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Drug Catalog - Product Detail

DILTIAZEM HCL ER (LA) - (MATZIM LA) TB 300MG 90

NDC Mfr Size Str Form
52544-0693-19 ACTAVIS PHARMA 90 300MG TABLET
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PACKAGE FILES

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Generic Name
DILTIAZEM HYDROCHLORIDE
Substance Name
DILTIAZEM HYDROCHLORIDE
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Application Number
ANDA077686
Description
11 DESCRIPTION Matzim ® LA (Diltiazem Hydrochloride) Extended-Release Tablets are a calcium ion cellular influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride, USP is 1,5-benzothiazepin-4(5 H )-one, 3-(acetyloxy)-5-[2­(dimethylamino)ethyl]-2, 3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride, (+)- cis -. The structural formula is: 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. Matzim LA (Diltiazem Hydrochloride) Extended-Release Tablets, for oral administration, are formulated as a once-a-day extended-release tablet containing 180 mg, 240 mg, 300 mg, 360 mg or 420 mg of diltiazem hydrochloride. Also contains: candelilla wax powder, colloidal silicon dioxide, corn starch, ethylcellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, nonoxynol 100, polyacrylate dispersion, polyethylene oxide, polysorbate 80, povidone, sucrose, talc, titanium dioxide and triacetin. structural formula
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING Matzim ® LA (Diltiazem Hydrochloride) Extended-Release Tablets are available as follows: 180 mg - White, capsule-shaped tablets debossed with “ 180 ” on one side and “ 691 ”on the other. Bottles of 30 NDC 52544-691-30 Bottles of 90 NDC 52544-691-19 240 mg - White, capsule-shaped tablets debossed with “ 240 ” on one side and “ 692 ”on the other. Bottles of 30 NDC 52544-692-30 Bottles of 90 NDC 52544-692-19 300 mg - White, capsule-shaped tablets debossed with “ 300 ” on one side and “ 693 ”on the other. Bottles of 30 NDC 52544-693-30 Bottles of 90 NDC 52544-693-19 360 mg - White, capsule-shaped tablets debossed with “ 360 ” on one side and “ 694 ”on the other. Bottles of 30 NDC 52544-694-30 Bottles of 90 NDC 52544-694-19 420 mg - White, capsule-shaped tablets debossed with “ 420 ” on one side and “ 695 ”on the other. Bottles of 30 NDC 52544-695-30 Bottles of 90 NDC 52544-695-19 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Avoid excessive humidity and temperatures above 30°C (86°F). Dispense in tight, light resistant container as defined in USP. logo logo logo logo logo
Indications & Usage
1 INDICATIONS AND USAGE Matzim LA (diltiazem hydrochloride) extended-release tablets are a nondihydropyridine calcium channel blocker indicated for treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. It can be used alone or in combination with other antihypertensives ( 1.1 ) improving exercise tolerance in patients with chronic stable angina ( 1.2 ) 1.1 Hypertension Matzim LA (diltiazem hydrochloride) extended-release tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes 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. Matzim LA (diltiazem hydrochloride) extended-release tablets may be used alone or in combination with other antihypertensive medications. 1.2 Angina Matzim LA (diltiazem hydrochloride) extended-release tablets are indicated to improve exercise tolerance in patients with chronic stable angina.
Dosage and Administration
2 DOSAGE AND ADMINISTRATION Take Matzim LA (diltiazem hydrochloride) extended-release tablets once a day at approximately the same time. Do not chew or crush the tablet. Tablet should be swallowed whole and not chewed or crushed. ( 2 ) Hypertension: Initial adult dose is 180 to 240 mg once daily. Adjust dose according to blood pressure response to a maximum of 540 mg daily ( 2.1 ) Angina: Initial adult dose is 180 mg once daily. Adjust dose according to response to a maximum of 360 mg. ( 2.2 ) Switching to Matzim LA (diltiazem hydrochloride) extended-release tablets: Patients may be switched to the nearest equivalent total daily diltiazem dose. ( 2.3 ) 2.1 Hypertension Initiate dosing at 180 to 240 mg once daily, although some patients may respond to lower doses. Titrate according to blood pressure to a maximum of 540 mg daily. Maximum antihypertensive effect is usually observed by 14 days of chronic therapy. 2.2 Angina Initiate dosing at 180 mg once daily and increase dose at intervals of 7 to 14 days if adequate response is not obtained, to a maximum of 360 mg. 2.3 Switching to Diltiazem Hydrochloride Extended-Release Tablets Patients controlled on diltiazem alone or in combination with other medications may be switched to diltiazem hydrochloride extended-release tablets once-a-day at the nearest equivalent total daily dose. Higher doses of Matzim LA (diltiazem hydrochloride) extended-release tablets may be needed in some patients based on clinical response.