Nicardipine

What is Nicardipine?

• Nicardipine (Cardene; Cardene SR) is a calcium ion influx inhibitor (slow channel blocker or calcium channel blocker) used in the treatment of hypertension and stable angina pectoris.
• Cardene iv (nicardipine hydrochloride) is a calcium channel blocker used for the short-term treatment of hypertension when oral therapy is not feasible.

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Nicardipine

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What are the uses of this medicine?

Nicardipine (Cardene; Cardene SR) is used:

• for the management of patients with chronic stable angina (effort-associated angina). Nicardipine hydrochloride capsules may be used alone or in combination with beta-blockers.
• for the treatment of hypertension. Nicardipine hydrochloride capsules may be used alone or in combination with other antihypertensive drugs.

How does this medicine work?

• Nicardipine (nye kar' di peen) belongs to the dihydropyridine class of calcium channel blockers and is used in the treatment of both angina pectoris and hypertension.
• Like other calcium channel blockers, nicardipine acts by blocking the influx of calcium ions into vascular smooth muscle and cardiac cells during depolarization.
• This inhibition of calcium flux results in a vasodilation and decrease in cardiac work and oxygen consumption.

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

• hypersensitivity to the drug.
• advanced aortic stenosis.

What drug interactions can this medicine cause?

• Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Be sure to mention any of the following:

• carbamazepine (Carbatrol, Equetro, Tegretol)
• cimetidine (Tagamet)
• cyclosporine (Neoral, Sandimmune)
• fentanyl (Actiq, Duragesic)
• heart and blood pressure medications such as beta-blockers, digoxin (Lanoxin), diuretics ('water pills'), and quinidine
• phenytoin (Dilantin)
• ranitidine (Zantac)
• theophylline (Theochron, Theolair, Theo-24)

Is this medicine FDA approved?

• Nicardipine was approved in the United States in 1988 and in remains in wide use.
• Nicardipine is available in multiple generic forms and under the commercial name Cardene in regular and as extended- or sustained-release capsules in 20, 30, 45 and 60 mg amounts.
• The current indications vary by formulation, but include both hypertension and angina pectoris.

How should this medicine be used?

Recommended dosage: Angina:

• The dose should be individually titrated for each patient beginning with 20 mg three times daily.
• Doses in the range of 20 to 40 mg three times a day have been shown to be effective.
• At least 3 days should be allowed before increasing the nicardipine hydrochloride capsules.

Hypertension:

• The dose of nicardipine hydrochloride capsules should be individually adjusted according to the blood pressure response beginning with 20 mg three times daily.
• The effective doses in clinical trials have ranged from 20 mg to 40 mg three times daily.
• The maximum blood pressure lowering effect occurs approximately 1 to 2 hours after dosing.

Renal Insufficiency:

• Although there is no evidence that nicardipine hydrochloride capsules impair renal function, careful dose titration beginning with 20 mg tid is advised.

Hepatic Insufficiency:

• A suggested starting dose of 20 mg twice a day is advised with individual titration based on clinical findings maintaining the twice a day schedule.

Administration:

• Nicardipine comes as a regular capsule and as an extended-release (long-acting) capsule to take by mouth.
• The regular capsule is usually taken three times a day.
• The extended-release capsule is usually taken two times a day.
• To help you remember to take nicardipine, take it around the same time(s) every day.
• Swallow the extended-release capsules whole; do not split, chew, or crush them.
• If taken regularly, nicardipine controls chest pain, but it does not stop chest pain once it starts. Your doctor may prescribe a different medication to take when you have chest pain.
• Nicardipine controls high blood pressure and chest pain but does not cure them.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As a regular capsule and as an extended-release (long-acting) capsule

This medicine is available in fallowing brand namesː

• Cardene; Cardene SR

What side effects can this medication cause?

