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Verelan PM

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Verelan PM

Verelan PM

Verelan PM Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Verelan PM (verapamil hydrochloride) Extended-Release Capsules are used to treat hypertension (high blood pressure), angina (chest pain), and certain heart rhythm disorders. It is a calcium channel blocker. This medication is available in generic form. Common side effects include dizziness, slow heartbeat, constipation, stomach upset, nausea, headache, and tiredness.

The usual daily dose of extended-release Verelan PM is 200 mg given by mouth once daily at bedtime. Verelan PM may interact with buspirone, cimetidine, clonidine, other blood pressure medications, cyclosporine, digoxin, lithium, lovastatin or simvastatin, theophylline, antibiotics, antifungals, beta-blockers, cancer medicines, heart rhythm medications, HIV/AIDS medicines, sedatives, or seizure medications. Tell your doctor all medications and supplements you use. During pregnancy, Verelan PM should be used only when prescribed. This medication passes into breast milk, but it is unlikely to harm a nursing infant. Consult your doctor before breastfeeding.

Our Verelan PM (verapamil hydrochloride) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Verelan PM in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • fast or slow heartbeats;
  • feeling like you might pass out;
  • fever, sore throat, and headache with a severe blistering, peeling, and red skin rash;
  • restless muscle movements in your eyes, tongue, jaw, or neck;
  • feeling short of breath, even with mild exertion;
  • swelling, rapid weight gain; or
  • nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

  • constipation, nausea;
  • skin rash or itching;
  • dizziness, headache, tired feeling; or
  • warmth, itching, redness, or tingly feeling under your skin.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Verelan PM (Verapamil Hydrochloride) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Verelan PM Overview - Patient Information: Side Effects

SIDE EFFECTS: Dizziness, slow heartbeat, constipation, stomach upset, nausea, headache, and tiredness may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

To lower your risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: swelling ankles/feet, shortness of breath, unusual tiredness, unexplained/sudden weight gain, severe dizziness, fainting, very slow heartbeat.

Tell your doctor immediately if any of these rare but very serious side effects occur: severe stomach/abdominal pain, dark urine, yellowing eyes/skin, persistent nausea/vomiting.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Verelan PM (Verapamil Hydrochloride)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Verelan PM FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Clinical 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 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 Verelan 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 Verelan 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 11.2 Dyspepsia 2.7 1.7
Infection 12.1 * 6.9 Rhinitis 2.7 2.6
Constipation 8.8 * 0.9 Diarrhea 2.4 1.7
Flu Syndrome 3.7 2.6 Pain 2.4 1.7
Peripheral edema 3.7 0.9 Edema 1.7 0.0
Dizziness 3.0 0.9 Nausea 1.7 0.0
Pharyngitis 3.0 2.6 Accidental Injury 1.5 0.0
Sinusitis 3.0 2.6      
*Infection, 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%.

In 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.

Open 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 Verelan 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], 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, macules, sweating, urticaria, Stevens-Johnson syndrome, erythema multiforme.

Special Senses: blurred vision, tinnitus.

Urogenital: gynecomastia, galactorrhea/hyperprolactinemia, impotence, increased urination, spotty menstruation.

Other: allergy aggravated, asthenia*.

Treatment of Acute Cardiovascular Adverse Reactions

The frequency of cardiovascular adverse reactions that require therapy is rare; hence, experience with their treatment is limited. Whenever severe hypotension or complete AV block occurs following oral administration of verapamil, apply the appropriate emergency measures immediately; e.g., intravenously administered norepinephrine bitartrate, atropine sulfate, isoproterenol HCl (all in the usual doses), or calcium gluconate (10% solution). In patients with hypertrophic cardiomyopathy, use alpha-adrenergic agents (phenylephrine HCl, metaraminol bitartrate, or methoxamine HCl) to maintain blood pressure, and isoproterenol and avoid norepinephrine. If further support is necessary, inotropic agents (dopamine HCl or dobutamine HCl) may be administered. Actual treatment and dosage depends on the severity of the clinical situation and the judgment and experience of the treating physician.

Read the entire FDA prescribing information for Verelan PM (Verapamil Hydrochloride) »

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Verelan PM - User Reviews

Verelan PM User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Verelan PM sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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