Verapamil Hydrochloride 200 mg Capsule, Extended Release, 100-count — NDC 52536-486-37 (Billing 52536-0486-37)
This is a package of 100 capsules of Verapamil Hydrochloride 200 mg Capsule, Extended Release from Wilshire Pharmaceuticals, Inc., marketed since Nov 2024 and currently FDA-listed; retail pharmacies pay about $5.64 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): 041652
- GCN: 94123
- GPI-14 (Medi-Span): 34000030107030
- HICL (First Databank): 000180
- AHFS class code: 24:04.04.24
- RxCUI (RxNorm): 897584
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
- 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 | $5.636 | $563.55 / 100 capsules |
| Medicaid paysCMS SDUD · 12 mo | $6.00 | $599.77 / 100 capsules |
| Medicare drug plans payPart D · Q2 2026 | $5.18 | $518.22 / 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 Q4 2025
- 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 |
|---|---|---|---|---|
| 52536-0486-37 You're viewing this Main listing | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE | 2024-11-26 | — | Active |
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Verapamil Hydrochloride 200 mgthis 52536-0486-37 | Wilshire | 100 capsules | $5.635 | — | 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
FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.
Where does this data come from?
- FDA Orange Book · refreshed Sep 3, 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.
Where does this data come from?
IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.- FDA label on DailyMed · label index refreshed Oct 1, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
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 ▾
1 INDICATIONS AND USAGE Verapamil Hydrochloride Extended-release Capsules (PM) for oral use is 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. Verapamil Hydrochloride Extended-release Capsules (PM) is a calcium channel blocker 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.
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION THE CONTENTS OF THE Verapamil Hydrochloride Extended-release Capsules (PM) SHOULD NOT BE CRUSHED OR CHEWED. Verapamil Hydrochloride Extended-release Capsules (PM) ARE TO BE SWALLOWED WHOLE OR THE ENTIRE CONTENTS OF THE CAPSULE SPRINKLED ONTO APPLESAUCE. Do not crush or chew capsule contents; swallow capsule whole or sprinkle entire contents onto applesauce ( 2.2 , 17 ) Usual dosage: 200 mg once daily at bedtime; if inadequate response, titrate upward to 300 mg, then 400 mg once daily at bedtime ( 2.1 ) Initial dose of 100 mg once daily at bedtime in patients with renal or hepatic impairment, elderly or low-weight patients ( 2.1 )
2.1Essential Hypertension Administer Verapamil Hydrochloride Extended-release Capsules (PM) once daily at bedtime. Clinical trials studied doses of 100 mg, 200 mg, 300 mg, and 400 mg. The usual daily dose of extended-release Verapamil Hydrochloride Extended-release Capsules (PM) in clinical trials has been 200 mg given by mouth once daily at bedtime.
In rare instances, initial doses of 100 mg a day may be warranted in patients who have an increased response to verapamil [e.g. patients with impaired renal function, impaired hepatic function, elderly, low-weight patients, etc. ( see Use in Specific Populations (8.5 , 8.6 , 8.7) )]. Base upward titration on therapeutic efficacy and safety evaluated approximately 24 hours after dosing.
The antihypertensive effects of Verapamil Hydrochloride Extended-release Capsules (PM) are evident within the first week of therapy. If an adequate response is not obtained with 200 mg of Verapamil Hydrochloride Extended-release Capsules (PM), the dose may be titrated upward in the following manner: a) 300 mg each evening b) 400 mg each evening (2 × 200 mg) When Verapamil Hydrochloride Extended-release Capsules (PM) is administered at bedtime, office evaluation of blood pressure during morning and early afternoon hours is essentially a measure of peak effect.
The usual evaluation of trough effect, which sometimes might be needed to evaluate the appropriateness of any given dose of Verapamil Hydrochloride Extended-release Capsules (PM), would be just prior to bedtime.
2.2Sprinkling the Capsule Contents on Food Verapamil Hydrochloride Extended-release Capsules (PM) capsules may also be administered by carefully opening the capsule and sprinkling the pellets onto one tablespoonful of applesauce. Swallow the applesauce immediately without chewing and follow with a glass of cool water to ensure complete swallowing of the pellets. The applesauce used should not be hot and it should be soft enough to be swallowed without chewing.
Use any pellet/applesauce mixture immediately and do not store for future use. Absorption of the pellets sprinkled onto other foods has not been tested. This method of administration may be beneficial for patients who have difficulty swallowing whole capsules.
Subdividing the contents of a Verapamil Hydrochloride Extended-release Capsules (PM) capsule is not recommended.
