DILTIAZEM HYDROCHLORIDE- diltiazem hydrochloride extended-release tablets tablet, extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Diltiazem Hydrochloride (UNII: OLH94387TE) (Diltiazem - UNII:EE92BBP03H)

Available from:

Oceanside Pharmaceuticals

INN (International Name):

Diltiazem Hydrochloride

Composition:

Diltiazem Hydrochloride 180 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 pharma

Product summary:

Diltiazem Hydrochloride Extended-Release Tablets are supplied as capsule shaped, white, film-coated tablets, debossed with “B” on one side and the diltiazem content (mg) on the other. 120 mg NDC 68682-704-30 NDC 68682-704-90 180 mg NDC 68682-705-30 NDC 68682-705-90 240 mg NDC 68682-706-30 NDC 68682-706-90 300 mg NDC 68682-707-30 NDC 68682-707-90 360 mg NDC 68682-708-30 NDC 68682-708-90 420 mg NDC 68682-709-30 NDC 68682-709-90 Storage conditions: Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°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.

Authorization status:

New Drug Application Authorized Generic

Summary of Product characteristics

DILTIAZEM HYDROCHLORIDE- DILTIAZEM HYDROCHLORIDE EXTENDED-RELEASE
TABLETS TABLET,
EXTENDED RELEASE
OCEANSIDE PHARMACEUTICALS
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DILTIAZEM HYDROCHLORIDE EXTENDED-
RELEASE TABLETS SAFELY AND EFFECTIVELY.
SEE FULL PRESCRIBING INFORMATION FOR DILTIAZEM HYDROCHLORIDE
EXTENDED-RELEASE TABLETS.
DILTIAZEM HYDROCHLORIDE EXTENDED-RELEASE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1982
INDICATIONS AND USAGE
Diltiazem Hydrochloride Extended-Release Tablets is a
nondihydropyridine calcium channel blocker indicated for:
•
•
DOSAGE AND ADMINISTRATION
•
•
•
•
DOSAGE FORMS AND STRENGTHS
•
CONTRAINDICATIONS
•
•
•
•
•
WARNINGS AND PRECAUTIONS
•
•
•
•
ADVERSE REACTIONS
The most common adverse reactions (>2%) are lower limb edema, sinus
congestion and rash in patients treated for
hypertension, and lower limb edema, headache, dizziness, fatigue,
bradycardia, first-degree AV block and cough in patients
treated for angina. (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT OCEANSIDE
PHARMACEUTICALS AT 1-800-321-4576 OR FDA
AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
•
•
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)
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 Diltiazem Hydrochloride Extended-Release Tablets:
Patients may be switched to the nearest equivalent
total daily diltiazem dose. (2.3)
Extended-r