OMEGA-3-ACID ETHYL ESTERS- omega-3-acid ethyl esters capsule, liquid filled

United States - English - NLM (National Library of Medicine)

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Active ingredient:
OMEGA-3-ACID ETHYL ESTERS (UNII: D87YGH4Z0Q) (OMEGA-3 FATTY ACIDS - UNII:71M78END5S)
Available from:
Direct_Rx
Administration route:
ORAL
Prescription type:
PRESCRIPTION DRUG
Therapeutic indications:
Omega-3-acid ethyl esters capsules, USP are indicated as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (greater than or equal to 500 mg per dL) hypertriglyceridemia (HTG). Usage Considerations: Patients should be placed on an appropriate lipid-lowering diet before receiving omega-3-acid ethyl esters capsules, USP and should continue this diet during treatment with omega-3-acid ethyl esters capsules, USP. Laboratory studies should be done to ascertain that the lipid levels are consistently abnormal before instituting therapy with omega-3-acid ethyl esters. Every attempt should be made to control serum lipids with appropriate diet, exercise, weight loss in obese patients, and control of any medical problems such as diabetes mellitus and hypothyroidism that are contributing to the lipid abnormalities. Medications known to exacerbate hypertriglyceridemia (such as beta blockers, thiazides, estrogens) should be discontinued or changed if possible prior to consideration of trigl
Product summary:
Omega-3-acid ethyl esters capsules, USP are supplied as 1-gram transparent, oblong soft gelatin capsules with light yellowish oil printed with white ink (Logo “APO900”). They are supplied as follows: Bottles of 30s Bottles of 60s Bottles of 120s Store in tight, light-resistant containers at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from light. Do not freeze. Keep out of reach of children.
Authorization status:
Abbreviated New Drug Application
Authorization number:
72189-024-60

OMEGA-3-ACID ETHYL ESTERS- omega-3-acid ethyl esters capsule, liquid filled

Direct_Rx

----------

OMEGA-3-ACID ETHYL ESTERS

Omega-3-acid ethyl esters capsules, USP are indicated as an adjunct to diet to reduce triglyceride (TG)

levels in adult patients with severe (greater than or equal to 500 mg per dL) hypertriglyceridemia

(HTG).

Usage Considerations: Patients should be placed on an appropriate lipid-lowering diet before receiving

omega-3-acid ethyl esters capsules, USP and should continue this diet during treatment with omega-3-

acid ethyl esters capsules, USP.

Laboratory studies should be done to ascertain that the lipid levels are consistently abnormal before

instituting therapy with omega-3-acid ethyl esters. Every attempt should be made to control serum lipids

with appropriate diet, exercise, weight loss in obese patients, and control of any medical problems such

as diabetes mellitus and hypothyroidism that are contributing to the lipid abnormalities. Medications

known to exacerbate hypertriglyceridemia (such as beta blockers, thiazides, estrogens) should be

discontinued or changed if possible prior to consideration of triglyceride-lowering drug therapy.

Limitations of Use:

The effect of omega-3-acid ethyl esters capsules, USP on the risk for pancreatitis has not been

determined.

The effect of omega-3-acid ethyl esters capsules, USP on cardiovascular mortality and morbidity has

not been determined.

Assess triglyceride levels carefully before initiating therapy. Identify other causes (e.g., diabetes

mellitus, hypothyroidism, medications) of high triglyceride levels and manage as appropriate [see

Indications and Usage (1)].

Patients should be placed on an appropriate lipid-lowering diet before receiving omega-3-acid ethyl

esters capsules, and should continue this diet during treatment with omega-3-acid ethyl esters capsules.

In clinical studies, omega-3-acid ethyl esters capsules were administered with meals.

The daily dose of omega-3-acid ethyl esters capsules is 4 grams per day. The daily dose may be taken

as a single 4-gram dose (4 capsules) or as two 2-gram doses (2 capsules given twice daily).

Patients should be advised to swallow omega-3-acid ethyl esters capsules whole. Do not break open,

crush, dissolve, or chew omega-3-acid ethyl esters capsules.