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Extended-release capsules controlled onset: 100 mg, 200 mg, and 300 mg. 100 mg: white opaque cap and amethyst body imprinted KU/485 100 mg. 200 mg: amethyst opaque cap and amethyst body imprinted KU/486 200 mg. 300 mg: lavender opaque cap and amethyst body imprinted KU/487 300 mg. Extended-release capsules controlled-onset: 100 mg, 200 mg, and 300 mg (3)
⛔ Contraindications ▾
4 CONTRAINDICATIONS Verapamil is contraindicated in: Severe left ventricular dysfunction [ see Warnings and Precautions (5.1) ]. Hypotension (less than 90 mm Hg systolic pressure) or cardiogenic shock. Sick sinus syndrome (except in patients with a functioning artificial ventricular pacemaker).
Second- or third-degree AV block (except in patients with a functioning artificial ventricular pacemaker). Patients with atrial flutter or atrial fibrillation and an accessory bypass tract (e.g., Wolff-Parkinson-White, Lown-Ganong-Levine syndromes) [ see Warnings and Precautions (5.4) ]. Severe left ventricular dysfunction (4) Hypotension (<90 mmHg systolic pressure) or cardiogenic shock (4) Sick sinus syndrome (except in patients with pacemaker) (4) 2nd- or 3rd-degree AV block (except in patients with pacemaker) (4) Atrial flutter or atrial fibrillation and an accessory bypass tract
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Congestive heart failure or pulmonary edema may develop ( 5.1 ) Hypotension/dizziness may occur ( 5.2 ) Elevated transaminases have occurred; monitor liver function ( 5.3 ) Ventricular fibrillation has occurred in patients with atrial flutter or atrial fibrillation and an accessory bypass tract ( 5.4 ) Reduce dose or discontinue therapy if marked first-degree AV block or progression to second- or third-degree AV block occurs ( 5.5 ) Sinus bradycardia, pulmonary edema, severe hypotension, second-degree AV block, sinus arrest, and death occurred in patients with hypertrophic cardiomyopathy ( 5.6 )
5.1Heart 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 previous clinical experience with 4,954 patients primarily with immediate-release verapamil, 87 (1.8%) developed congestive heart failure or pulmonary edema. Avoid verapamil 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 Drug Interactions (7.4) ].
Control patients with milder ventricular dysfunction, if possible, with optimum doses of digitalis and/or diuretics before verapamil treatment is started [ see Drug Interactions (7.5) ].
5.2Hypotension Occasionally, the pharmacologic action of verapamil may produce a decrease in blood pressure below normal levels which may result in dizziness or symptomatic hypotension. In hypertensive patients, decreases in blood pressure below normal are unusual. The incidence of hypotension observed in 4,954 patients enrolled in clinical trials of other verapamil formulations was 2.5% [ see Adverse Reactions (6.1) ].
In clinical studies of Verapamil Hydrochloride Extended-release Capsules (PM), 1.7% of the patients developed significant hypotension. Tilt table testing (60 degrees) was not able to induce orthostatic hypotension.
5.3Elevated 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.
5.4Accessory 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 (4) ].
Treatment is usually DC-cardioversion. Cardioversion has been used safely and effectively after oral verapamil.
5.5Atrioventricular 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 in previous verapamil clinical trials [see Adverse Reactions (6.1)] .
Marked first-degree b… [Excerpted — this section continues on DailyMed.]
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS Most common adverse reactions (incidence ≥ 3% and more common than in patients treated with placebo) are headache, infection, constipation, flu syndrome, peripheral edema, dizziness, pharyngitis, and sinusitis ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Wilshire Pharmaceuticals, Inc. at 1-877-495-6856 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The adverse reaction information from clinical trials does, however, provide a basis for identifying the adverse events that appear to be related to drug use and for approximating rates. Serious adverse reactions are uncommon when verapamil therapy is initiated with upward dose titration within the recommended single and total daily dose.
See Warnings and Precautions (5.1 , 5.2 , 5.3 , 5.4 , 5.5 ) 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. The following reactions (Table 1) to orally administered Verapamil Hydrochloride Extended-release Capsules (PM) occurred at rates of 2.0% or greater or occurred at lower rates but appeared to be drug-related in clinical trials in hypertension.
Table 1. Adverse Events Occurring in ≥ 2% of Verapamil Hydrochloride Extended-release Capsules (PM) Patients in Placebo- Controlled Clinical Trials All Doses Studied N = 297 % Placebo N = 116 % All Doses Studied N = 297 % Placebo N = 116 % Headache 12.1
11.2Dyspepsia 2.7
1.7 Infection
12.1Infection, primarily upper respiratory infection (URI) and unrelated to study medication. Constipation was typically mild and easily manageable. At the usual once-daily dose of 200 mg, the observed incidence of constipation was 3.9%.
