Ranolazine (Page 5 of 6)

14.2 Lack of Benefit in Acute Coronary Syndrome

In a large (n = 6560) placebo-controlled trial (MERLIN-TIMI 36) in patients with acute coronary syndrome, there was no benefit shown on outcome measures. However, the study is somewhat reassuring regarding proarrhythmic risks, as ventricular arrhythmias were less common on ranolazine [see Clinical Pharmacology (12.2)] , and there was no difference between ranolazine and placebo in the risk of all-cause mortality (relative risk ranolazine:placebo 0.99 with an upper 95% confidence limit of 1.22).

15 REFERENCES

M.A. Suckow et al. The anti-ischemia agent ranolazine promotes the development of intestinal tumors in APC (min/+) mice. Cancer Letters 209 (2004) :165−9.

16 HOW SUPPLIED/STORAGE AND HANDLING

Ranolazine extended-release tablets are supplied as film-coated, oblong-shaped, extended-release tablets in the following strengths:
500 mg tablets are light orange colored, debossed with “RL49 ” on one side and plain on the other side.
1000 mg tablets are pale yellow colored, debossed with “RL50 ” on one side and plain on the other side.
Ranolazine extended-release tablets are available in:

Strength

NDC

Bottle of 60 Tablets

(with child-resistant closure)

500 mg

1000 mg

63304-017-60

63304-018-60

Bottle of 180 Tablets

(with child-resistant closure)

500 mg

1000 mg

63304-017-28

63304-018-28

Bottle of 500 Tablets

500 mg

1000 mg

63304-017-05

63304-018-05

Store ranolazine extended-release tablets at 20° C to 25° C (68° F to 77° F). [See USP Controlled Room Temperature.]
Keep out of reach of children.

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Patient Information).

Inform patients that ranolazine extended-release tablets will not abate an acute angina episode.

Strong CY3PA Inhibitors, CYP3A Inducers, Liver Cirrhosis

Inform patients that ranolazine extended-release tablets should not be used with drugs that are strong CYP3A inhibitors (e.g., ketoconazole, clarithromycin, nefazodone, ritonavir) [(see Contraindications (4), Drug Interactions (7.1)].
Inform patients that ranolazine extended-release tablets should not be used with drugs that are inducers of CYP3A (e.g., rifampin, rifabutin, rifapentine, barbiturates, carbamazepine, phenytoin, St. John’s wort) [(see Contraindications (4), Drug Interactions (7.1)].
Inform patients that ranolazine extended-release tablets should not be used in patients with liver cirrhosis [(see Contraindications (4), Use in Specific Populations (8.6)].

Moderate CYP3A Inhibitors, P-gp Inhibitors, Grapefruit Products

Advise patients to inform their physician if they are receiving drugs that are moderate CYP3A inhibitors (e.g., diltiazem, verapamil, erythromycin) [see Drug Interactions (7)].
Advise patients to inform their physician if they are receiving drugs that are P-gp inhibitors (e.g., cyclosporine) [see Drug Interactions (7)].
Advise patients to limit grapefruit juice or grapefruit products when taking ranolazine extended-release tablets [see Drug Interactions (7)].

QT Interval Prolongation

Inform patients that ranolazine extended-release tablets may produce changes in the electrocardiogram (QTc interval prolongation) [see Warnings and Precautions (5.1)].
Advise patients to inform their physician of any personal or family history of QTc prolongation, congenital long QT syndrome, or if they are receiving drugs that prolong the QTc interval such as Class Ia (e.g., quinidine) or Class III (e.g., dofetilide, sotalol, amiodarone) antiarrhythmic agents, erythromycin, and certain antipsychotics (e.g., thioridazine, ziprasidone) [see Warnings and Precautions (5.1)].

Use in Patients with Renal Impairment

Patients with severe renal impairment may be at risk of renal failure while on ranolazine extended-release tablets. Advise patients to inform their physician if they have impaired renal function before or while taking ranolazine extended-release tablets [see Warnings and Precautions (5.2)].

