (most of them refractory or intolerant to propranolol) who received therapy with verapamil at doses up to 720 mg/day, a variety of serious adverse effects were seen. Three patients died in pulmonary edema; all had severe left ventricular outflow obstruction and a past history of left ventricular dysfunction. Eight other patients had pulmonary edema and/or severe hypotension; abnormally high (over 20 mmHg) capillary wedge pressure and a marked left ventricular outflow obstruction were present in most of these patients.
Concomitant administration of quinidine (see PRECAUTIONS: Drug Intera… [Excerpted — this section continues on DailyMed.]
🤒 Adverse Reactions ▾
ADVERSE REACTIONS Serious adverse reactions are uncommon when verapamil HCl therapy is initiated with upward dose titration within the recommended single and total daily dose. See WARNINGS for discussion of heart failure, hypotension, elevated liver enzymes, AV block, and rapid ventricular response. Reversible (upon discontinuation of verapamil) non-obstructive, paralytic ileus has been infrequently reported in association with the use of verapamil.
In clinical trials involving 285 hypertensive patients on verapamil hydrochloride extended-release capsules for greater than 1 week the following adverse reactions were reported in greater than 1.0% of the patients: Constipation 7.4% Headache 5.3% Dizziness 4.2% Lethargy 3.2% Dyspepsia 2.5% Rash 1.4% Ankle Edema 1.4% Sleep Disturbance 1.4% Myalgia 1.1% In clinical trials of other formulations of verapamil HCl (N = 4,954) the following reactions have occurred at rates greater than 1.0%: Constipation 7.3% CHF/Pulmonary Edema 1.8% Dizziness 3.3% Fatigue 1.7% Nausea 2.7% Bradycardia (HR < 50/min) 1.4% Hypotension 2.5% AV block-total 1º, 2º, 3º 1.2% 2º and 3º 0.8% Edema 1.9% Headache 2.2% Flushing 0.6% Rash 1.2% Elevated Liver Enzymes (see WARNINGS ) In clinical trials related to the control of ventricular response in digitalized patients who had atrial fibrillation or atrial flutter, ventricular rate below 50/min at rest occurred in 15% of patients and asymptomatic hypotension occurred in 5% of patients.
The following reactions, reported in 1.0% or less of patients, occurred under conditions (open trials, marketing experience) where a causal relationship is uncertain; they are listed to alert the physician to a possible relationship: Cardiovascular: angina pectoris, atrioventricular dissociation, chest pain, claudication, myocardial infarction, palpitations, purpura (vasculitis), syncope. Digestive System: diarrhea, dry mouth, gastrointestinal distress, gingival hyperplasia. Hemic and Lymphatic: ecchymosis or bruising.
Nervous System: cerebrovascular accident, confusion, equilibrium disorders, extrapyramidal symptoms insomnia, muscle cramps, paresthesia, psychotic symptoms, shakiness, somnolence. Respiratory: dyspnea. Skin: arthralgia and rash, exanthema, hair loss, hyperkeratosis, maculae, sweating, urticaria, Stevens-Johnson syndrome, erythema multiforme.
Special Senses: blurred vision, tinnitus. Urogenital: gynecomastia, impotence, increased urination, spotty menstruation. Treatment of Acute Cardiovascular Adverse Reactions The frequency of cardiovascular adverse reactions which require therapy is rare; hence, experience with their treatment is limited.
Whenever severe hypotension or complete AV block occurs following oral administration of verapamil, the appropriate emergency measures should be applied immediately, e.g., intravenously administered isoproterenol HCl, levarterenol bitartrate, atropine (all in the usual doses), or calcium gluconate (10% solution). In patients with hypertrophic cardiomyopathy (IHSS), alpha-adrenergic agents (phenylephrine, metaraminol bitartrate or methoxamine) should be used to maintain blood pressure, and isoproterenol and levarterenol should be avoided.
If further support is necessary, inotropic agents (dopamine or dobutamine) may be administered. Actual treatment and dosage should depend on the severity and the clinical situation and the judgment and experience of the treating physician.
🧓 Geriatric Use ▾
Geriatric Use The pharmacokinetics of verapamil GITS were studied after 5 consecutive nights of dosing 180 mg in 30 healthy young (19-43 years) versus 30 healthy elderly (65-80 years) male and female subjects. Older subjects had significantly higher mean verapamil C max , C min and AUC (0-24h) compared to younger subjects. Older subjects had mean AUCs that were approximately 1.7-2.0 times higher than those of younger subjects as well as a longer average verapamil t 1/2 (approximately 20 hr vs 13 hr).
