Pronunciation:

ra-NOE-la-zeen

Brand Names:

• Aspruzyo Sprinkle
• Ranexa

Dosage Forms:

• Packet
• Tablet, Extended Release

Classifications:

Therapeutic—

Antianginal

Chemical—

Piperazine (class)

Uses of This Medicine:

Ranolazine is used to treat chronic angina (chest pain). This medicine is usually used together with other medicines (eg, ACE inhibitors, angiotensin receptor blockers, calcium channel blockers, beta-blockers, nitrates, antiplatelets, or lipid-lowering medicines).

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

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 geriatric-specific problems that would limit the usefulness of ranolazine in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require an adjustment in the dose for patients receiving ranolazine.

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—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. 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 medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Amitriptyline
• Amoxapine
• Amprenavir
• Atazanavir
• Bepridil
• Carbamazepine
• Cisapride
• Clarithromycin
• Clomipramine
• Cobicistat
• Colchicine
• Darunavir
• Desipramine
• Doxepin
• Dronedarone
• Fluconazole
• Fosamprenavir
• Fosphenytoin
• Idelalisib
• Imipramine
• Indinavir
• Itraconazole
• Ketoconazole
• Levoketoconazole
• Lopinavir
• Mesoridazine
• Nefazodone
• Nelfinavir
• Nirmatrelvir
• Nortriptyline
• Phenobarbital
• Phenytoin
• Pimozide
• Piperaquine
• Posaconazole
• Primidone
• Protriptyline
• Rifabutin
• Rifampin
• Rifapentine
• Ritonavir
• Saquinavir
• Sparfloxacin
• St John's Wort
• Terfenadine
• Thioridazine
• Trimipramine
• Ziprasidone

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Abametapir
• Acecainide
• Adagrasib
• Afatinib
• Alfentanil
• Alfuzosin
• Alprazolam
• Amiodarone
• Amisulpride
• Anagrelide
• Apomorphine
• Aprepitant
• Aripiprazole
• Aripiprazole Lauroxil
• Arsenic Trioxide
• Artemether
• Asenapine
• Astemizole
• Azimilide
• Azithromycin
• Bedaquiline
• Benzhydrocodone
• Berotralstat
• Betrixaban
• Bretylium
• Buprenorphine
• Buserelin
• Capmatinib
• Ceritinib
• Chloroquine
• Chlorpromazine
• Ciprofloxacin
• Citalopram
• Clofazimine
• Clothiapine
• Clozapine
• Codeine
• Conivaptan
• Crizotinib
• Cyclobenzaprine
• Cyclosporine
• Dabigatran Etexilate
• Dabrafenib
• Dasatinib
• Degarelix
• Delamanid
• Deslorelin
• Deutetrabenazine
• Dexmedetomidine
• Digoxin
• Dihydrocodeine
• Dihydroergotamine
• Diltiazem
• Dofetilide
• Dolasetron
• Domperidone
• Donepezil
• Doxorubicin
• Doxorubicin Hydrochloride Liposome
• Droperidol
• Efavirenz
• Eliglustat
• Encorafenib
• Entrectinib
• Ergotamine
• Erythromycin
• Escitalopram
• Fedratinib
• Fentanyl
• Fexinidazole
• Finerenone
• Fingolimod
• Flecainide
• Fluoxetine
• Formoterol
• Fosaprepitant
• Foscarnet
• Fosnetupitant
• Fostemsavir
• Gatifloxacin
• Gemifloxacin
• Gepirone
• Glasdegib
• Gonadorelin
• Goserelin
• Granisetron
• Halofantrine
• Haloperidol
• Histrelin
• Hydrocodone
• Hydroxychloroquine
• Hydroxyzine
• Ibutilide
• Iloperidone
• Inotuzumab Ozogamicin
• Ivabradine
• Ivosidenib
• Lapatinib
• Lefamulin
• Lemborexant
• Lenvatinib
• Leuprolide
• Levofloxacin
• Lofexidine
• Lovastatin
• Lumefantrine
• Macimorelin
• Mavacamten
• Mefloquine
• Meperidine
• Metformin
• Methadone
• Metronidazole
• Mifepristone
• Mirtazapine
• Mobocertinib
• Morphine
• Morphine Sulfate Liposome
• Moxifloxacin
• Nafarelin
• Netupitant
• Nilotinib
• Norfloxacin
• Octreotide
• Ofloxacin
• Olanzapine
• Omaveloxolone
• Ondansetron
• Osilodrostat
• Osimertinib
• Oxaliplatin
• Oxycodone
• Ozanimod
• Pacritinib
• Paliperidone
• Panobinostat
• Paroxetine
• Pasireotide
• Pazopanib
• Pentazocine
• Pimavanserin
• Pitolisant
• Pixantrone
• Ponesimod
• Pralsetinib
• Prochlorperazine
• Promethazine
• Propafenone
• Quetiapine
• Quinidine
• Quinine
• Quizartinib
• Relugolix
• Ribociclib
• Rimegepant
• Selpercatinib
• Sematilide
• Sertraline
• Sevoflurane
• Simeprevir
• Simvastatin
• Siponimod
• Sirolimus Protein-Bound
• Sodium Phosphate
• Sodium Phosphate, Dibasic
• Sodium Phosphate, Monobasic
• Solifenacin
• Sorafenib
• Sotalol
• Sufentanil
• Sulpiride
• Sunitinib
• Tacrolimus
• Tedisamil
• Telithromycin
• Tenofovir Alafenamide
• Tetrabenazine
• Topotecan
• Toremifene
• Tramadol
• Trazodone
• Triclabendazole
• Trifluoperazine
• Triptorelin
• Ubrogepant
• Vandetanib
• Vardenafil
• Vemurafenib
• Venetoclax
• Verapamil
• Vilanterol
• Vincristine
• Vincristine Sulfate Liposome
• Vinflunine
• Voclosporin
• Voriconazole
• Zolpidem
• Zuclopenthixol

