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Verelan

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Verelan

Verelan

Verelan Side Effects Center

Medical Editor: Charles Patrick Davis, MD, PhD

Verelan (verapamil hydrochloride) is indicated for the management of essential hypertension. Verrelan is available in a generic form termed verapamil. Adverse side effects reported have been (in patients with hypertrophic cardiomyopathy) pulmonary edema, severe hypotension, and sinus bradycardia.

Verelan capsules are available in 120, 180, 240 and 360 mg strengths. Verelan sustained-release capsules are for once-a-day administration. If adequate response is not obtained with 120 mg of Verelan, 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. The contents of the Verelan capsule should not be crushed or chewed. Verelan capsules are to be swallowed whole, however, of the entire content of the capsule may be sprinkled onto a spoonful of applesauce and swallowed, not chewed. Severe side effects include heart failure, hypotension, and cardiac problems. Liver problems and interactions with many other medications may occur. Verelan should be used during pregnancy only if clearly needed. Verelan crosses the placental barrier and can be detected in umbilical vein blood at delivery. Verelan is excreted in human milk. Because of the potential for adverse reactions in nursing infants from Verelan, nursing should be discontinued while verapamil is administered. Safety and efficacy of Verelan in the pediatric population has not been established.

Our Verelan 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 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 (Verapamil Hydrochloride) »

What is Prescribing information?

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

Verelan FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

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 Verelan 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 1°,2°, 1.2%
  2° and 3° 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, tinnitis.

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.

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

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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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