Diltiazem Hydrochloride Extended-release
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Questions & Answers
Side Effects & Adverse Reactions
Diltiazem prolongs AV node refractory periods without significantly prolonging sinus node recovery time, except in patients with sick sinus syndrome. This effect may rarely result in abnormally slow heart rates (particularly in patients with sick sinus syndrome) or second- or third-degree AV block (9 of 2,111 patients or 0.43%). Concomitant use of diltiazem with beta-blockers or digitalis may result in additive effects on cardiac conduction. A patient with Prinzmetal's angina developed periods of asystole (2 to 5 seconds) after a single dose of 60 mg of diltiazem. (See ADVERSE REACTIONS.)
Although diltiazem has a negative inotropic effect in isolated animal tissue preparations, hemodynamic studies in humans with normal ventricular function have not shown a reduction in cardiac index nor consistent negative effects on contractility (dp/dt). An acute study of oral diltiazem in patients with impaired ventricular function (ejection fraction 24% +/- 6%) showed improvement in indices of ventricular function without significant decrease in contractile function (dp/dt). Experience with the use of diltiazem in combination with beta-blockers in patients with impaired ventricular function is limited. Caution should be exercised when using this combination.
Decreases in blood pressure associated with diltiazem therapy may occasionally result in symptomatic hypotension.
Mild elevations of transaminases with and without concomitant elevation in alkaline phosphatase and bilirubin have been observed in clinical studies. Such elevations were usually transient and frequently resolved even with continued diltiazem treatment. In rare instances, significant elevations in enzymes such as alkaline phosphatase, LDH, SGOT, SGPT, and other phenomena consistent with acute hepatic injury have been noted. These reactions tended to occur early after therapy initiation (1 to 8 weeks) and have been reversible upon discontinuation of drug therapy. The relationship to diltiazem is uncertain in some cases, but probable in some. (See PRECAUTIONS.)
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Diltiazem Hydrochloride Extended-release Capsules, USP (Twice-a-Day Dosage) are indicated for the treatment of hypertension. They may be used alone or in combination with other antihypertensive medications, such as diuretics.
History
There is currently no drug history available for this drug.
Other Information
Diltiazem hydrochloride is a calcium ion influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-4(5H)one,3-(acetyloxy)-5-[2-(dimethylamino)-ethyl]-2,3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride, (+)-cis-. The structural formula is:
C22H26N204S•HCl
Diltiazem hydrochloride, USP is a white to off-white crystalline powder with a bitter taste. It is soluble in water, methanol and chloroform. It has a molecular weight of 450.99. Each extended-release capsule, for oral administration, contains 60 mg, 90 mg, or 120 mg diltiazem hydrochloride. In addition, each capsule contains the following inactive ingredients: Diethyl phthalate, gelatin, hypromellose, maltodextrin, methacrylic acid copolymer Type B, pharmaceutical glaze, polyethylene glycol, povidone, propylene glycol, silicon dioxide, sodium lauryl sulfate, sugar spheres (25/30 mesh), synthetic black iron oxide, titanium dioxide, FD&C Red #40, FD&C Blue #2 Aluminum Lake, FD&C Red #40 Aluminum Lake, FD&C Blue #1 Aluminum Lake, D&C Yellow #10 Aluminum Lake. In addition, the 90 mg product contains D&C Yellow #10 coloring agent.
Diltiazem Hydrochloride Extended-release Capsules, USP (Twice-a-Day Dosage) 60 mg, 90 mg, and 120 mg meet USP Drug Release Test 4.
Sources
Diltiazem Hydrochloride Extended-release Manufacturers
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Cardinal Health
![Diltiazem Hydrochloride Extended-release (Diltiazem Hydrochloride) Capsule [Cardinal Health]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Diltiazem Hydrochloride Extended-release | Cardinal Health
Dosages must be adjusted to each patient's needs, starting with 60 to 120 mg twice daily. Maximum antihypertensive effect is usually observed by 14 days of chronic therapy; therefore, dosage adjustments should be scheduled accordingly. Although individual patients may respond to lower doses, the usual optimum dosage range in clinical trials was 240 to 360 mg/day.
Diltiazem hydrochloride extended-release capsules have an additive antihypertensive effect when used with other antihypertensive agents. Therefore, the dosage of diltiazem hydrochloride extended-release capsules or the concomitant antihypertensives may need to be adjusted when adding one to the other. See WARNINGS and PRECAUTIONS regarding use with beta-blockers.
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