Nifedical capsules

Nifedical

  • Active Ingredient: Nifedipine
  • 30 mg, 20 mg
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What is Nifedical?

The active ingredient of Nifedical brand is nifedipine. Nifedipine is in a group of drugs called calcium channel blockers. It works by relaxing the muscles of your heart and blood vessels. Nifedipine, USP is a yellow powder, practically insoluble in water but soluble in ethanol. It has a molecular weight of 346.33. Nifedipine Extended-Release Tablets, USP are formulated as a once-a-day controlled-release tablet for oral administration designed to deliver 30 mg, 60 mg or 90 mg of nifedipine. Inert ingredients in the formulations are: black iron oxide, cellulose acetate, ferric oxide, hydroxypropyl cellulose, hypromellose, magnesium stearate, polyethylene glycol, polyethylene oxide, polyvinyl alcohol, propylene glycol, red iron oxide, sodium chloride, talc, titanium dioxide and yellow iron oxide. Meets USP Dissolution Test 8.

Used for

Nifedical is used to treat diseases such as: Angina Pectoris Prophylaxis, Heart Failure, High Blood Pressure, Hypertensive Emergency, Hypertrophic Cardiomyopathy, Migraine Prevention, Premature Labor, Raynaud's Syndrome.

Side Effect

Possible side effects of Nifedical include: headache, severe and throbbing; large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs; joint stiffness; stuffy nose; loss of strength or energy; yellow eyes and skin; tightness in the chest; wheezing.

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How should I take Nifedical?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Swallow the tablet or capsule whole and do not crush, chew, or break it.

Take the extended-release tablet on an empty stomach.

Your dose needs may change if you switch to a different brand, strength, or form of this medicine. Avoid medication errors by using only the form and strength your doctor prescribes.

Your blood pressure will need to be checked often and you may need other medical tests.

Keep using this medicine even if you feel well. Use all your heart or blood pressure medications as directed and read all medication guides you receive. Do not change your dose or stop taking your medicine without your doctor's advice.

You may have very low blood pressure while taking this medication. Call your doctor if you are sick with vomiting or diarrhea, or if you are sweating more than usual.

If you need surgery, tell the surgeon ahead of time that you are using Nifedical. You may need to stop using the medicine at least 36 hours before surgery.

Some tablets are made with a shell that is not absorbed or melted in the body. Part of this shell may appear in your stool. This is normal and will not make the medicine less effective.

Store in the original container at room temperature, away from moisture, heat, and light.

What Is Nifedical and How Does It Work?

Nifedical 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. In those patients who have had angiography, the presence of significant fixed obstructive disease is not incompatible with the diagnosis of vasospastic angina, provided that the above criteria are satisfied. Nifedical may also be used where the clinical presentation suggests a possible vasospastic component but where vasospasm has not been confirmed, e.g., where pain has a variable threshold on exertion or when angina is refractory to nitrates and/or adequate doses of beta blockers.

Nifedical 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. In chronic stable angina (effort-associated angina) Nifedical has been effective in controlled trials of up to eight weeks duration in reducing angina frequency and increasing exercise tolerance, but confirmation of sustained effectiveness and evaluation of long-term safety in these patients are incomplete. Controlled studies in small numbers of patients suggest concomitant use of Nifedical and beta-blocking agents may be beneficial in patients with chronic stable angina, but available information is not sufficient to predict with confidence the effects of concurrent treatment, especially in patients with compromised left ventricular function or cardiac conduction abnormalities. When introducing such concomitant therapy, care must be taken to monitor blood pressure closely since severe hypotension can occur from the combined effects of the drugs.

Nifedical is available under the following different brand names: Procardia, Procardia XL, Adalat CC, Nifedical XL, Adalat, Afeditab CR, and Nifediac CC.

Incidence Less Than 0.5%

Face and Throat: angioedema (mostly oropharyngeal edema with breathing difficulty in a few patients), gingival hyperplasia

CNS: depression, paranoid syndrome

Special Senses: transient blindness at the peak of plasma level, tinnitus

Several of these side effects appear to be dose related. Peripheral edema occurred in about one in 25 patients at doses less than 60 mg per day and in about one patient in eight at 120 mg per day or more. Transient hypotension, generally of mild to moderate severity and seldom requiring discontinuation of therapy, occurred in one of 50 patients at less than 60 mg per day and in one of 20 patients at 120 mg per day or more.

