Ranexa

DRUG DESCRIPTION

Ranexa (ranolazine) is available as a film-coated, non-scored, extended-release tablet for oral administration.

Ranolazine is a racemic mixture, chemically described as 1-piperazineacetamide, N-(2,6dimethylphenyl)-4-[2-hydroxy-3-(2-methoxyphenoxy)propyl]-, (?±)-. It has an empirical formula of C24H33N3O4, a molecular weight of 427.54 g/mole, and the following structural formula:

Ranexa® (ranolazine)  Structural Formula Illustration

Ranolazine is a white to off-white solid. Ranolazine is soluble in dichloromethane and methanol; sparingly soluble in tetrahydrofuran, ethanol, acetonitrile, and acetone; slightly soluble in ethyl acetate, isopropanol, toluene, and ethyl ether; and very slightly soluble in water.

Ranexa tablets contain 500 mg or 1000 mg of ranolazine and the following inactive ingredients: carnauba wax, hypromellose, magnesium stearate, methacrylic acid copolymer (Type C), microcrystalline cellulose, polyethylene glycol, sodium hydroxide, and titanium dioxide. Additional inactive ingredients for the 500 mg tablet include polyvinyl alcohol, talc, Iron Oxide Yellow, and Iron Oxide Red; additional inactive ingredients for the 1000 mg tablet include lactose monohydrate, triacetin, and Iron Oxide Yellow.

What are the possible side effects of ranolazine (Ranexa)?

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 any of these serious side effects:

  • feeling like you might pass out;
  • swelling in your hands, ankles, or feet;
  • slow, fast, or pounding heartbeats;
  • tremors or shaking;
  • blood in your urine;
  • urinating less than usual or not at all;
  • shortness of breath; or
  • ...

Read All Potential Side Effects and See Pictures of Ranexa »

What are the precautions when taking ranolazine (Ranexa)?

Before taking ranolazine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: liver problems.

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

Ranolazine may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can infrequently result in serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that require immediate medical attention. The risk of QT prolongation may be increased if you have certain medical conditions or are taking other...

Read All Potential Precautions of Ranexa »


Ranexa Consumer (continued)

SIDE EFFECTS: Dizziness, headache, lightheadedness, nausea, tiredness, and constipation may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

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: numbness, shaking (tremor), swelling of the ankles/feet, unexpected weight gain, vision changes, change in the amount of urine.

Seek immediate medical attention if any of these rare but serious side effects occur: fainting, sudden dizziness, slow/fast/irregular/pounding heartbeat.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: 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 ranolazine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: liver problems.

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

Ranolazine may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can infrequently result in serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that require immediate medical attention. The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may affect the heart rhythm (see also Drug Interactions section). Before using ranolazine, tell your doctor or pharmacist if you have any of the following conditions: certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death).

Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/"water pills") or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using ranolazine safely.

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.

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

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

Caution is advised when using this drug in the elderly because they may be more sensitive to its effects, especially dizziness and constipation.

This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.

It is not known whether ranolazine passes into breast milk. Therefore, breast-feeding is not recommended while using this drug. Consult your doctor before breast-feeding.


Ranexa Patient Information Including Side Effects

Brand Names: Ranexa

Generic Name: ranolazine (Pronunciation: ra NOE la zeen)

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

What is ranolazine (Ranexa)?

Ranolazine is an anti-anginal medication. It works by improving blood flow to help the heart work more efficiently.

Ranolazine is used to treat chronic angina (chest pain).

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

What are the possible side effects of ranolazine (Ranexa)?

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 any of these serious side effects:

  • feeling like you might pass out;
  • swelling in your hands, ankles, or feet;
  • slow, fast, or pounding heartbeats;
  • tremors or shaking;
  • blood in your urine;
  • urinating less than usual or not at all;
  • shortness of breath; or
  • skin rash, bruising, severe tingling, numbness, pain, and muscle weakness.

Less serious side effects may include:

  • mild dizziness, spinning sensation, headache;
  • dry mouth;
  • mild nausea, vomiting, stomach pain, constipation;
  • weakness; or
  • ringing in your ears.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about ranolazine (Ranexa)?

You should not take ranolazine if you have liver disease. Ranolazine should not be taken together with certain medicines to treat heart rhythm disorders, infections, HIV or AIDS, seizures, mental illness, pain, cancer, or stomach disorders. Before you take ranolazine, tell your doctor about all other medications you are using.

Ranolazine is not for use during an acute (emergency) attack of angina. Continue using any other medicines prescribed by your doctor (such as nitroglycerin) to treat acute angina.

Before you take ranolazine, tell your doctor about all of your medical conditions, especially if you have a personal or family history of "Long QT syndrome." Also tell your doctor about all other medications you use regularly.

Do not crush, chew, or break an extended-release tablet. Swallow the pill whole. It is specially made to release medicine slowly in the body. Breaking the pill would cause too much of the drug to be released at one time.

Chronic angina is often treated with a combination of different drugs. To best treat your condition, use all of your medications as directed by your doctor. Do not change your doses or medication schedule without advice from your doctor.

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