METOPROLOL TARTRATE tablet, film coated

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

METOPROLOL TARTRATE (UNII: W5S57Y3A5L) (METOPROLOL - UNII:GEB06NHM23)

Sẵn có từ:

Aphena Pharma Solutions - Tennessee, LLC

INN (Tên quốc tế):

METOPROLOL TARTRATE

Thành phần:

METOPROLOL TARTRATE 25 mg

Tuyến hành chính:

ORAL

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

Metoprolol tartrate tablets are indicated for the treatment of hypertension. They may be used alone or in combination with other antihypertensive agents. Metoprolol tartrate tablets are indicated in the long-term treatment of angina pectoris. Metoprolol tartrate tablets are indicated in the treatment of hemodynamically stable patients with definite or suspected acute myocardial infarction to reduce cardiovascular mortality when used alone or in conjunction with intravenous metoprolol. Oral metoprolol tartrate tablets therapy can be initiated after intravenous metoprolol therapy or, alternatively, oral treatment can begin within 3 to 10 days of the acute event (see DOSAGE AND ADMINISTRATION, CONTRAINDICATIONS and WARNINGS). Metoprolol tartrate tablets are contraindicated in sinus bradycardia, heart block greater than first degree, cardiogenic shock, and overt cardiac failure (see WARNINGS). Hypersensitivity to metoprolol and related derivatives, or to any of the excipients; hypersensitivity to other beta-block

Tóm tắt sản phẩm:

Repackaged by Aphena Pharma Solutions - TN. See Repackaging Information for available configurations. Metoprolol Tartrate Tablets, USP are available containing 25 mg, 50 mg or 100 mg of metoprolol tartrate, USP. The 25 mg tablets are white film-coated, round, scored tablets debossed with M over 18 on one side of the tablet and scored on the other side. They are available as follows: NDC 0378-0018-91 bottles of 60 tablets NDC 0378-0018-01 bottles of 100 tablets NDC 0378-0018-05 bottles of 500 tablets The 50 mg tablets are pink film-coated, round, scored tablets debossed with M over 32 on one side of the tablet and scored on the other side. They are available as follows: NDC 0378-0032-01 bottles of 100 tablets NDC 0378-0032-10 bottles of 1000 tablets The 100 mg tablets are light blue film-coated, round, scored tablets debossed with M over 47 on one side of the tablet and scored on the other side. They are available as follows: NDC 0378-0047-01 bottles of 100 tablets NDC 0378-0047-10 bottles of 1000 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from moisture. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. To report SUSPECTED ADVERSE REACTIONS, contact Mylan Pharmaceuticals Inc. Toll free at 1-877-446-3679 (1-877-4-INFO-RX) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. REVISED MARCH 2013 MTPL:R13

Tình trạng ủy quyền:

Abbreviated New Drug Application

Đặc tính sản phẩm

METOPROLOL TARTRATE- METOPROLOL TARTRATE TABLET, FILM COATED
APHENA PHARMA SOLUTIONS - TENNESSEE, LLC
----------
DESCRIPTION
Metoprolol tartrate is a selective beta -adrenoreceptor blocking
agent, available as 25 mg, 50 mg and
100 mg tablets for oral administration. Metoprolol tartrate is
(±)-1-(isopropylamino)-3-[_p-_2-
methoxyethyl)phenoxy]-2-propanol (2:1) _dextro_-tartrate salt. Its
structural formula is:
Metoprolol tartrate, USP is a white, practically odorless, crystalline
powder with a molecular weight
of 684.82. It is very soluble in water; freely soluble in methylene
chloride, in chloroform, and in
alcohol; slightly soluble in acetone; and insoluble in ether.
Each tablet for oral administration contains 25 mg, 50 mg or 100 mg of
metoprolol tartrate and the
following inactive ingredients: anhydrous lactose, colloidal silicon
dioxide, croscarmellose sodium,
hypromellose, magnesium stearate, microcrystalline cellulose,
polydextrose, polyethylene glycol,
povidone, sodium lauryl sulfate, titanium dioxide and triacetin. In
addition, the 50 mg product contains
FD&C Blue No. 2 Aluminum Lake, D&C Red No. 27 Aluminum Lake and FD&C
Red No. 40 Aluminum
Lake and the 100 mg product contains FD&C Blue No. 2 Aluminum Lake as
coloring agents.
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
Metoprolol is a beta -selective (cardioselective) adrenergic receptor
blocker. This preferential effect
is not absolute, however, and at higher plasma concentrations,
metoprolol also inhibits beta
adrenoreceptors, chiefly located in the bronchial and vascular
musculature.
Clinical pharmacology studies have demonstrated the beta-blocking
activity of metoprolol, as shown by
(1) reduction in heart rate and cardiac output at rest and upon
exercise, (2) reduction of systolic blood
pressure upon exercise, (3) inhibition of isoproterenol-induced
tachycardia, and (4) reduction of reflex
orthostatic tachycardia.
Hypertension
The mechanism of the antihypertensive effects of beta-blocking agents
has not been fully elucidated.
However, several possible