pharmacopeia
2D structure
2-(3,4-dimethoxyphenyl)-5-[2-(3,4-dimethoxyphenyl)ethyl-methylamino]-2-propan-2-ylpentanenitrile
SMILES CC(C)C(CCCN(C)CCC1=CC(=C(C=C1)OC)OC)(C#N)C2=CC(=C(C=C2)OC)OC
InChIKey SGTNSNPWRIOYBX-UHFFFAOYSA-N

Mechanism of action

Sourced from openFDA

Mechanism-of-action classes: Adrenergic beta-Antagonists; Calcium Channel Antagonists; Cytochrome P450 3A Inhibitors; Cytochrome P450 3A4 Inhibitors; L-Calcium Channel Receptor Antagonists; P-Glycoprotein Inhibitors.

Calcium ChannelCytochrome P450 3ACytochrome P450 3A4L-Calcium Channel ReceptorP-Glycoprotein

Indications

Sourced from openFDA
  • Verapamil Hydrochloride Tablets are indicated for the treatment of the following: Angina 1. Angina at rest including: – Vasospastic (Prinzmetal’s variant) angina – Unstable (crescendo, pre-infarction) angina 2.ICD-10: I20.9

Contraindications

Sourced from openFDA
  • Verapamil Hydrochloride Tablets are contraindicated in: 1. Severe left ventricular dysfunction (see WARNINGS ) 2.contraindicated

Dosage & administration

Sourced from openFDA

The dose of verapamil must be individualized by titration. The usefulness and safety of dosages exceeding 480 mg/day have not been established; therefore, this daily dosage should not be exceeded. Since the half-life of verapamil increases during chronic dosing, maximum response may be delayed. Angina: Clinical trials show that the usual dose is 80 mg to 120 mg three times a day. However, 40 mg three times a day may be warranted in patients who may have an increased response to verapamil (e.g., decreased hepatic function, elderly, etc.). Upward titration should be based on therapeutic efficacy and safety evaluated approximately eight hours after dosing. Dosage may be increased at daily (e.g., patients with unstable angina) or weekly intervals until optimum clinical response is obtained. Arrhythmias: The dosage in digitalized patients with chronic atrial fibrillation (see PRECAUTIONS ) ranges from 240 to 320 mg/day in divided (three times a day or four times a day) doses. The dosage for prophylaxis of PSVT (non-digitalized patients) ranges from 240 to 480 mg/day in divided (three times a day or four times a day) doses. In general, maximum effects for any given dosage will be apparent during the first 48 hours of therapy. Essential hypertension: Dose should be individualized by titration. The usual initial monotherapy dose in clinical trials was 80 mg three times a day (240 mg/day). Daily dosages of 360 and 480 mg have been used but there is no evidence that dosages beyond 360 mg provided added effect.

Warnings & precautions

Sourced from openFDA

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 with continued verapamil treatment.

Adverse reactions

Sourced from openFDA

Serious adverse reactions are uncommon when verapamil hydrochloride 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. The following reactions to orally administered verapamil occurred at rates greater than 1% or occurred at lower rates but appeared clearly drug-related in clinical trials in 4,954 patients: Constipation 7.3% Dyspnea 1.4% Dizziness 3.3% Bradycardia (HR<50/min) 1.4% Nausea 2.7% AV block total (1°, 2°, 3°) 1.2 % 1.2% Hypotension 2.5% 2° and 3° 0.8% Headache 2.2% Rash 1.2% Edema 1.9% Flushing 0.6% CHF,Pulmonary edema 1.8% Fatigue 1.7% Elevated liver enzymes (see WARNINGS ) In clinical trials related to the control of ventricular response in digitalized patients who had atrial fibrillation or flutter, ventricular rates below 50 at rest occurred in 15% of patients and asymptomatic hypotension occurred in 5% of patients. The following reactions, reported in 1% 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.