6.9Rhinitis 2.7
2.6Constipation 8.8
0.9Diarrhea 2.4
1.7Flu Syndrome 3.7
2.6Pain 2.4
1.7Peripheral edema 3.7
0.9Edema 1.7
0.0Dizziness 3.0
0.9Nausea 1.7
0.0Pharyngitis 3.0
2.6Accidental Injury 1.5
0.0Sinusitis 3.0
2.6In previous experience with other formulations of verapamil (N=4,954) the following reactions (Table 2) have occurred at rates greater than 1.0% or occurred at lower rates but appeared clearly drug related in clinical trials in 4,954 patients. Table 2. Adverse Events Occurring in >1% (or lower rates and clearly drug related) of Patients with Other Verapamil Formulations Constipation 7.3% Fatigue 1.7% Dizziness 3.3% Bradycardia (HR<50/min) 1.4% Nausea 2.7% Rash 1.2% Hypotension 2.5% AV block (total 1°, 2°, 3°) 1.2% Headache 2.2% AV block (2° and 3°) 0.8% Edema 1.9% Flushing 0.6% CHF/Pulmonary Edema 1.8% In clinical trials related to the control of ventricular response in patients taking digoxin 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.
6.2Open Trials / Postmarketing Experience The following reactions, reported with orally administered verapamil in 2.0% or less of patients, occurred under conditions (open verapamil trials, postmarketing experience [reactions added since the initial US approval of Verapamil Hydrochloride Extended-release Capsules (PM) in 1998 are marked with an asterisk]) where a causal relationship is uncertain; they are listed to alert the physician to a possible relationship: Cardiovascular: angina pectoris, atrioventricular dissociation, ECG Abnormal*, chest pain, claudication, hypertension*, myocardial infarction, palpitations, purpura (vasculitis), syncope.
Digestive System: diarrhea, dry mouth, elevated liver enzymes* [see Warnings and Precautions (5.3)] , gastrointestinal distress… [Excerpted — this section continues on DailyMed.]
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS CYP3A4 inhibitors increase verapamil levels ( 7.1 ) CYP3A4 inducers decrease verapamil levels ( 7.1 ) If simvastatin is co-administered with verapamil, do not exceed doses greater than 10 mg daily of simvastatin ( 7.2 ) If lovastatin is co-administered with verapamil, do not exceed doses greater than 40 mg daily of lovastatin ( 7.2 ) Grapefruit juice may significantly increase verapamil levels ( 7.3 ) Beta blockers: reports of excess bradycardia and AV block, including complete heart block; monitor closely ( 7.4 ) Digoxin levels can increase by 50 to 75%; reduce digoxin dose ( 7.5 ) Alcohol elimination inhibited resulting in elevated ethanol levels ( 7.6)
7.1CYP3A4 Inhibitors and Inducers 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. Hypotension, bradyarrhythmias, and lactic acidosis have been observed in patients receiving concurrent telithromycin, an antibiotic in the ketolide class of antibiotics.
Inducers of CYP3A4 (e.g., rifampin) have caused a lowering of plasma levels of verapamil. Ivabradine Concurrent use of verapamil increases exposure to ivabradine and may exacerbate bradycardia and conduction disturbances. Avoid concomitant use of ivabradine and verapamil.
7.2HMG-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.
7.3Grapefruit Juice Grapefruit juice may significantly increase concentrations of verapamil. Grapefruit juice given to nine healthy volunteers increased S- and R- verapamil AUC 0-12 by 36% and 28%, respectively. Steady state Cmax and Cmin of S-verapamil increased by 57% and 16.7%, respectively with grapefruit juice compared to control.
Similarly, Cmax and Cmin of R-verapamil increased by 40% and 13%, respectively. Grapefruit juice did not affect half-life, nor was there a significant change in AUC 0-12 ratio R/S compared to control. Grapefruit juice did not cause a significant difference in the pharmacokinetics of norverapamil.
This increase in verapamil plasma concentration is not expected to have any clinical consequences.
7.4Beta 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. Asymptomatic bradycardia (36 beats/min) with a wandering atrial pacemaker has been observed in a patient receiving concomitant timolol (a beta-adrenergic blocker) eyedrops and oral verapamil.
A decrease in metoprolol and propranolol clearance has been observed when either drug is administered concomitantly with verapamil. A variable effect has been seen when verapamil and atenolol were given together.
7.5Digitalis Consider reducing digoxin dose when verapamil and digoxin are to be given together. Monitor digoxin level periodically during therapy. Chr… [Excerpted — this section continues on DailyMed.]
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS Use during pregnancy only if potential benefit justifies the potential risk to the fetus ( 8.1 ) Discontinue nursing while verapamil is administered ( 8.3 ) Safety and effectiveness in pediatric patients have not been established ( 8.4 )
8.1Pregnancy Pregnancy Category C. Reproduction studies have been performed in rabbits and rats at oral doses up to 1.9 (15 mg/kg/day) and 7.5 (60 mg/kg/day) times the human oral daily dose, respectively, and have revealed no evidence of teratogenicity. In the rat, however, this multiple of the human dose was embryocidal and retarded fetal growth and development, probably because of adverse maternal effects reflected in reduced weight gains of the dams.
