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Lopressor HCT

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Overview

What is Lopressor HCT?

Lopressor HCT has the antihypertensive effect of Lopressor®, metoprolol tartrate, a selective beta1-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-[-(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 -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 -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:



What does Lopressor HCT look like?



What are the available doses of Lopressor HCT?

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What should I talk to my health care provider before I take Lopressor HCT?

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How should I use Lopressor HCT?

Lopressor HCT is 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 should be determined by individual titration (see ).

Hydrochlorothiazide is usually given at a dosage of 12.5 to 50 mg per day. The usual initial dosage of Lopressor 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 selectivity diminishes as dosage of Lopressor is increased.

The following dosage schedule may be used to administer from 100 to 200 mg of Lopressor per day and from 25 to 50 mg of hydrochlorothiazide per day:

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.


What interacts with Lopressor HCT?

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What are the warnings of Lopressor HCT?

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What are the precautions of Lopressor HCT?

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What are the side effects of Lopressor HCT?

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What should I look out for while using Lopressor HCT?


What might happen if I take too much Lopressor HCT?


How should I store and handle Lopressor HCT?

Store at 20°-25°C (68°-77°F) (see USP Controlled Room Temperature). Avoid freezing and protect from light.Tablets 50/25 - capsule-shaped, white and mottled-blue, scored (imprinted Geigy on one side and 35 twice on the scored side), 50 mg of metoprolol tartrate and 25 mg of hydrochlorothiazide    Bottles of 100..........................................NDC 30698-460-01Tablets 100/25 - capsule-shaped, white and mottled-pink, scored (imprinted Geigy on one side and 53 twice on the scored side), 100 mg of metoprolol tartrate and 25 mg of hydrochlorothiazide    Bottles of 100..........................................NDC 30698-461-01Tablets 100/50 - capsule- shaped, white and mottled-yellow, scored (imprinted Geigy on one side and 73 twice on the scored side), 100 mg of metoprolol tartrate and 50 mg of hydrochlorothiazide    Bottles of 100..........................................NDC 30698-462-01Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F). Protect from moisture.Dispense in tight, light-resistant container (USP).To report SUSPECTED ADVERSE REACTIONS, contact Validus Pharmaceuticals LLC at 1-866-9VALIDUS (1-866-982-5438) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch© 2012 Validus Pharmaceuticals LLCOctober 2012463000-01Tablets 50/25 - capsule-shaped, white and mottled-blue, scored (imprinted Geigy on one side and 35 twice on the scored side), 50 mg of metoprolol tartrate and 25 mg of hydrochlorothiazide    Bottles of 100..........................................NDC 30698-460-01Tablets 100/25 - capsule-shaped, white and mottled-pink, scored (imprinted Geigy on one side and 53 twice on the scored side), 100 mg of metoprolol tartrate and 25 mg of hydrochlorothiazide    Bottles of 100..........................................NDC 30698-461-01Tablets 100/50 - capsule- shaped, white and mottled-yellow, scored (imprinted Geigy on one side and 73 twice on the scored side), 100 mg of metoprolol tartrate and 50 mg of hydrochlorothiazide    Bottles of 100..........................................NDC 30698-462-01Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F). Protect from moisture.Dispense in tight, light-resistant container (USP).To report SUSPECTED ADVERSE REACTIONS, contact Validus Pharmaceuticals LLC at 1-866-9VALIDUS (1-866-982-5438) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch© 2012 Validus Pharmaceuticals LLCOctober 2012463000-01Tablets 50/25 - capsule-shaped, white and mottled-blue, scored (imprinted Geigy on one side and 35 twice on the scored side), 50 mg of metoprolol tartrate and 25 mg of hydrochlorothiazide    Bottles of 100..........................................NDC 30698-460-01Tablets 100/25 - capsule-shaped, white and mottled-pink, scored (imprinted Geigy on one side and 53 twice on the scored side), 100 mg of metoprolol tartrate and 25 mg of hydrochlorothiazide    Bottles of 100..........................................NDC 30698-461-01Tablets 100/50 - capsule- shaped, white and mottled-yellow, scored (imprinted Geigy on one side and 73 twice on the scored side), 100 mg of metoprolol tartrate and 50 mg of hydrochlorothiazide    Bottles of 100..........................................NDC 30698-462-01Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F). Protect from moisture.Dispense in tight, light-resistant container (USP).To report SUSPECTED ADVERSE REACTIONS, contact Validus Pharmaceuticals LLC at 1-866-9VALIDUS (1-866-982-5438) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch© 2012 Validus Pharmaceuticals LLCOctober 2012463000-01Tablets 50/25 - capsule-shaped, white and mottled-blue, scored (imprinted Geigy on one side and 35 twice on the scored side), 50 mg of metoprolol tartrate and 25 mg of hydrochlorothiazide    Bottles of 100..........................................NDC 30698-460-01Tablets 100/25 - capsule-shaped, white and mottled-pink, scored (imprinted Geigy on one side and 53 twice on the scored side), 100 mg of metoprolol tartrate and 25 mg of hydrochlorothiazide    Bottles of 100..........................................NDC 30698-461-01Tablets 100/50 - capsule- shaped, white and mottled-yellow, scored (imprinted Geigy on one side and 73 twice on the scored side), 100 mg of metoprolol tartrate and 50 mg of hydrochlorothiazide    