Pronunciation:

ra-NOE-la-zeen

Brand Names:

• Ranexa

Dosage Forms:

• Tablet, Extended Release

Uses of This Medicine:

Ranolazine is used to treat chronic angina (chest pain) in patients who have taken other medicines for chest pain. This medicine is usually used together with other medicines such as amlodipine, beta-blockers, or nitrates .

This medicine is available only with your doctor's prescription .

Grapefruit and grapefruit juice may increase the effects of ranolazine by increasing the amount of this medicine in the body. You should not eat grapefruit or drink grapefruit juice while you are taking this medicine .

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of ranolazine in the pediatric population. Safety and efficacy have not been established .

Older adults—

Appropriate studies performed to date have not demonstrated geriatrics-specific problems that would limit the usefulness of ranolazine in the elderly. However, elderly patients are more likely to have age-related kidney or heart problems which may require caution or dosage adjustment in patients receiving ranolazine .

Pregnancy—

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Acecainide
• Ajmaline
• Amiodarone
• Amprenavir
• Aripiprazole
• Arsenic Trioxide
• Atazanavir
• Azimilide
• Bretylium
• Cisapride
• Clarithromycin
• Diltiazem
• Disopyramide
• Dofetilide
• Droperidol
• Erythromycin
• Fluconazole
• Fosamprenavir
• Gatifloxacin
• Hydroquinidine
• Ibutilide
• Indinavir
• Itraconazole
• Ketoconazole
• Levofloxacin
• Lopinavir
• Mesoridazine
• Methadone
• Moxifloxacin
• Nelfinavir
• Paliperidone
• Pimozide
• Pirmenol
• Prajmaline
• Procainamide
• Quinidine
• Quinine
• Ritonavir
• Saquinavir
• Sematilide
• Sodium Phosphate
• Sodium Phosphate, Dibasic
• Sodium Phosphate, Monobasic
• Sotalol
• Sunitinib
• Tedisamil
• Telithromycin
• Thioridazine
• Vardenafil
• Verapamil
• Voriconazole
• Ziprasidone

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is not recommended. Your doctor may decide not to treat you with this medication, change some of the other medicines you take, or give you special instructions about the use of food, alcohol, or tobacco.

• Grapefruit Juice

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Heart rhythm problems (QT prolongation), history of or
• Hypokalemia, untreated (low potassium in the blood) or
• Liver disease—This medicine should NOT be used in patients with these conditions .

• Kidney disease, severe—This medicine may increase blood pressure .

Proper Use of This Medicine:

You may take this medicine with or without food .

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

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For chronic angina:
  • For oral dosage form (extended-release tablets):
    • Adults—At first, 500 milligrams (mg) two times a day, as instructed by your doctor. Your doctor may increase your dose as needed. However, the dose usually is not more than 1000 mg two times a day.
    • Children—Use and dose must be determined by your doctor .

Missed dose—

If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using This Medicine:

If you will be taking this medicine for a long time, it is very important that your doctor check you at regular visits for any problems or unwanted effects that may be caused by this medicine.

This medicine can cause a change in heart rhythm called prolongation of the QTc interval. This condition may change the way your heart beats and can cause palpitations or fainting spells. Check with your doctor right away if you start having any of these symptoms .

Do not use this medicine to treat a sudden onset of chest pain .

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements .

This medicine may cause some people to become dizzy, lightheaded, drowsy, or less alert than they are normally. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or not alert .

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Dizziness

Less common

Bloating or swelling of face, arms, hands, lower legs, or feet

continuous ringing or buzzing or other unexplained noise in ears

difficult or labored breathing

fast, irregular, pounding, or racing heartbeat or pulse

feeling of constant movement of self or surroundings

hearing loss

lightheadedness

rapid weight gain

sensation of spinning

shortness of breath

tightness in chest

tingling of hands or feet

unusual weight gain or loss

wheezing

Rare

Abnormal or decreased touch sensation

blood in urine

blurred vision

burning, crawling, itching, numbness, prickling, "pins and needles" , or tingling feelings

chest pain or discomfort

chills

cold sweats

confusion

dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly

fainting

shakiness in legs, arms, hands, or feet

slow or irregular heartbeat

sweating

trembling or shaking of hands or feet

unusual tiredness or weakness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Difficulty having a bowel movement (stool)

headache

Less common

Dry mouth

nausea

stomach pain

vomiting

Rare

Lack or loss of strength

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.