"The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended the marketing of selexipag (Uptravi, Actelion Registration Ltd) for the treatment of adults with pulmonary arterial hypertension (PAH)./"...
In multiple-dose US and foreign controlled studies, 667 patients received CARDENE SR (nicardipine hydrochloride sustained release capsules) . In these studies adverse events were elicited by nondirected 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.
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 (nicardipine hydrochloride sustained release capsules) (n=322) and placebo (n=140), respectively, that occurred in 0.6% of patients or more on CARDENE SR (nicardipine hydrochloride sustained release capsules) . These represent events considered probably drug related by the investigator. Where the frequency of adverse events for CARDENE SR (nicardipine hydrochloride sustained release capsules) and placebo is similar, causal relationship is uncertain. The only dose-related effect was pedal edema.
Percentage of Patients With Probably Drug Related Adverse
Events in Placebo-Controlled Studies
|Adverse Event||CARDENE SR
|Increased Urinary Frequency||0.6||0|
Incidence (%) of Discontinuations Due to Any Adverse Event
in Placebo-Controlled Studies
|Adverse Event||CARDENE SR
Uncontrolled experience in over 300 patients with hypertension treated for up to 27.5 months with CARDENE SR (nicardipine hydrochloride sustained release capsules) has shown no unexpected adverse events or increase in incidence of adverse events compared to the controlled clinical trials.
The following rare adverse events have been reported in clinical trials or the literature:
Digestive: sore throat, abnormal liver chemistries
Special Senses: tinnitus, abnormal vision, blurred vision
Data are available from only 91 patients with chronic stable angina pectoris who received CARDENE SR (nicardipine hydrochloride sustained release capsules) 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 (nicardipine hydrochloride sustained release capsules) were vasodilatation (5.5%), pedal edema (4.4%), asthenia (4.4%), and dizziness (3.3%).
Read the Cardene SR (nicardipine hydrochloride sustained release capsules) Side Effects Center for a complete guide to possible side effects
In controlled clinical studies, adrenergic beta-receptor blockers have been frequently administered concomitantly with CARDENE. The combination is well tolerated.
Cimetidine increases CARDENE plasma levels. Patients receiving the two drugs concomitantly should be carefully monitored.
Some calcium blockers may increase the concentration of digitalis preparations in the blood. CARDENE usually does not alter the plasma levels of digoxin; however, serum digoxin levels should be evaluated after concomitant therapy with CARDENE is initiated.
Severe hypotension has been reported during fentanyl anesthesia with concomitant use of a beta-blocker and a calcium channel blocker. Even though such interactions were not seen during clinical studies with CARDENE, an increased volume of circulating fluids might be required if such an interaction were to occur.
Concomitant administration of nicardipine and cyclosporine results in elevated plasma cyclosporine levels. Plasma concentrations of cyclosporine should therefore be closely monitored, and its dosage reduced accordingly, in patients treated with nicardipine.
When therapeutic concentrations of furosemide, propranolol, dipyridamole, warfarin, quinidine or naproxen were added to human plasma (in vitro), the plasma protein binding of CARDENE was not altered.
Read the Cardene SR Drug Interactions Center for a complete guide to possible interactions
Last reviewed on RxList: 6/19/2009
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