The most common side effects of this medicine include: In Angina:

• Pedal Edema
• Dizziness
• Headache
• Asthenia
• Flushing
• Increased Angina
• Palpitations
• Nausea
• Dyspepsia
• Dry Mouth
• Somnolence
• Rash
• Tachycardia
• Myalgia
• Edema
• Paresthesia
• Sustained Tachycardia
• Syncope
• Constipation
• Dyspnea
• Abnormal ECG
• Malaise
• Nervousness
• Tremor

In Hypertension:

• Flushing
• Headache
• Pedal Edema
• Asthenia
• Palpitations
• Dizziness
• Tachycardia
• Nausea
• Somnolence
• Dyspepsia
• Insomnia
• Malaise
• Edema
• Abnormal Dreams
• Dry Mouth
• Nocturia
• Rash
• Vomiting

Less common side effects, may include:

• Body as a Whole: infection, allergic reaction
• Cardiovascular: hypotension, postural hypotension, atypical chest pain, peripheral vascular disorder, ventricular extrasystoles, ventricular tachycardia
• Digestive: sore throat, abnormal liver chemistries
• Musculoskeletal: arthralgia
• Nervous: hot flashes, vertigo, hyperkinesia, impotence, depression, confusion, anxiety
• Respiratory: rhinitis, sinusitis
• Special Senses: tinnitus, abnormal vision, blurred vision
• Urogenital: increased urinary frequency

What special precautions should I follow?

• Caution should be exercised when using the drug in congestive heart failure patients, particularly in combination with a beta-blocker.
• Nicardipine hydrochloride capsules are not a beta-blocker and therefore gives no protection against the dangers of abrupt beta-blocker withdrawal; any such withdrawal should be by gradual reduction of the dose of beta-blocker, preferably over 8 to 10 days.
• Because nicardipine hydrochloride capsules decrease peripheral resistance, careful monitoring of blood pressure during the initial administration and titration of nicardipine hydrochloride capsules are suggested.
• Nicardipine hydrochloride capsules like other calcium channel blockers, may occasionally produce symptomatic hypotension. Caution is advised to avoid systemic hypotension when administering the drug to patients who have sustained an acute cerebral infarction or hemorrhage.
• nicardipine hydrochloride capsules are subject to first pass metabolism, the drug should be used with caution in patients having impaired liver function or reduced hepatic blood flow.
• Studies in rats have shown significant concentrations of nicardipine in maternal milk following oral administration. For this reason it is recommended that women who wish to breastfeed should not take this drug.
• If you are having surgery, including dental surgery, tell your doctor or dentist that you are taking nicardipine.
• Nicardipene therapy has been associated with a low rate of transient serum enzyme elevations, but has not been linked convincingly to instances of clinically apparent liver injury with jaundice.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• hypotension
• bradycardia
• drowsiness
• confusion
• slurred speech
• progressive atrioventricular conduction block
• hepatic necrosis

Management of overdosage:

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.
• 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.

Can this medicine be used in pregnancy?

• Pregnancy Category C.
• There are no adequate and well-controlled studies in pregnant women.
• Nicardipine hydrochloride capsules should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Can this medicine be used in children?

• Safety and efficacy in patients under the age of 18 have not been established.

What are the active and inactive ingredients in this medicine?

Active ingredients:

• NICARDIPINE HYDROCHLORIDE

Inactive ingredients:

• STARCH, CORN
• MAGNESIUM STEARATE
• TITANIUM DIOXIDE
• GELATIN
• FD&C BLUE NO. 1
• FD&C BLUE NO. 2
• FD&C RED NO. 40
• D&C YELLOW NO. 10
• FERROSOFERRIC OXIDE

Who manufactures and distributes this medicine?

Manufactured by:

• Epic Pharma, LLC
• Laurelton, NY
• Manufactured in USA

What should I know about storage and disposal of this medication?

• Store at 20° to 25°C (68° to 77°F).
• Dispense contents in a tight, light-resistant container with a child-resistant closure.

calcium channel blockers

• amlodipine, diltiazem, felodipine, isradipine, nicardipine, nifedipine, nimodipine, nisoldipine, verapamil

Antihypertensive agents

• Dailymed label info on Nicardipine
• FDA Nicardipine

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