Omega-3-acid ethyl esters capsules, USP are supplied as 1-gram transparent, soft gelatin capsules

filled with light yellowish oil printed with white ink (Logo “APO900”).

Omega-3-acid ethyl esters capsules are contraindicated in patients with known hypersensitivity (e.g.,

anaphylactic reaction) to omega-3-acid ethyl esters capsules or any of its components.

5.1 Monitoring: Laboratory Tests

In patients with hepatic impairment, alanine aminotransferase (ALT) and aspartate aminotransferase

(AST) levels should be monitored periodically during therapy with omega-3-acid ethyl esters capsules.

In some patients, increases in ALT levels without a concurrent increase in AST levels were observed.

In some patients, omega-3-acid ethyl esters capsule increases low-density lipoprotein cholesterol

(LDL-C) levels. LDL-C levels should be monitored periodically during therapy with omega-3-acid

ethyl esters.

Laboratory studies should be performed periodically to measure the patient’s TG levels during therapy

with omega-3-acid ethyl esters.

5.2 Fish Allergy

Omega-3-acid ethyl esters capsules contain ethyl esters of omega-3 fatty acids (EPA and DHA)

obtained from the oil of several fish sources. It is not known whether patients with allergies to fish

and/or shellfish, are at increased risk of an allergic reaction to omega-3-acid ethyl esters capsules.

Omega-3-acid ethyl esters capsules should be used with caution in patients with known hypersensitivity

to fish and/or shellfish.

5.3 Recurrent Atrial Fibrillation (AF) or Flutter

In a double-blind, placebo-controlled trial of 663 subjects with symptomatic paroxysmal AF (n=542) or

persistent AF (n=121), recurrent AF or flutter was observed in subjects randomized to omega-3-acid

ethyl esters who received 8 grams per day for 7 days and 4 grams per day thereafter for 23 weeks at a

higher rate relative to placebo. Subjects in this trial had median baseline triglycerides of 127 mg per dL,

had no substantial structural heart disease, were taking no anti-arrhythmic therapy (rate control

permitted), and were in normal sinus rhythm at baseline.

At 24 weeks, in the paroxysmal AF stratum, there were 129 (47%) first recurrent symptomatic AF or

flutter events on placebo and 141 (53%) on omega-3-acid ethyl esters (primary endpoint, HR 1.19; 95%

CI: 0.93, 1.35). In the persistent AF stratum, there were 19 (35%) events on placebo and 34 (52%) events

on omega-3-acid ethyl esters (HR 1.63; 95% CI: 0.91, 2.18). For both strata combined, the HR was 1.25;

95% CI: 1.00, 1.40. Although the clinical significance of these results is uncertain, there is a possible

association between omega-3-acid ethyl esters and more frequent recurrences of symptomatic atrial

fibrillation or flutter in patients with paroxysmal or persistent atrial fibrillation, particularly within the

first 2 to 3 months of initiating therapy.

Omega-3-acid ethyl esters capsules are not indicated for the treatment of AF or flutter.

6.1 Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed

in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another

drug and may not reflect the rates observed in practice.

Adverse reactions reported in at least 3% of subjects treated with omega-3-acid ethyl esters capsules

and at a greater rate than placebo based on pooled data across 23 clinical trials are listed in Table 1.

Table 1. Adverse Reactions Occurring at Incidence ≥3% and Greater than Placebo in Clinical Trials of

omega-3-acid ethyl esters capsules

Trials included subjects with HTG and severe HTG.

Adverse Reactions * Omega-3-acid ethyl esters

capsules

(n = 655) Placebo

(n = 370)

n % n %

Eructation 29 4 5 1

Dyspepsia 22 3 6 2

Taste perversion 27 4 1 ≤1

Additional adverse reactions from clinical trials are listed below:

Digestive System: Constipation, gastrointestinal disorder and vomiting.

Metabolic and Nutritional Disorders: Increased ALT and increased AST.

Skin: Pruritus and rash.

6.2 Postmarketing Experience

In addition to adverse reactions reported from clinical trials, the events described below have been

identified during post-approval use of omega-3-acid ethyl esters capsules. Because these events are

reported voluntarily from a population of unknown size, it is not possible to reliably estimate their

frequency or to always establish a causal relationship to drug exposure.