🆘 Overdosage ▾
OVERDOSAGE There is no specific antidote for verapamil overdosage; treatment should be supportive. Delayed pharmacodynamic consequences may occur with extended-release formulations, and patients should be observed for at least 48 hours, preferably under continuous hospital care. Reported effects include hypotension, bradycardia, cardiac conduction defects, arrhythmias, hyperglycemia, and decreased mental status.
In addition, there have been literature reports of non-cardiogenic pulmonary edema in patients taking large overdoses of verapamil (up to approximately 9 g). In acute overdosage, gastrointestinal decontamination with cathartics and whole bowel irrigation should be considered. Calcium, inotropes (i.e., isoproterenol, dopamine, and glucagon), atropine, vasopressors (i.e., norepinephrine, and epinephrine), and cardiac pacing have been used with variable results to reverse hypotension and myocardial depression.
In a few reported cases, overdose with calcium channel blockers that was initially refractory to atropine became more responsive to this treatment when the patients received large doses (close to 1 g/hour for more than 24 hours) of calcium chloride. Calcium chloride is preferred to calcium gluconate since it provides 3 times more calcium per volume. Asystole should be handled by the usual measures including cardiopulmonary resuscitation.
Verapamil cannot be removed by hemodialysis.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY Verapamil hydrochloride extended-release capsules are a calcium ion influx inhibitor (slow channel blocker or calcium ion antagonist) which exert its pharmacologic effects by modulating the influx of ionic calcium across the cell membrane of the arterial smooth muscle as well as in conductile and contractile myocardial cells. Normal sinus rhythm is usually not affected by verapamil HCl. However in patients with sick sinus syndrome, verapamil HCl may interfere with sinus node impulse generation and may induce sinus arrest or sinoatrial block.
Atrioventricular block can occur in patients without preexisting conduction defects. (See WARNINGS .) Verapamil HCl does not alter the normal atrial action potential or intraventricular conduction time, but depresses amplitude, velocity of depolarization and conduction in depressed atrial fibers. Verapamil HCl may shorten the antegrade effective refractory period of accessory bypass tracts.
Acceleration of ventricular rate and/or ventricular fibrillation has been reported in patients with atrial flutter or atrial fibrillation and a coexisting accessory AV pathway following administration of verapamil. (See WARNINGS .) Verapamil HCl 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.
Mechanism of Action Essential Hypertension Verapamil HCl exerts antihypertensive effects by decreasing systemic vascular resistance, usually without orthostatic decreases in blood pressure or reflex tachycardia; bradycardia (rate less than 50 beats/minute is uncommon). Verapamil HCl regularly reduces arterial pressure at rest and at a given level of exercise by dilating peripheral arterioles and reducing the total peripheral resistance (afterload) against which the heart works. Pharmacokinetics and Metabolism With the immediate release formulations, more than 90% of the orally administered dose is absorbed, and peak plasma concentrations of verapamil are observed 1 to 2 hours after dosing.
Because of rapid biotransformation of verapamil during its first pass through the portal circulation, the absolute bioavailability ranges from 20% to 35%. Chronic oral administration of the highest recommended dose (120 mg every 6 hours) resulted in plasma verapamil levels ranging from 125 to 400 ng/mL with higher values reported occasionally. A nonlinear correlation between the verapamil HCl dose administered and verapamil plasma levels does exist.
During initial dose titration with verapamil a relationship exists between verapamil plasma concentrations and the prolongation of the PR interval. However, during chronic administration this relationship may disappear. The quantitative relationship between plasma verapamil concentrations and blood pressure reduction has not been fully characterized.
In a multiple dose pharmacokinetic study, peak concentrations for a single daily dose of verapamil hydrochloride extended-release capsules 240 mg were approximately 65% of those obtained with an 80 mg t.i.d. dose of the conventional immediate-release tablets, and the 24 hour post-dose concentrations were approximately 30% higher. At a total daily dose of 240 mg, verapamil hydrochloride extended-release capsules were shown to have a similar extent of verapamil bioavailability based on the AUC-24 as that obtained with the conventional immediate-release tablets.
In this same study verapamil hydrochloride extended-release capsules doses of 120 mg, 240 mg and 360 mg once daily were compared after multiple doses. The ratios of the verapamil and norverapamil AUCs for the verapamil hydrochloride extended-release capsules 120 mg, 240 mg and 360 mg once daily doses are 1 (565 ng•hr/mL):3 (1660 ng•hr/mL):5 (2729 ng•hr/mL) and 1 (621 ng•hr/mL):3 (1614 ng•hr/mL):4 (2535 ng•hr/mL) respectively, indicating that the AUC increased non-proportionately with increasing doses. Food does not affect the extent or rate of the a… [Excerpted — this section continues on DailyMed.]