Dizziness, Fainting

Inform patients that ranolazine extended-release tablets may cause dizziness and lightheadedness. Patients should know how they react to ranolazine extended-release tablets before they operate an automobile or machinery, or engage in activities requiring mental alertness or coordination [see Adverse Reactions (6.1)].
Advise patients to contact their physician if they experience fainting spells while taking ranolazine extended-release tablets.

Administration

Instruct patients to swallow ranolazine extended-release tablets whole, with or without meals, and not to crush, break, or chew tablets. Inform patients that if a dose is missed, to take the usual dose at the next scheduled time. The next dose should not be doubled. Inform patients that doses of ranolazine extended-release tablets higher than 1000 mg twice daily should not be used [see Dosage and Administration (2)].
Advise patients to inform their physician of any other medications taken concurrently with ranolazine extended-release tablets, including over-the-counter medications.
Manufactured by:
Sun Pharmaceutical Industries Ltd.
Mohali, INDIA
Distributed by:
Sun Pharmaceutical Industries, Inc.
Cranbury, NJ 08512
December 2019 FDA-04

Patient Information

Ranolazine (ran-OH-lah-zeen)

extended-release tablets

Dosing Strengths:

500 mg tablets

1000 mg tablets

Rx only

Read this Patient Information before you start taking ranolazine extended-release tablets and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or treatment.

What are ranolazine extended-release tablets?

Ranolazine extended-release tablets are a prescription medicine used to treat angina that keeps coming back (chronic angina).

Ranolazine extended-release tablets may be used with other medicines that are used for heart problems and blood pressure control.

It is not known if ranolazine extended-release tablets is safe and effective in children.

Who should not take ranolazine extended-release tablets? Do not take ranolazine extended-release tablets if:

you take any of the following medicines:
for fungus infection: ketoconazole (Nizoral®), itraconazole (Sporanox® , Onmel®)
for infection: clarithromycin (Biaxin®)
for depression: nefazodone
for HIV: nelfinavir (Viracept®), ritonavir (Norvir®), lopinavir and ritonavir (Kaletra®), indinavir (Crixivan®), saquinavir (Invirase®)
for tuberculosis (TB): rifampin (Rifadin®), rifabutin (Mycobutin®), rifapentine (Priftin®)
for seizures: phenobarbital, phenytoin (Phenytek® , Dilantin® , Dilantin‑125®), carbamazepine (Tegretol®)
St. John’s wort (Hypericum perforatum)
you have scarring (cirrhosis) of your liver

What should I tell my doctor before taking ranolazine extended-release tablets?

Before you take ranolazine extended-release tablets, tell your doctor if you:

have or have a family history of a heart problem, called ‘QT prolongation’ or ‘long QT syndrome’.
have liver problems.
have kidney problems.
are pregnant or plan to become pregnant. It is not known if ranolazine extended-release tablets will harm your unborn baby.
are breast-feeding or plan to breast-feed. It is not known if ranolazine passes into your breast milk. You and your doctor should decide if you will breast-feed.

Tell your doctor about all the medicines you take, including all prescription and nonprescription medicines, vitamins, and herbal supplements. Ranolazine extended-release tablets may affect the way other medicines work and other medicines may affect how ranolazine extended-release tablets work.

Tell your doctor if you take medicines:

for your heart
for cholesterol
for diabetes
for infection
for fungus
for transplant
for nausea and vomiting because of cancer treatments
for mental problems

Know the medicines you take. Keep a list of them to show your doctor or pharmacist when you get a new medicine.

How should I take ranolazine extended-release tablets?

