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Product

Therapeutic Category

Nifedipine

Nifedipine is in a group of drugs called calcium channel blockers. It works by relaxing the muscles of your heart and blood vessels.


Generic Name

Nifedipine


Packing

30,100&500


Therapeutic Category

Cardiovascular


Storage

Store at room temperature away from moisture, heat, and light.


adobe-pdf-logoProduct Insert(PIL)

adobe-pdf-logoPrescribing Information(SPC)


Description

Product Overview


What 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 is used to treat hypertension (high blood pressure) and angina (chest pain).

Nifedipine may also be used for purposes not listed in this medication guide.

What is the most important information I should know about nifedipine?

You should not use nifedipine if you have severe coronary artery disease, or if you have had a heart attack within the past 2 weeks.

Before taking nifedipine, tell your doctor if you have kidney or liver disease, a blockage in your digestive tract (stomach or intestines), a history of stomach surgery, coronary artery disease, underactive thyroid, diabetes, or congestive heart failure.

If you need surgery, tell the surgeon ahead of time that you are using nifedipine. You may need to stop using the medicine for a short time.

Do not stop taking nifedipine without first talking to your doctor, even if you feel fine. Stopping suddenly may make your condition worse. High blood pressure often has no symptoms. You may need to use blood pressure medication for the rest of your life.

Before taking this medicine

You should not use this medicine if you are allergic to nifedipine, if you have severe coronary artery disease, or if you have had a heart attack within the past 2 weeks.

To make sure nifedipine is safe for you, tell your doctor if you have:

• severe COPD (chronic obstructive pulmonary disease);
• kidney disease;
• congestive heart failure; or
• if you take other medications that can lower your blood pressure.

FDA pregnancy category C. It is not known whether nifedipine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

Nifedipine can pass into breast milk and may harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

The nifedipine extended-release tablet may contain lactose. Talk to your doctor before using this form of nifedipine if you have galactose intolerance, or severe problems with lactose (milk sugar).

How should I take nifedipine?

Take nifedipine exactly as prescribed by your doctor. Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not take this medicine in larger or smaller amounts or for longer than recommended.

You may need to take an extended-release tablet on an empty stomach. Follow the directions on your medicine label about taking this medication with or without food.

Do not crush, chew, or break a nifedipine extended-release tablet. Swallow it whole.

Your blood pressure will need to be checked often and you may need other blood tests at your doctor’s office.

Some tablet forms of nifedipine are made with a shell that is not absorbed or melted in the body. Part of the tablet shell may appear in your stool. This is a normal side effect of nifedipine and will not make the medication less effective.

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

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 are also taking a beta-blocker (atenolol, carvedilol, labetalol, metoprolol, nadolol, nebivolol, propranolol, sotalol, and others) you should not stop using the beta-blocker suddenly or you could have serious heart problems that will not be prevented by nifedipine. Follow your doctor’s instructions about tapering your beta-blocker dose.

You should not stop using nifedipine suddenly. Stopping suddenly may make your condition worse.

If you are being treated for high blood pressure, keep using this medication even if you feel well. High blood pressure often has no symptoms. You may need to use blood pressure medication for the rest of your life.

What happens if I miss a dose?
Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid?
Grapefruit and grapefruit juice may interact with nifedipine and lead to unwanted side effects. Discuss the use of grapefruit products with your doctor.

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.

Nifedipine dosing information

Usual Adult Dose of Nifedipine for Hypertension:

Initial dose:
Extended release tablets: 30 to 60 mg orally once a day
Dosage can be increased gradually every 7 to 14 days.

Maximum dose:
Adalat (R) CC: 90 mg/day
Procardia XL (R): 120 mg/day

Usual Adult Dose for Migraine Prophylaxis:

Initial dose:
Extended release tablets: 30 mg orally once a day
Immediate release capsules: 10 mg orally 3 times a day

Usual Adult Dose of Nifedipine for Angina Pectoris Prophylaxis:

Initial dose:
Extended release tablets: 30 to 60 mg orally once a day
Immediate release capsules: 10 mg orally 3 times a day

Dosage can be increased gradually every 7 to 14 days.