🧬 Mechanism of Action ▾
Mechanism of Action Essential Hypertension Verapamil HCl exerts antihypertensive effects by decreasing systemic vascular resistance, usually without orthostatic decreases in blood pressure or reflex tachycardia; bradycardia (rate less than 50 beats/minute is uncommon). Verapamil HCl regularly reduces arterial pressure at rest and at a given level of exercise by dilating peripheral arterioles and reducing the total peripheral resistance (afterload) against which the heart works.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Verapamil Hydrochloride Extended-Release Capsules, USP are available containing 120 mg, 180 mg or 240 mg of verapamil hydrochloride, USP. The 120 mg capsules are hard-shell gelatin capsules with a bluish green opaque cap and white opaque body filled with white to off-white beads. The capsules are radially printed with MYLAN over 6320 in black ink on both the cap and the body.
They are available as follows: NDC 0378-6320-01 bottles of 100 capsules The 180 mg capsules are hard-shell gelatin capsules with a bluish green opaque cap and light green opaque body filled with white to off-white beads. The capsules are radially printed with MYLAN over 6380 in black ink on both the cap and the body. They are available as follows: NDC 0378-6380-01 bottles of 100 capsules The 240 mg capsules are hard-shell gelatin capsules with a bluish green opaque cap and bluish green opaque body filled with white to off-white beads.
The capsules are radially printed with MYLAN over 6440 in black ink on both the cap and the body. They are available as follows: NDC 0378-6440-01 bottles of 100 capsules Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Brief digressions above 25°C while not detrimental, should be avoided. Avoid excessive heat.
Protect from moisture. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Call your doctor for medical advice about side effects.
You may report side effects to Mylan at 1-877-446-3679 (1-877-4-INFO-RX) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.
Manufactured by: Mylan Laboratories Limited Hyderabad — 500 096, India 75080580 Revised: 6/2021 MX:CVERER:R1
📋 Description ▾
DESCRIPTION Verapamil hydrochloride extended-release capsules, USP are a calcium ion influx inhibitor (slow channel blocker or calcium ion antagonist). Verapamil hydrochloride extended-release capsules are available for oral administration as a 120 mg hard gelatin capsule (bluish green opaque cap and white opaque body), a 180 mg hard gelatin capsule (bluish green opaque cap and light green opaque body) and a 240 mg hard gelatin capsule (bluish green opaque cap and bluish green opaque body). These bead filled capsules provide an extended-release of the drug in the gastrointestinal tract.
The structural formula of verapamil HCl is given below: C 27 H 38 N 2 O 4 • HCl M.W. 491.07 Chemical name: (±)-5-[(3,4-Dimethoxyphenethyl)methylamino]-2-(3,4-dimethoxyphenyl)-2-isopropylvaleronitrile monohydrochloride. Verapamil HCl, USP is a white or almost white, crystalline powder, practically free of odor, with a bitter taste.
It is soluble in water, chloroform and methanol. Verapamil HCl is not structurally related to other cardioactive drugs. In addition to verapamil HCl the verapamil hydrochloride extended-release capsules contain the following inactive ingredients: ammonium hydroxide, dibutyl sebacate, diethyl phthalate, ethylcellulose, FD&C Green No.
3, gelatin, hypromellose, maltodextrin, methacrylic acid copolymer Type A and B, oleic acid, polyethylene glycol, povidone, silicon dioxide, sodium lauryl sulfate, sugar spheres (which contain cornstarch and sucrose), talc and titanium dioxide, the 180 mg capsules also contain D&C Yellow No. 10. In addition, the black imprinting ink contains black iron oxide, D&C Yellow No.
10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C Red No.
40 Aluminum Lake, propylene glycol and shellac glaze. Verapamil Hydrochloride Structural Formula
⚠️ Precautions ▾
PRECAUTIONS THE CONTENTS OF THE VERAPAMIL HYDROCHLORIDE EXTENDED-RELEASE CAPSULE SHOULD NOT BE CRUSHED OR CHEWED. VERAPAMIL HYDROCHLORIDE EXTENDED-RELEASE CAPSULES ARE TO BE SWALLOWED WHOLE OR THE ENTIRE CONTENTS OF THE CAPSULE SPRINKLED ONTO APPLESAUCE (see DOSAGE AND ADMINISTRATION ). General Use in Patients with Impaired Hepatic Function Since verapamil is highly metabolized by the liver, it should be administered cautiously to patients with impaired hepatic function.
