Omega-3-acid Ethyl Esters (Page 3 of 4)

14 CLINICAL STUDIES

14.1 Severe Hypertriglyceridemia

The effects of omega-3-acid ethyl esters 4 grams per day were assessed in 2 randomized, placebo-controlled, double-blind, parallel-group trials of 84 adult subjects (42 on omega-3-acid ethyl esters, 42 on placebo) with very high triglyceride levels. Subjects whose baseline triglyceride levels were between 500 and 2,000 mg per dL were enrolled in these 2 trials of 6 and 16 weeks’ duration. The median triglyceride and LDL-C levels in these subjects were 792 mg per dL and 100 mg per dL, respectively. Median HDL-C level was 23.0 mg per dL.

The changes in the major lipoprotein lipid parameters for the groups receiving omega-3-acid ethyl esters or placebo are shown in Table 2.

Table 2. Median Baseline and Percent Change From Baseline in Lipid Parameters in Subjects With Severe Hypertriglyceridemia (≥500 mg per dL)

BL = Baseline (mg per dL); % Change = Median Percent Change from Baseline;

Difference = Omega-3-acid ethyl esters Median % Change – Placebo Median % Change. VLDL-C = Very-low-density lipoprotein (VLDL) cholesterol.

Parameter Omega-3-Acid Ethyl Esters n = 42 Placebo n = 42 Difference
BL % Change BL % Change
TG 816 -44.9 788 +6.7 -51.6
Non-HDL-C 271 -13.8 292 -3.6 -10.2
TC 296 -9.7 314 -1.7 -8.0
VLDL-C 175 -41.7 175 -0.9 -40.8
HDL-C 22 +9.1 24 0.0 +9.1
LDL-C 89 +44.5 108 -4.8 +49.3

Omega-3-acid ethyl esters 4 grams per day reduced median TG, VLDL-C, and non-HDL-C levels and increased median HDL-C from baseline relative to placebo. Treatment with omega-3-acid ethyl esters to reduce very high TG levels may result in elevations in LDL-C and non-HDL-C in some individuals. Patients should be monitored to ensure that the LDL-C level does not increase excessively.

The effect of omega-3-acid ethyl esters on the risk of pancreatitis has not been determined.

The effect of omega-3-acid ethyl esters on cardiovascular mortality and morbidity has not been determined.

16 HOW SUPPLIED/STORAGE AND HANDLING

Omega-3-Acid Ethyl Esters Capsules, USP are supplied as 1-gram clear, natural colored oblong shaped soft gelatin capsules containing pale yellow colored oily liquid imprinted with ’740′

Bottles of 120: NDC 64380-761-11

Store at 20° to 25°C (68° to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) Protect from light. [See USP Controlled Room Temperature]. Do not freeze. Keep out of reach of children.

17 PATIENT COUNSELING INFORMATION

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

Information for Patients

  • Omega-3-acid ethyl esters capsules should be used with caution in patients with known sensitivity or allergy to fish and/or shellfish [see Warnings and Precautions (5.2)].
  • Advise patients that use of lipid-regulating agents does not reduce the importance of adhering to diet [see Dosage and Administration (2)].
  • Advise patients not to alter omega-3-acid ethyl esters capsules in any way and to ingest intact capsules only [see Dosage and Administration (2)].
  • Instruct patients to take omega-3-acid ethyl esters capsules as prescribed. If a dose is missed, advise patients to take it as soon as they remember. However, if they miss one day of omega-3-acid ethyl esters capsules, they should not double the dose when they take it.

Manufactured by:

Strides Pharma Science Ltd.

Bengaluru — 562106, India

Distributed by:

Strides Pharma Inc.

East Brunswick, NJ 08816

Revised: 07/2019

PHARMACIST-DETACH HERE AND GIVE INSTRUCTIONS TO PATIENT

————————————————————————————————————————–

PATIENT INFORMATION

Omega-3-Acid Ethyl Esters

(oh-may-ga-as -id-eth-il-es -ters)

Capsules, USP

What is omega-3-acid ethyl esters capsules?

Omega-3-acid ethyl esters capsules are prescription medicine used along with a low fat and low cholesterol diet to lower very high triglyceride (fat) levels in adults.

It is not known if omega-3-acid ethyl esters capsules changes your risk of having inflammation of your pancreas [pancreatitis].

It is not known if omega-3-acid ethyl esters capsules prevents you from having a heart attack or stroke.

It is not known if omega-3-acid ethyl esters capsules is safe and effective in children.

Who should not take omega-3-acid ethyl esters capsules?

Do not take omega-3-acid ethyl esters capsules if you are allergic to omega-3-acid ethyl esters or any of the ingredients in omega-3-acid ethyl esters capsules. See the end of this leaflet for a complete list of ingredients in omega-3-acid ethyl esters capsules.

