Label Changes for:
Lopressor (Metoprolol Tartrate) Tablets and Injection
Changes have been made to the PRECAUTIONS sections of the safety label.
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
- Start at a low dose and uptitrate slowly…
- Catecholamine-depleting drugs….
- …..Increase in plasma concentrations of Metoprolol would decrease the cardioselectivity of Metoprolol…
- Hydralazine: Concomitant administration of hydralazine may inhibit presystemic metabolism of metoprolol leading to increased concentrations of metoprolol.
- Alpha-adrenergic agents: Antihypertensive effect of alpha-adrenergic blockers such as guanethidine, betanidine, reserpine, alpha-methyldopa or clonidine may be potentiated by betablockers including Lopressor…
- Ergot alkaloid: Concomitant administration with beta-blockers may enhance the vasoconstrictive action of ergot alkaloids.
- Dipyridamole: In general, administration of a beta-blocker should be withheld before dipyridamole testing, with careful monitoring of heart rate following the dipyridamole injection.
Carcinogenesis, Mutagenesis, Impairment of Fertility
- Reproduction toxicity studies in mice, rats and rabbits did not indicate teratogenic potential for metoprolol tartrate…
Pregnancy Category C
- Upon confirming the diagnosis of pregnancy, women should immediately inform the doctor…
- The effects of Lopressor on the fertility of human have not been studied…