Verelan PM
- Generic Name: verapamil hydrochloride
- Brand Name: Verelan PM
- Drug Class: Antidysrhythmics, IV
Verelan PM(Verapamil Hydrochloride) side effects drug center
Verelan PM Side Effects Center
What Is Verelan PM?
Verelan PM (verapamil hydrochloride) Extended-Release Capsules are a calcium channel blocker used to treat hypertension (high blood pressure), angina (chest pain), and certain heart rhythm disorders. Verelan PM is available in generic form.
What Are Side Effects of Verelan PM?
Common side effects of Verelan PM include:
- dizziness,
- slow heartbeat,
- constipation,
- stomach upset,
- nausea,
- headache,
- tiredness,
- skin rash or itching, or
- flushing (warmth, itching, redness, or tingly feeling under your skin)
Dosage for Verelan PM
The usual daily dose of extended-release Verelan PM is 200 mg given by mouth once daily at bedtime.
What Drugs, Substances, or Supplements Interact with Verelan PM?
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.
Verelan PM During Pregnancy or Breastfeeding
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.
Additional Information
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.
Verelan PM Consumer Information
Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:
- chest pain, fast or slow heart rate;
- a light-headed feeling, like you might pass out;
- shortness of breath (even with mild exertion), swelling, rapid weight gain;
- fever, upper stomach pain, not feeling well; or
- lung problems--anxiety, sweating, pale skin, wheezing, gasping for breath, cough with foamy mucus.
Common side effects may include:
- nausea, constipation;
- headache, dizziness; or
- low blood pressure.
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)
Verelan PM Professional Information
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 alphaadrenergic 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)
&Copy; Verelan PM Patient Information is supplied by Cerner Multum, Inc. and Verelan PM Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.