"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)./"...
Dynacirc CR Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
DynaCirc CR (isradipine) is used to treat high blood pressure (hypertension). It is sometimes given with other blood pressure medications. It is a calcium channel blocker. Common side effects include dizziness, nausea, headache, tiredness, flushing and swelling of the ankles/feet.
The recommended initial dose of DynaCirc CR is 5 mg once-daily as monotherapy or in combination with a thiazide diuretic. If necessary, the dose may be adjusted in increments of 5 mg at 2-4 week intervals up to a maximum dose of 20 mg/day. DynaCirc CR may interact with cimetidine, fentanyl, or rifampin. Tell your doctor all medications and supplements you use. During pregnancy, DynaCirc CR should be used only when prescribed. It is unknown if this medication passes into breast milk. Consult your doctor before breastfeeding.
Our DynaCirc CR (isradipine) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Dynacirc CR in Detail - Patient Information: Side Effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have any of these serious side effects:
- feeling like you might pass out;
- feeling short of breath, even with mild exertion;
- swelling in your hands and feet;
- fast or pounding heartbeats; or
- chest pain.
Less serious side effects may include:
- warmth, redness, or tingly feeling under your skin;
- weakness, tired feeling;
- nausea, vomiting, diarrhea, upset stomach; or
- skin rash or itching.
This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Dynacirc CR (Isradipine)
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Dynacirc CR Overview - Patient Information: Side Effects
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the entire patient information overview for Dynacirc CR (Isradipine)
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Dynacirc CR FDA Prescribing Information: Side Effects
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 entire FDA prescribing information for Dynacirc CR (Isradipine)
Additional Dynacirc CR Information
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Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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