The following events have been reported: anaphylactic reaction, hemorrhagic diathesis, urticaria.

7.1 Anticoagulants or Other Drugs Affecting Coagulation

Some trials with omega-3-acids demonstrated prolongation of bleeding time. The prolongation of

bleeding time reported in these trials has not exceeded normal limits and did not produce clinically

significant bleeding episodes. Clinical trials have not been done to thoroughly examine the effect of

omega-3-acid ethyl esters and concomitant anticoagulants. Patients receiving treatment with omega-3-

acid ethyl esters and an anticoagulant or other drug affecting coagulation (e.g., anti-platelet agents)

should be monitored periodically.

8.1 Pregnancy

Pregnancy Category C: There are no adequate and well-controlled studies in pregnant women. It is

unknown whether omega-3-acid ethyl esters capsules can cause fetal harm when administered to a

pregnant woman or can affect reproductive capacity. Omega-3-acid ethyl esters capsules should be

used during pregnancy only if the potential benefit to the patient justifies the potential risk to the fetus.

Animal Data:

Omega-3-acid ethyl esters have been shown to have an embryocidal effect in pregnant rats when given

in doses resulting in exposures 7 times the recommended human dose of 4 grams per day based on a

body surface area comparison.

In female rats given oral gavage doses of 100, 600, and 2,000 mg per kg per day beginning 2 weeks

prior to mating and continuing through gestation and lactation, no adverse effects were observed in the

high-dose group (5 times human systemic exposure following an oral dose of 4 grams per day based on

body surface area comparison).

In pregnant rats given oral gavage doses of 1,000, 3,000, and 6,000 mg per kg per day from gestation

day 6 through 15, no adverse effects were observed (14 times human systemic exposure following an

oral dose of 4 grams per day based on a body surface area comparison).

In pregnant rats given oral gavage doses of 100, 600, and 2,000 mg per kg per day from gestation day

14 through lactation day 21, no adverse effects were seen at 2,000 mg per kg per day (5 times the human

systemic exposure following an oral dose of 4 grams per day based on a body surface area

comparison). However, decreased live births (20% reduction) and decreased survival to postnatal day 4

(40% reduction) were observed in a dose-ranging study using higher doses of 3,000 mg per kg per day

(7 times the human systemic exposure following an oral dose of 4 grams per day based on a body

surface area comparison).

In pregnant rabbits given oral gavage doses of 375, 750, and 1,500 mg per kg per day from gestation day

7 through 19, no findings were observed in the fetuses in groups given 375 mg/kg/day (2 times human

systemic exposure following an oral dose of 4 grams per day based on a body surface area

comparison). However, at higher doses, evidence of maternal toxicity was observed (4 times human

systemic exposure following an oral dose of 4 grams per day based on a body surface area

comparison).

8.3 Nursing Mothers

Studies with omega-3-acid ethyl esters have demonstrated excretion in human milk. The effect of this

excretion on the infant of a nursing mother is unknown; caution should be exercised when omega-3-acid

ethyl esters capsules are administered to a nursing mother. An animal study in lactating rats given oral

gavage 14C-ethyl EPA demonstrated that drug levels were 6 to 14 times higher in milk than in plasma.

8.4 Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

8.5 Geriatric Use

A limited number of subjects older than 65 years were enrolled in the clinical trials of omega-3-acid

ethyl esters capsules. Safety and efficacy findings in subjects older than 60 years did not appear to

differ from those of subjects younger than 60 years.

Omega-3-acid ethyl esters capsules do not have any known drug abuse or withdrawal effects.

Omega-3-acid ethyl esters capsules, USP, a lipid-regulating agent, are supplied as a liquid-filled gel

capsule for oral administration. Each 1-gram capsule of omega-3-acid ethyl esters capsules, USP

contains at least 900 mg of the ethyl esters of omega-3 fatty acids sourced from fish oils. These are

predominantly a combination of ethyl esters of eicosapentaenoic acid (EPA - approximately 465 mg) and

docosahexaenoic acid (DHA - approximately 375 mg).

