Cardene SR (Oral)

Nicardipine is used by itself or with other medicines to treat severe chest pain (angina) or high blood pressure (hypertension). High blood pressure puts extra strain on the heart and arteries. 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 may also raise the risk of heart attacks. Controlling blood pressure may help reduce the chance of these problems.

Nicardipine 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 blood and oxygen flow to the heart, and lowers 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 look for unwanted effects.

In deciding to use a medicine, it's important to consider the risks against the benefits. This is a choice you will make with your doctor. For this medicine, keep the following in mind:

Allergies

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

Pediatric

Studies have not been done to determine how nicardipine affects children. Its safety and effectiveness have not been established for this age group.

Geriatric

Studies to date have not shown any specific problems that would limit the use of nicardipine in elderly patients. However, older adults are more likely to have age-related kidney, liver, or heart issues that may require a dose adjustment for those taking nicardipine.

Breast Feeding

There are not enough studies in women to determine the risk to infants when using this medication while breastfeeding. Consider the potential benefits and risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should never be used together, while others can be used together even if there may be interactions. If you are taking this medicine, it is very important for your healthcare professional to know if you are also taking any of the medicines listed below. The following interactions are highlighted for their potential significance and are not necessarily a complete list.

Using this medicine with any of the following medicines is not recommended. Your doctor may choose not to prescribe this medication or may change some of the other medicines you are taking.

• Levoketoconazole

Using this medicine with any of the following medicines is usually not recommended, but it may be necessary in some cases. If both medicines are prescribed, your doctor may adjust the dose or frequency of use for one or both medicines.

• Atazanavir
• Clarithromycin
• Clopidogrel
• Cyclosporine
• Dantrolene
• Darunavir
• Digoxin
• Droperidol
• Epirubicin
• Fentanyl
• Itraconazole
• Lacosamide
• Melphalan
• St John's Wort
• Tacrolimus
• Vecuronium

Using this medicine with any of the following medicines may increase the risk of certain side effects, but using both may be the best option for you. If both are prescribed, your doctor may adjust the dose or frequency of use for one or both medicines.

• Dalfopristin
• Fluconazole
• Indinavir
• Ketoconazole
• Magnesium
• Quinupristin
• Rifapentine

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be taken around mealtimes or with specific types of food because of possible interactions. Using alcohol or tobacco with some medicines may also lead to interactions. The following interactions are highlighted for their potential significance and are not necessarily a complete list.

Other Medical Problems

Other medical issues may affect the use of this medicine. Be sure to inform your doctor if you have any other medical conditions, particularly:

• Aortic stenosis (narrowing of a heart valve)—Should not be used in patients with this condition.

• Congestive heart failure—Use with caution. May worsen this condition.

• Kidney disease or
• Liver disease—Use with caution. The effects may be stronger due to slower elimination of the medicine from the body.

• Recent stroke—The blood pressure-lowering effects of this medicine may be stronger.

Along with its needed effects, Cardene SR (Oral) may cause some unwanted effects. Not all of these side effects may occur, but if they do, they may need medical attention.

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

More common

• Arm, back, or jaw pain
• Chest pain or discomfort
• Chest tightness or heaviness
• Fast or irregular heartbeat
• Nausea
• Palpitations
• Shortness of breath
• Sweating
• Swelling of the legs

Less common

• Shakiness
• Swelling

Rare

• Blurred vision
• Cold hands and feet
• Cold sweats
• Confusion
• Cough or hoarseness
• Difficulty swallowing
• Dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly
• Extra heartbeat
• Fever or chills
• Hives
• Increase in frequency of urination
• Itching
• Lower back or side pain
• Painful or difficult urination
• Puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• Skin rash
• Unusual tiredness or weakness
• Wheezing

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

Symptoms of overdose

• Sleepiness
• Slurred speech

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 Cardene SR (Oral). 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

• Feeling of warmth
• Headache
• Lack or loss of strength
• Redness of the face, neck, arms and occasionally, upper chest

Less common

• Acid or sour stomach
• Belching
• Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• Difficulty in moving
• Dry mouth
• Heartburn
• Indigestion
• Joint pain
• Muscle aching or cramping
• Muscle pains or stiffness
• Rash
• Stomach discomfort, upset, or pain
• Swollen joints

Rare

• Changes in vision
• Constipation
• Continuing ringing or buzzing or other unexplained noise in ears
• Decreased interest in sexual intercourse
• Difficult or labored breathing
• Discouragement
• Fear or nervousness
• Feeling of constant movement of self or surroundings
• Feeling sad or empty
• Hearing loss
• Inability to have or keep an erection
• Increase in body movements
• Irritability
• Lack of appetite
• Loss of interest or pleasure
• Loss in sexual ability, desire, drive, or performance
• Nervousness
• Pain or tenderness around eyes and cheekbones
• Runny nose
• Sensation of spinning
• Sneezing
• Sore throat
• Stuffy nose
• Trouble concentrating
• Trouble sleeping

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.

• Cardene
• Cardene SR

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.

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 chest pain:For oral dosage form (capsules): Adults—At first, 20 milligrams (mg) three times a day. Your doctor may increase your dose if needed. Children—Use must be determined by your doctor.
• For high blood pressure: For oral dosage form (capsules): Adults—At first, 20 milligrams (mg) three times a day. Your doctor may increase your dose if needed. Children—Use must be determined by your doctor. For oral dosage form (extended-release capsules): Adults—At first, 30 milligrams (mg) two times a day. Your doctor may increase your dose if needed. Children—Use 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.