Maintenance dose:
Immediate release capsules: 10 to 30 mg orally 3 to 4 times a day

Maximum dose:
Extended release tablets:
Adalat (R) CC: 90 mg/day
Procardia XL (R): 120 mg/day

Immediate release capsules: 180 mg/day

Usual Adult Dose for Congestive Heart Failure:

Initial dose:
Procardia XL (R): 30 to 60 mg orally once a day
Adalat (R) CC: 30 mg orally once a day

Usual Adult Dose of Nifedipine for Premature Labor:

The tocolytic properties of nifedipine have been evaluated in several studies. Doses used in these studies have ranged from 10 to 40 mg as an initial “one time” dose. Subsequent dosages have ranged from 10 to 20 mg every 6 to 8 hours as needed and tolerated to delay delivery.

Immediate release capsules are not approved by the FDA for the treatment of premature labor. In addition, their use in patients with hypertension is not recommended because of data that have revealed evidence of increased risk of adverse cardiovascular events associated with the use of short-acting nifedipine in patients with hypertension. Elderly patients with coronary artery disease may be at particular risk (unlikely to pertain to pregnant women).

Usual Pediatric Dose for Hypertensive Emergency:

Children:
Immediate release capsules: 0.25 to 0.5 mg/kg/dose (maximum 10 mg/dose) repeated every 4 to 6 hours if necessary
Maximum dose: 1 to 2 mg/kg/day

Initial doses less than or equal to 0.25 mg/kg/dose may result in a less dramatic decrease in blood pressure and be safer than larger initial doses. Some centers use initial doses of 0.1 mg/kg/dose.

Usual Pediatric Dose for Hypertension:

Extended release tablets:
Children: 0.25 to 0.5 mg/kg/day in 1 to 2 divided doses; dose should be titrated to effect
Maximum dose: 3 mg/kg/day up to 120 mg/day (or 180 mg/day in some centers)

Adolescents:
Initial dose: 30 mg orally once a day

Usual Pediatric Dose for Hypertrophic Cardiomyopathy:

Children: 0.6 to 0.9 mg/kg/24 hours in 3 to 4 divided doses

What other drugs will affect nifedipine?

Other drugs may interact with nifedipine, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Possible Side Effects

If any of the following side effects occur while taking nifedipine, check with your doctor immediately:

More common
• Bloating or swelling of the face, arms, hands, lower legs, or feet
• cough
• difficult or labored breathing
• dizziness or lightheadedness
• fast, irregular, pounding, or racing heartbeat or pulse
• feeling of warmth
• headache
• muscle cramps
• rapid weight gain

Less common
• Blue lips and fingernails
• chest congestion
• chest pain
• chills
• coughing that sometimes produces a pink frothy sputum
• decreased urine output
• difficult, fast, or noisy breathing, sometimes with wheezing

Rare
• Black, tarry stools
• bleeding gums
• blood in the eyes
• blood in the urine or stools
• bloody stools
• bluish color
• blurred vision
• body aches or pain

Some nifedipine side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:

More common
• Belching
• feeling of indigestion
• mood changes
• pain in the chest below the breastbone
• redness of the face, neck, arms, and occasionally, upper chest

Less common
• Abnormal ejaculation
• bloody nose
• burning, crawling, itching, numbness, prickling, “pins and needles”, or tingling feelings
• decreased interest in sexual intercourse
• decreased sexual performance or desire
• diarrhea
• difficulty having a bowel movement (stool)
• excess air or gas in stomach or intestines

Rare
• Acid or sour stomach
• ankle, knee, or great toe joint pain
• cracks in the skin
• difficulty with moving
• discouragement
• excessive muscle tone
• fear or nervousness
• feeling sad or empty
• hair loss or thinning of the hair
• heartburn
• increased sensitivity of the skin to sunlight

Storage

Store at room temperature away from moisture, heat, and light.Nifedipine – Taj Dearob Pharma | Nifedipine is in a group of drugs called calcium channel blockers. It works by relaxing the muscles of your heart and blood vessels.Nifedipine is used to treat hypertension (high blood pressure) and angina (chest pain).
Nifedipine – Taj Dearob Pharma | Nifedipine is in a group of drugs called calcium channel blockers. It works by relaxing the muscles of your heart and blood vessels.Nifedipine is used to treat hypertension (high blood pressure) and angina (chest pain).
Nifedipine – Taj Dearob Pharma | Nifedipine is in a group of drugs called calcium channel blockers. It works by relaxing the muscles of your heart and blood vessels.Nifedipine is used to treat hypertension (high blood pressure) and angina (chest pain).
Nifedipine – Taj Dearob Pharma | Nifedipine is in a group of drugs called calcium channel blockers. It works by relaxing the muscles of your heart and blood vessels.Nifedipine is used to treat hypertension (high blood pressure) and angina (chest pain).

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