MATZIM LA- diltiazem hydrochloride tablet, extended release

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

DILTIAZEM HYDROCHLORIDE (UNII: OLH94387TE) (DILTIAZEM - UNII:EE92BBP03H)

Dostopno od:

Actavis Pharma, Inc.

INN (mednarodno ime):

DILTIAZEM HYDROCHLORIDE

Sestava:

DILTIAZEM HYDROCHLORIDE 120 mg

Pot uporabe:

ORAL

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

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 o

Povzetek izdelek:

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.

Status dovoljenje:

Abbreviated New Drug Application

Lastnosti izdelka

MATZIM LA- DILTIAZEM HYDROCHLORIDE TABLET, EXTENDED RELEASE
ACTAVIS PHARMA, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
MATZIM LA (DILTIAZEM
HYDROCHLORIDE) EXTENDED-RELEASE TABLETS SAFELY AND EFFECTIVELY. SEE
FULL PRESCRIBING INFORMATION
FOR MATZIM LA (DILTIAZEM HYDROCHLORIDE) EXTENDED-RELEASE TABLETS.
MATZIM LA (DILTIAZEM HYDROCHLORIDE) EXTENDED-RELEASE TABLETS, FOR ORAL
USE
INITIAL U.S. APPROVAL: 1982
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)
DOSAGE AND ADMINISTRATION
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)
DOSAGE FORMS AND STRENGTHS
Extended-release tablets with 180 mg, 240 mg, 300 mg, 360 mg, or 420
mg diltiazem hydrochloride per tablet. (3)
CONTRAINDICATIONS
Sick sinus syndrome except in the presence of a functioning
ventricular pacemaker. (4)
Second- or third-degree AV block except in the presence of a
functioning ventricular pacemaker. (4)
Hypotension (less than 90 mm Hg systolic). (4)
Hypersensitivity to the drug. (4)
Acute myocardial infarction and pulmonary. (4)
WARNINGS AND PRECAUTIONS
Bradycardia, second or third degree AV bloc