Nifedipine

What is Nifedipine?

• Nifedipine is a first generation calcium channel blocker used to treat hypertension and to control angina (chest pain).

Nifedipine Structure

Nifedipine-from-xtal-3D-balls

Nifedipine 3D

What are the uses of this medicine?

Nifedipine is used for the treatment of: Vasospastic Angina:

• Nifedipine is indicated for the management of vasospastic angina confirmed by any of the following criteria:
• 1) classical pattern of angina at rest accompanied by ST segment elevation,
• 2) angina or coronary artery spasm provoked by ergonovine, or
• 3) angiographically demonstrated coronary artery spasm.

Chronic Stable Angina (Classical Effort-Associated Angina):

• Nifedipine is indicated for the management of chronic stable angina (effort-associated angina) without evidence of vasospasm in patients who remain symptomatic despite adequate doses of beta blockers and/or organic nitrates or who cannot tolerate those agents.

How does this medicine work?

• Nifedipine (nye fed' i peen) belongs to the dihydropyridine class of calcium channel blockers (first in its class and similar to amlodipine, felodipine and nicardipine) and is used for the treatment of hypertension and angina pectoris.
• Like other calcium channel blockers, nifedipine acts by inhibiting the transmembrane influx of calcium into cardiac and smooth muscle cells during depolarization.
• The inhibition of calcium influx causes arterial vasodilation and decreases cardiac work and oxygen consumption.

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

• Known hypersensitivity reaction to nifedipine.

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:

• acarbose (Precose)
• anticoagulants ('blood thinners') such as warfarin (Coumadin, Jantoven)
• antifungals such as fluconazole (Diflucan), itraconazole (Onmel, Sporanox), and ketoconazole (Nizoral)
• beta blockers such as atenolol (Tenormin), labetalol (Trandate), metoprolol (Lopressor, Toprol XL, in Dutoprol), nadolol (Corgard, in Corzide), propranolol (Inderal, Innopran, in Inderide), and timolol )
• carbamazepine (Carbatrol, Epitol, Tegretol)
• cimetidine (Tagamet)
• digoxin (Lanoxin)
• diltiazem (Cardizem)
• doxazosin (Cardura)
• erythromycin (E.E.S., E-Mycin, Erythrocin)
• fentanyl (Actiq, Duragesic, Fentora)
• flecainide (Tambocor)
• HIV protease inhibitors including amprenavir (Agenerase), atazanavir (Reyataz), delavirdine (Rescriptor), fosamprenavir (Lexiva), indinavir (Crixivan), nelfinavir (Viracept), and ritonavir (Norvir, in Kaletra)
• metformin (Glucophage)
• nefazodone
• phenobarbital
• phenytoin (Dilantin, Phenytek)
• quinidine (in Nuedexta)
• quinupristin and dalfopristin (Synercid)
• rifampin (Rifadin, in Rifa ate, in Rifater, Rimactane)
• rifapentine (Priftin)
• tacrolimus (Astagraf SL,Prograf)
• valproic acid (Depakene)
• verapamil (Calan, Covera, Verelan, in Tarka)

Tell your doctor what herbal products you are taking, especially St. John's wort.

• Co-administration of nifedipine with grapefruit juice is to be avoided.

Is this medicine FDA approved?

• Nifedipine was approved in the United States in 1982 and currently several million prescriptions are filled yearly.
• Current indications include hypertension and chronic stable and Prinzmetal's variant angina pectoris.
• It is also used off label to treat Raynaud phenomenon.

How should this medicine be used?

Recommended dosage:

• Therapy should be initiated with the 10 mg capsule.
• The starting dose is one 10 mg capsule, swallowed whole, 3 times/day.
• The usual effective dose range is 10–20 mg three times daily.
• Some patients, especially those with evidence of coronary artery spasm, respond only to higher doses, more frequent administration, or both.
• In such patients, doses of 20–30 mg three or four times daily may be effective.
• Doses above 120 mg daily are rarely necessary.
• More than 180 mg per day is not recommended.

Administration:

• Nifedipine comes as a capsule and an extended-release (long-acting) tablet to take by mouth.
• The capsule is usually taken three or four times a day.
• The extended-release tablet should be taken once daily on an empty stomach, either 1 hour before or 2 hours after a meal. To help you remember to take nifedipine, take it at around the same time(s) every day.
• Swallow the extended-release tablets whole; do not split, chew, or crush them.
• Your doctor will probably start you on a low dose of nifedipine and gradually increase your dose, generally once every 7 to 14 days.
• If taken regularly, nifedipine 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.
• Nifedipine controls high blood pressure and chest pain (angina) but does not cure them.
• Continue to take nifedipine even if you feel well.

