Omega-3-Acid Ethyl Esters (Omega-3-Acid Ethyl Esters)

Trade Name : Omega-3-acid ethyl esters

Par Pharmaceutical Inc.

CAPSULE

Strength 900 mg/1

OMEGA-3-ACID ETHYL ESTERS Fatty Acids, Omega-3 [CS],Omega-3 Fatty Acid [EPC]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Omega-3-Acid Ethyl Esters (Omega-3-Acid Ethyl Esters) which is also known as Omega-3-acid ethyl esters and Manufactured by Par Pharmaceutical Inc.. It is available in strength of 900 mg/1 per ml. Read more

Omega-3-Acid Ethyl Esters (Omega-3-Acid Ethyl Esters) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • Indications and Usage, Limitations of Use u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 05/2014
  • Omega-3-acid ethyl esters capsules, USP are indicated as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (u2265500 mg/dL) hypertriglyceridemia (HTG).
  • Usage Considerations:
  • Laboratory studies should be done to ascertain that the lipid levels are consistently abnormal before institutingu00a0 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.
  • Omega-3-acid ethyl esters capsules, USP are combination of ethyl esters of omega 3 fatty acids, principally EPA and DHA, indicated as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (u2265500 mg/dL) hypertriglyceridemia (HTG). n
  • Limitations of Use:
  • The effect of omega-3-acid ethyl esters capsules, USP on the risk for pancreatitis has not been determined. n
  • The effect of omega-3-acid ethyl esters capsules, USP on cardiovascular mortality and morbidity has not beenu00a0u00a0u00a0u00a0u00a0 determined. n
  • 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.
  • The daily dose of omega-3-acid ethyl esters capsules, USP are 4 grams per day taken as a single 4-gram dose (4 capsules) or as two 2-gram doses (2 capsules given twice daily). n
  • 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. n
  • 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'.
  • Capsules: 1-gram n
  • 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.
  • 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. n
  • No data
  • In patients with hepatic impairment, monitor ALT and AST levelsu00a0 periodically during therapy. ()
  • Omega-3-acid ethyl esters capsules may increase levels of LDL. Monitor LDL levels periodically during therapy. ()
  • Use with caution in patients with known hypersensitivity to fish and/or shellfish. ()
  • 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 months of initiating therapy. ()
  • The most common adverse reactions (incidence >3% and greater than placebo) were eructation, dyspepsia and taste perversion. ()
  • To report SUSPECTED ADVERSE REACTIONS, contact Par Pharmaceutical at 1-800-828-9393 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
  • 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.
  • Omega-3-acids may prolong bleeding time. Patients taking omega-3-acid ethyl esters capsules and an anticoagulant or other drug affecting coagulation (e.g., anti-platelet agents) should be monitored periodically. ()
  • No data
  • Pregnancy: Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. ()
  • Omega-3-acid ethyl esters capsules does 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 empirical formula of EPA ethyl ester is CHO, and the molecular weight of EPA ethyl ester is 330.51. The structural formula of EPA ethyl ester is:
  • The empirical formula of DHA ethyl ester is CHO, and the molecular weight of DHA ethyl ester is 356.55. The structural formula of DHA ethyl ester is:
  • Omega-3-acid ethyl esters capsules, USP also contain the following inactive ingredients: gelatin, glycerin, purified water and opacode white ink (contains shellac glaze, titanium dioxide, purified water, N-butyl alcohol, lecithin and simethicone).
  • No data
  • In a rat carcinogenicity study with oral gavage doses of 100, 600, and 2,000 mg/kg/day, males were treated with omega-3-acid ethyl esters for 101 weeks and females for 89 weeksu00a0 without an increased incidence of tumors (up to 5 times human systemic exposures following anu00a0 oral dose of 4 grams/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 andu00a0 or in the chromosomal aberration assay in Chinese hamster V79 lung cells or human lymphocytes. Omega-3-acid ethyl esters were negative in the mouse micronucleus assay.
  • In a rat fertility study with oral gavage doses of 100, 600, and 2,000 mg/kg/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).
  • 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/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/dL and 100 mg/dL, respectively. Median HDL-C level was 23.0 mg/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.
  • BL = Baseline (mg/dL); % Change = Median Percent Change from Baseline;
  • Difference =u00a0 Omega-3-acid ethyl esters Median % Change u2013 Placebo Median % Change.
  • 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 ofu00a0 omega-3-acid ethyl esters on the risk of pancreatitis has not been determined.
  • The effect ofu00a0 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 clear, natural colored oblong shaped soft gelatin capsules containing pale yellow colored oily liquid imprinted with '740'
  • Bottles of 120: NDC 0254-3010-08
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F); excursions permitted between 15u00b0C to 30u00b0C (59u00b0F to 86u00b0F) Protect from light. [See USP Controlled Room Temperature]. Do not freeze. Keep out of reach of children.
  • Advise the patient to read the FDA-approved patient labeling (Patient Information).
  • Arrayn- Information for Patients:
  • Manufactured by:
  • Strides Shasun Limited
  • Bengaluru, India
  • Distributed by:
  • Par Pharmaceutical
  • Chestnut Ridge, NY 10977 USA
  • Revised: 07/2017
  • 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,n- USP
  • Read the Patient Information before you start taking omega-3-acid ethyl esters capsules, 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 your treatment.
  • What is omega-3-acid ethyl esters capsules?u00a0
  • 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.
  • What should I tell my doctor before taking omega-3-acid ethyl esters capsules?
  • Before you takeu00a0 omega-3-acid ethyl esters capsules, tell your doctor if you:
  • Tell your doctor about all the medicines you take,
  • 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.
  • Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.
  • How should I takeu00a0 omega-3-acid ethyl esters capsules?
  • What are the possible side effects of omega-3-acid ethyl esters capsules?
  • Omega-3-acid ethyl esters capsulesn- may cause serious side effects, including:
  • The most common side effects of omega-3-acid ethyl esters capsules include:
  • Talk to your doctor if you have a side effect that bothers you or does not go away.
  • 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 Par Pharmaceutical at 1-800-828-9393 or FDA at 1-800-FDA-1088.
  • How should I store omega-3-acid ethyl esters capsules?
  • Keep omega-3-acid ethyl esters capsulesn- 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.
  • This Patient Information Leaflet summarizes the most important information about omega-3-acid ethyl esters capsules. If you would like more information, talk with your doctor.
  • You can ask your doctor or pharmacist for information about omega-3-acid ethyl esters capsules that is written for health professionals.
  • For more information go to www.parpharm.com or call at 1-800-828-9393.
  • 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 Shasun Limited
  • Bengaluru -560076, India
  • Distributed by:
  • Par Pharmaceutical
  • Chestnut Ridge, NY 10977 USA
  • Revised: 07/2017
  • NDC 0254-3010-08
  • Omega-3-Acid Ethyl Esters Capsules, USP
  • 1 gram
  • 120 Capsules
  • R only

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