Covera-HS® (verapamil hydrochloride) Adverse Reactions

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Prescribing Information

Covera-HS^® (verapamil hydrochloride)
Adverse Reactions


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Serious adverse reactions are uncommon when verapamil 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 COVERA-HS occurred at rates greater than 2.0% or occurred at lower rates but appeared drug-related in clinical trials in hypertension and angina:

In previous experience with other formulations of verapamil, the following reactions occurred at rates greater than 1.0% or occurred at lower rates but appeared clearly drug related in clinical trials in 4,954 patients.

The following reactions, reported with orally administered verapamil in 2% 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, AV block (2° & 3°), atrioventricular dissociation, CHF, pulmonary edema, 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, insomnia, muscle cramps, psychotic symptoms, shakiness, somnolence, extrapyramidal symptoms.

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, increased urination, spotty menstruation, impotence.

Other: allergy aggravated, dyspnea.

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, the appropriate emergency measures should be applied immediately; eg, intravenously administered norepinephrine bitartrate, atropine sulfate, isoproterenol HCl (all in usual doses), or calcium gluconate (10% solution). In patients with hypertrophic cardiomyopathy (IHSS), alpha-adrenergic agents (phenylephrine HCl, metaraminol bitartrate, or methoxamine HCl) should be used to maintain blood pressure, and isoproterenol and norepinephrine should be avoided. If further support is necessary, dopamine HCl or dobutamine HCl may be administered. Actual treatment and dosage should depend on the severity of the clinical situation and the judgement and experience of the treating physician.

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Covera-HS® (verapamil hydrochloride)

COVERA-HS Indication and Important Safety Information

Please scroll to see the Indication below.

Important Safety Information

COVERA-HS is indicated for the management of hypertension and angina.

COVERA-HS is contraindicated in patients with severe left ventricular dysfunction, hypotension or cardiogenic shock, sick sinus syndrome, 2° or 3° AV block, or atrial flutter or atrial fibrillation and an accessory bypass tract.

The most commonly reported side effects of COVERA-HS (N=572) compared with placebo (N=261) were constipation (11.7%*/2.7%), headache (6.6%/7.3%), upper respiratory infection (5.4%/4.6%), dizziness (4.7%/2.7%), fatigue (4.5%/3.8%), edema (3.0%/3.1%), nausea (2.1%/1.9%), 1° AV block (1.7%/0.0%), elevated liver enzymes (1.4%/0.8%), and bradycardia (1.4%/0.4%).

Concomitant therapy with β-adrenergic blockers and verapamil may result in additive negative effects on heart rate, AV conduction, and/or cardiac contractility. There have been reports of excessive bradycardia and AV block, including complete heart block. The combination should be used only with caution and close monitoring.

Potential clinically significant interactions can be seen with concomitant therapy of verapamil with digitalis, disopyramide, flecamide, quinidine, lithium, carbamazepine and theophylline as well as other agents. These interactions may result in, but are not limited to, digitalis toxicity, significant hypotension, heart failure, or an increased concentration/sensitivity of the concomitant medication.

Concomitant therapy with oral hypertensive agents, including ACE inhibitors, will usually have an additive effect on lowering BP; patients receiving these combinations should be appropriately monitored.

Since verapamil is highly metabolized by the liver it should be administered cautiously to patients with hepatic impairment. In patients with severe hepatic dysfunction approximately 30% of the recommended dosage may be given; patients should be appropriately monitored.

^*At the typical 240-mg dose, incidence of constipation was 7.2%.

Indication

COVERA-HS is indicated for the management of hypertension and angina.

COVERA-HS is contraindicated in:

Severe left ventricular dysfunction
Hypotension (systolic pressure less than 90 mmHg) 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 (eg, Wolff-Parkinson-White, Lown-Ganong-Levine syndromes)
Patients with known hypersensitivity to verapamil hydrochloride

Please see full prescribing information.

COVERA-HS^®(verapamil hydrochloride) Extended-Release Tablets Controlled-Onset

covera_hs_safety_information.htm

Full Prescribing Information