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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


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Clinical Information

Chemical Structure

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Clinical Pharmacology

Lopressor

Lopressor is a beta-adrenergic receptor blocking agent. In vitro and in vivo animal studies have shown that it has a preferential effect on beta adrenoreceptors, chiefly located in cardiac muscle. This preferential effect is not absolute, however, and at higher doses, Lopressor also inhibits beta2 adrenoreceptors, chiefly located in the bronchial and vascular musculature.

Clinical pharmacology studies have confirmed the beta-blocking activity of metoprolol in man, 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.

Relative beta selectivity has been confirmed by the following: (1) In normal subjects, Lopressor is unable to reverse the beta-mediated vasodilating effects of epinephrine. This contrasts with the effect of nonselective (beta plus beta) beta blockers, which completely reverse the vasodilating effects of epinephrine. (2) In asthmatic patients, Lopressor reduces FEV and FVC significantly less than a nonselective beta blocker, propranolol at equivalent beta-receptor blocking doses.

Lopressor has no intrinsic sympathomimetic activity and only weak membrane-stabilizing activity. Lopressor crosses the blood-brain barrier and has been reported in the CSF in a concentration 78% of the simultaneous plasma concentration. Animal and human experiments indicate that Lopressor slows the sinus rate and decreases AV nodal conduction.

In controlled clinical studies, Lopressor has been shown to be an effective antihypertensive agent when used alone or as concomitant therapy with thiazide-type diuretics, at dosages of 100-450 mg daily. In controlled, comparative, clinical studies, Lopressor has been shown to be as effective an antihypertensive agent as propranolol, methyldopa, and thiazide-type diuretics, and to be equally effective in supine and standing positions.

The mechanism of the antihypertensive effects of beta-blocking agents has not been elucidated. However, several possible mechanisms have been proposed: (1) competitive antagonism of catecholamines at peripheral (especially cardiac) adrenergic neuron sites, leading to decreased cardiac output; (2) a central effect leading to reduced sympathetic outflow to the periphery; and (3) suppression of renin activity.

Non-Clinical Toxicology
Drug/Drug Interactions

Lopressor:

Both digitalis glycosides and beta blockers slow atrioventricular conduction and decrease heart rate. Concomitant use can increase the risk of bradycardia.

Risk of Anaphylactic Reaction:

General

Lopressor:

Hydrochlorothiazide:

Hypokalemia may develop, especially in cases of brisk diuresis or severe cirrhosis.

Interference with adequate oral intake of electrolytes will also contribute to hypokalemia. Hypokalemia may be avoided or treated by the use of potassium supplements or foods with high potassium content.

Any chloride deficit is generally mild and usually does not require specific treatment, except under extraordinary circumstances (as in liver disease or renal disease). Dilutional hyponatremia may occur in edematous patients in hot weather; appropriate therapy is water restriction, rather than administration of salt, except in rare instances when the hyponatremia is life-threatening. In cases of actual salt depletion, appropriate replacement is the therapy of choice.

Hyperuricemia may occur or frank gout may be precipitated in certain patients receiving thiazide therapy.

Latent diabetes may become manifest during thiazide administration (see ).

The antihypertensive effects of the drug may be enhanced in the postsympathectomy patient.

If progressive renal impairment becomes evident, withholding or discontinuing diuretic therapy should be considered.

Calcium excretion is decreased by thiazides. Pathological changes in the parathyroid gland with hypercalcemia and hypophosphatemia have been observed in a few patients on prolonged thiazide therapy. The common complications of hyperparathyroidism, such as renal lithiasis, bone resorption, and peptic ulceration, have not been seen.

Thiazide diuretics have been shown to increase the urinary excretion of magnesium; this may result in hypomagnesemia.

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Interactions

Interactions

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