Drug Catalog - Product Detail
METOPROLOL TARTRATE/ HCTZ, USP TB 100/25MG 100
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 13811-0670-10 | TRIGEN LABORATORIES | 100 | 100-25MG | TABLET |
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Description
DESCRIPTION Metoprolol tartrate and hydrochlorothiazide tablethas the antihypertensive effect of metoprolol tartrate, a selective beta 1 -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 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. Structure Metoprolol Tartrate Structure Hydrochlorothiazide
How Supplied
HOW SUPPLIED 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 Trigen
Indications & Usage
INDICATIONS AND USAGE 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.
Dosage and Administration
DOSAGE AND ADMINISTRATION Dosage should be determined by individual titration (see INDICATIONS AND USAGE). Hydrochlorothiazide is usually given at a dosage of 12.5 to 50 mg per day. The usual initial dosage of metoprolol tartrate tablets is 100 mg daily in single or divided doses. Dosage may be increased gradually until optimum blood pressure control is achieved. The effective dosage range is 100 to 450 mg per day. While once-daily dosing is effective and can maintain a reduction in blood pressure throughout the day, lower doses (especially 100 mg) may not maintain a full effect at the end of the 24-hour period, and larger or more frequent daily doses may be required. This can be evaluated by measuring blood pressure near the end of the dosing interval to determine whether satisfactory control is being maintained throughout the day. Beta 1 selectivity diminishes as dosage of metoprolol tartrate tablets is increased. The following dosage schedule may be used to administer from 100 to 200 mg of metoprolol tartrate per day and from 25 to 50 mg of hydrochlorothiazide per day: Metoprolol Tartrate and Hydrochlorothiazide Dosage Tablets of 50/25 2 tablets per day in single or divided doses Tablets of 100/25 1 to 2 tablets per day in single or divided doses Tablets of 100/50 1 tablet per day in single or divided doses Dosing regimens that exceed 50 mg of hydrochlorothiazide per day are not recommended. When necessary, another antihypertensive agent may be added gradually, beginning with 50% of the usual recommended starting dose to avoid an excessive fall in blood pressure.