Nisoldipine

Nisoldipine is a prescription medication used to treat high blood pressure. Nisoldipine belongs to a group of drugs called calcium channel blockers, which relax blood vessels, making it easier for the heart to pump blood.

This medication comes in an extended release tablet form and is taken once a day and should be taken without food.

Common side effects of nisoldipine include swelling, headache, and nausea. Nisoldipine can cause dizziness. Do not drive or operate heavy machinery until you know how nisoldipine affects you.

Nisoldipine is a prescription medication used to treat high blood pressure.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Nisoldipine may be found in some form under the following brand names:

• Sular

Serious side effects have been reported with nisoldipine. See the “Drug Precautions” section.

Common side effects of nisoldipine include:

• swelling (medically known as edema)
• headache
• nausea
• dizziness
• rash

This is not a complete list of nisoldipine side effects. Ask your doctor or pharmacist for more information.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• medications that block the enzyme CYP3A4, such as some macrolide antibiotics (clarithromycin, telithromycin), some HIV protease inhibitors (indinavir, nelfinavir, ritonavir, saquinavir), some HCV protease inhibitors (boceprevir, telaprevir), some azole antimycotics (ketoconazole, itraconazole, posaconazole, voriconazole), conivaptan, delavirdine, and nefazodone
• medications that increase the enzyme CYP3A4 such as carbamazepine, phenobarbital, phenytoin, rifampin, St John's wort
• cimetidine (Tagamet)

This is not a complete list of nisoldipine drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with nisoldipine including:

• chest pain. Use of nisoldipine may lead to an increased number or severity of heart attacks, particularly in those with coronary artery disease (when blood vessels to the heart become hardened and narrowed). Tell your healthcare provider right away if you have some or all of the following symptoms of angina:
  • a pressure, squeezing, burning, or tightness in the chest
  • pain in the chest, breastbone area, arms, neck, shoulders, or back
  • nausea
  • fatigue
  • shortness of breath
  • light headedness
  • weakness
• hypotension. Hypotension, or low blood pressure, may cause you to feel faint or dizzy. Inadequate fluid intake, excessive sweating, diarrhea, or vomiting can lead to an excessive fall in blood pressure, too. Lie down if you feel faint or dizzy. Call your doctor right away.
• cirrhosis (scarring of the liver). People already diagnosed with cirrhosis are at an increased risk of serious side effects when taking this medication. Your doctor may want to monitor blood pressure and pulse rate closely and administer a lower dosage of nisoldipine.

• congestive heart failure (CHF). Tell your healthcare provider right away if you experience any of the following symptoms of CHF:
  • sudden weight gain
  • worsening shortness of breath
  • increased swelling of your feet, legs, or abdomen
  • needing more pillows or sleeping in a recliner
  • waking from sleep to catch your breath
  • a cough that does not go away
  • new or increasing irregularities in your heart rate

Nisoldipine can cause dizziness. Do not drive or operate heavy machinery until you know how nisoldipine affects you.

Do not take nisoldipine if you are allergic to nisoldipine or any of this medication’s ingredients.

Grapefruit and grapefruit juice may interact with nisoldipine and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor.

Before taking nisoldipine, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• have a known hypersensitivity to nisoldipine or to any of its ingredients
• have a known hypersensitivity to aspirin
• have a known hypersensitivity to the inactive ingredient FD&C Yellow No. 5 (tartrazine)
• have liver problems
• have kidney problems
• have heart problems
• are pregnant or breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Nisoldipine falls into category C. There are no well-controlled studies done in pregnant women. Nisoldipine should be used during pregnancy only if the possible benefit outweighs the possible risk.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if nisoldipine crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious negative reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using nisoldipine.

• Take nisoldipine exactly as prescribed.
• Nisoldipine comes in an extended release tablet form and is given once a day.
• Take nisoldipine on an empty stomach, 1 hour before or 2 hours after a meal.
• Nisoldipine must be swallowed whole. Do not chew, divide, or crush tablets.
• If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of nisoldipine at the same time.

Take nisoldipine exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The recommended dose range for nisoldipine is 8.5 to 34 mg once daily. Dose adjustments may be done based on your liver function, kidney function, response to the medication, the severity of your condition, or other medications that you are taking in addition to nisoldipine.

If you take too much nisoldipine, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

• Store at room temperature between 15 – 30°C (59 – 86°F).
• Dispense in tight, light-resistant containers.
• Protect from light and moisture.
• Keep this and all medicines out of the reach of children.