This oral dose has also been shown to cause hypotension in rats. There are no adequate and well-controlled studies in pregnant women. Verapamil should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Verapamil crosses the placental barrier and can be detected in umbilical vein blood at delivery.
8.2Labor and Delivery It is not known 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 in Europe in the treatment of cardiac side effects of beta-adrenergic agonist agents used to treat premature labor.
8.3Nursing Mothers Verapamil is excreted into human milk. In case studies where verapamil concentration in human milk was calculated, the nursing infant doses ranged from less than 0.01% to 0.1% of the mother's verapamil dose. Consider possible infant exposure when verapamil is administered to a nursing woman.
8.4Pediatric Use Safety and effectiveness in pediatric patients have not been established.
8.5Geriatric Use Clinical studies of Verapamil Hydrochloride Extended-release Capsules (PM) were not adequate to determine if subjects aged 65 or over respond differently from younger patients. Other reported clinical experience has not identified differences in response between the elderly and younger patients; however, greater sensitivity to Verapamil Hydrochloride Extended-release Capsules (PM) by some older individuals cannot be ruled out. Aging may affect the pharmacokinetics of verapamil.
Elimination half-life may be prolonged in the elderly [see Clinical Pharmacology (12.3)] . Verapamil is highly metabolized by the liver, and about 70% of the administered dose is excreted as metabolites in the urine. Clinical circumstances, some of which may be more common in the elderly, such as hepatic or renal impairment, should be considered [see Use in Specific Populations (8.6, 8.7)] .
In general, lower initial doses of Verapamil Hydrochloride Extended-release Capsules (PM) may be warranted in the elderly [see Dosage and Administration (2.1)] .
8.6Impaired Hepatic Function Since verapamil is highly metabolized by the liver, consider lower dosages and closely monitor responses to the drug in 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. Monitor for abnormal prolongation of the PR interval or other signs of excessive pharmacologic effects [see Overdosage (10)] .
8.7Impaired Renal Function About 70% of an administered dose of verapamil is excreted as metabolites in the urine. Until further data are available, monitor these patients for abnormal prolongation of the PR interval or other signs of overdosage [see Overdosage (10)] .
8.8Attenuated (decreased) Neuromuscular Transmission It has been reported that verapamil decreases neuromuscular transmission in patients w… [Excerpted — this section continues on DailyMed.]
🤰 Pregnancy ▾
8.1Pregnancy Pregnancy Category C. Reproduction studies have been performed in rabbits and rats at oral doses up to 1.9 (15 mg/kg/day) and 7.5 (60 mg/kg/day) times the human oral daily dose, respectively, and have revealed no evidence of teratogenicity. In the rat, however, this multiple of the human dose was embryocidal and retarded fetal growth and development, probably because of adverse maternal effects reflected in reduced weight gains of the dams.
This oral dose has also been shown to cause hypotension in rats. There are no adequate and well-controlled studies in pregnant women. Verapamil should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Verapamil crosses the placental barrier and can be detected in umbilical vein blood at delivery.
🧒 Pediatric Use ▾
8.4Pediatric Use Safety and effectiveness in pediatric patients have not been established.
🧓 Geriatric Use ▾
8.5Geriatric Use Clinical studies of Verapamil Hydrochloride Extended-release Capsules (PM) were not adequate to determine if subjects aged 65 or over respond differently from younger patients. Other reported clinical experience has not identified differences in response between the elderly and younger patients; however, greater sensitivity to Verapamil Hydrochloride Extended-release Capsules (PM) by some older individuals cannot be ruled out. Aging may affect the pharmacokinetics of verapamil.
Elimination half-life may be prolonged in the elderly [see Clinical Pharmacology (12.3)] . Verapamil is highly metabolized by the liver, and about 70% of the administered dose is excreted as metabolites in the urine. Clinical circumstances, some of which may be more common in the elderly, such as hepatic or renal impairment, should be considered [see Use in Specific Populations (8.6, 8.7)] .
In general, lower initial doses of Verapamil Hydrochloride Extended-release Capsules (PM) may be warranted in the elderly [see Dosage and Administration (2.1)] .