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 usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, 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 (eg, QT prolongation, long QT syndrome), or history of or
• Kidney disease, severe—Use with caution. May make these conditions worse.

• Liver cirrhosis—Should not be used in patients with this condition.

Proper Use of This Medicine:

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.

This medicine should come with a patient information leaflet. Read and follow these instructions carefully. Ask your doctor if you have any questions.

You may take this medicine with or without food.

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

To use the extended-release granules:

• With soft food: Sprinkle the granules on one tablespoonful of soft food (eg, applesauce or yogurt) and swallow it right away. Do not crush or chew the granules.
• Nasogastric tube: Add the granules with 50 milliliters (mL) of water into a syringe. Gently shake the mixture for at least 15 seconds, then flush it through the tube right away. Rinse the syringe with 15 mL of water, then flush it through the tube until all of the medicine is washed out.
• Gastric tube: Add the granules with 30 mL of water into a syringe. Gently shake the mixture for at least 15 seconds, then flush it through the tube right away. Rinse the syringe with 20 mL of water, then flush it through the tube. Rinse it again with 15 mL of water until all of the medicine is washed out.

Do not eat grapefruit or drink grapefruit juice while you are using this medicine.

Avoid drinking alcohol while you are using the extended-release granules.

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 oral dosage form (extended-release tablets or extended-release granules):
  • For chronic angina:
    • Adults—At first, 500 milligrams (mg) 2 times a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 1000 mg 2 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.

Do not keep outdated medicine or medicine no longer needed.

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

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. Blood tests may be needed to check for unwanted effects.

Do not use ranolazine together with carbamazepine (Tegretol®), clarithromycin (Biaxin®), nefazodone (Serzone®), phenobarbital, phenytoin (Dilantin®), rifabutin (Mycobutin®), rifampin (Rifadin®, Rimactane®), rifapentine (Priftin®), medicine to treat fungus infections (eg, itraconazole, ketoconazole, Nizoral®, Sporanox®), medicine to treat HIV or AIDS (eg, indinavir, lopinavir, nelfinavir, ritonavir, saquinavir, Crixivan®, Fortovase®, Invirase®, Norvir®, Viracept®), or St. John's wort.

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

Contact your doctor right away if you have any changes to your heart rhythm. You might feel dizzy or faint, or you might have a fast, pounding, or uneven heartbeat. Make sure your doctor knows if you had a heart rhythm problem, such as QT prolongation.

Check with your doctor right away if you have bloody urine, a decrease in frequency or amount of urine, an increase in blood pressure, increased thirst, loss of appetite, lower back or side pain, nausea, swelling of the face, fingers, or lower legs, trouble breathing, unusual tiredness or weakness, vomiting, or weight gain. These could be symptoms of a serious kidney problem.

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.

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.

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 the face, arms, hands, lower legs, or feet

chest tightness

difficult or labored breathing

fast, irregular, pounding, or racing heartbeat or pulse

feeling of constant movement of self or surroundings

lightheadedness

rapid weight gain

sensation of spinning

tingling of the hands or feet

unusual weight gain or loss

Rare

Abnormal or decreased touch sensation

agitation

blood in the urine

blurred vision

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

chest pain or discomfort

chills

cold sweats

coma

confusion

decreased urine output

depression

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

fainting

headache

hostility

irritability

lethargy

muscle twitching

nausea

seizures

shakiness in the legs, arms, hands, or feet

slow or irregular heartbeat

stupor

sweating

trembling or shaking of the hands or feet

unusual tiredness or weakness

Incidence not known

Decrease in frequency of urination

decrease in urine volume

difficulty in passing urine [dribbling]

large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

painful urination

seeing, hearing, or feeling things that are not there

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)

Less common

Dry mouth

stomach pain

Rare

Acid or sour stomach

belching

continuing ringing or buzzing or other unexplained noise in the ears

hearing loss

heartburn

indigestion

lack or loss of strength

stomach discomfort or upset

vomiting

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

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