Covera-HS® (verapamil hydrochloride) Description

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Prescribing Information

Covera-HS^® (verapamil hydrochloride)
Description


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COVERA-HS (verapamil hydrochloride) is a calcium ion influx inhibitor (slow-channel blocker or calcium ion antagonist). COVERA-HS is available for oral administration as pale yellow, round, film-coated tablets containing 240 mg of verapamil hydrochloride and as lavender, round, film-coated tablets containing 180 mg of verapamil hydrochloride. Verapamil is administered as a racemic mixture of the R and S enantiomers. The structural formulae of the verapamil HCl enantiomers are:

Verapamil HCl is an almost white, crystalline powder, practically free of odor, with a bitter taste. It is soluble in water, chloroform, and methanol. Verapamil HCl is not chemically related to other cardioactive drugs.

Inactive ingredients are black ferric oxide, BHT, cellulose acetate, hydroxyethyl cellulose, hydroxypropyl cellulose, hypromellose, magnesium stearate, polyethylene glycol, polyethylene oxide, polysorbate 80, povidone, sodium chloride, titanium dioxide, and coloring agents: 240 mg—FD&C Blue No. 2 Lake and D&C Yellow No. 10 Lake; 180 mg—FD&C Blue No. 2 Lake and D&C Red No. 30 Lake.

System components and performance: The COVERA-HS formulation has been designed to initiate the release of verapamil 4–5 hours after ingestion. This delay is introduced by a layer between the active drug core and outer semipermeable membrane. As water from the gastrointestinal tract enters the tablet, this delay coating is solubilized and released. As tablet hydration continues, the osmotic layer expands and pushes against the drug layer, releasing drug through precision laser-drilled orifices in the outer membrane at a constant rate. This controlled rate of drug delivery in the gastrointestinal lumen is independent of posture, pH, gastrointestinal motility, and fed or fasting conditions.

The biologically inert components of the delivery system remain intact during GI transit and are eliminated in the feces as an insoluble shell.

PRINTER-FRIENDLY

covera_hs_pi_description.htm

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