🆘 Overdosage ▾
10 OVERDOSAGE There is no specific antidote for verapamil overdosage; treatment is supportive. Delayed pharmacodynamic consequences may occur with sustained-release formulations, and observe patients 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 noncardiogenic pulmonary edema in patients taking large overdoses of verapamil (up to approximately 9 g). In acute overdosage, consider gastrointestinal decontamination with cathartics and whole bowel irrigation. Calcium, inotropes (i.e., isoproterenol HCl, dopamine HCl, and glucagon), atropine sulfate, 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 gram/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 ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Verapamil is a calcium ion influx inhibitor (L-type calcium channel blocker or calcium channel antagonist). Verapamil exerts its pharmacologic effects by selectively inhibiting the transmembrane influx of ionic calcium into arterial smooth muscle as well as in conductile and contractile myocardial cells without altering serum calcium concentrations. Verapamil binding is voltage-dependent with affinity increasing as the vascular smooth muscle membrane potential is reduced.
In addition, verapamil binding is frequency dependent and apparent affinity increases with increased frequency of depolarizing stimulus. The L-type calcium channel is an oligomeric structure consisting of five putative subunits designated alpha-1, alpha-2, beta, tau, and epsilon. Biochemical evidence points to separate binding sites for 1,4-dihydropyridines, phenylalkylamines, and the benzothiazepines (all located on the alpha-1 subunit).
Although they share a similar mechanism of action, calcium channel blockers represent three heterogeneous categories of drugs with differing vascular-cardiac selectivity ratios.
12.2Pharmacodynamics Essential Hypertension: Verapamil produces its antihypertensive effect by a combination of vascular and cardiac effects. It acts as a vasodilator with selectivity for the arterial portion of the peripheral vasculature. As a result the systemic vascular resistance is reduced and usually without orthostatic hypotension or reflex tachycardia.
Bradycardia (rate less than 50 beats/min) is uncommon. During isometric or dynamic exercise verapamil does not alter systolic cardiac function in patients with normal ventricular function. Verapamil does not alter total serum calcium levels.
However, one report has suggested that calcium levels above the normal range may alter the therapeutic effect of verapamil. Verapamil regularly reduces the total systemic resistance (afterload) against which the heart works both at rest and at a given level of exercise by dilating peripheral arterioles. Electrophysiologic Effects: Electrical activity through the AV node depends, to a significant degree, upon the transmembrane influx of extracellular calcium through the L-type (slow) channel.
By decreasing the influx of calcium, verapamil prolongs the effective refractory period within the AV node and slows AV conduction in a rate-related manner. Normal sinus rhythm is usually not affected, but in patients with sick sinus syndrome, verapamil may interfere with sinus-node impulse generation and may induce sinus arrest or sinoatrial block. Atrioventricular block can occur in patients without pre-existing conduction defects [ see Warnings and Precautions (5.5) ].
Verapamil 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 may shorten the antegrade effective refractory period of the accessory bypass tract. 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 and Precautions (5.4) ].
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. Hemodynamics: Verapamil reduces afterload and myocardial contractility.
In most patients, including those with organic cardiac disease, the negative inotropic action of verapamil is countered by reduction of afterload and cardiac index remains unchanged. During isometric or dynamic exercise, verapamil does not alter systolic cardiac function in patients with normal ventricular function. In patients with severe left ventricular dysfunction (e.g., pulmonary wedge pressure above 20 mm Hg or ejection fraction less than 30%), or in patients taking beta-adr… [Excerpted — this section continues on DailyMed.]
🧬 Mechanism of Action ▾
12.1Mechanism of Action Verapamil is a calcium ion influx inhibitor (L-type calcium channel blocker or calcium channel antagonist). Verapamil exerts its pharmacologic effects by selectively inhibiting the transmembrane influx of ionic calcium into arterial smooth muscle as well as in conductile and contractile myocardial cells without altering serum calcium concentrations. Verapamil binding is voltage-dependent with affinity increasing as the vascular smooth muscle membrane potential is reduced.
In addition, verapamil binding is frequency dependent and apparent affinity increases with increased frequency of depolarizing stimulus. The L-type calcium channel is an oligomeric structure consisting of five putative subunits designated alpha-1, alpha-2, beta, tau, and epsilon. Biochemical evidence points to separate binding sites for 1,4-dihydropyridines, phenylalkylamines, and the benzothiazepines (all located on the alpha-1 subunit).
Although they share a similar mechanism of action, calcium channel blockers represent three heterogeneous categories of drugs with differing vascular-cardiac selectivity ratios.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING Verapamil Hydrochloride Extended-release Capsules (PM); pellet filled capsules are supplied in three dosage strengths: 100 mg: Two piece size 2 hard gelatin capsule, white opaque cap and amethyst body imprinted KU/485 100 mg. Product identification printed in black ink, supplied as follows: NDC 52536-485-37 Bottle of 100s 200 mg: Two piece size 0 hard gelatin capsule, amethyst opaque cap and amethyst body imprinted KU/486 200 mg. Product identification printed in black ink, supplied as follows: NDC 52536-486-37 Bottle of 100s 300 mg: Two piece size 00 hard gelatin capsule, lavender opaque cap and amethyst body imprinted KU/487 300 mg.
