Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 ADVERSE REACTIONS Discontinuation because of adverse reactions occurred in 4% of amlodipine and benazepril hydrochloride-treated patients and 3% of placebo-treated patients.
The most common reasons for discontinuation of therapy with amlodipine and benazepril hydrochloride were cough and edema.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Lupin Pharmaceuticals, Inc.
at 1-800-399-2561 or FDA at 1-800-FDA-1088 or www.fda.gov/ medwatch.
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The adverse reaction information from clinical trials does, however, provide a basis for identifying the adverse events that appear to be related to drug use and for approximating rates.
Amlodipine and benazepril hydrochloride has been evaluated for safety in over 2,991 patients with hypertension;
over 500 of these patients were treated for at least 6 months, and over 400 were treated for more than 1 year.
In a pooled analysis of 5 placebo-controlled trials involving amlodipine and benazepril hydrochloride capsules doses up to 5 mg/20 mg, the reported side effects were generally mild and transient, and there was no relationship between side effects and age, sex, race, or duration of therapy.
Discontinuation of therapy due to side effects was required in approximately 4% of patients treated with amlodipine and benazepril hydrochloride capsules and in 3% of patients treated with placebo.
5 WARNINGS AND PRECAUTIONS Anaphylactoid reactions, including angioedema ( 5.1 ).
Myocardial infarction or increased angina in patients with obstructive coronary artery disease ( 5.2 ).
Assess for hypotension and hyperkalemia ( 5.4 , 5.8 ).
Titrate slowly in patients with impaired hepatic or severely impaired renal function ( 5.6 , 5.7 ).
5.1 Fetal Toxicity Amlodipine and benazepril hydrochloride can cause fetal harm when administered to a pregnant woman.
Like all medications, Amlodipine Besylate And Benazepril Hydrochloride can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: