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Dynacirc CR

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Dynacirc CR

Dynacirc CR

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:

  • dizziness;
  • warmth, redness, or tingly feeling under your skin;
  • headache;
  • 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

SIDE EFFECTS: Dizziness, nausea, headache, tiredness, flushing and swelling of the ankles/feet may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

An empty tablet shell may appear in your stool. This is harmless since your body has already absorbed the medication.

To reduce dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: fainting, fast/irregular/pounding heartbeat.

Tell your doctor immediately if any of these rare but very serious side effects occurs: severe abdominal pain/constipation, vision changes.

Some people who already have severe heart disease may rarely develop worsening chest pain or a heart attack after starting this medication or increasing the dose. Get medical help right away if you experience: worsening chest pain, symptoms of a heart attack (such as chest/jaw/left arm pain, shortness of breath, unusual sweating).

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

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
(Adverse Reactions)

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)
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) »

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Dynacirc CR - User Reviews

Dynacirc CR User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Dynacirc CR sorted by most helpful. Patient Discussions FAQs

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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