Very rarely, introduction of PROCARDIA therapy was associated with an increase in anginal pain, possibly due to associated hypotension. Transient unilateral loss of vision has also occurred.

In addition, more serious adverse events were observed, not readily distinguishable from the natural history of the disease in these patients. It remains possible, however, that some or many of these events were drug related. Myocardial infarction occurred in about 4% of patients and congestive heart failure or pulmonary edema in about 2%. Ventricular arrhythmias or conduction disturbances each occurred in fewer than 0.5% of patients.

In a subgroup of over 1000 patients receiving PROCARDIA with concomitant beta blocker therapy, the pattern and incidence of adverse experiences were not different from that of the entire group of PROCARDIA (Nifedical) treated patients. (See PRECAUTIONS.)

In a subgroup of approximately 250 patients with a diagnosis of congestive heart failure as well as angina pectoris (about 10% of the total patient population), dizziness or lightheadedness, peripheral edema, headache, or flushing each occurred in one in eight patients. Hypotension occurred in about one in 20 patients. Syncope occurred in approximately one patient in 250. Myocardial infarction or symptoms of congestive heart failure each occurred in about one patient in 15. Atrial or ventricular dysrhythmias each occurred in about one patient in 150.

In post-marketing experience, there have been rare reports of exfoliative dermatitis caused by Nifedical. There have been rare reports of exfoliative or bullous skin adverse events (such as erythema multiforme, Stevens-Johnson Syndrome, and toxic epidermal necrolysis) and photosensitivity reactions. Acute generalized exanthematous pustulosis also has been reported.

Read the entire FDA prescribing information for Procardia (Nifedical)

What should I avoid while taking Nifedical?

Grapefruit may interact with Nifedical and lead to unwanted side effects. Avoid the use of grapefruit products.

Avoid taking an herbal supplement containing St. John's wort.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.

Mechanism of Injury

The mechanism of Nifedical hepatotoxicity is not known, but is likely to be due to production of a toxic or immunogenic intermediate during its metabolism by the liver.

Management of adverse drug reactions

The effect of Nifedical on magnesium-induced adverse effects has been studied in a retrospective chart review of 377 women who were given intravenous magnesium sulfate for pre-eclampsia 162 received magnesium sulfate and contemporaneous Nifedical and 215 controls received magnesium sulfate and either another antihypertensive ( n = 32 ) or no antihypertensive ( n = 183 ) (39 c ) . The cases had more severe pre-eclampsia and a longer infusion of magnesium sulfate. However, they had no excess of neuromuscular weakness (53%) compared with controls who received antihypertensive medication (53%), or controls who received no antihypertensive medication (45); nor were there other serious magnesium-related effects. Those who received magnesium had less neuromuscular blockade than controls who received antihypertensive medication (OR = 0.04; 95% CI = 0.002, 0.80) and less maternal hypotension than those who received no antihypertensive medication (41 versus 53%). The authors concluded that Nifedical does not alter the risk of serious magnesium-related effects.

Getting the most from your treatment

  • Try to keep your regular appointments with your doctor. This is so your doctor can check on your progress.
  • Your doctor will discuss with you the possibility of unwanted side-effects. When you first start taking Nifedical you may experience headaches, feeling flushed, and some dizziness. These effects usually only last for a few days, but if they continue or become troublesome, you should let your doctor know.
  • If you drink alcohol, ask your doctor for advice. Your doctor may recommend that you do not drink alcohol while you are on this medicine, as it may increase the chance that you experience side-effects, such as feeling dizzy or light-headed.
  • Treatment with Nifedical is often long-term. Continue to take the tablets/capsules unless you are told otherwise by your doctor. If it is necessary for you to stop, your doctor may want you to reduce your dose over a few days, as there is some evidence to suggest that stopping taking Nifedical suddenly can cause some symptoms to return.
  • If you buy any medicines, always check with a pharmacist that they are suitable to take with your other medicines. Some anti-inflammatory painkillers may reduce the effectiveness of Nifedical.
  • If you need to have an operation or any medical treatment, always tell the person carrying out the treatment which medicines you are taking. Nifedical and some anaesthetics can interact, meaning that unwanted effects are more likely.
  • It is not advisable for you to drink grapefruit juice while you are on Nifedical. This is because a chemical in grapefruit juice can increase the amount of Nifedical in your bloodstream and this increases the risk of side-effects.
  • There are several brands of modified-release Nifedical available and your treatment could be affected by switching between brands. Each time you collect a new supply from your pharmacy, check to see if the tablets/capsules are the same as before. If your medicine or packaging looks different from what you have had before, discuss this with your pharmacist who will advise you.
  • Parts of some modified-release tablets pass through the digestive system intact and it is possible to see bits of the tablets when you go to the toilet. This is nothing to be concerned about and it does not stop the medicine from working.
  • If you have diabetes you may need to check your blood glucose more frequently for a time. Nifedical can affect the levels of sugar in your blood but your doctor will advise you about this.

