Verapamil Hydrochloride Pm
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FDA Labeling Changes
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Uses
Verapamil hydrochloride extended-release capsules (PM) for oral use are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily stokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including this drug.
Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC).
Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly.
Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal.
Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy.
History
There is currently no drug history available for this drug.
Other Information
Verapamil hydrochloride is a calcium ion influx inhibitor (slow channel blocker or calcium ion antagonist). Verapamil hydrochloride extended-release capsules, USP (PM) are available for oral administration as a 100 mg hard gelatin capsule (red opaque cap/white opaque body), a 200 mg hard gelatin capsule (red opaque cap/light orange opaque body), and as a 300 mg hard gelatin capsule (red opaque cap/red opaque body). Verapamil is administered as a racemic mixture of the R and S enantiomers.
The structural formula of verapamil hydrochloride is:
Chemical Name: Benzeneacetonitrile, α-[3-[[2-(3,4-dimethoxyphenyl) ethyl]methylamino]propyl]-3,4-dimethoxy-α-(1-methylethyl)-,monohydrochloride,(±)-
Verapamil hydrochloride, USP is an almost white, crystalline powder, practically free of odor, with a bitter taste. It is soluble in water, chloroform and methanol. Verapamil hydrochloride is not structurally related to other cardioactive drugs.
In addition to verapamil hydrochloride, the verapamil hydrochloride extended-release capsules (PM) contain the following inactive ingredients: ammonium hydroxide, colloidal anhydrous silica, dibutyl sebacate, diethyl phthalate, ethylcellulose, hypromellose, maltodextrin, methacrylic acid copolymer, oleic acid, polyethylene glycol, povidone, silicon dioxide, sugar spheres and talc.
Each of the empty gelatin capsules for the 100 mg, 200 mg and 300 mg capsule strengths contain the following: D&C Red No. 28, D&C Red No. 33, D&C Yellow No. 10, FD&C Red No. 40, gelatin, sodium lauryl sulfate and titanium dioxide. In addition, the 200 mg empty gelatin capsule contains FD&C Yellow No. 6.
The imprinting ink contains the following: black iron oxide, D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, propylene glycol and shellac glaze.
Meets USP Dissolution Test 2.
System Components and Performance
Verapamil hydrochloride extended-release capsules (PM) are designed for bedtime dosing, and it incorporates a delayed drug delivery system. This slow onset results in an average maximum plasma concentration (Cmax) of verapamil in the morning hours (approximately 9 to 12 hours following product administration). These bead-filled capsules provide for extended-release of the drug in the gastrointestinal tract. This delay is introduced by the release-controlling polymers applied to drug loaded beads. The release-controlling polymer is a combination of water soluble and water insoluble polymers. As water from the gastrointestinal tract comes into contact with the polymer coated beads, the water soluble polymer slowly dissolves and the drug diffuses through the resulting pores in the coating. The water insoluble polymer continues to act as a barrier, maintaining the controlled release of drug. The rate of release is essentially independent of posture and food. Multiparticulate systems such as verapamil capsules (PM) have been shown to be independent of gastrointestinal motility.
Sources
Verapamil Hydrochloride Pm Manufacturers
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Mylan Pharmaceuticals Inc.
![Verapamil Hydrochloride Pm (Verapamil Hydrochloride) Capsule, Extended Release [Mylan Pharmaceuticals Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Verapamil Hydrochloride Pm | Mylan Pharmaceuticals Inc.
THE CONTENTS OF THE VERAPAMIL HYDROCHLORIDE EXTENDED-RELEASE CAPSULE (PM) SHOULD NOT BE CRUSHED OR CHEWED. VERAPAMIL HYDROCHLORIDE EXTENDED-RELEASE CAPSULES (PM) ARE TO BE SWALLOWED WHOLE OR THE ENTIRE CONTENTS OF THE CAPSULE SPRINKLED ONTO APPLESAUCE.
2.1 Essential HypertensionAdminister verapamil hydrochloride extended-release capsules (PM) once daily at bedtime. Clinical trials studied doses of 100 mg, 200 mg, 300 mg and 400 mg. The usual daily dose of verapamil hydrochloride extended-release capsules (PM) in clinical trials has been 200 mg given by mouth once daily at bedtime. In rare instances, initial doses of 100 mg a day may be warranted in patients who have an increased response to verapamil, [e.g., patients with impaired renal function, impaired hepatic function, elderly, low-weight patients, etc. (see Use in Specific Populations (8.5, 8.6, 8.7))]. Base upward titration on therapeutic efficacy and safety evaluated approximately 24 hours after dosing. The antihypertensive effects of verapamil hydrochloride extended-release capsules (PM) are evident within the first week of therapy.
If an adequate response is not obtained with 200 mg of verapamil hydrochloride extended-release capsules (PM), the dose may be titrated upward in the following manner:
a. 300 mg each evening b. 400 mg each evening (2 x 200 mg)When verapamil hydrochloride extended-release capsules (PM) are administered at bedtime, office evaluation of blood pressure during morning and early afternoon hours is essentially a measure of peak effect. The usual evaluation of trough effect, which sometimes might be needed to evaluate the appropriateness of any given dose of verapamil hydrochloride extended-release capsules (PM), would be just prior to bedtime.
2.2 Sprinkling the Capsule Contents on FoodVerapamil hydrochloride extended-release capsules (PM) may also be administered by carefully opening the capsule and sprinkling the beads onto one tablespoonful of applesauce. Swallow the applesauce immediately without chewing and follow with a glass of cool water to ensure complete swallowing of the beads. The applesauce used should not be hot, and it should be soft enough to be swallowed without chewing. Use any bead/applesauce mixture immediately and do not store for future use. Absorption of the beads sprinkled onto other foods has not been tested. This method of administration may be beneficial for patients who have difficulty swallowing whole capsules. Subdividing the contents of a verapamil hydrochloride extended-release capsule (PM) is not recommended.
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