libido have also been reported, but a drug relationship is not clear.
Cardiovascular : In the randomized comparison of Lopressor and placebo described in the CLINICAL PHARMACOLOGY section, the following adverse reactions were reported:
Respiratory: Dyspnea of pulmonary origin has been reported in fewer than 1 of 100 patients.
Gastrointestinal : Nausea and abdominal pain have been reported in fewer than 1 of 100 patients.
Dermatologi c: Rash and worsened psoriasis have been reported, but a drug relationship is not clear.
Miscellaneous : Unstable diabetes and claudication have been reported, but a drug relationship is not clear.
|
|
Lopressor ® |
Placebo |
|
Hypotension (systolic BP <90 mmHg) |
27.4% |
23.2% |
|
Bradycardia (heart rate <40 beats/min) |
15.9% |
6.7% |
|
Second- or third-degree heart block |
4.7% |
4.7% |
|
First-degree heart block (P-R ≥0.26 sec) |
5.3% |
1.9% |
|
Heart failure |
27.5% |
29.6% |
A variety of adverse reactions not listed above have been reported with other beta-adrenergic blocking agents and should be considered potential adverse reactions to Lopressor.
Central Nervous System : Reversible mental depression progressing to catatonia; an acute reversible syndrome characterized by disorientation for time and place, short-term memory loss, emotional lability, slightly clouded sensorium, and decreased performance on neuropsychometrics.
Cardiovascular : Intensification of AV block (see CONTRAINDICATIONS).
Hematologic : Agranulocytosis, nonthrombocytopenic purpura, thrombocytopenic purpura.
Hypersensitive Reaction s : Fever combined with aching and sore throat, laryngospasm, and respiratory distress.
The following adverse reactions have been reported during postapproval use of Lopressor: confusional state, an increase in blood triglycerides and a decrease in High Density Lipoprotein (HDL). Because these reports are from a population of uncertain size and are subject to confounding factors, it is not possible to reliably estimate their frequency.
Several cases of overdosage have been reported, some leading to death.
Oral LD ’s (mg/kg): mice, 1158-2460; rats, 3090-4670.
Potential signs and symptoms associated with overdosage with Lopressor are bradycardia, hypotension, bronchospasm, and cardiac failure.
There is no specific antidote.
In general, patients with acute or recent myocardial infarction may be more hemodynamically unstable than other patients and should be treated accordingly (see WARNINGS, Myocardial Infarction).
On the basis of the pharmacologic actions of Lopressor, the following general measures should be employed:
Elimination of the Drug : Gastric lavage should be performed.
Bradycardia : Atropine should be administered. If there is no response to vagal blockade, isoproterenol should be administered cautiously.
Hypotension : A vasopressor should be administered, e.g., levarterenol or dopamine.
Bronchospasm : A beta-stimulating agent and/or a theophylline derivative should be administered.
Cardiac Failure : A digitalis glycoside