The molecular formula of EPA ethyl ester is C22H34O2, and the molecular weight of EPA ethyl ester

is 330.51. The structural formula of EPA ethyl ester is:

[EPA-structure]

The molecular formula of DHA ethyl ester is C24H36O2, and the molecular weight of DHA ethyl

ester is 356.55. The structural formula of DHA ethyl ester is:

[DHA-structure]

Omega-3-acid ethyl esters capsules, USP also contain the following inactive ingredients: 4 mg α-

tocopherol (in a carrier of soybean oil), and gelatin, glycerin, purified water, and white ink (components

of the capsule shell). The capsule imprinting ink contains ammonium hydroxide, propylene glycol,

shellac glaze, simethicone and titanium dioxide.

12.1 Mechanism of Action

The mechanism of action of omega-3-acid ethyl esters is not completely understood. Potential

mechanisms of action include inhibition of acyl-CoA:1,2-diacylglycerol acyltransferase, increased

mitochondrial and peroxisomal β-oxidation in the liver, decreased lipogenesis in the liver, and

increased plasma lipoprotein lipase activity. Omega-3-acid ethyl esters may reduce the synthesis of

triglycerides in the liver because EPA and DHA are poor substrates for the enzymes responsible for

TG synthesis, and EPA and DHA inhibit esterification of other fatty acids.

12.3 Pharmacokinetics

Absorption

In healthy volunteers and in subjects with hypertriglyceridemia, EPA and DHA were absorbed when

administered as ethyl esters orally. Omega-3-acids administered as ethyl esters induced significant,

dose-dependent increases in serum phospholipid EPA content, though increases in DHA content were

less marked and not dose-dependent when administered as ethyl esters.

Specific Populations:

Age: Uptake of EPA and DHA into serum phospholipids in subjects treated with omega-3-acid ethyl

esters was independent of age (younger than 49 years versus 49 years and older).

Male and Female Patients: Females tended to have more uptake of EPA into serum phospholipids than

males. The clinical significance of this is unknown.

Pediatric Patients: Pharmacokinetics of omega-3-acid ethyl esters have not been studied.

Patients with Renal or Hepatic Impairment: Omega-3-acid ethyl esters has not been studied in patients

with renal or hepatic impairment.

Drug Interaction Studies:

Simvastatin: In a 14-day trial of 24 healthy adult subjects, daily coadministration of simvastatin 80 mg

with omega-3-acid ethyl esters 4 grams did not affect the extent (AUC) or rate (Cmax) of exposure to

simvastatin or the major active metabolite, beta-hydroxy simvastatin at steady state.

Atorvastatin: In a 14-day trial of 50 healthy adult subjects, daily coadministration of atorvastatin 80 mg

with omega-3-acid ethyl esters 4 grams did not affect AUC or Cmax of exposure to atorvastatin, 2-

hydroxyatorvastatin, or 4-hydroxyatorvastatin at steady state.

Rosuvastatin: In a 14-day trial of 48 healthy adult subjects, daily coadministration of rosuvastatin 40 mg

with omega-3-acid ethyl esters 4 grams did not affect AUC or Cmax of exposure to rosuvastatin at

steady state.

In vitro studies using human liver microsomes indicated that clinically significant cytochrome P450-

mediated inhibition by EPA/DHA combinations are not expected in humans.

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

In a rat carcinogenicity study with oral gavage doses of 100, 600, and 2,000 mg per kg per day, males

were treated with omega-3-acid ethyl esters for 101 weeks and females for 89 weeks without an

increased incidence of tumors (up to 5 times human systemic exposures following an oral dose of 4

grams per day based on a body surface area comparison). Standard lifetime carcinogenicity bioassays

were not conducted in mice.

Omega-3-acid ethyl esters were not mutagenic or clastogenic with or without metabolic activation in

the bacterial mutagenesis (Ames) test with Salmonella typhimurium and Escherichia coli or in the

chromosomal aberration assay in Chinese hamster V79 lung cells or human lymphocytes. Omega-3-acid

ethyl esters were negative in the in vivo mouse micronucleus assay.

