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EXFORGE(amlodipine besylate and valsartan)tablet, film coate(七)
were also observed in clinical trials:exanthema, syncope, visual disturbance, hypersensitivity, tinnitus, and hypotension.
Studies with Amlodipine:
Norvasc®* has been eva luated for safety in more than 11,000 patients in U.S. and foreign clinical trials. Other adverse events that have been reported <1% but >0.1% of patients in controlled clinical trials or under conditions of open trials or marketing experience where a causal relationship is uncertain were:
Cardiovascular: arrhythmia (including ventricular tachycardia and atrial fibrillation), bradycardia, chest pain, peripheral ischemia, syncope, postural hypotension, vasculitis
Central and Peripheral Nervous System: neuropathy peripheral, tremor
Gastrointestinal: anorexia, dysphagia, pancreatitis, gingival hyperplasia
General: allergic reaction, hot flushes, malaise, rigors, weight gain, weight loss
Musculoskeletal System: arthrosis, muscle cramps
Psychiatric: sexual dysfunction (male and female), nervousness, abnormal dreams, depersonalization
Respiratory System: dyspnea
Skin and Appendages: angioedema, erythema multiforme, rash erythematous, rash maculopapular
Special Senses: abnormal vision, conjunctivitis, diplopia, eye pain, tinnitus
Urinary System: micturation frequency, micturation disorder, nocturia
Autonomic Nervous System: sweating increased
Metabolic and Nutritional: hyperglycemia, thirst
Hemopoietic: leukopenia, purpura, thrombocytopenia
Other events reported with amlodipine at a frequency of ≤0.1% of patients include: cardiac failure, pulse irregularity, extrasystoles, skin discoloration, urticaria, skin dryness, alopecia, dermatitis, muscle weakness, twitching, ataxia, hypertonia, migraine, cold and clammy skin, apathy, agitation, amnesia, gastritis, increased appetite, loose stools, rhinitis, dysuria, polyuria, parosmia, taste perversion, abnormal visual accommodation, and xerophthalmia. Other reactions occurred sporadically and cannot be distinguished from medications or concurrent disease states such as myocardial infarction and angina.
Adverse reactions reported for amlodipine for indications other than hypertension may be found in the prescribing information for Norvasc.
Studies with Valsartan:
Diovan® has been eva luated for safety in more than 4,000 hypertensive patients in clinical trials. In trials in which valsartan was compared to an ACE inhibitor with or without placebo, the incidence of dry cough was significantly greater in the ACE inhibitor group (7.9%) than in the groups who received valsartan (2.6%) or placebo (1.5%). In a 129 patient trial limited to patients who had had dry cough when they had previously received ACE inhibitors, the incidences of cough in patients who received valsartan, HCTZ, or lisinopril were 20%, 19%, and 69% respectively (p<0.001).
Other adverse reactions, not listed above, occurring in >0.2% of patients in controlled clinical trials with valsartan are:
Body as a Whole: allergic reaction, asthenia
Musculoskeletal: muscle cramps
Neurologic and Psychiatric: paresthesia
Respiratory:sinusitis, pharyngitis
Urogenital:impotence
Other reported events seen less frequently in clinical trials were: angioedema.
Adverse reactions reported for valsartan for indications other than hypertension may be found in the prescribing information for Diovan.
6.2 Postmarketing Experience
Amlodipine: Gyn |
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