Product identification printed in black ink, supplied as follows: NDC 52536-487-37 Bottle of 100s Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F). [See USP Controlled Room Temperature]. Protect from moisture. Dispense in tight, light-resistant container as defined in USP.
📦 Storage and Handling ▾
Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F). [See USP Controlled Room Temperature]. Protect from moisture. Dispense in tight, light-resistant container as defined in USP.
📋 Description ▾
11 DESCRIPTION Verapamil Hydrochloride Extended-release Capsules (PM) is a calcium ion influx inhibitor (slow channel blocker or calcium ion antagonist). Verapamil Hydrochloride Extended-release Capsules (PM) is available for oral administration as a 100 mg hard gelatin capsule (white opaque cap/amethyst body), a 200 mg hard gelatin capsule (amethyst opaque cap/amethyst body), and as a 300 mg hard gelatin capsule (lavender opaque cap/amethyst body). Verapamil is administered as a racemic mixture of the R and S enantiomers.
The structural formulae of the verapamil HCl enantiomers are: C 27 H 38 N 2 O 4 ∙HCl M.W.=491.07 Chemical name: Benzeneacetonitrile, α-[3-[[2-(3,4-dimethoxyphenyl)ethyl]methylamino]propyl]- 3,4-dimethoxy-α-(1-methylethyl)-, monohydrochloride,(±)-. Verapamil HCl is an 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 (PM) capsule contains the following inactive ingredients: D&C Red #28, FD & C Blue #1, FD&C red #40, fumaric acid, gelatin, povidone, shellac, silicon dioxide, sodium lauryl sulfate, starch, sugar spheres, talc, and titanium dioxide. Chemical Structure System Components and Performance: Verapamil Hydrochloride Extended-release Capsules (PM) uses the proprietary CODAS ® (Chronotherapeutic Oral Drug Absorption System) technology, which is designed for bedtime dosing, incorporating a 4 to 5-hour delay in drug delivery.
The controlled-onset delivery system results in a maximum plasma concentration (C max ) of verapamil in the morning hours. These pellet filled capsules provide for extended-release of the drug in the gastrointestinal tract. The Verapamil Hydrochloride Extended-release Capsules (PM) formulation has been designed to initiate the release of verapamil 4-5 hours after ingestion.
This delay is introduced by the level of non-enteric release-controlling polymer applied to drug loaded beads. The release-controlling polymer is a combination of water soluble and water insoluble polymers. As water from the gastrointestinal tract comes into contact with the polymer coated beads, the water soluble polymer slowly dissolves and the drug diffuses through the resulting pores in the coating.
The water insoluble polymer continues to act as a barrier, maintaining the controlled release of the drug. The rate of release is essentially independent of pH, posture and food. Multiparticulate systems such as Verapamil Hydrochloride Extended-release Capsules (PM) have been shown to be independent of gastrointestinal motility.
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION THE CONTENTS OF THE Verapamil Hydrochloride Extended-release Capsules (PM) SHOULD NOT BE CRUSHED OR CHEWED. Verapamil Hydrochloride Extended-release Capsules (PM) ARE TO BE SWALLOWED WHOLE OR THE ENTIRE CONTENTS OF THE CAPSULE SPRINKLED ONTO APPLESAUCE [ see Dosage and Administration (2.2) ]. When the sprinkle method of administration is prescribed, explain the details of the proper technique to the patient. [ See Dosage and Administration (2.2) ].
🍼 Nursing Mothers ▾
8.3Nursing Mothers Verapamil is excreted into human milk. In case studies where verapamil concentration in human milk was calculated, the nursing infant doses ranged from less than 0.01% to 0.1% of the mother's verapamil dose. Consider possible infant exposure when verapamil is administered to a nursing woman.
🧬 Pharmacokinetics ▾
12.3Pharmacokinetics Verapamil is administered as a racemic mixture of the R and S enantiomers. The systemic concentrations of R and S enantiomers, as well as overall bioavailability, are dependent upon the route of administration and the rate and extent of release from the dosage forms. Upon oral administration, there is rapid stereoselective biotransformation during the first pass of verapamil through the portal circulation.
Absorption: In a study in 5 subjects with oral immediate-release verapamil, the systemic bioavailability was from 33% to 65% for the R enantiomer and from 13% to 34% for the S enantiomer. Following oral administration of an immediately releasing formulation every 8 hours in 24 subjects, the relative systemic availability of the S enantiomer compared to the R enantiomer was approximately 13% following a single day's administration and approximately 18% following administration to steady-state. The degree of stereoselectivity of metabolism for Verapamil Hydrochloride Extended-release Capsules (PM) was similar to that for the immediately releasing formulation.
The R and S enantiomers have differing levels of pharmacologic activity. In studies in animals and humans, the S enantiomer has 8 to 20 times the activity of the R enantiomer in slowing AV conduction. In animal studies, the S enantiomer has 15 to 50 times the activity of the R enantiomer in reducing myocardial contractility in isolated blood-perfused dog papillary muscle, respectively, and twice the effect in reducing peripheral resistance.
In isolated septal strip preparations from 5 patients, the S enantiomer was 8 times more potent than the R in reducing myocardial contractility. Dose escalation study data indicate that verapamil concentrations increase disproportionally to dose as measured by relative peak plasma concentrations (C max ) or areas under the plasma concentration vs time curves (AUC). Consumption of a high fat meal just prior to dosing in the morning had no effect on the extent of absorption and a modest effect on the rate of absorption from Verapamil Hydrochloride Extended-release Capsules (PM).
The rate of absorption was not affected by whether the volunteers were supine two hours after night-time dosing or non-supine for four hours following morning dosing. Administering Verapamil Hydrochloride Extended-release Capsules (PM) in the morning increased the extent of absorption of verapamil and/or decreased the metabolism to norverapamil. When the contents of the Verapamil Hydrochloride Extended-release Capsules (PM) 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. Distribution: Although some evidence of lack of dose linearity was observed for Verapamil Hydrochloride Extended-release Capsules (PM), this non-linearity was enantiomer specific, with the R enantiomer showing the greatest degree of non-linearity. Table 3.
Pharmacokinetic Characteristics of Verapamil Enantiomers After Administration of Escalating Doses of Verapamil Hydrochloride Extended-release Capsules (PM) ISOMER 200 300 400 Dose Ratio 1 1.5 2 Relative Cmax R 1 1.89
2.34S 1 1.88
2.5Relative AUC R 1 1.67
2.34S 1 1.35
2.20Racemic verapamil is released from Verapamil Hydrochloride Extended-release Capsules (PM) by diffusion following the gradual solubilization of the water soluble polymer. The rate of solubilization of the water soluble polymer produces a lag period in drug release for approximately 4-5 hours. The drug release phase is prolonged with the peak plasma concentration (C max ) occurring approximately 11 hours after administration.
Trough concentrations occur approximately 4 hours after bedtime dosing while the patient is sleeping. Steady-state pharmacokinetics were determined in healthy volunteers. Steady-state concentration is achieved by day 5 of dos… [Excerpted — this section continues on DailyMed.]
🧬 Pharmacodynamics ▾
12.2Pharmacodynamics Essential Hypertension: Verapamil produces its antihypertensive effect by a combination of vascular and cardiac effects. It acts as a vasodilator with selectivity for the arterial portion of the peripheral vasculature. As a result the systemic vascular resistance is reduced and usually without orthostatic hypotension or reflex tachycardia.
Bradycardia (rate less than 50 beats/min) is uncommon. During isometric or dynamic exercise verapamil does not alter systolic cardiac function in patients with normal ventricular function. Verapamil does not alter total serum calcium levels.
However, one report has suggested that calcium levels above the normal range may alter the therapeutic effect of verapamil. Verapamil regularly reduces the total systemic resistance (afterload) against which the heart works both at rest and at a given level of exercise by dilating peripheral arterioles. Electrophysiologic Effects: Electrical activity through the AV node depends, to a significant degree, upon the transmembrane influx of extracellular calcium through the L-type (slow) channel.
By decreasing the influx of calcium, verapamil prolongs the effective refractory period within the AV node and slows AV conduction in a rate-related manner. Normal sinus rhythm is usually not affected, but in patients with sick sinus syndrome, verapamil may interfere with sinus-node impulse generation and may induce sinus arrest or sinoatrial block. Atrioventricular block can occur in patients without pre-existing conduction defects [ see Warnings and Precautions (5.5) ].
Verapamil 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 may shorten the antegrade effective refractory period of the accessory bypass tract. 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 and Precautions (5.4) ].
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. Hemodynamics: Verapamil reduces afterload and myocardial contractility.
In most patients, including those with organic cardiac disease, the negative inotropic action of verapamil is countered by reduction of afterload and cardiac index remains unchanged. During isometric or dynamic exercise, verapamil does not alter systolic cardiac function in patients with normal ventricular function. In patients with severe left ventricular dysfunction (e.g., pulmonary wedge pressure above 20 mm Hg or ejection fraction less than 30%), or in patients taking beta-adrenergic blocking agents or other cardiodepressant drugs, deterioration of ventricular function may occur [see Drug Interactions (7.4) ].
Pulmonary Function: Verapamil does not induce bronchoconstriction and, hence, does not impair ventilatory function. Verapamil has been shown to have either a neutral or relaxant effect on bronchial smooth muscle.