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

This medicine is available in fallowing doasage form:

• Nifedipine is available in capsules of 10 and 20 mg and as extended release tablets of 30, 60 and 90 mg in several generic formulations

This medicine is available in fallowing brand namesː

• Adalat
• Adalat
• Afeditab
• Nifedical
• Nifeditab
• Procardia
• Procardia XL

What side effects can this medication cause?

The most common side effects of this medicine include:

• Dizziness
• lightheadedness
• giddiness
• Flushing
• heat sensation
• Headache
• Weakness
• Nausea
• heartburn
• Muscle cramps
• tremor
• Peripheral edema
• Nervousness
• mood changes
• Palpitation
• Dyspnea
• cough
• wheezing
• Nasal congestion
• sore throat

Nifedipine can cause some serious side effects which may include:

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

What special precautions should I follow?

• Because nifedipine decreases peripheral vascular resistance, careful monitoring of blood pressure during the initial administration and titration of nifedipine is suggested. Close observation is especially recommended for patients already taking medications that are known to lower blood pressure.
• Mild to moderate peripheral edema, typically associated with arterial vasodilation and not due to left ventricular dysfunction, occurs in about one in ten patients treated with nifedipine. With patients whose angina is complicated by congestive heart failure, care should be taken to differentiate this peripheral edema from the effects of increasing left ventricular dysfunction.
• Rare, usually transient, but occasionally significant elevations of enzymes such as alkaline phosphatase, CPK, LDH, SGOT and SGPT have been noted.
• Nifedipine capsules should not be used for the acute reduction of blood pressure.
• Nifedipine capsules should not be used for the control of essential hypertension.
• Nifedipine capsules should not be administered within the first week or two after myocardial infarction, and they should also be avoided in the setting of acute coronary syndrome (when infarction may be imminent).
• Rarely, patients, particularly those who have severe obstructive coronary artery disease, have developed well documented increased frequency, duration and/or severity of angina or acute myocardial infarction on starting nifedipine or at the time of dosage increase.
• Patients recently withdrawn from beta blockers may develop a withdrawal syndrome with increased angina, probably related to increased sensitivity to catecholamines. t is important to taper beta blockers if possible, rather than stopping them abruptly before beginning nifedipine.
• Rarely, patients, usually receiving a beta blocker, have developed heart failure after beginning nifedipine.
• Nifedipine therapy is associated with a low rate of serum enzyme elevations and has been linked to several instances of clinically apparent acute liver injury.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• dizziness
• fast heartbeat
• flushing
• nervousness
• nausea
• vomiting
• swelling of the hands, feet, ankles, or lower legs
• blurred vision
• fainting

Management of overdosage:

• Clearance of nifedipine would be expected to be prolonged in patients with impaired liver function.
• Since nifedipine is highly protein bound, dialysis is not likely to be of any benefit; however, plasmapheresis may be beneficial.
• 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.

Can this medicine be used in pregnancy?

• There are no adequate and well-controlled studies in pregnant women.
• Nifedipine 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 effectiveness in pediatric patients have not been established.
• Use in pediatric population is not recommended.

What are the active and inactive ingredients in this medicine?

Active ingredients:

• NIFEDIPINE

Inactive Ingredients:

• POLYETHYLENE GLYCOL
• MENTHOL
• GLYCERIN
• WATER
• SORBITOL
• SORBITAN
• GELATIN
• FERRIC OXIDE RED
• SHELLAC
• POVIDONE K30
• FD&C BLUE NO. 1
• TITANIUM DIOXIDE

Who manufactures and distributes this medicine?

Manufactured by:

• International Vitamin Corporation
• Irvington, NJ

Distributed by:

• Lupin Pharmaceuticals, Inc.
• Baltimore, MD

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

• Keep this medication in the container it came in, tightly closed, and out of reach of children.
• Store it at room temperature, away from light, and away from excess heat and moisture (not in the bathroom).

calcium channel blockers

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

Antihypertensive agents

• Dailymed label info on Nifedipine
• FDA Nifedipine

Nifedipine Resources
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