Medical Editor: John P. Cunha, DO, FACOEP
What Is Dynacirc CR?
DynaCirc CR (isradipine) is a calcium channel blocker used to treat high blood pressure (hypertension). DynaCirc CR is sometimes given with other blood pressure medications.
What Are Side Effects of Dynacirc CR?
Common side effects of DynaCirc CR include:
- dizziness
- nausea
- vomiting
- upset stomach
- diarrhea
- headache
- tiredness
- weakness
- flushing (warmth, redness, or tingly feeling under the skin)
- swelling of the ankles/feet, and
- skin rash or itching
Seek medical care or call 911 at once if you have the following serious side effects:
- Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
- Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in your chest; shortness of breath; and sudden dizziness, lightheadedness, or passing out;
- Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors.
This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.
Dosage for Dynacirc CR
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.
What Drugs, Substances, or Supplements Interact with Dynacirc CR?
DynaCirc CR may interact with cimetidine, fentanyl, or rifampin. Tell your doctor all medications and supplements you use.
Dynacirc CR During Pregnancy or Breastfeeding
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.
Additional Information
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.
QUESTION
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Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:
- a light-headed feeling, like you might pass out;
- pounding heartbeats or fluttering in your chest;
- flushing (warmth, redness, or tingly feeling);
- tiredness; or
- heart problems--swelling, rapid weight gain, feeling short of breath.
Common side effects may include:
- flushing;
- headache, dizziness;
- swelling;
- fast heartbeats; or
- upset stomach.
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.
SLIDESHOW
How to Lower Blood Pressure: Exercise Tips See SlideshowSIDE 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) | ||||
| 5 mg (N=79) |
10 mg (N=79) |
15 mg (N=82) |
20 mg (N=78) |
Placebo Group (N=83) |
|
| Headache | 13.9% | 12.7% | 18.3% | 10.3% | 15.7% |
| Edema | 8.9% | 12.7% | 15.9% | 35.9% | 3.6% |
| Dizziness | 5.1% | 6.3% | 3.7% | 6.4% | 2.4% |
| Constipation | 3.8% | 1.3% | 1.2% | 2.6% | 0.0% |
| Fatigue | 2.5% | 7.6% | 3.7% | 3.8% | 2.4% |
| Flushing | 2.5% | 3.8% | 1.2% | 1.3% | 1.2% |
| Abdominal Discomfort | 1.3% | 5.1% | 3.7% | 5.1% | 1.2% |
| Rash | 1.3% | 1.3% | 0.0% | 2.6% | 0.0% |
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 | |
| DynaCirc CR®(isradipine) (N=422) |
Placebo (N=186) |
|
| Edema | 15.2% | 2.2% |
| Headache | 13.0% | 12.4% |
| Dizziness | 4.7% | 2.7% |
| Fatigue | 4.3% | 2.2% |
| Abdominal Discomfort | 2.8% | 0.5% |
| Flushing | 1.9% | 0.5% |
| Constipation | 1.7% | 0.0% |
| Palpitations | 1.2% | 0.0% |
| Nausea | 1.2% | 1.6% |
| Abdominal Distention | 1.2% | 0.0% |
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.
SKIN:Pruritus, urticaria, angioedema.
MUSCULOSKELETAL: Backache/pain, joint pain,neck pain/sore/stiff,legs ache/pain,cramps of legs/feet.
RESPIRATORY: Dyspnea, nasal congestion,cough.
CARDIOVASCULAR: Epistaxis,tachycardia,chest pain,shortness of breath,hypotension, syncope,atrial or ventricular fibrillation,myocardial infarction,heart failure.
GASTROINTESTINAL:Diarrhea,vomiting,appetite increased or decreased.
UROGENITAL: Pollakiuria,impotence,dysuria,nocturia.
CENTRAL NERVOUS: Drowsiness, insomnia, lethargy,nervousness, libido decrease/frigidity,impotence, depression, paresthesia (which includes numbness and tingling), transient ischemic attack,stroke.
AUTONOMIC: Dry mouth,hyperhidrosis,visual disturbance.
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 (N=297) % |
ActiveControls* (N=414) % |
|||
| All Doses | 2.5 mg b.i.d. | 5 mg b.i.d.† | 10 mg b.i.d.†† | |||
| Headache | 13.7 | 12.6 | 10.7 | 22.0 | 14.1 | 9.4 |
| Dizziness | 7.3 | 8.0 | 5.3 | 3.4 | 4.4 | 8.2 |
| Edema | 7.2 | 3.5 | 8.7 | 8.5 | 3.0 | 2.9 |
| Palpitations | 4.0 | 1.0 | 4.7 | 5.1 | 1.4 | 1.5 |
| Fatigue | 3.9 | 2.5 | 2.0 | 8.5 | 0.3 | 6.3 |
| Flushing | 2.6 | 3.0 | 2.0 | 5.1 | 0.0 | 1.2 |
| Chest Pain | 2.4 | 2.5 | 2.7 | 1.7 | 2.4 | 2.9 |
| Nausea | 1.8 | 1.0 | 2.7 | 5.1 | 1.7 | 3.1 |
| Dyspnea | 1.8 | 0.5 | 2.7 | 3.4 | 1.0 | 2.2 |
| Abdominal Discomfort | 1.7 | 0.0 | 3.3 | 1.7 | 1.7 | 3.9 |
| Tachycardia | 1.5 | 1.0 | 1.3 | 3.4 | 0.3 | 0.5 |
| Rash | 1.5 | 1.5 | 2.0 | 1.7 | 0.3 | 0.7 |
| Pollakiuria | 1.5 | 2.0 | 1.3 | 3.4 | 0.0 | <1.0 |
| Weakness | 1.2 | 0.0 | 0.7 | 0.0 | 0.0 | 1.2 |
| Vomiting | 1.1 | 1.0 | 1.3 | 0.0 | 0.3 | 0.2 |
| Diarrhea | 1.1 | 0.0 | 2.7 | 3.4 | 2.0 | 1.9 |
| †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. *Propranolol,prazosin,hydrochlorothiazide,enalapril,captopril. |
||||||
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)
© Dynacirc CR Patient Information is supplied by Cerner Multum, Inc. and Dynacirc CR Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.
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