Sular

DRUG DESCRIPTION

SULAR (nisoldipine) is an extended release tablet dosage form of the dihydropyridine calcium channel blocker nisol- dipine. Nisoldipine is 3,5-pyridinedicarboxylic acid, 1,4-dihydro-2,6-dimethyl-4-(2-nitrophenyl)-, methyl 2-methyl- propyl ester, C20H24N2O6 , and has the structural formula:

SULAR  (nisoldipine) structural formula illustration

Nisoldipine is a yellow crystalline substance, practically insoluble in water but soluble in ethanol. It has a molecular weight of 388.4. SULAR (nisoldipine) tablets consist of an external coat and an internal core. Both coat and core contain nisoldipine, the coat as a slow release formulation and the core as a fast release formulation. SULAR tablets contain either 10, 20, 30 or 40 mg of nisoldipine for once-a-day oral administration.

Inert ingredients in the formulation are: hydroxypropylcellulose, lactose, corn starch, crospovidone, microcrystalline cellulose, sodium lauryl sulfate, povidone and magnesium stearate. The inert ingredients in the film coating are: hypromellose, polyethylene glycol, ferric oxide, and titanium dioxide.

What are the possible side effects of nisoldipine (Sular)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • swelling in your legs or ankles;
  • chest pain;
  • fast or pounding heartbeats; or
  • feeling like you might pass out.

Less serious side effects may include:

  • dizziness;
  • warmth, redness, or tingly feeling under your skin;
  • ...

Read All Potential Side Effects and See Pictures of Sular

What are the precautions when taking nisoldipine (Sular)?

Before taking nisoldipine, tell your doctor or pharmacist if you are allergic to it; or to other dihydropyridine calcium channel blockers (such as amlodipine, nifedipine); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: a certain structural heart problem (aortic stenosis).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease.

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until...

Read All Potential Precautions of Sular


Sular Consumer (continued)

SIDE EFFECTS: Dizziness, swelling ankles/feet, flushing, or headache may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

To reduce dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

An empty tablet shell may appear in your stool. This effect is harmless because your body has already absorbed the medication.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: fast/irregular/pounding heartbeat, fainting.

Tell your doctor immediately if any of these rare but very serious side effects occur: vision changes.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking nisoldipine, tell your doctor or pharmacist if you are allergic to it; or to other dihydropyridine calcium channel blockers (such as amlodipine, nifedipine); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: a certain structural heart problem (aortic stenosis).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease.

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

Before having surgery, tell your doctor or dentist that you are taking this medication.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known if this medication passes into breast milk. Consult your doctor before breast-feeding.


Sular Patient Information Including Side Effects

Brand Names: Sular

Generic Name: nisoldipine (Pronunciation: nye ZOL di peen)

  • What is nisoldipine (Sular)?
  • What are the possible side effects of nisoldipine (Sular)?
  • What is the most important information I should know about nisoldipine (Sular)?
  • What should I discuss with my healthcare provider before taking nisoldipine (Sular)?
  • How should I take nisoldipine (Sular)?
  • What happens if I miss a dose (Sular)?
  • What happens if I overdose (Sular)?
  • What should I avoid while taking nisoldipine (Sular)?
  • What other drugs will affect nisoldipine (Sular)?
  • Where can I get more information?

What is nisoldipine (Sular)?

Nisoldipine is in a group of drugs called calcium channel blockers. Nisoldipine relaxes (widens) blood vessels and improves blood flow.

Nisoldipine is used to treat high blood pressure (hypertension).

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

What are the possible side effects of nisoldipine (Sular)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • swelling in your legs or ankles;
  • chest pain;
  • fast or pounding heartbeats; or
  • feeling like you might pass out.

Less serious side effects may include:

  • dizziness;
  • warmth, redness, or tingly feeling under your skin;
  • headache;
  • nausea;
  • stuffy nose, sore throat; or
  • mild skin rash.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about nisoldipine (Sular)?

You should not use this medication if you are allergic to nisoldipine, or to similar medications such as amlodipine (Norvasc), felodipine (Plendil), nicardipine (Cardene), nifedipine (Procardia, Adalat), or nimodipine (Nimotop).

Before using nisoldipine, tell your doctor if you are allergic to any drugs, or if you have coronary artery disease, congestive heart failure, or liver disease.

Take nisoldipine on an empty stomach, at least 1 hour before or 2 hours after a meal. Avoid eating grapefruit or drinking grapefruit juice when you take nisoldipine.

Call your doctor at once if you have a serious side effect such as swelling in your legs or ankles, chest pain, fast or pounding heartbeats, or if you feel like you might pass out.

Keep using this medicine as directed, even if you feel well. High blood pressure often has no symptoms, so you may not know when your blood pressure is high. You may need to use blood pressure medication for the rest of your life.

There are many other medicines that can interact with nisoldipine. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor. Keep a list with you of all the medicines you use and show this list to any doctor or other healthcare provider who treats you.

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