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Metoprolol and Hydrochlorothiazide (Metoprolol Tartrate / Hydrochlorothiazide) - Indications and Dosage

 
 



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 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. Beta1 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.

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 16714-417-01                bottle of 30 tablets
NDC 16714-417-02                bottles of 100 tablets
NDC 16714-417-03                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 16714-418-01                bottle of 30 tablets
NDC 16714-418-02                bottle of 100 tablets
NDC 16714-418-03                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 16714-419-01                bottle of 30 tablets
NDC 16714-419-02                bottle of 100 tablets
NDC 16714-419-03                bottle of 500 tablets

Store at 25ºC (77ºF); excursions permitted to 15 to 30ºC (59 to 86ºF) [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 to Northstar Rx LLC at 1-800-206-7821 or FDA at 1-800-FDA-1088.                                                    

 

Manufactured for:

Northstar Rx LLC

Memphis, TN 38141


Manufactured by:
Alembic Limited

(Formulation Division),
Village Panelav, P. O. Tajpura, Near Baska,
Taluka-Halol, Panchmahal, Gujarat, India.

Revised: 11/2013

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