Nifedate capsules

Nifedate

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

The active ingredient of Nifedate 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

Nifedate 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 Nifedate include: increased sweating; tender, swollen glands in the neck; body aches or pain; shortness of breath; unable to sleep; shakiness in the legs, arms, hands, or feet.

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Background

Nifedate (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, Nifedate 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. Nifedate 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. Nifedate is available in capsules of 10 and 20 mg and as extended release tablets of 30, 60 and 90 mg in several generic formulations as well as under brand names including Procardia, Adala, Afeditab, Nifediac, and Nifedical. The typical dose in adults is 30 to 60 mg daily, usually starting with lower doses. Nifedate is generally well tolerated and side effects are largely due to its vasodilating activities and can include dizziness, flushing, headache, fatigue, nausea, diarrhea, palpitations, bradycardia, peripheral edema and skin rash.

Pregnancy and Nifedate

It’s not known whether Nifedate can harm an unborn baby.

Tell your doctor if you’re pregnant or plan to become pregnant before taking this medicine.

Nifedate can pass into breast milk and hurt a breastfeeding baby. Don’t take this medicine if you’re breastfeeding.

Hepatotoxicity

Mild and transient elevations in serum aminotransferase levels may occur during Nifedate therapy, but often resolve even with continuation of therapy. Clinically apparent acute liver injury with jaundice due to Nifedate is rare and described only in isolated case reports. The time to onset of injury is typically 1 to 2 months and the pattern of serum enzyme elevations is usually hepatocellular or mixed. Rash, arthralgias, fever and eosinophilia can occur, but are not prominent. Chronic aminotransferase elevations during continued therapy with Nifedate have been described sometimes with histological features of alcoholic liver disease (steatosis and Mallory bodies), but chronic liver injury after withdrawal has not. Nifedate has not been implicated in cases of vanishing bile duct syndrome or acute liver failure in the published literature.

Likelihood score: B (likely cause of clinically apparent liver injury).

Nifedate and Alcohol

Alcohol may worsen certain side effects of Nifedate.

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

Calcium Channel Blockers

Nifedate is a calcium channel blocker (CCB) commonly prescribed for the treatment of hypertension, but it is also used in Raynaud phenomenon, which is characterized by cold intolerance and vasospasm. This observation led to a case series that showed a reduction of pain in 9 of 13 patients with CRPS treated with oral Nifedate. 75 A retrospective study of 124 patients with CRPS, 35 treated with Nifedate, showed a reduction in pain in 60% of patients with acute pain and 30% of patients with chronic pain. 76 Common side effects include headache, dizziness, lightheadedness, and nausea. CCBs need further support with placebo-controlled clinical trials to recommend their usage in CRPS.

Antiseizure drugs

Taking certain antiseizure drugs with Nifedate can cause lower levels of Nifedate in your body. This can make it less effective. These drugs include:

Taking other antiseizure drugs with Nifedate can cause higher levels of Nifedate in your body. This raises your risk of side effects from Nifedate. These drugs include:

Other drugs

Beta-blockers are used to treat many conditions. These include high blood pressure, migraines, or heart failure. Using these drugs with Nifedate has a low risk of causing heart failure, extremely low blood pressure, or a worsening of chest pain (angina).

If you’re taking a beta-blocker and your doctor has you stop taking it before starting Nifedate, the beta-blocker should be tapered slowly. Stopping it suddenly could cause increased chest pains. Beta-blockers include:

Doxazosin is used to treat high blood pressure, as well as benign prostate hyperplasia in men. Using doxazosin with Nifedate can lower the amount of doxazosin in your body. This makes it less effective. Using these drugs together can also cause increased levels of Nifedate in your body. This raises your risk of dangerous side effects.

Disclaimer: Our goal is to provide you with the most relevant and current information. However, because drugs interact differently in each person, we cannot guarantee that this information includes all possible interactions. This information is not a substitute for medical advice. Always speak with your healthcare provider about possible interactions with all prescription drugs, vitamins, herbs and supplements, and over-the-counter drugs that you are taking.

This dosage information is for Nifedate oral tablet. All possible dosages and drug forms may not be included here. Your doctor will tell you what dosage is right for you. Your dose, drug form, and how often you take the drug will depend on:

  • your age
  • the condition being treated
  • how severe your condition is
  • other medical conditions you have
  • how you react to the first dose

6. How to cope with s >

What to do about:

  • headaches - make sure you rest and drink plenty of fluids. Do not drink too much alcohol. Ask your pharmacist to recommend a painkiller for a headache. Paracetamol is safe to take with Nifedate. Headaches should usually go away after the first week of taking Nifedate. Talk to your doctor if they last longer than a week or are severe.
  • feeling dizzy - if Nifedate makes you feel dizzy, stop what you're doing and sit or lie down until you feel better.
  • flushing - try cutting down on coffee, tea and alcohol. It might help to keep the room cool and use a fan. You could also spray your face with cool water or sip cold or iced drinks. The flushing should go away after a few days, so try to carry on taking Nifedate for this time. If it does not go away or is causing you problems, contact your doctor.
  • a pounding heartbeat - if this happens regularly after you take your medicine try to take it at a time when you can sit or lie down while the symptoms are at their worst. It might also help to cut down on alcohol, smoking, caffeine and big meals as these can make the problem worse. If you are still having problems after a week or so speak to your doctor as they may need to change you to a different type of medicine.
  • swollen ankles - raise your legs when you're sitting down.
  • constipation - eat plenty of high-fibre foods such as fresh fruit and vegetables and cereals, and drink lots of water. Try to exercise regularly, for example by going for a daily walk or run. It's ok to occasionally use a laxative.

Nifedate (SED-15, 2516; SEDA-28, 220; SEDA-29, 198; SEDA-30, 227)

The use of Nifedate as a tocolytic is becoming more frequent, even if there is no consensus about the appropriate regimen. Two cases of serious complications have been reported.

A 37-year-old previously healthy woman went into preterm labor at 33 weeks and was given two doses of sublingual Nifedate 20 mg 30 minutes apart, followed by maintenance oral Nifedate 40 mg 6-hourly (13 A ) . Her contractions subsided and it was decided to maintain tocolysis until 34 weeks of gestation. On day 3, she complained of dyspnea and orthopnea with tachycardia and tachypnea. Chest radiography showed bilateral interstitial and central alveolar shadowing but no pleural effusions. Nifedate was withdrawn and she received intravenous furosemide during the first 24 hours and oxygen, with transient improvement. A cesarean delivery was performed. She was extubated 24 hours after delivery and furosemide was maintained for 4 days. She recovered completely.

A 38-year-old woman developed threatened preterm labor at 33 weeks of gestation and was given Nifedate 30 mg followed by three doses of modified-release Nifedate tablets 20 mg 8-hourly (14 A ) . Within 4 hours of the last dose, she had palpitation and left-sided chest pain with an irregular pulse. Electrocardiography confirmed fast atrial fibrillation. Transthoracic echocardiography showed no major structural cardiac abnormality. The left atrium was not dilated. Cardioversion was undertaken under a short general anesthetic. She reverted to sinus rhythm.

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 Nifedate 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)

Can Nifedate cause problems?

Along with their useful effects, most medicines can cause unwanted side-effects although not everyone experiences them. The table below contains some of the most common ones associated with Nifedate. You will find a full list in the manufacturer's information leaflet supplied with your medicine. The unwanted effects often improve as your body adjusts to the new medicine, but speak with your doctor or pharmacist if any of the following continue or become troublesome.


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