Icosapent (Page 3 of 3)

16 HOW SUPPLIED/STORAGE AND HANDLING

Icosapent ethyl capsules are supplied as:

Strength Quantity Description NDC
1 gram capsules Bottles of 120 transparent natural colored oblong shaped soft-gelatin capsules imprinted with “RDY 267” in white ink 43598-267-04

Store at 20° to 25°C (68° to 77°F); excursions permitted to 15 to 30 °C (59 to 86°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 before starting icosapent ethyl capsules (Patient Information).

Inform patients that icosapent ethyl capsules may increase their risk for atrial fibrillation or atrial flutter [see Warnings and Precautions (5.1) ].

Inform patients with known hypersensitivity to fish and/or shellfish about the potential for allergic reactions to icosapent ethyl capsules and advise them to discontinue icosapent ethyl capsules and seek medical attention if any reactions occur [see Warnings and Precautions (5.2) ].

Inform patients that icosapent ethyl capsules may increase their risk for bleeding, especially if they are receiving other antithrombotic agents [see Warnings and Precautions (5.3)].

Advise patients to swallow icosapent ethyl capsules whole. Do not break open, crush, dissolve, or chew icosapent ethyl capsules [see Dosage and Administration (2.2)].

Instruct patients to take icosapent ethyl capsules as prescribed. If a dose is missed, patients should take it as soon as they remember. However, if they miss one day of, they icosapent ethyl capsules should not double the dose when they take it.

For more information, call 1-888-375-3784.

Distributed by:

Dr. Reddy’s Laboratories, Inc.

Princeton, NJ 08540
Issued: 0621
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PATIENT INFORMATION
Icosapent Ethyl (eye koe’ sa pent eth il)
Capsules

Icosapent ethyl capsules are prescription medicine used:

along with a low-fat and low-cholesterol diet to lower high levels of triglycerides (fats) in adults. It is not known if icosapent ethyl capsules changes your risk of having inflammation of your pancreas (pancreatitis). It is not known if icosapent ethyl capsules is safe and effective in children.

Do not take Icosapent Ethyl Capsules if you are allergic to icosapent ethyl or any of the ingredients in icosapent ethyl capsules. See the end of this leaflet for a complete list of ingredients in icosapent ethyl capsules.

Before taking icosapent ethyl capsules, tell your doctor about all of your medical conditions, including if you:

  • have diabetes.
  • have a low thyroid problem (hypothyroidism).
  • have a liver problem.
  • have a pancreas problem.
  • are allergic to fish or shellfish. It is not known if people who are allergic to fish or shellfish are also allergic to icosapent ethyl capsules.
  • are pregnant, or planning to become pregnant. It is not known if icosapent ethyl capsules will harm your unborn baby.
  • are breastfeeding or plan to breastfeed. Icosapent ethyl can pass into your milk, and may harm your baby. Talk to your doctor about the best way to feed your baby if you take icosapent ethyl capsules.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and dietary or herbal supplements.

Icosapent ethyl capsules can interact with certain other medicines that you are taking.

Especially tell your doctor if you take medicines that affect your blood clotting (anticoagulants or blood thinners).

How should I take icosapent ethyl capsules?

  • Take icosapent ethyl capsules exactly as your doctor tells you to take it.
  • Do not change your dose or stop taking icosapent ethyl capsules without talking to your doctor.
  • Do not take more capsules than what is prescribed by your doctor.
    • If you are prescribed the 0.5 gram capsules, you should not take more than 8 capsules each day.
    • If you are prescribed the 1 gram capsules, you should not take more than 4 capsules per day.
  • Take icosapent ethyl capsules whole. Do not break, crush, dissolve, or chew icosapent ethyl capsules before swallowing.
  • If you miss a dose of icosapent ethyl capsules, take it as soon as you remember. However, if you miss one day of icosapent ethyl capsules, do not double your dose when you take it.
  • Your doctor may start you on a diet that is low in saturated fat, cholesterol, carbohydrates, and low in added sugars before giving you icosapent ethyl capsules. Stay on this diet while taking icosapent ethyl capsules.
  • Your doctor may do blood tests to check your triglyceride and other lipid levels while you take icosapent ethyl capsules.