Bottles of 100..........................................NDC 30698-462-01Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F). Protect from moisture.Dispense in tight, light-resistant container (USP).To report SUSPECTED ADVERSE REACTIONS, contact Validus Pharmaceuticals LLC at 1-866-9VALIDUS (1-866-982-5438) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch© 2012 Validus Pharmaceuticals LLCOctober 2012463000-01Tablets 50/25 - capsule-shaped, white and mottled-blue, scored (imprinted Geigy on one side and 35 twice on the scored side), 50 mg of metoprolol tartrate and 25 mg of hydrochlorothiazide    Bottles of 100..........................................NDC 30698-460-01Tablets 100/25 - capsule-shaped, white and mottled-pink, scored (imprinted Geigy on one side and 53 twice on the scored side), 100 mg of metoprolol tartrate and 25 mg of hydrochlorothiazide    Bottles of 100..........................................NDC 30698-461-01Tablets 100/50 - capsule- shaped, white and mottled-yellow, scored (imprinted Geigy on one side and 73 twice on the scored side), 100 mg of metoprolol tartrate and 50 mg of hydrochlorothiazide    Bottles of 100..........................................NDC 30698-462-01Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F). Protect from moisture.Dispense in tight, light-resistant container (USP).To report SUSPECTED ADVERSE REACTIONS, contact Validus Pharmaceuticals LLC at 1-866-9VALIDUS (1-866-982-5438) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch© 2012 Validus Pharmaceuticals LLCOctober 2012463000-01Tablets 50/25 - capsule-shaped, white and mottled-blue, scored (imprinted Geigy on one side and 35 twice on the scored side), 50 mg of metoprolol tartrate and 25 mg of hydrochlorothiazide    Bottles of 100..........................................NDC 30698-460-01Tablets 100/25 - capsule-shaped, white and mottled-pink, scored (imprinted Geigy on one side and 53 twice on the scored side), 100 mg of metoprolol tartrate and 25 mg of hydrochlorothiazide    Bottles of 100..........................................NDC 30698-461-01Tablets 100/50 - capsule- shaped, white and mottled-yellow, scored (imprinted Geigy on one side and 73 twice on the scored side), 100 mg of metoprolol tartrate and 50 mg of hydrochlorothiazide    Bottles of 100..........................................NDC 30698-462-01Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F). Protect from moisture.Dispense in tight, light-resistant container (USP).To report SUSPECTED ADVERSE REACTIONS, contact Validus Pharmaceuticals LLC at 1-866-9VALIDUS (1-866-982-5438) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch© 2012 Validus Pharmaceuticals LLCOctober 2012463000-01Tablets 50/25 - capsule-shaped, white and mottled-blue, scored (imprinted Geigy on one side and 35 twice on the scored side), 50 mg of metoprolol tartrate and 25 mg of hydrochlorothiazide    Bottles of 100..........................................NDC 30698-460-01Tablets 100/25 - capsule-shaped, white and mottled-pink, scored (imprinted Geigy on one side and 53 twice on the scored side), 100 mg of metoprolol tartrate and 25 mg of hydrochlorothiazide    Bottles of 100..........................................NDC 30698-461-01Tablets 100/50 - capsule- shaped, white and mottled-yellow, scored (imprinted Geigy on one side and 73 twice on the scored side), 100 mg of metoprolol tartrate and 50 mg of hydrochlorothiazide    Bottles of 100..........................................NDC 30698-462-01Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F). Protect from moisture.Dispense in tight, light-resistant container (USP).To report SUSPECTED ADVERSE REACTIONS, contact Validus Pharmaceuticals LLC at 1-866-9VALIDUS (1-866-982-5438) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch© 2012 Validus Pharmaceuticals LLCOctober 2012463000-01Tablets 50/25 - capsule-shaped, white and mottled-blue, scored (imprinted Geigy on one side and 35 twice on the scored side), 50 mg of metoprolol tartrate and 25 mg of hydrochlorothiazide    Bottles of 100..........................................NDC 30698-460-01Tablets 100/25 - capsule-shaped, white and mottled-pink, scored (imprinted Geigy on one side and 53 twice on the scored side), 100 mg of metoprolol tartrate and 25 mg of hydrochlorothiazide    Bottles of 100..........................................NDC 30698-461-01Tablets 100/50 - capsule- shaped, white and mottled-yellow, scored (imprinted Geigy on one side and 73 twice on the scored side), 100 mg of metoprolol tartrate and 50 mg of hydrochlorothiazide    Bottles of 100..........................................NDC 30698-462-01Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F). Protect from moisture.Dispense in tight, light-resistant container (USP).To report SUSPECTED ADVERSE REACTIONS, contact Validus Pharmaceuticals LLC at 1-866-9VALIDUS (1-866-982-5438) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch© 2012 Validus Pharmaceuticals LLCOctober 2012463000-01Tablets 50/25 - capsule-shaped, white and mottled-blue, scored (imprinted Geigy on one side and 35 twice on the scored side), 50 mg of metoprolol tartrate and 25 mg of hydrochlorothiazide    Bottles of 100..........................................NDC 30698-460-01Tablets 100/25 - capsule-shaped, white and mottled-pink, scored (imprinted Geigy on one side and 53 twice on the scored side), 100 mg of metoprolol tartrate and 25 mg of hydrochlorothiazide    Bottles of 100..........................................NDC 30698-461-01Tablets 100/50 - capsule- shaped, white and mottled-yellow, scored (imprinted Geigy on one side and 73 twice on the scored side), 100 mg of metoprolol tartrate and 50 mg of hydrochlorothiazide    Bottles of 100..........................................NDC 30698-462-01Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F). Protect from moisture.Dispense in tight, light-resistant container (USP).To report SUSPECTED ADVERSE REACTIONS, contact Validus Pharmaceuticals LLC at 1-866-9VALIDUS (1-866-982-5438) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch© 2012 Validus Pharmaceuticals LLCOctober 2012463000-01