LOPRESSOR Tablet (2021)
Βιβλιογραφική αναφορά
Συγγραφείς
Validus Pharmaceuticals LLC
Λέξεις κλειδιά
30698-458 30698-459
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1. Description
Lopressor, metoprolol tartrate USP is a selective beta<sub>1</sub>-adrenoreceptor blocking agent, available as 50 mg and 100 mg tablets for oral administration. Metoprolol tartrate USP is (±)1(Isopropylamino) ...
2. Clinical Pharmacology
Mechanism of Action Lopressor is a beta<sub>1</sub>-selective (cardioselective) adrenergic receptor blocker. This preferential effect is not absolute, however, and at higher plasma concentrations, Lopressor ...
3. Indications and Usage
Hypertension Lopressor tablets are indicated for the treatment of hypertension. They may be used alone or in combination with other antihypertensive agents. Angina Pectoris Lopressor is indicated in the ...
4. Contraindications
Hypertension and Angina Lopressor is contraindicated in sinus bradycardia, heart block greater than first degree, cardiogenic shock, and overt cardiac failure (<em>see WARNINGS</em>). Hypersensitivity ...
5. Warnings
Heart Failure Beta-blockers, like Lopressor, can cause depression of myocardial contractility and may precipitate heart failure and cardiogenic shock. If signs or symptoms of heart failure develop, treat ...
6. Precautions
Risk of Anaphylactic Reactions While taking beta-blockers, patients with a history of severe anaphylactic reaction to a variety of allergens may be more reactive to repeated challenge, either accidental, ...
6.2. Information for Patients
Advise patients to take Lopressor regularly and continuously, as directed, with or immediately following meals. If a dose should be missed, the patient should take only the next scheduled dose (without ...
6.4. Drug Interactions
Catecholamine-depleting drugs Catecholamine-depleting drugs (e.g., reserpine) may have an additive effect when given with beta-blocking agents or monoamine oxidase (MAO) inhibitors. Observe patients treated ...
6.6. Carcinogenesis, Mutagenesis, Impairment of Fertility
Long-term studies in animals have been conducted to evaluate carcinogenic potential. In a 2-year study in rats at three oral dosage levels of up to 800 mg/kg per day, there was no increase in the development ...
6.7. Pregnancy
Pregnancy Category C. Upon confirming the diagnosis of pregnancy, women should immediately inform the doctor. Lopressor has been shown to increase postimplantation loss and decrease neonatal survival in ...
6.9. Nursing Mothers
Lopressor is excreted in breast milk in a very small quantity. An infant consuming 1 liter of breast milk daily would receive a dose of less than 1 mg of the drug.
6.10. Pediatric Use
Safety and effectiveness in pediatric patients have not been established.
6.11. Geriatric Use
Clinical trials of Lopressor in hypertension did not include sufficient numbers of elderly patients to determine whether patients over 65 years of age differ from younger subjects in their response to ...
7. Adverse Reactions
Hypertension and Angina Most adverse effects have been mild and transient. <u>Central Nervous System:</u> Tiredness and dizziness have occurred in about 10 of 100 patients. Depression has been reported ...
9. Overdosage
Acute Toxicity Several cases of overdosage have been reported, some leading to death. Oral LD<sub>50</sub>'s (mg/kg): mice, 1158-2460; rats, 3090-4670. Signs and Symptoms Potential signs and symptoms associated ...
10. Dosage and Administration
Hypertension Individualize the dosage of Lopressor tablets. Lopressor tablets should be taken with or immediately following meals. The usual initial dosage of Lopressor tablets is 100 mg daily in single ...
11. How Supplied
Lopressor Tablets metoprolol tartrate USP Tablets <u>Tablets 50 mg:</u> capsule-shaped, biconvex, pink, scored (imprinted LOPRESSOR on one side and 458 twice on the scored side) Bottles of 100 NDC 30698-458-01 ...
12. Storage and Handling
Store at 77°F (25°C); excursions permitted to 59° to 86°F (15° to 30°C) [See USP Controlled Room Temperature]. Protect from moisture and heat. Dispense in a tight, light-resistant container (USP).
13. Clinical Studies
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 ...