Severe liver dysfunction prolongs the elimination half-life of immediate-release verapamil to about 14 to 16 hours; hence, approximately 30% of the dose given to patients with normal liver function should be administered to these patients. Careful monitoring for abnormal prolongation of the PR interval or other signs of excessive pharmacologic effects (see OVERDOSAGE ) should be carried out. Use in Patients with Attenuated (Decreased) Neuromuscular Transmission It has been reported that verapamil decreases neuromuscular transmission in patients with Duchenne’s muscular dystrophy, and that verapamil prolongs recovery from the neuromuscular blocking agent vecuronium and causes a worsening of myasthenia gravis.
It may be necessary to decrease the dosage of verapamil when it is administered to patients with attenuated neuromuscular transmission. Use in Patients with Impaired Renal Function About 70% of an administered dose of verapamil is excreted as metabolites in the urine. Until further data are available, verapamil should be administered cautiously to patients with impaired renal function.
These patients should be carefully monitored for abnormal prolongation of the PR interval or other signs of overdosage. (See OVERDOSAGE .) Information for Patients When the sprinkle method of administration is prescribed, details of the proper technique should be explained to the patient. (See DOSAGE AND ADMINISTRATION .) Drug-Drug Interactions Drug Interactions Effects of other drugs on verapamil pharmacokinetics In vitro metabolic studies indicate that verapamil is metabolized by cytochrome P450, CYP3A4, CYP1A2, and CYP2C.
Clinically significant interactions have been reported with inhibitors of CYP3A4 (e.g. , erythromycin, ritonavir) causing elevation of plasma levels of verapamil while inducers of CYP3A4 (e.g., rifampin) have caused a lowering of plasma levels of verapamil. Hypotension, bradyarrhythmias, and lactic acidosis have been observed in patients receiving concurrent telithromycin, and antibiotic in the ketolide class of antibiotics. Ivabradine Concurrent use of verapamil increases exposure to ivabradine and may exacerbate bradycardia and conductions disturbances.
Avoid concomitant use of ivabradine and verapamil. HMG-CoA Reductase Inhibitors The use of HMG-CoA reductase inhibitors that are CYP3A4 substrates in combination with verapamil has been associated with reports of myopathy/rhabdomyolysis. Co-administration of multiple doses of 10 mg of verapamil with 80 mg simvastatin resulted in exposure to simvastatin 2.5-fold that following simvastatin alone.
Limit the dose of simvastatin in patients on verapamil to 10 mg daily. Limit the daily dose of lovastatin to 40 mg. Lower starting and maintenance doses of other CYP3A4 substrates (e.g., atorvastatin) may be required as verapamil may increase the plasma concentration of these drugs.
Beta-Blockers Concomitant therapy with beta-adrenergic blockers and verapamil may result in additive negative effects on heart rate, atrioventricular conduction, and/or cardiac contractility. The combination of extended-release verapamil and beta-adrenergic blocking agents has not been studied. However, there have been reports of excess bradycardia and AV block, including complete heart block, when the combination has been used for the treatment of hypertension.
For hypertensive patients, the risk of combined therapy may outweigh the potential benefits. The combination should be used only with caution and close monitoring. Asymptomati… [Excerpted — this section continues on DailyMed.]
🧬 Pharmacokinetics ▾
Pharmacokinetics and Metabolism With the immediate release formulations, more than 90% of the orally administered dose is absorbed, and peak plasma concentrations of verapamil are observed 1 to 2 hours after dosing. Because of rapid biotransformation of verapamil during its first pass through the portal circulation, the absolute bioavailability ranges from 20% to 35%. Chronic oral administration of the highest recommended dose (120 mg every 6 hours) resulted in plasma verapamil levels ranging from 125 to 400 ng/mL with higher values reported occasionally.
A nonlinear correlation between the verapamil HCl dose administered and verapamil plasma levels does exist. During initial dose titration with verapamil a relationship exists between verapamil plasma concentrations and the prolongation of the PR interval. However, during chronic administration this relationship may disappear.
The quantitative relationship between plasma verapamil concentrations and blood pressure reduction has not been fully characterized. In a multiple dose pharmacokinetic study, peak concentrations for a single daily dose of verapamil hydrochloride extended-release capsules 240 mg were approximately 65% of those obtained with an 80 mg t.i.d. dose of the conventional immediate-release tablets, and the 24 hour post-dose concentrations were approximately 30% higher. At a total daily dose of 240 mg, verapamil hydrochloride extended-release capsules were shown to have a similar extent of verapamil bioavailability based on the AUC-24 as that obtained with the conventional immediate-release tablets.