Use in specific populations

Sourced from openFDA

Pregnancy: Pregnancy Category C. Reproduction studies have been performed in rabbits and rats at oral doses up to 1.5 (15 mg/kg/day) and 6 (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. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Verapamil crosses the placental barrier and can be detected in umbilical vein blood at delivery.

Overdosage

Sourced from openFDA

Treat all verapamil overdoses as serious and maintain observation for at least 48 hours (especially the extended-release formulation), preferably under continuous hospital care. Delayed pharmacodynamic consequences may occur with the extended-release formulation. Verapamil is known to decrease gastrointestinal transit time. Treatment of overdosage should be supportive. Beta-adrenergic stimulation or parenteral administration of calcium solutions may increase calcium ion flux across the slow channel and have been used effectively in treatment of deliberate overdosage with verapamil. In a few reported cases, overdose with calcium channel blockers has been associated with hypotension and bradycardia, initially refractory to atropine but becoming more responsive to this treatment when the patients received large doses (close to 1 gram/hour for more than 24 hours) of calcium chloride. Verapamil cannot be removed by hemodialysis. Clinically significant hypotensive reactions or high degree AV block should be treated with vasopressor agents or cardiac pacing, respectively. Asystole should be handled by the usual measures, including cardiopulmonary resuscitation.

Approval history

Sourced from openFDA
  • Mar 30, 1984NDANDA018925Exela Pharma
  • Oct 1, 1986ANDAANDA070994Watson Labs
  • Oct 1, 1986ANDAANDA070995Watson Labs
  • May 6, 1987ANDAANDA070737Hospira
  • May 6, 1987ANDAANDA070738Hospira
  • Apr 5, 1988ANDAANDA071881Heritage
  • May 29, 1990NDANDA019614Azurity
  • Nov 25, 1998NDANDA020943Azurity

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
4,229 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Dyspnoea3508.3%
  2. 2Nausea3448.1%
  3. 3Drug Interaction3157.4%
  4. 4Dizziness2906.9%
  5. 5Hypotension2906.9%
  6. 6Fatigue2666.3%
  7. 7Diarrhoea2636.2%
  8. 8Completed Suicide2475.8%
  9. 9Vomiting2405.7%
  10. 10Abdominal Pain2395.7%
  11. 11Headache2375.6%
  12. 12Cough2355.6%
  13. 13Drug Ineffective2355.6%
  14. 14Asthenia2345.5%
  15. 15Fall2335.5%

Literature

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Recent PubMed references pinned to Verapamil as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 168 ClinicalTrials.gov registrations naming Verapamil as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Verapamil work?
Mechanism-of-action classes: Adrenergic beta-Antagonists; Calcium Channel Antagonists; Cytochrome P450 3A Inhibitors; Cytochrome P450 3A4 Inhibitors; L-Calcium Channel Receptor Antagonists; P-Glycoprotein Inhibitors.
What is Verapamil used for?
According to FDA labeling, Verapamil carries indications including: Verapamil Hydrochloride Tablets are indicated for the treatment of the following: Angina 1. Angina at rest including: – Vasospastic (Prinzmetal’s variant) angina – Unstable (crescendo, pre-infarction) angina 2.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Verapamil?
Verapamil is classified as Phenylalkylamine derivatives, Calcium Channel Blocker, Adrenergic beta-Antagonists, Calcium Channel Antagonists, Cytochrome P450 3A Inhibitors, Cytochrome P450 3A4 Inhibitors, L-Calcium Channel Receptor Antagonists, P-Glycoprotein Inhibitors, Coronary Arterial Vasodilation, Decreased Blood Pressure, Negative Chronotropy.
What are the brand names for Verapamil?
Verapamil is marketed under brand names including Calan, Isoptin, Verelan.
What are the contraindications for Verapamil?
Verapamil labeling lists contraindications including: Verapamil Hydrochloride Tablets are contraindicated in: 1. Severe left ventricular dysfunction (see WARNINGS ) 2.. Always consult the full prescribing information and a clinician.
Note. Data for verapamil is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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