"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 a controlled clinical trial with DynaCirc CR® (isradipine), dose-related edema occurred at an incidence of approximately 9% at 5 mg; 13% at 10 mg; 16% at 15 mg; and 36% at the highest dose studied (20 mg), was mild to moderate in severity,and was not related to age or gender.
The incidences of elicited or volunteered adverse reactions (excluding non-drug related) in the following tables are based on 6-week multicenter, placebo-controlled, double-blind hypertension studies. Less than 1% of DynaCirc CR® (isradipine) or placebo-treated patients discontinued from these studies due to adverse reactions.
The most common adverse experiences ( ≥ 1.0%) reported with DynaCirc CR® (isradipine) in a dose-response study are shown in the following table.There were no discontinuations of patients treated with DynaCirc CR® (isradipine) in this study due to these common side effects.
Most Frequently Reported Newly-Occurring Adverse Reactions
in Dose-Response Study
|Adverse Reactions (Excluding Non-Drug Related)||DynaCirc CR® (isradipine)|
The table below shows elicited or volunteered adverse experiences for DynaCirc CR® (isradipine) treated patients in two 6-week, placebo-controlled, multicenter studies, at doses from 5-20 mg, and considered by the investigator to be at least possibly drug related.The results for DynaCirc CR® (isradipine) treated patients are presented for all doses pooled together (reported by at least 1.0% of active drug treated patients).The incidence of adverse reactions are listed below:
|Adverse Reactions (Excluding Non-Drug Related)||Treatment Group|
The following adverse experiences were reported in 0.5%-1.0% or less of DynaCirc CR® (isradipine) or immediate-release DynaCirc® (isradipine) treated patients in hypertensive studies,or were noted in postmarketing experience with immediate-release DynaCirc® (isradipine) Capsules. More serious events are shown in italics. The relationship of these adverse experiences to isradipine administration is uncertain.
MUSCULOSKELETAL: Backache/pain, joint pain,neck pain/sore/stiff,legs ache/pain,cramps of legs/feet.
GASTROINTESTINAL:Diarrhea,vomiting,appetite increased or decreased.
MISCELLANEOUS: Weight gain, throat discomfort, drug fever, leukopenia, elevated liver function tests.
No gastrointestinal bleeding has been reported in clinical trials with DynaCirc CR® (isradipine) Controlled Release Tablets.
In a long-term (one-year) DynaCirc CR® (isradipine) open-label, hypertension trial, the adverse events reported were generally the same as those seen in the short-term placebo-controlled studies. About 6% of DynaCirc CR® (isradipine) treated patients discontinued the long-term trial due to adverse reactions.
With immediate-release DynaCirc® (isradipine) Capsules, most of the adverse experiences were transient, mild, and related to vasodilatory effects.The following table shows the most common adverse events reported in U.S.clinical tri-als for immediate-release DynaCirc® (isradipine) Capsules, volunteered or elicited, and considered by the investigator to be at least possibly drug related.
|Adverse Experience||DynaCirc® (isradipine)||Placebo
|All Doses||2.5 mg b.i.d.||5 mg b.i.d.†||10 mg b.i.d.††|
|†Initial dose of 2.5 mg b.i.d.followed by maintenance dose
of 5.0 mg b.i.d.
††Initial dose of 2.5 mg b.i.d.followed by sequential titration to 5.0 mg b.i.d.,7.5 mg b.i.d.,and maintenance dose of 10.0 mg b.i.d.
In open-label,long-term studies of up to two years in duration with immediate-release DynaCirc® (isradipine) Capsules, the adverse experiences reported were generally the same as those reported in the short-term controlled trials. The overall frequencies of these adverse events were slightly higher in the long-term than in the controlled studies, but in the controlled studies most adverse reactions were mild and transient.
Read the Dynacirc CR (isradipine) Side Effects Center for a complete guide to possible side effects
Nitroglycerin: Immediate-release DynaCirc® (isradipine) has been safely coadministered with nitroglycerin.
Hydrochlorothiazide: A study in normal healthy volunteers has shown that concomitant administration of immediate-release DynaCirc® (isradipine) and hydrochlorothiazide does not result in altered pharmacokinetics of either drug. In a study in hypertensive patients, addition of isradipine to existing hydrochlorothiazide therapy did not result in any unexpected adverse effects, and isradipine had an additional antihypertensive effect.
Propranolol: In a single dose study in normal volunteers using immediate-release DynaCirc® (isradipine),co-administration of propranolol had a small effect on the rate but no effect on the extent of isradipine bioavailability. Significant increases in AUC (27%) and Cmax (58%) and decreases in tmax (23%) of propranolol were noted in this study.
Digoxin: The concomitant administration of immediate-release DynaCirc® (isradipine) and digoxin in a single-dose pharmacokinetic study did not affect renal, non-renal and total body clearance of digoxin.
Fentanyl Anesthesia: Severe hypotension has been reported during fentanyl anesthesia with concomitant use of a beta blocker and a calcium channel blocker. An increased volume of circulating fluids might be required if such an interaction were to occur.
Read the Dynacirc CR Drug Interactions Center for a complete guide to possible interactions
Last reviewed on RxList: 12/30/2008
Additional Dynacirc CR Information
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