"The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended the marketing of selexipag (Uptravi, Actelion Registration Ltd) for the treatment of adults with pulmonary arterial hypertension (PAH)./"...
Lopressor HCT (metoprolol tartrate and hydochlorothiazide) 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 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 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. Beta1 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:
|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.
|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 0078-0460-05
|Tablets 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 0078-0461-05
|Tablets 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 0078-0462-05
Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Protect from moisture.
Dispense in tight, light-resistant container (USP).
To report SUSPECTED ADVERSE REACTIONS, contact Novartis Pharmaceuticals Corporation at 1-888-669-6682 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
Manufactured by: Novartis Pharmaceuticals Corporation Suffern, New York 10901. Distributed by: Novartis Pharmaceuticals Corporation East Hanover, New Jersey 07936. REV: March 2011This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 5/9/2011
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