In this same study verapamil hydrochloride extended-release capsules doses of 120 mg, 240 mg and 360 mg once daily were compared after multiple doses. The ratios of the verapamil and norverapamil AUCs for the verapamil hydrochloride extended-release capsules 120 mg, 240 mg and 360 mg once daily doses are 1 (565 ng•hr/mL):3 (1660 ng•hr/mL):5 (2729 ng•hr/mL) and 1 (621 ng•hr/mL):3 (1614 ng•hr/mL):4 (2535 ng•hr/mL) respectively, indicating that the AUC increased non-proportionately with increasing doses. Food does not affect the extent or rate of the absorption of verapamil from the controlled release verapamil hydrochloride extended-release capsule.
The verapamil hydrochloride extended-release 240 mg capsule when administered with food had a C max of 77 ng/mL which occurred 9.0 hours after dosing, and an AUC( 0-inf ) of 1387 ng•hr/mL. Verapamil hydrochloride extended-release capsules 240 mg under fasting conditions had a C max of 77 ng/mL which occurred 9.8 hours after dosing, and an AUC( 0-inf ) of 1541 ng•hr/mL. The bioequivalence of verapamil hydrochloride extended-release capsules 240 mg, administered as the beads sprinkled on applesauce and as the intact capsule, was demonstrated in a single-dose, cross-over study in 32 healthy adults.
Comparative ratios (sprinkled/intact) of verapamil were 0.95, 1.02, and 1.01 for C max , T max , and AUC( 0-inf ) respectively. When the contents of the verapamil hydrochloride extended-release capsule were administered by sprinkling onto one tablespoonful of applesauce, the rate and extent of verapamil absorption were found to be bioequivalent to the same dose when administered as an intact capsule. Similar results were observed with norverapamil.
The time to reach maximum verapamil concentrations (T max ) with verapamil hydrochloride extended-release capsules have been found to be approximately 7-9 hours in each of the single dose (fasting), single dose (fed), the multiple dose (steady state) studies and dose proportionality pharmacokinetic studies. Similarly the apparent half-life (t 1/2 ) has been found to be approximately 12 hours independent of dose. Aging may affect the pharmacokinetics of verapamil.
Elimination half-life may be prolonged in the elderly. In healthy man, orally administered verapamil HCl undergoes extensive metabolism in the liver. Twelve metabolites have been identified in plasma; all except norverapamil are pr… [Excerpted — this section continues on DailyMed.]
📄 Package Label / Principal Display Panel ▾
PRINCIPAL DISPLAY PANEL - 120 mg NDC 0378-6320-01 Verapamil HCl Extended-Release Capsules, USP 120 mg Rx only 100 Capsules Each capsule contains: Verapamil hydrochloride, USP 120 mg Usual Dosage: See accompanying prescribing information. Keep this and all medication out of the reach of children. Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Brief digressions above 25ºC while not detrimental, should be avoided.
Avoid excessive heat. Protect from moisture. Manufactured for: Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A. Made in India Mylan.com RMX6320A1 Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Keep container tightly closed.
Code No.: MH/DRUGS/25/NKD/89 Verapamil Hydrochloride Extended-Released Capsules 120 mg Bottle Label
PRINCIPAL DISPLAY PANEL - 180 mg NDC 0378-6380-01 Verapamil HCl Extended-Release Capsules, USP 180 mg Rx only 100 Capsules Each capsule contains: Verapamil hydrochloride, USP 180 mg Usual Dosage: See accompanying prescribing information. Keep this and all medication out of the reach of children. Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Brief digressions above 25ºC while not detrimental, should be avoided.
Avoid excessive heat. Protect from moisture. Manufactured for: Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A. Made in India Mylan.com RMX6380A1 Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Keep container tightly closed.
Code No.: MH/DRUGS/25/NKD/89 Verapamil Hydrochloride Extended-Released Capsules 180 mg Bottle Label
PRINCIPAL DISPLAY PANEL - 240 mg NDC 0378-6440-01 Verapamil HCl Extended-Release Capsules, USP 240 mg Rx only 100 Capsules Each capsule contains: Verapamil hydrochloride, USP 240 mg Usual Dosage: See accompanying prescribing information. Keep this and all medication out of the reach of children. Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Brief digressions above 25ºC while not detrimental, should be avoided.
Avoid excessive heat. Protect from moisture. Manufactured for: Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A. Made in India Mylan.com RMX6440A1 Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Keep container tightly closed.
Code No.: MH/DRUGS/25/NKD/89 Verapamil Hydrochloride Extended-Released Capsules 240 mg Bottle Label