METOPROLOL TARTRATE tablet, film coated

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

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

可用日期:

Cardinal Health 107, LLC

INN（国际名称）:

METOPROLOL TARTRATE

组成:

METOPROLOL TARTRATE 25 mg

给药途径:

ORAL

处方类型:

PRESCRIPTION DRUG

疗效迹象:

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-blockers (cross-sensitivity between beta-blockers can occur). Metoprolol is contraindicated in patients with a heart rate < 45 beats/min; second- and third-degree heart block; significant first-degree heart block (P-R interval ≥ 0.24 sec); systolic blood pressure < 100 mmHg; or moderate to severe cardiac failure (see WARNINGS).

產品總結:

Metoprolol Tartrate Tablets, USP are available containing 25 mg or 50 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: Overbagged with 10 tablets per bag, NDC 55154-5356-0 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: Overbagged with 10 tablets per bag, NDC 55145-5512-0 Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light and moisture. To report SUSPECTED ADVERSE REACTIONS, contact Mylan at 1-877-446-3679 (1-877-4-INFO-RX) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Manufactured by: Mylan Laboratories Limited Hyderabad — 500 096, India Distributed by: Mylan Institutional Inc. Rockford, IL 61103 U.S.A. Distributed by: Cardinal Health Dublin, OH 43017 L36556850124 L29070610124 S-12628 6/20

授权状态:

Abbreviated New Drug Application

产品特点

METOPROLOL TARTRATE- METOPROLOL TARTRATE TABLET, FILM COATED
CARDINAL HEALTH 107, 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. The 50 mg tablets also contain FD&C Blue No. 2 Aluminum
Lake, D&C Red No.
27 Aluminum Lake and FD&C Red No. 40 Aluminum Lake. The 100 mg tablets
also
contain FD&C Blue No. 2 Aluminum Lake.
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 mechanisms have been
proposed: (1)
1
1