Before you take omega-3-acid ethyl esters capsules, tell your doctor if you:

  • have diabetes.
  • have a low thyroid problem (hypothyroidism).
  • have a liver problem.
  • have a pancreas problem.
  • have a certain heart rhythm problem called atrial fibrillation or flutter.
  • are allergic to fish or shellfish. It is not known if people who are allergic to fish or shellfish are also allergic to omega-3-acid ethyl esters capsules.
  • are pregnant or plan to become pregnant. It is not known if omega-3-acid ethyl esters capsules will harm your unborn baby.
  • are breastfeeding or plan to breastfeed. Omega-3-acid ethyl esters can pass into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you take omega-3-acid ethyl esters capsules.

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicine, vitamins, and herbal supplements.

Omega-3-Acid Ethyl Esters Capsules can interact with certain other medicines that you are taking. Using omega-3-acid ethyl esters capsules with medicines that affect blood clotting (anticoagulants or blood thinners) may cause serious side effects.

How should I take omega-3-acid ethyl esters capsules?

  • Take omega-3-acid ethyl esters capsules exactly as your healthcare provider tells you to take it.
  • You should not take more than 4 capsules of omega-3-acid ethyl esters capsules each day. Either take all 4 capsules at one time, or 2 capsules two times a day.
  • Do not change your dose or stop omega-3-acid ethyl esters capsules without talking to your healthcare provider.
  • Take omega-3-acid ethyl esters capsules with food.
  • Take omega-3-acid ethyl esters capsules whole. Do not break, crush, dissolve, or chew omega-3-acid ethyl esters capsules before swallowing. If you cannot swallow omega-3-acid ethyl esters capsules whole, tell your healthcare provider. You may need a different medicine.
  • If you miss a dose of omega-3-acid ethyl esters capsules, take the missed dose as soon as you remember. If you miss one day of omega-3-acid ethyl esters capsules, do not double your dose the next time you take it.
  • Your healthcare provider may start you on a cholesterol-lowering diet before giving you omega-3-acid ethyl esters capsules. Stay on this diet while taking omega-3-acid ethyl esters capsules.
  • Your healthcare provider should do blood tests to check your triglyceride, bad cholesterol and liver function levels while you take omega-3-acid ethyl esters capsules.

What are the possible side effects of omega-3-acid ethyl esters capsules?

Omega-3-acid ethyl esters capsules may cause serious side effects, including:

  • changes in certain blood tests. Omega-3-acid ethyl esters capsules may cause an increase in the results of blood tests used to check your liver function and your bad cholesterol levels.
  • increased risk of a heart rhythm problem in people who have a heart rhythm problem. Omega-3-acid ethyl esters capsules may cause an increase in the frequency of a heart rhythm problem (atrial fibrillation or flutter), especially in the first few months of taking omega-3-acid ethyl esters capsules, if you already have a heart rhythm problem.

The most common side effects of omega-3-acid ethyl esters capsules include:

  • burping
  • upset stomach
  • a change in your sense of taste

These are not all the possible side effects of omega-3-acid ethyl esters capsules. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to Strides Pharma Inc. at 1-877-244-9825 or FDA at 1-800-FDA- 1088.

How should I store omega-3-acid ethyl esters capsules?

  • Store omega-3-acid ethyl esters capsules at room temperature between 68°F to 77° F (20°C to 25°C). Protect from light.
  • Do not freeze omega-3-acid ethyl esters capsules.
  • Safely throw away medicine that is out of date or no longer needed.

Keep omega-3-acid ethyl esters capsules and all medicines out of the reach of children.

General information about the safe and effective use of omega-3-acid ethyl esters capsules

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information Leaflet. Do not use omega-3-acid ethyl esters capsules for a condition for which it was not prescribed. Do not give omega-3-acid ethyl esters capsules to other people, even if they have the same symptoms you have. It may harm them. You can ask your healthcare provider or pharmacist for information about omega-3-acid ethyl esters capsules that is written for health professionals.

For more information go to www.strides.com or call at 1-877-244-9825.

What are the ingredients in omega-3-acid ethyl esters capsules?

Active Ingredient: omega-3-acid ethyl esters 90 USP, mostly EPA and DHA

Inactive Ingredients: gelatin, glycerin, purified water and opacode white ink (contains shellac glaze, titanium dioxide, purified water, N-butyl alcohol, lecithin and simethicone).

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

Manufactured by:

Strides Pharma Science Ltd.

Bengaluru — 562106, India

Distributed by:

Strides Pharma Inc.

East Brunswick, NJ 08816

Revised: 07/2019

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