Dilacor Xr
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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 (22 of 10,119 patients, or 0.2%); 41% of these 22 patients were receiving concomitant beta-adrenoceptor antagonists vs. 17% of the total group. 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 60 mg dose of diltiazem.
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 of 24% ± 6%) showed improvement in indices of ventricular function without significant decrease in contractile function (dp/dt). Worsening of congestive heart failure has been reported in patients with preexisting impairment of ventricular function. 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 serum 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 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 6 weeks) and have been reversible upon discontinuation of drug therapy. The relationship to diltiazem is uncertain in some cases, but probable in some others (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
Dilacor XR capsules are indicated for the treatment of hypertension. Diltiazem hydrochloride may be used alone or in combination with other antihypertensive medications, such as diuretics.
Dilacor XR capsules are indicated for the management of chronic stable angina.
History
There is currently no drug history available for this drug.
Other Information
DILACOR XR® (diltiazem hydrochloride, USP) 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-. Its molecular formula is C22H26N2O4S HCl and its molecular weight is 450.99. Its structural formula is as follows:
Diltiazem hydrochloride, USP is a white to off-white crystalline powder with a bitter taste. It is soluble in water, methanol, and chloroform.
DILACOR XR capsules, for oral administration, contain four units of diltiazem hydrochloride extended-release 60 mg, resulting in the 240 mg dosage strength allowing for the controlled release of diltiazem hydrochloride over a 24-hour period. In addition, each capsule contains the following inactive ingredients: ammonium hydroxide, colloidal silicon dioxide, dibutyl sebacate, ethylcellulose, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, oleic acid, polyethylene glycol and sodium lauryl sulfate. The empty hard-shell gelatin capsules contain FD&C Blue No. 1, FD&C Red No. 40 Aluminum Lake, gelatin, sodium lauryl sulfate and titanium dioxide.
The imprinting ink contains 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.
DILACOR XR capsules 240 mg meet USP Drug Release Test 8.
Sources
Dilacor Xr Manufacturers
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Watson Pharma, Inc.
![Dilacor Xr (Diltiazem Hydrochloride) Capsule, Extended Release [Watson Pharma, Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Dilacor Xr | Watson Pharma, Inc.
Hypertensive or anginal patients who are treated with other formulations of diltiazem can safely be switched to Dilacor XR capsules at the nearest equivalent total daily dose. Subsequent titration to higher or lower doses may, however, be necessary and should be initiated as clinically indicated.
Studies have shown a slight increase in the rate of absorption of Dilacor XR, when ingested with a high fat breakfast; therefore, administration in the morning on an empty stomach is recommended.
Patients should be cautioned that the Dilacor XR capsules should not be opened, chewed or crushed and should be swallowed whole.
Dosage HypertensionDosages must be adjusted to each patient’s needs, starting with 180 mg or 240 mg once daily. Based on the antihypertensive effect, the dose may be adjusted as needed. Individual patients, particularly ≥ 60 years of age, may respond to a lower dose of 120 mg. The usual dosage range studied in clinical trials was 180 mg to 480 mg once daily.
Current clinical experience with the 540 mg dose is limited, the dose may be increased to 540 mg with little or no increased risk of adverse reactions. Doses should not exceed 540 mg once daily.
While a dose of Dilacor XR given once daily may produce an antihypertensive effect similar to the same total daily dose given in divided doses, individual dose adjustment may be needed.
AnginaDosages for the treatment of angina should be adjusted to each patient’s needs, starting with a dose of 120 mg once daily, which may be titrated to doses of up to 480 mg once daily. When necessary, titration may be carried out over a 7 to 14 day period.
Concomitant Use with Other Cardiovascular Agents Sublingual NitroglycerinSublingual nitroglycerin may be taken as required to abort acute anginal attacks during diltiazem therapy.
Prophylactic Nitrate TherapyDiltiazem hydrochloride may be safely coadministered with short- and long-acting nitrates.
Beta-Blockers(See WARNINGS and PRECAUTIONS.)
AntihypertensivesDiltiazem has an additive antihypertensive effect when used with other antihypertensive agents. Therefore, the dosage of diltiazem hydrochloride or the concomitant antihypertensives may need to be adjusted when adding one to the other.
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Actavis Pharma, Inc.
Dilacor Xr | Actavis Pharma, Inc.
Hypertensive or anginal patients who are treated with other formulations of diltiazem can safely be switched to Dilacor XR capsules at the nearest equivalent total daily dose. Subsequent titration to higher or lower doses may, however, be necessary and should be initiated as clinically indicated.
Studies have shown a slight increase in the rate of absorption of Dilacor XR when ingested with a high-fat breakfast; therefore, administration in the morning on an empty stomach is recommended.
Patients should be cautioned that the Dilacor XR capsules should not be opened, chewed or crushed, and should be swallowed whole.
Dosage: Hypertension: Dosages must be adjusted to each patient’s needs, starting with 180 mg or 240 mg once daily. Based on the antihypertensive effect, the dose may be adjusted as needed. Individual patients, particularly ≥60 years of age, may respond to a lower dose of 120 mg. The usual dosage range studied in clinical trials was 180 mg to 480 mg once daily.
Current clinical experience with the 540 mg dose is limited; the dose may be increased to 540 mg with little or no increased risk of adverse reactions. Doses should not exceed 540 mg once daily.
While a dose of Dilacor XR given once daily may produce an antihypertensive effect similar to the same total daily dose given in divided doses, individual dose adjustment may be needed.
Dosage: Angina: Dosages for the treatment of angina should be adjusted to each patient’s needs, starting with a dose of 120 mg once daily, which may be titrated to doses of up to 480 mg once daily. When necessary, titration may be carried out over a 7 to 14 day period.
Concomitant Use with Other Cardiovascular Agents.
Sublingual Nitroglycerin may be taken as required to abort acute anginal attacks during diltiazem hydrochloride therapy.
Prophylactic Nitrate Therapy – Diltiazem hydrochloride may be safely co-administered with short- and long-acting nitrates.
Beta-blockers. (See WARNINGS and PRECAUTIONS.)
Antihypertensives – Diltiazem hydrochloride has an additive antihypertensive effect when used with other antihypertensive agents. Therefore, the dosage of diltiazem hydrochloride or the concomitant antihypertensives may need to be adjusted when adding one to the other.
![Dilacor Xr (Diltiazem Hydrochloride) Capsule, Extended Release [Actavis Pharma, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=a6ad506a-a3f9-45be-ae03-24313b9a9b7c&name=dilacor-xr-2.jpg)
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