In a rat fertility study with oral gavage doses of 100, 600, and 2,000 mg per kg per day, males were

treated for 10 weeks prior to mating and females were treated for 2 weeks prior to and throughout

mating, gestation, and lactation. No adverse effect on fertility was observed at 2,000 mg/kg/day (5 times

human systemic exposure following an oral dose of 4 grams/day based on a body surface area

comparison).

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 high-density lipoprotein cholesterol (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/dL)

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

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-lowdensity lipoprotein (VLDL) cholesterol.

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.

Omega-3-acid ethyl esters capsules, USP are supplied as 1-gram transparent, oblong soft gelatin

capsules with light yellowish oil printed with white ink (Logo “APO900”).

They are supplied as follows:

Bottles of 30s

Bottles of 60s

Bottles of 120s

Store in tight, light-resistant containers at 25°C (77°F); excursions permitted to 15° to 30°C (59° to

86°F) [see USP Controlled Room Temperature]. Protect from light. Do not freeze. Keep out of reach

of children.

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.

APOTEX INC.

Omega-3-Acid Ethyl Esters Capsules, USP1 gram

Manufactured in Canada for:

Apotex Corp.

Weston, FL. 33326 USA

Revision: 5

Revised: April 2019

Omega-3-Acid Ethyl Esters

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

Capsules, USP

What are omega-3-acid ethyl esters capsules?

Omega-3-acid ethyl esters capsules are a 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 change your risk of having inflammation of your

pancreas (pancreatitis).

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

It is not known if omega-3-acid ethyl esters capsules are 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 taking omega-3-acid ethyl esters capsules, tell your healthcare provider 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.

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.

Tell your healthcare provider about all the medicines you take, including prescription and over-the

counter medicines, 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 doctor 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 doctor. 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. 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 (LDL-C)

and liver function (ALT and AST) 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 LOVAZA, 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.

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 omega-3-acid ethyl esters capsules ?

Store omega-3-acid ethyl esters capsules at room temperature, 59° to 86° F (15° to 30° 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.

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

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

Inactive Ingredients: alpha-tocopherol (in soybean oil), gelatin, glycerin, purified water and white ink.

The capsule imprinting ink contains ammonium hydroxide, propylene glycol, shellac glaze, simethicone

and titanium dioxide.

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

APOTEX INC.

Omega-3-Acid Ethyl Esters Capsules, USP

1 gram

Manufactured in Canada for:

Apotex Corp.

Weston, FL. 33326 USA

Revision: 5

Revised: April 2019

OMEGA-3-ACID ETHYL ESTERS

omega-3-acid ethyl esters capsule, liquid filled

Product Information

Product T ype

HUMAN PRESCRIPTION DRUG

Ite m Code (Source )

NDC:7218 9 -0 24(NDC:6 0 50 5-3170 )

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

O MEGA-3 -ACID ETHYL ESTERS (UNII: D8 7YGH4Z0 Q) (OMEGA-3 FATTY ACIDS -

UNII:71M78 END5S)

OMEGA-3-ACID ETHYL

ESTERS

Inactive Ingredients

Ingredient Name

Stre ng th

.ALPHA.-TO CO PHERO L (UNII: H4N8 55PNZ1)

GELATIN (UNII: 2G8 6 QN327L)

WATER (UNII: 0 59 QF0 KO0 R)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

GLYCERIN (UNII: PDC6 A3C0 OX)

AMMO NIA (UNII: 5138 Q19 F1X)

PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)

SHELLAC (UNII: 46 N10 7B71O)

DIMETHICO NE (UNII: 9 2RU3N3Y1O)

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

Product Characteristics

Color

yello w ((Light Yello w))

S core

no sco re

S hap e

CAPSULE (APO9 0 0 )

S iz e

22mm

Flavor

Imprint Code

APO9 0 0

Contains

Dire ct_Rx

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:7218 9 -0 24-6 0

6 0 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 8 /0 2/20 19

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

ANDA

ANDA0 9 0 9 73

0 8 /0 2/20 19

Labeler -

Direct_Rx (079254320)

Registrant -

Direct_Rx (079254320)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Dire c t_Rx

0 79 254320

re pa c k(7218 9 -0 24)

Revised: 8/2019

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