CARDENE SR adverse reactions: Difference between revisions
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===Angina=== | ===Angina=== | ||
Data are available from only 91 patients with chronic stable angina pectoris who received CARDENE SR 30 to 60 mg administered twice daily in open-label clinical trials. Fifty-eight of these patients were treated for at least 30 days. The four most frequently reported adverse events thought by the investigators to be probably related to the use of CARDENE SR were vasodilatation (5.5%), pedal edema (4.4%), asthenia (4.4%), and dizziness (3.3%). | Data are available from only 91 patients with chronic stable angina pectoris who received CARDENE SR 30 to 60 mg administered twice daily in open-label clinical trials. Fifty-eight of these patients were treated for at least 30 days. The four most frequently reported adverse events thought by the investigators to be probably related to the use of CARDENE SR were vasodilatation (5.5%), pedal edema (4.4%), asthenia (4.4%), and dizziness (3.3%).<ref> {{cite web | url = http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=ce141ca0-d734-11df-8537-0002a5d5c51b | title = CARDENE SR (nicardipine hydrochloride) capsule, extended release [EKR Therapeutics] | accessdate =}}</ref> | ||
==References== | |||
{{Reflist|2}} | {{Reflist|2}} | ||
[[Category:Cardiovascular Drugs]] | [[Category:Cardiovascular Drugs]] | ||
[[Category:Drugs]] | [[Category:Drugs]] | ||
Revision as of 16:21, 20 February 2014
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: :Abdurahman Khalil, M.D. [2]
For patient information about Nicardipine, click here.
ADVERSE REACTIONS
In multiple-dose US and foreign controlled studies, 667 patients received CARDENE SR. In these studies adverse events were elicited by non-directed and in some cases directed questioning; adverse events were generally not serious and about 9% of patients withdrew prematurely from the studies because of them.
Hypertension
The incidence rates of adverse events in hypertensive patients were derived from placebo-controlled clinical trials. Following are the rates of adverse events for CARDENE SR (n=322) and placebo (n=140), respectively, that occurred in 0.6% of patients or more on CARDENE SR. These represent events considered probably drug related by the investigator. Where the frequency of adverse events for CARDENE SR and placebo is similar, causal relationship is uncertain. The only dose-related effect was pedal edema.
Uncontrolled experience in over 300 patients with hypertension treated for up to 27.5 months with CARDENE SR has shown no unexpected adverse events or increase in incidence of adverse events compared to the controlled clinical trials.
Rare Events
The following rare adverse events have been reported in clinical trials or the literature:
Body as a Whole: infection, allergic reaction
Cardiovascular: hypotension, atypical chest pain, peripheral vascular disorder, ventricular extrasystoles, ventricular tachycardia, angina pectoris
Digestive: sore throat, abnormal liver chemistries
Musculoskeletal: arthralgia
Nervous: hot flashes, vertigo, hyperkinesia,impotence, depression, confusion, anxiety
Respiratory: rhinitis, sinusitis
Special Senses: tinnitus, abnormal vision, blurred vision
Angina
Data are available from only 91 patients with chronic stable angina pectoris who received CARDENE SR 30 to 60 mg administered twice daily in open-label clinical trials. Fifty-eight of these patients were treated for at least 30 days. The four most frequently reported adverse events thought by the investigators to be probably related to the use of CARDENE SR were vasodilatation (5.5%), pedal edema (4.4%), asthenia (4.4%), and dizziness (3.3%).[1]