Dynacirc CR (Oral)

Isradipine is used on its own or with other medicines (like hydrochlorothiazide) to treat high blood pressure (hypertension). High blood pressure makes the heart and arteries work harder. If it lasts for a long time, the heart and arteries may not work properly. This can harm the blood vessels in the brain, heart, and kidneys, leading to a stroke, heart failure, or kidney failure. High blood pressure can also raise the risk of heart attacks. Controlling blood pressure may help lower the chances of these problems.

Isradipine is a calcium channel blocker. It works by changing how calcium moves into the cells of the heart and blood vessels. This helps relax blood vessels, increases the flow of blood and oxygen to the heart, and lessens its workload.

This medicine is available only with your doctor's prescription.

It is very important that your doctor checks your progress at regular visits to ensure this medicine is working properly and to check for any unwanted effects.

Low blood pressure (hypotension) may happen while taking this medicine. Contact your doctor immediately if you experience any of the following symptoms: blurred vision; confusion; severe dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position; sweating; or unusual tiredness or weakness.

This medicine may cause fluid retention (edema) in some patients. Inform your doctor right away if you have bloating or swelling of the face, arms, hands, lower legs, or feet; tingling in the hands or feet; or unusual weight gain or loss.

In deciding to use a medicine, you and your doctor must consider the risks of taking the medicine against the benefits it will provide.

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, let your healthcare professional know if you have other allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

There have not been enough studies to determine how isradipine affects children. Its safety and effectiveness in children have not been established.

Geriatric

Current studies have not shown any specific problems for elderly patients that would limit the usefulness of isradipine. However, older adults are more likely to have liver or kidney issues, which may require a dose adjustment for those taking isradipine.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication while breastfeeding. Weigh the potential benefits against the potential risks before using this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all. In other cases, two different medicines may be used together even if an interaction might happen. In these situations, your doctor may adjust the dose or take other precautions. It is especially important for your healthcare professional to know if you are taking any of the medicines listed below. The following interactions are based on their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or adjust some of the other medicines you take.

• Mefloquine

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in some cases. If both medicines are prescribed together, your doctor may adjust the dose or how often you take one or both of the medicines.

• Acecainide
• Acetophenazine
• Ajmaline
• Amiodarone
• Amitriptyline
• Amoxapine
• Aprindine
• Arsenic Trioxide
• Astemizole
• Azimilide
• Bretylium
• Ceritinib
• Chloral Hydrate
• Chloroquine
• Chlorpromazine
• Clarithromycin
• Clopidogrel
• Dantrolene
• Darunavir
• Desipramine
• Dibenzepin
• Digoxin
• Disopyramide
• Dofetilide
• Dolasetron
• Doxepin
• Dronedarone
• Droperidol
• Encainide
• Enflurane
• Epirubicin
• Erythromycin
• Ethopropazine
• Flecainide
• Fluconazole
• Fluoxetine
• Fluphenazine
• Foscarnet
• Gemifloxacin
• Halofantrine
• Halothane
• Hydroquinidine
• Ibutilide
• Imipramine
• Isoflurane
• Itraconazole
• Lacosamide
• Lidoflazine
• Lorcainide
• Melphalan
• Methotrimeprazine
• Nortriptyline
• Octreotide
• Ondansetron
• Pentamidine
• Perphenazine
• Pipotiazine
• Pirmenol
• Prajmaline
• Probucol
• Procainamide
• Prochlorperazine
• Promazine
• Promethazine
• Propafenone
• Propiomazine
• Protriptyline
• Quinidine
• Sematilide
• Sotalol
• Spiramycin
• St John's Wort
• Sulfamethoxazole
• Tedisamil
• Telithromycin
• Thiethylperazine
• Trifluoperazine
• Triflupromazine
• Trimeprazine
• Trimethoprim
• Trimipramine
• Zolmitriptan

Using this medicine with any of the following medicines may increase the risk of certain side effects, but using both drugs may be necessary for your treatment. If both medicines are prescribed together, your doctor may adjust the dose or how often you take one or both of the medicines.

• Amprenavir
• Dalfopristin
• Indinavir
• Ketoconazole
• Magnesium
• Quinupristin
• Rifampin
• Rifapentine

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used around the time of eating food or specific types of food due to possible interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. Discuss with your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical issues may affect how this medicine works. Be sure to tell your doctor if you have any other medical problems, especially:

• Bowel blockage or
• Congestive heart failure—Use with caution. It may worsen these conditions.

• Kidney disease or
• Liver disease—Use with caution. The effects of isradipine may be stronger because the medicine may be removed from the body more slowly.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

• Bloating or swelling of face, arms, hands, lower legs, or feet
• Tingling of hands or feet
• Unusual weight gain or loss

Less common

• Chest pain
• Difficult or labored breathing
• Dizziness
• Fast, irregular, pounding, or racing heartbeat or pulse
• Feeling of warmth
• Full or bloated feeling
• Nausea
• Pressure in the stomach
• Redness of the face, neck, arms and occasionally, upper chest
• Shortness of breath
• Swelling of abdominal or stomach area
• Tightness in chest
• Unusual tiredness or weakness
• Vomiting
• Wheezing

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of Overdose

• Blurred vision
• Confusion
• Dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly
• Flushing
• Sweating

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Headache

Less common

• Diarrhea
• Difficulty having a bowel movement (stool)
• Rash
• Stomach soreness or discomfort

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Dynacirc
• Dynacirc CR

Available Dosage Forms:

• Capsule

Therapeutic Class: Cardiovascular Agent

Pharmacologic Class: Calcium Channel Blocker

Chemical Class: Dihydropyridine

In addition to the use of this medicine, treatment for your high blood pressure may include weight control and changes in the types of foods you eat, especially foods high in sodium. Your doctor will tell you which of these are most important for you. You should check with your doctor before changing your diet.

Many patients who have high blood pressure will not notice any signs of the problem. In fact, many may feel normal. It is very important that you take your medicine exactly as directed and that you keep your appointments with your doctor even if you feel well.

Remember that this medicine will not cure your high blood pressure, but it does help control it. You must continue to take it as directed if you expect to lower your blood pressure and keep it down. You may have to take high blood pressure medicine for the rest of your life. If high blood pressure is not treated, it can cause serious problems such as heart failure, blood vessel disease, stroke, or kidney disease.

Swallow the extended-release tablet whole with a full glass of water. Do not break, crush, or chew it.

If you are taking the extended-release tablets, part of the tablet may pass into your stools after your body has absorbed the medicine. This is normal and is nothing to worry about.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For high blood pressure:For oral dosage form (capsules): Adults—At first, 2.5 milligrams (mg) twice a day. Your doctor may increase your dose if needed. Children—Use and dose must be determined by your doctor. For oral dosage form (extended-release tablets): Adults—At first, 5 milligrams (mg) once a day. Your doctor may increase your dose if needed. Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.