METOPROLOL TARTRATE tablet, film coated

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

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

Dostupné s:

Apotheca Inc.

INN (Mezinárodní Name):

METOPROLOL TARTRATE

Složení:

METOPROLOL TARTRATE 50 mg

Podání:

ORAL

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

Metoprolol tartrate tablets, USP are indicated for the treatment of hypertension. They may be used alone or in combination with other antihypertensive agents. Metoprolol tartrate tablets, USP are indicated in the long-term treatment of angina pectoris. Metoprolol tartrate tablets, USP 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, USP 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

Přehled produktů:

Metoprolol Tartrate Tablets, USP are available as follows: Tablets 50 mg are pink round shaped, film coated tablets debossed with ‘C over 74’ on one side and deep break line on other side. NDC 12634-771-00 Bottles of 10 NDC 12634-771-01 Bottles of 100 NDC 12634-771-09 Bottles of 35 NDC 12634-771-12 Bottles of 120 NDC 12634-771-18 Bottles of 180 NDC 12634-771-40 Bottles of 40 NDC 12634-771-42 Bottles of 42 NDC 12634-771-45 Bottles of 45 NDC 12634-771-50 Bottles of 50 NDC 12634-771-52 Blister Pack of 12 NDC 12634-771-54 Blister Pack of 14 NDC 12634-771-57 Blister Pack of 20 NDC 12634-771-59 Blister Pack of 30 NDC 12634-771-60 Bottles of 60 NDC 12634-771-61 Blister Pack of 10 NDC 12634-771-63 Blister Pack of 3 NDC 12634-771-66 Blister Pack of 6 NDC 12634-771-67 Blister Pack of 7 NDC 12634-771-69 Blister Pack of 9 NDC 12634-771-71 Bottles of 30 NDC 12634-771-74 Bottles of 24 NDC 12634-771-78 Bottles of 28 NDC 12634-771-79 Bottles of 25 NDC 12634-771-80 Bottles of 20 NDC 12634-771-81 Bottles of 21 NDC 12634-771-82 Bottles of 12 NDC 12634-771-84 Bottles of 14 NDC 12634-771-85 Bottles of 15 NDC 12634-771-90 Bottles of 90 NDC 12634-771-91 Blister Pack of 1 NDC 12634-771-92 Bottles of 2 NDC 12634-771-93 Bottles of 3 NDC 12634-771-94 Bottles of 4 NDC 12634-771-95 Bottles of 5 NDC 12634-771-96 Bottles of 6 NDC 12634-771-97 Bottles of 7 NDC 12634-771-98 Bottles of 8 NDC 12634-771-99 Bottles of 9 Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature] . Protect from moisture and heat. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. To report SUSPECTED ADVERSE REACTIONS, contact Aurobindo Pharma USA, Inc. at 1-866-850-2876 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch Manufactured by: Aurobindo Pharma Limited Hyderabad-500 090, India Revised: 12/2015 Repackaged & Distributed by: Apotheca Inc. Phoenix, AZ 85006

Stav Autorizace:

Abbreviated New Drug Application

Charakteristika produktu

METOPROLOL TARTRATE- METOPROLOL TARTRATE TABLET, FILM COATED
APOTHECA INC.
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METOPROLOL TARTRATE TABLETS, USP
RX ONLY
DESCRIPTION
Metoprolol tartrate USP is a selective beta
-adrenoreceptor blocking agent, available as 25, 50 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.
The tablets contain the following inactive ingredients:
microcrystalline cellulose, corn starch, sodium
starch glycollate, colloidal silicon dioxide, sodium lauryl sulfate,
talc, magnesium stearate,
hypromellose, titanium dioxide, polyethylene glycol and polysorbate
80. In addition, 50 mg tablet
contains D&C Red #30 Aluminium Lake and 100 mg tablet contains FD&C
Blue #2 Aluminium Lake as
coloring agents.
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
Metoprolol tartrate 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
1
1
2
The mechanism of the antihypertensive effects of beta-blocking agents
has not been fully elucidated.
However, several possible mechanisms have been proposed: (1)
competitive a