Cardene

Nicardipine may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• headache
• upset stomach
• dizziness or lightheadedness
• excessive tiredness
• flushing
• numbness
• fast heartbeat
• muscle cramps
• constipation
• heartburn
• increased sweating
• dry mouth

If you experience any of the following symptoms, call your doctor immediately or get emergency medical treatment:

• swelling of the face, eyes, lips, tongue, arms, or legs
• difficulty breathing or swallowing
• fainting
• rash
• increase in frequency or severity of chest pain (angina)

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Cardene is a prescription medication used to treat high blood pressure and chest pain. Cardene belongs to a group of drugs called calcium channel blockers, which relax blood vessels, making it easier for the heart to pump blood.

This medication comes in immediate release capsule and sustained release capsules. The immediate release capsules are usually taken three times a day, with or without food. 

The sustained release capsules are usually taken twice a day. 

Cardene is also available as an injection and is given into the vein by a healthcare professional. 

Common side effects include headache and nausea. Cardene can cause dizziness. Do not drive or operate heavy machinery until you know how this medication affects you.

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• cimetidine (Tagamet)
• digoxin (Lanoxin)
• cyclosporine (Gengraf, Neoral, Sandimmune)

This is not a complete list of Cardene drug interactions. Ask your doctor or pharmacist for more information.

Take Cardene exactly as prescribed.

This medication comes in immediate release capsule and sustained release capsules. 

• The immediate release capsules are usually taken three times a day, with or without food. 
• The sustained release capsules are usually taken twice a day. 

Cardene is also available as an injection and is given into the vein by a healthcare professional. 

If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of Cardene at the same time.

Take Cardene exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The recommended dosage range for Cardene immediate release capsules for chest pain is 20 to 40 mg three times daily.

The recommended dose range for Cardene sustained-release for high blood pressure is 30 to 60 mg twice daily.

Dose adjustments may be necessary in those with liver impairment, kidney impairment, or heart failure.

Hypertension

Oral management of hypertension (alone or in combination with other classes of antihypertensive agents).1 2 3 500

Therapy with extended-release capsules generally is preferred because of less frequent dosing, potentially smoother BP control,500 and concerns raised by experience with short-acting (conventional, immediate-release) nifedipine.35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 61 72 73

Calcium-channel blockers are recommended as one of several preferred agents for the initial management of hypertension; other options include ACE inhibitors, angiotensin II receptor antagonists, and thiazide diuretics.501 502 503 504 While there may be individual differences with respect to specific outcomes, these antihypertensive drug classes all produce comparable effects on overall mortality and cardiovascular, cerebrovascular, and renal outcomes.501 502 503 504 Individualize choice of therapy; consider patient characteristics (e.g., age, ethnicity/race, comorbidities, cardiovascular risk) as well as drug-related factors (e.g., ease of administration, availability, adverse effects, cost).500 501 502 503 504 515

Calcium-channel blockers may be preferred in hypertensive patients with certain coexisting conditions (e.g., ischemic heart disease)523 and in geriatric patients, including those with isolated systolic hypertension.502 510

Black hypertensive patients generally respond better to monotherapy with calcium-channel blockers or thiazide diuretics than to other antihypertensive drug classes (e.g., ACE inhibitors, angiotensin II receptor antagonists).500 501 504 However, diminished response to these other drug classes is largely eliminated when administered concomitantly with a calcium-channel blocker or thiazide diuretic.500 504

The optimum BP threshold for initiating antihypertensive drug therapy is controversial.501 504 505 506 507 508 515 523 530 Further study needed to determine optimum BP thresholds/goals; individualize treatment decisions.501 503 507 515 526 530

JNC 7 recommends initiation of drug therapy in all patients with uncomplicated hypertension and BP ≥140/90 mm Hg;500 JNC 8 panel recommends SBP threshold of 150 mm Hg for patients ≥60 years of age.501 Although many experts agree that SBP goal of <150 mm Hg may be appropriate for patients ≥80 years of age,502 504 505 530 application of this goal to those ≥60 years of age is controversial, especially for those at higher cardiovascular risk.501 502 505 506 508 511 515

