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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 Text Continues Below
Intensification of AV block (see CONTRAINDICATIONS). Hematologic: Agranulocytosis, nonthrombocytopenic purpura, thrombocytopenic purpura. Hypersensitive Reactions Fever combined with aching and sore throat, laryngospasm, and respiratory distress. Heart Failure In the MERIT-HF study, serious adverse events and adverse events leading to discon-tinuation of study medication were systematically collected. In the MERIT-HF study comparing TOPROL-XL in daily doses up to 200 mg (mean dose 159 mg once-daily) (n= 1990) to placebo (n= 2001), 10.3% of TOPROL-XL patients discontinued for adverse events vs. 12.2% of placebo patients. The table below lists adverse events in the MERIT-HF study that occurred at an incidence of equal to or greater than 1% in the TOPROL-XL group and greater than placebo by more than 0.5%, regardless of the assessment of causality. Adverse Events Occurring in the MERIT-HF Study at an Incidence 1% in the TOPROL-XL Group and Greater Than Placebo by More Than 0.5% TOPROL-XL Placebo N= 1990 N= 2001 % of patients % of patients
Dizziness/ vertigo 1.8 1.0
Bradycardia 1.5 0.4
Accident and/ or injury 1.4 0.8 Other adverse events with an incidence of > 1% on TOPROL-XL and as common on placebo (within 0.5%) included myocardial infarction, pneumonia, cerebrovascular disorder, chest pain, dyspnea/ dyspnea aggravated, syncope, coronary artery disorder, ventricular tachycardia/ arrhythmia aggravated, hypotension, diabetes mellitus/ diabetes mellitus aggravated, abdominal pain, and fatigue. Post-Marketing Experience The following adverse reactions have been reported with TOPROL-XL in worldwide post-marketing use, regardless of causality: Page: << Prev | 1 | 2 | 3 | 4 | Next >>
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