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%.