METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE - metoprolol tartrate and hydrochlorothiazide tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

METOPROLOL TARTRATE (UNII: W5S57Y3A5L) (METOPROLOL - UNII:GEB06NHM23), HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH)

Available from:

Trigen Laboratories, LLC

INN (International Name):

METOPROLOL TARTRATE

Composition:

METOPROLOL TARTRATE 50 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Metoprolol tartrate and hydrochlorothiazide tablets are indicated for the management of hypertension This fixed-combination drug is not indicated for initial therapy of hypertension. If the fixed combination represents the dose titrated to the individual patient’s needs, therapy with the fixed combination may be more convenient than with the separate components. Metoprolol 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 tartrate and related derivatives, or to any of the excipients; hypersensitivity to other beta blockers (cross sensitivity between beta blockers can occur). Sick-sinus syndrome. Severe peripheral arterial circulatory disorders. Hydrochlorothiazide Hydrochlorothiazide is contraindicated in patients with anuria or hypersensitivity to this or other sulfonamide-derived drugs (see WARNINGS).

Product summary:

Metoprolol Tartrate and Hydrochlorothiazide Tablets USP are available containing 50 mg/25 mg, 100 mg/25 mg or 100 mg/50 mg of metoprolol tartrate, USP and hydrochlorothiazide, USP. 50 mg/25 mg tablets are white to off-white colored, round shaped, biconvex, bevel edged scored uncoated tablet debossed with “L” on one side of score line and “230” on another side of score line and plain on other side. NDC 13811-669-30 bottle of 30 tablets NDC 13811-669-10 bottles of 100 tablets NDC 13811-669-01 bottles of 1000 tablets 100 mg/25 mg tablets are white to off-white colored, oval shaped, biconvex, bevel edged scored uncoated tablet debossed with “L” on one side of score line and “232” on another side of score line and plain on other side. NDC 13811-670-30 bottle of 30 tablets NDC 13811-670-10 bottle of 100 tablets NDC 13811-670-50 bottle of 500 tablets 100 mg/50 mg tablets are white to off-white colored, capsule shaped, biconvex, bevel edged scored uncoated tablet debossed with “L” on one side of score line and “231” on another side of score line and plain on other side. NDC 13811-671-30 bottle of 30 tablets NDC 13811-671-10 bottle of 100 tablets NDC 13811-671-50 bottle of 500 tablets Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from moisture. Dispense in tight, light-resistant container (USP). CALL YOUR DOCTOR FOR MEDICAL ADVICE ABOUT SIDE EFFECTS. YOU MAY REPORT SIDE EFFECTS BY CALLING 888 9 TRIGEN (888-987-4436). Made in India. Manufactured for: Trigen Laboratories, LLC Bridgewater, NJ 08807 www.trigenlab.com Issued: 09/2016

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE - METOPROLOL TARTRATE AND
HYDROCHLOROTHIAZIDE TABLET
TRIGEN LABORATORIES, LLC
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METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE TABLETS USP
50 MG/25 MG, 100 MG/25 MG AND 100 MG/50 MG
BETA BLOCKER/DIURETIC ANTIHYPERTENSIVE
RX ONLY
PRESCRIBING INFORMATION
DESCRIPTION
Metoprolol tartrate and hydrochlorothiazide tablethas the
antihypertensive effect of metoprolol tartrate,
a selective beta -adrenoreceptor blocking agent, and the
antihypertensive and diuretic actions of
hydrochlorothiazide. It is available as tablets for oral
administration. The 50/25 tablets contain 50 mg of
metoprolol tartrate USP and 25 mg of hydrochlorothiazide USP; the
100/25 tablets contain 100 mg of
metoprolol tartrate USP and 25 mg of hydrochlorothiazide USP; and the
100/50 tablets contain 100 mg
of metoprolol tartrate USP and 50 mg of hydrochlorothiazide USP.
Metoprolol tartrate USP is (±)-1-
(Isopropylamino)-3-[_p_-(2-methoxyethyl)phenoxy]-2-propanol
L-(+)-tartrate (2:1) salt, and its structural
formula is
Metoprolol tartrate USP is a white, crystalline powder. It is very
soluble in water; freely soluble in
methylene chloride, in chloroform, and in alcohol; slightly soluble in
acetone; and insoluble in ether. Its
molecular weight is 684.82.
Hydrochlorothiazide is
6-chloro-3,4-dihydro-2_H_-1,2,4-benzothiadiazine-7-sulfonamide 1,1-
dioxide,
and its structural formula is
1
Hydrochlorothiazide USP is a white, or practically white, practically
odorless, crystalline powder. It is
freely soluble in sodium hydroxide solution, in _n_-butylamine, and in
dimethylformamide; sparingly
soluble in methanol; slightly soluble in water; and insoluble in
ether, in chloroform, and in dilute mineral
acids. Its molecular weight is 297.73.
_Inactive Ingredients: _colloidal silicon dioxide, magnesium stearate,
microcrystalline cellulose, sodium
starch glycolate, povidone, lactose, pregelatinized starch.
CLINICAL PHARMACOLOGY
METOPROLOL
Metoprolol is a beta-adrenergic receptor blocking agent. In vitro and
in vivo ani