Cardene (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 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 chances of these problems.

Nicardipine is a calcium channel blocker. It works by influencing how calcium moves into the cells of the heart and blood vessels. As a result, nicardipine relaxes blood vessels and increases the blood and oxygen supply to the heart while decreasing its workload.

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

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly and to check for side effects.

In deciding to use a medicine, you and your doctor need to consider the risks and benefits. For this medicine, please think about the following:

Allergies

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

Pediatric

There have not been appropriate studies on how nicardipine affects children. Its safety and effectiveness have not been established for this age group.

Geriatric

Current studies have not shown any specific problems in older adults that would limit the use of nicardipine. However, older patients may have age-related kidney, liver, or heart issues that could require a dose adjustment while taking nicardipine.

Breast Feeding

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

Interactions with Medicines

Some medicines should never be used together, while others may be used together even if there might be an interaction. In such cases, your doctor may need to adjust the dose or take other precautions. When taking this medicine, it is crucial for your healthcare professional to know if you are taking any of the medicines listed below. The following interactions are significant but may not include all possible interactions.

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

• Levoketoconazole

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

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

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken 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. The following interactions are significant but may not include all possible interactions.

Other Medical Problems

Having other medical problems may affect the use of this medicine. Be sure to inform your doctor if you have any other medical issues, especially:

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

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

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

• Stroke, recent—The blood pressure-lowering effects of this medicine may be increased.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may happen, 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 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

• 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.