What are the possible side effects of icosapent ethyl capsules?

Icosapent ethyl capsules may cause serious side effects, including: Heart rhythm problems (atrial fibrillation and atrial flutter). Heart rhythm problems which can be serious and cause hospitalization have happened in people who take icosapent ethyl capsules, especially in people who have heart (cardiovascular) disease or diabetes with a risk factor for heart (cardiovascular) disease, or who have had heart rhythm problems in the past. Tell your doctor if you get any symptoms of heart rhythm problems such as feeling as if your heart is beating fast and irregular, lightheadedness, dizziness, shortness of breath, chest discomfort, or youfaint.

Possible allergic reactions if you are allergic to fish or shellfish. Stop taking icosapent ethyl capsules and tell your doctor right away or get emergency medical help if you have any signs or symptoms of an allergic reaction

Bleeding. Serious bleeding can happen in people who take icosapent ethyl capsules. Your risk of bleeding may increase if you are also taking a blood thinner medicine.

If you have liver problems and are taking icosapent ethyl capsules, your doctor should do blood tests during treatment.

The most common side effects of icosapent ethyl capsules include:

Muscle and joint pain.

Swelling of the hands, legs, or feet.

ConstipationGout

Heart rhythm problems (atrial fibrillation).

These are not all the possible side effects of icosapent ethyl capsules. 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 icosapent ethyl capsules?

  • Store icosapent ethyl capsules at room temperature between 68 to 77° F (20 to 25° C).
  • Safely throw away medicine that is out of date or no longer needed.

Keep icosapent ethyl capsules and all medicine out of the reach of children.

General information about the safe and effective use of icosapent ethyl capsules.

Medicines are sometimes prescribed for purposes other than those listed in Patient Information Leaflets. Do not use icosapent ethyl capsules for a condition for which it was not prescribed. Do not give icosapent ethyl capsules to other people, even if they have the same symptoms you have. It may harm them.

You can ask your pharmacist or healthcare provider for information about icosapent ethyl capsules that is written for health professionals.

For more information, (1-888-375-3784).

What are the ingredients in icosapent ethyl capsules?

Active Ingredient: icosapent ethyl

Inactive Ingredients: alpha tocopherol, gelatin, glycerin, mannitol, sorbitol, and purified water.

The imprinting Opacode NSP-78-18022 White contains, ammonium hydroxide, macrogol, polyvinyl acetate phthalate, propylene glycol and titanium dioxide.

This patient information has been approved by the U.S. Food and Drug Administration.

Distributed by:

Dr. Reddy’s Laboratories, Inc.

Princeton, NJ 08540

Issued: 0621
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PRINCIPAL DISPLAY PANEL — 120 Capsules Bottle Label

NDC 43598-267 -04


Icosapent Ethyl Capsules

1 gram

120 Capsules

Rx only

label1
(click image for full-size original)
ICOSAPENT
icosapent ethyl capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43598-267
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Icosapent Ethyl (icosapent) Icosapent Ethyl 1000 mg
Inactive Ingredients
Ingredient Name Strength
Tocopherol 2 mg
Gelatin
Sorbitol
Glycerin
Mannitol
Water
Ammonia
Polyvinyl Acetate Phthalate
Titanium Dioxide
POLYETHYLENE GLYCOL, UNSPECIFIED
Propylene Glycol
Product Characteristics
Color YELLOW (Natural colored) Score no score
Shape OVAL (Oblong) Size 24mm
Flavor Imprint Code RDY;267
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:43598-267-04 120 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA209499 06/21/2021
Labeler — Dr. Reddy’s Laboratories, Inc. (802315887)

Revised: 06/2021 Dr. Reddy’s Laboratories, Inc.

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