🔬 Clinical Studies ▾
14 CLINICAL STUDIES Verapamil Hydrochloride Extended-release Capsules (PM) was evaluated in two placebo-controlled, parallel design, double-blind studies of patients with mild to moderate hypertension. In the clinical trials, 413 evaluable patients were randomized to either placebo, 100 mg, 200 mg, 300 mg, or 400 mg and treated for up to 8 weeks. Verapamil Hydrochloride Extended-release Capsules (PM) or placebo was given once daily between 9 pm and 11 pm (nighttime) and blood pressure changes were measured with 36-hour ambulatory blood pressure monitoring (ABPM).
The results of these studies demonstrate that Verapamil Hydrochloride Extended-release Capsules (PM), at 200, 300, and 400 mg, is a consistently and significantly more effective antihypertensive agent than placebo in reducing ambulatory blood pressures. Over this dose range, the placebo-subtracted net decreases in diastolic BP at trough (averaged over 6-10 pm) were dose-related, and ranged from 3.8 to 10.0 mm Hg after 8 weeks of therapy. Although Verapamil Hydrochloride Extended-release Capsules (PM) 100 mg was not effective in reducing diastolic BP at trough when measured by ABPM, efficacy was demonstrated in reducing diastolic BP when measured manually at trough and peak and, from 6 am to 12 noon and over 24 hours when measured by ABPM [ see Dosage and Administration (2.1) for titration schedule].
There were no apparent treatment differences between patient subgroups of different age (older or younger than 65 years), sex and race. For severity of hypertension, "moderate" hypertensives (mean daytime diastolic BP ≥ 105 mm Hg and ≤ 114 mm Hg) appeared to respond better than "mild" hypertensives (mean daytime diastolic BP ≥ 90 mm Hg and ≤ 104 mm Hg). However, sample size for the subgroup comparisons were limited.
🧪 Nonclinical Toxicology ▾
13 NONCLINICAL TOXICOLOGY
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility An 18-month toxicity study in rats, at a low multiple (6-fold) of the maximum recommended human dose, and not the maximum tolerated dose, did not suggest a tumorigenic potential. There was no evidence of a carcinogenic potential of verapamil administered in the diet of rats for two years at doses of 10, 35 and 120 mg/kg/day or approximately 1.3, 4.4 and 15 times, respectively, the maximum recommended human daily dose (400 mg/day or 8 mg/kg/day). Verapamil was not mutagenic in the Ames test in 5 test strains at 3 mg per plate, with or without metabolic activation.
Studies in female rats at daily dietary doses up to 6.9 times (55 mg/kg/day) the maximum recommended human dose did not show impaired fertility. Effects on male fertility have not been determined.
13.2Animal Toxicology and/or Pharmacology In chronic animal toxicology studies verapamil caused lenticular and/or suture line changes at 30 mg/kg/day or greater and frank cataracts at 62.5 mg/kg/day or greater in the beagle dog but not in the rat. Development of cataracts due to verapamil has not been reported in man.
📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ▾
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility An 18-month toxicity study in rats, at a low multiple (6-fold) of the maximum recommended human dose, and not the maximum tolerated dose, did not suggest a tumorigenic potential. There was no evidence of a carcinogenic potential of verapamil administered in the diet of rats for two years at doses of 10, 35 and 120 mg/kg/day or approximately 1.3, 4.4 and 15 times, respectively, the maximum recommended human daily dose (400 mg/day or 8 mg/kg/day). Verapamil was not mutagenic in the Ames test in 5 test strains at 3 mg per plate, with or without metabolic activation.
Studies in female rats at daily dietary doses up to 6.9 times (55 mg/kg/day) the maximum recommended human dose did not show impaired fertility. Effects on male fertility have not been determined.
📄 Package Label / Principal Display Panel ▾
PRINCIPAL DISPLAY PANEL - 100 mg Capsule Bottle Label NDC 52536- 485-37 Verapamil Hydrochloride Extended-release Capsules (PM) 100 mg Rx Only 100 Capsules Wilshire PRINCIPAL DISPLAY PANEL - 100 mg Capsule Bottle Label
PRINCIPAL DISPLAY PANEL - 200 mg Capsule Bottle Label NDC 52536- 486-37 Verapamil Hydrochloride Extended-release Capsules (PM) 200 mg Rx Only 100 Capsules Wilshire Principal Display Panel - 200 mg Capsule Bottle Label
PRINCIPAL DISPLAY PANEL - 300 mg Capsule Bottle Label NDC 52536- 487-37 Verapamil Hydrochloride Extended-release Capsules (PM) 300 mg Rx Only 100 Capsules Wilshire Principal Display Panel - 300 mg Capsule Bottle Label