In the past, initial antihypertensive drug therapy was recommended for patients with diabetes mellitus or chronic kidney disease who had BP ≥130/80 mm Hg;500 503 current hypertension management guidelines generally recommend a BP threshold of 140/90 mm Hg for these individuals (same as for the general population of patients without these conditions), although a goal of <130/80 mm Hg may still be considered.501 502 503 504 520 530 535 536 541

IV, short-term management of hypertension when oral therapy is not feasible or desirable.18

IV management of hypertensive crises (e.g., emergencies) in adults.18 500

IV, rapid reduction of BP in the management of severe hypertension in pediatric patients 1–17 years of age†.99

Angina

Management of chronic stable angina pectoris (alone or in combination with other antianginal agents).1 3 25

Nicardipine is used alone or together with other medicines to treat severe chest pain (angina) or high blood pressure (hypertension). High blood pressure adds to the workload of the heart and arteries. If it continues for a long time, the heart and arteries may not function properly. This can damage the blood vessels of the brain, heart, and kidneys, resulting in a stroke, heart failure, or kidney failure. High blood pressure may also increase the risk of heart attacks. These problems may be less likely to occur if blood pressure is controlled .

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

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

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:

• 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

• Shakiness
• swelling

• 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:

• 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:

• Feeling of warmth
• headache
• lack or loss of strength
• redness of the face, neck, arms and occasionally, upper chest

• 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

• 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.

Cardene is contraindicated in patients with hypersensitivity to the drug.

Because part of the effect of Cardene is secondary to reduced afterload, the drug is also contraindicated in patients with advanced aortic stenosis. Reduction of diastolic pressure by any means in these patients may worsen rather than improve myocardial oxygen balance.

Three overdosages with Cardene or Cardene SR have been reported. Two occurred in adults, 1 of whom ingested 600 mg of Cardene and the other 2160 mg of Cardene SR. Symptoms included marked hypotension, bradycardia, palpitations, flushing, drowsiness, confusion, and slurred speech. All symptoms resolved without sequelae. The third overdosage occurred in a 1-year-old child who ingested half of the powder in a 30-mg Cardene capsule. The child remained asymptomatic.

Based on results obtained in laboratory animals, overdosage may cause systemic hypotension, bradycardia (following initial tachycardia) and progressive atrioventricular conduction block. Reversible hepatic function abnormalities and sporadic focal hepatic necrosis were noted in some animal species receiving very large doses of nicardipine.

For treatment of overdose standard measures (for example, evacuation of gastric contents, elevation of extremities, attention to circulating fluid volume, and urine output) including monitoring of cardiac and respiratory functions should be implemented. The patient should be positioned so as to avoid cerebral anoxia. Frequent blood pressure determinations are essential. Vasopressors are clinically indicated for patients exhibiting profound hypotension. Intravenous calcium gluconate may help reverse the effects of calcium entry blockade.

The dose of Cardene SR should be individually adjusted according to the blood pressure response beginning with 30 mg two times daily. The effective doses in clinical trials have ranged from 30 mg to 60 mg two times daily. The maximum blood pressure lowering effect at steady-state is sustained from 2 hours until 6 hours after dosing.

When initiating therapy or upon increasing dose, blood pressure should be measured 2 to 4 hours after the first dose or dose increase, as well as at the end of a dosing interval.

The total daily dose of immediate release nicardipine (Cardene) may not be a useful guide to judging the effective dose of Cardene SR. Patients currently receiving immediate release nicardipine may be titrated with Cardene SR starting at their current total daily dose of immediate release nicardipine and then reexamined to assess the adequacy of blood pressure control.

Concomitant Use With Other Antihypertensive Agents

1. Diuretics: Cardene may be safely coadministered with thiazide diuretics.
   
2. Beta-Blockers: Cardene may be safely coadministered with beta-blockers (see Drug Interactions).

Special Patient Populations

Although there is no evidence that Cardene SR impairs renal function, careful dose titration beginning with 30-mg Cardene SR bid is advised (see PRECAUTIONS).

Cardene SR has not been studied in patients with severe liver impairment (see PRECAUTIONS).

Caution is advised when titrating Cardene SR dosage in patients with congestive heart failure (see WARNINGS).

LactMed Record Number

408

Last Revision Date

20170411

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