Take ranolazine extended-release tablets exactly as your doctor tells you.
Your doctor will tell you how much ranolazine extended-release tablets to take and when to take it.
Do not change your dose unless your doctor tells you to.
Tell your doctor if you still have symptoms of angina after starting ranolazine extended-release tablets.
Take ranolazine extended-release tablets by mouth, with or without food.
Swallow the ranolazine extended-release tablets whole. Do not crush, break, or chew ranolazine extended-release tablets before swallowing.
If you miss a dose of ranolazine extended-release tablets, wait to take the next dose of ranolazine extended-release tablets at your regular time. Do not make up for the missed dose. Do not take more than 1 dose at a time.
If you take too much ranolazine extended-release tablets, call your doctor, or go to the nearest emergency room right away.

What should I avoid while taking ranolazine extended-release tablets?

Grapefruit and grapefruit juice. Limit products that have grapefruit in them. They can cause your blood levels of ranolazine extended-release tablets to increase.
Ranolazine extended-release tablets can cause dizziness, lightheadedness, or fainting. If you have these symptoms, do not drive a car, use machinery, or do anything that needs you to be alert.

What are the possible side effects of ranolazine extended-release tablets?

Ranolazine extended-release tablets may cause serious side effects, including:

changes in the electrical activity of your heart called QT prolongation. Your doctor may check the electrical activity of your heart with an ECG. Tell your doctor right away if you feel faint, lightheaded, or feel your heart beating irregularly or fast while taking ranolazine extended-release tablets. These may be symptoms related to QT prolongation.
kidney failure in people who already have severe kidney problems. Your doctor may need to do tests to check how your kidneys are working.

The most common side effects of ranolazine extended-release tablets include:

dizziness
headache
constipation
nausea

Tell your doctor if you have any side effect that bothers you or does not go away. These are not all the possible side effects of ranolazine extended-release tablets. For more information, ask your doctor or pharmacist.

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

How should I store ranolazine extended-release tablets?

Store ranolazine extended-release tablets at room temperature between 20° C to 25° C (68° F to 77° F).

Keep ranolazine extended-release tablets and all medicines out of the reach of children.

General information about ranolazine extended-release tablets.

Medicines are sometimes prescribed for purposes other than those listed in the Patient Information. Do not use ranolazine extended-release tablets for a condition for which it was not prescribed. Do not give ranolazine extended-release tablets to other people, even if they have the same condition you have. It may harm them.

The Patient Information summarizes the most important information about ranolazine extended-release tablets. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about ranolazine extended-release tablets that is written for health professionals.

For more information, call 1-800-818-4555.

What is chronic angina?

Chronic angina means pain or discomfort in the chest, jaw, shoulder, back, or arm that keeps coming back. There are other possible signs and symptoms of angina including shortness of breath. Angina usually comes on when you are active or under stress. Chronic angina is a symptom of a heart problem called coronary heart disease (CHD), also known as coronary artery disease (CAD). When you have CHD, the blood vessels in your heart become stiff and narrow. Oxygen-rich blood cannot reach your heart muscle easily. Angina comes on when too little oxygen reaches your heart muscle.

What are the ingredients in ranolazine extended-release tablets?

Active ingredient: ranolazine

Inactive ingredients:

500 mg tablet: colloidal silicon dioxide, ferric oxide yellow, ferric oxide red, hypromellose, lactose monohydrate, magnesium stearate, methacrylic acid copolymer, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium hydroxide, sodium lauryl sulfate, titanium dioxide and triacetin.

1000 mg tablet: colloidal silicon dioxide, ferric oxide yellow, hypromellose, lactose monohydrate, magnesium stearate, methacrylic acid copolymer, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium hydroxide, sodium lauryl sulfate, titanium dioxide and triacetin.

This Patient Information has been approved by the U.S. Food and Drug Administration.

All trademarks are property of their respective owners.

Manufactured by:
Sun Pharmaceutical Industries Ltd.
Mohali, INDIA
Distributed by:
Sun Pharmaceutical Industries, Inc.
Cranbury, NJ 08512

December 2019 FDA-03

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