How it works

Nifedical belongs to a class of drugs called calcium channel blockers. A class of drugs is a group of medications that work in a similar way. These drugs are often used to treat similar conditions.

Calcium channel blockers help lower blood pressure by relaxing the blood vessels throughout your body. As a result, less pressure is built up and your heart does not have to work as hard to pump blood.

Calcium channel blockers help to prevent angina in two ways. First, they lower pressure in the coronary arteries (the arteries that supply blood to your heart). As a result, your heart receives more blood and oxygen. Second, they help prevent spasm of the coronary arteries. (A spasm is a temporary, sudden narrowing of these arteries.)

Nifedical oral tablet doesn’t cause drowsiness. However, it may cause other side effects.

Will my dose go up or down?

If the starting dose isn't working well enough (your blood pressure doesn't come down enough, or you are still getting symptoms), you may need to increase your dose. If you're bothered by side effects, you may need to stay on a lower dose.

The usual maximum doses of Nifedical are:

  • short acting capsules or liquid: 20mg 3 times a day (total of 60mg a day)
  • long acting capsules or tablets: 40mg twice a day or 90mg once a day (total of 80mg or 90mg a day)

COMMON BRAND(S): Procardia

GENERIC NAME(S): Nifedical

This medication is used to prevent certain types of chest pain (angina). It may allow you to exercise more and decrease the frequency of angina attacks. Nifedical belongs to a class of medications known as calcium channel blockers. It works by relaxing blood vessels so blood can flow more easily. This medication must be taken regularly to be effective. It should not be used to treat attacks of chest pain when they occur. Use other medications (such as sublingual nitroglycerin) to relieve attacks of chest pain as directed by your doctor. Consult your doctor or pharmacist for details.

Older adults should discuss the risks and benefits of this medication with their doctor or pharmacist, as well as other possibly safer forms of Nifedical (such as the long-acting tablets).

Nifedical and Alcohol

Alcohol may worsen certain side effects of Nifedical.

Talk to your doctor about how much alcohol is safe to consume while taking this medicine.

Further information

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Nifedical only for the indication prescribed.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Copyright 1996-2019 Cerner Multum, Inc. Version: 12.01.

Missed Dose of Nifedical

If you miss a dose of Nifedical, take it as soon as you remember.

However, if it’s almost time for your next dose, skip the missed dose and continue on your regular medication schedule.

Don’t double up on doses to make up for a missed one.

Interactions

Drug-drug. Beta-adrenergic blockers: increased risk of heart failure, severe hypotension, or angina exacerbation

Cimetidine: increased Nifedical blood level

Coumarin anticoagulants: increased prothrombin time

Digoxin: increased risk of digoxin toxicity

Quinidine: decreased quinidine blood level

Drug-diagnostic tests. Antinuclear antibody, direct Coombs' test false-positive results

Drug-food. Grapefruit, grapefruit juice: increased Nifedical blood level and effects

Drug-herbs. Ephedra (ma huang), yohimbine: antagonism of Nifedical effect

Ginkgo, ginseng: increased Nifedical blood level

St. John's wort: decreased Nifedical blood level

Drug-behaviors. Alcohol use: additive hypotension

How should this medicine be used?

Nifedical 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 Nifedical, take it at around the same time(s) every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take Nifedical exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Swallow the extended-release tablets whole; do not split, chew, or crush them.

Your doctor will probably start you on a low dose of Nifedical and gradually increase your dose, generally once every 7 to 14 days.

If taken regularly, Nifedical 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.

Nifedical controls high blood pressure and chest pain (angina) but does not cure them. Continue to take Nifedical even if you feel well. Do not stop taking Nifedical without talking to your doctor. Your doctor will probably decrease your dose gradually.

What if I take too much?

If you take too much Nifedical by accident, contact your doctor or go to your nearest hospital straight away.

An overdose of Nifedical can cause dizziness and irregular heartbeats, and make you feel sick (nausea), confused and sleepy.

The amount of Nifedical that can lead to an overdose varies from person to person.


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