LOPRESSOR
These highlights do not include all the information needed to use LOPRESSOR safely and effectively. See full prescribing information for LOPRESSOR . LOPRESSOR (metoprolol tartrate) oral solution Initial U.S. Approval: 1992
9f448171-9588-4a54-88b3-5d870060ce86
HUMAN PRESCRIPTION DRUG LABEL
Apr 18, 2025
VALIDUS PHARMACEUTICALS LLC
DUNS: 801194619
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Metoprolol Tartrate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (8)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PRINCIPAL DISPLAY PANEL
LOPRESSOR**®****(Metoprolol Tartrate) Oral Solution 10 mg/mL - NDC 30698-464-30 - 300 mL Bottle Label**
LOPRESSOR**®****(Metoprolol Tartrate) Oral Solution 10 mg/mL - NDC 30698-464-30 - 300 mL Carton Label**
LOPRESSOR® (Metoprolol Tartrate) Oral Solution 10 mg/mL - NDC 30698-464-31 - 300 mL Bottle Label Physician Sample Not for Sale
LOPRESSOR® (Metoprolol Tartrate) Oral Solution 10 mg/mL - NDC 30698-464-31 - 300 mL Carton Label Physician Sample Not for Sale
CLINICAL STUDIES SECTION
14 CLINICAL STUDIES
14.1 Hypertension
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 mg to 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, to be equally effective in supine and standing positions.
14.2 Angina Pectoris
In controlled clinical trials, LOPRESSOR, administered two or four times daily, has been shown to be an effective antianginal agent, reducing the number of angina attacks and increasing exercise tolerance. The dosage used in these studies ranged from 100 mg to 400 mg daily. A controlled, comparative, clinical trial showed that LOPRESSOR was indistinguishable from propranolol in the treatment of angina pectoris.
14.3 Myocardial Infarction
In a large (1395 patients randomized), double-blind, placebo-controlled clinical study, LOPRESSOR was shown to reduce 3-month mortality by 36% in patients with suspected or definite myocardial infarction.
Patients were randomized and treated as soon as possible after their arrival in the hospital, once their clinical condition had stabilized and their hemodynamic status had been carefully evaluated. Subjects were ineligible if they had hypotension, bradycardia, peripheral signs of shock, and/or more than minimal basal rales as signs of congestive heart failure. Initial treatment consisted of intravenous followed by oral administration of LOPRESSOR or placebo, given in a coronary care or comparable unit. Oral maintenance therapy with LOPRESSOR or placebo was then continued for 3 months. After this double- blind period, all patients were given LOPRESSOR and followed up to 1 year.
The median delay from the onset of symptoms to the initiation of therapy was 8 hours in both the LOPRESSOR - and placebo-treatment groups. Among patients treated with LOPRESSOR, there were comparable reductions in 3-month mortality for those treated early (≤ 8 hours) and those in whom treatment was started later. Significant reductions in the incidence of ventricular fibrillation and in chest pain following initial intravenous therapy were also observed with LOPRESSOR and were independent of the interval between onset of symptoms and initiation of therapy.
In this study, patients treated with metoprolol received the drug both very early (intra-venously) and during a subsequent 3-month period, while placebo patients received no beta-blocker treatment for this period. The study thus was able to show a benefit from the overall metoprolol regimen but cannot separate the benefit of very early intravenous treatment from the benefit of later beta- blocker therapy. Nonetheless, because the overall regimen showed a clear beneficial effect on survival without evidence of an early adverse effect on survival, one acceptable dosage regimen is the precise regimen used in the trial. Because the specific benefit of very early treatment remains to be defined however, it is also reasonable to administer the drug orally to patients at a later time as is recommended for certain other beta-blockers.
DESCRIPTION SECTION
11 DESCRIPTION
LOPRESSOR Oral Solution contain metoprolol tartrate, a selective beta 1-adrenoreceptor blocking agent. Metoprolol tartrate 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, practically odorless, crystalline powder with a molecular weight of 684.82 g/mol. It is very soluble in water; freely soluble in methylene chloride, in chloroform, and in alcohol; slightly soluble in acetone; and insoluble in ether.
LOPRESSOR: Each mL contains 10 mg metoprolol tartrate (equivalent to 3.9 mg metoprolol) and the following inactive ingredients: citric acid monohydrate, disodium edetate, glycerin, purified water, sodium benzoate, sucralose, and xanthan gum.
INSTRUCTIONS FOR USE SECTION
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INSTRUCTIONS FOR USE LOPRESSOR**®****(Lo-pres-sor)** (Metoprolol Tartrate Oral Solution) | |||
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This Instructions for Use contains information on how to take LOPRESSOR. Important Information You Need to Know Before Taking LOPRESSOR:
Storing LOPRESSOR
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Supplies included in the LOPRESSOR Carton | |||
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Step 1: Preparing the Bottle | |||
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**Note:**Save the cap so you can close the bottle after each use.
Note: You may not be able to push the bottle adapter fully down, but it will be forced into the bottle when you screw the cap back on. Now the bottle is ready to use with the syringe. The bottle adapter must always stay in the bottle.Do notremove the bottle adapter. The child- resistant cap should seal the bottle in between use. | ||
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Step 2: Measuring the Dose of LOPRESSOR | |||
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**Note:**Always put the cap tightly back on the bottle after use. | ||
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Step 5: | |||
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**Note:**If the prescribed dose is more than 10 mL, you will need to repeat steps 2 through 7 to refill the syringe and to take your full dose. Ask your pharmacist or healthcare provider to show you how to measure your dose if you are not sure. | ||
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Step 6: | |||
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Step 7: Taking the dose of LOPRESSOR | |||
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*Important: Sit in an upright position when taking LOPRESSOR.
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Step 8: Cleaning up
Step 9: Disposing of LOPRESSOR
Manufactured for and distributed by: Validus Pharmaceuticals LLC Parsippany, NJ 07054 info@validuspharma.com This Instructions for Use has been approved by the U.S. Food and Drug Administration. Issued 04/2025 | |||