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Covera-HS

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Covera-HS

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

DRUG DESCRIPTION

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:

COVERA-HS® (verapamil hydrochloride) Structural Formula Illustration

C27H38N2O4• HCl       M.W.= 491.07
Benzeneacetonitrile, (&plsmn;) -α-[3[[2-(3,4-dimethoxyphenyl)
ethyl] methylamino] propyl]- 3,4- dimethoxy-α-
(1-methylethyl) hydrochloride

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.

What are the possible side effects of verapamil?

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...

Read All Potential Side Effects and See Pictures of Covera-HS »

Last reviewed on RxList: 11/9/2011
This monograph has been modified to include the generic and brand name in many instances.

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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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