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omega-3-acid ethyl esters

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Overview

What is Omtryg?

OMTRYG, a lipid-regulating agent, is supplied as a liquid-filled gel capsule for oral administration. Each OMTRYG capsule contains 1.2 grams of omega-3-acid ethyl esters type A, USP, liquid concentrate consisting of at least 900 mg omega-3-acid ethyl esters 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:

OMTRYG capsules also contain the following inactive ingredients: 4.6 mg α-tocopherol (in a carrier of sunflower oil), gelatin, glycerol, and purified water (components of the capsule shell).



What does Omtryg look like?



What are the available doses of Omtryg?

Capsules: 1.2 grams. ()

What should I talk to my health care provider before I take Omtryg?

How should I use Omtryg?

OMTRYG™ (omega-3-acid ethyl esters) capsules, USP, is indicated as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia.

Usage Considerations:

Laboratory studies should be done to ascertain that the lipid levels are consistently abnormal before instituting OMTRYG therapy. 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 OMTRYG on the risk for pancreatitis has not been determined.

The effect of OMTRYG on cardiovascular mortality and morbidity has not been determined.

The daily dose of OMTRYG is 4 capsules per day taken as a single dose (4 capsules) or as 2 capsules given twice daily. OMTRYG should be taken with meals.

Patients should be advised to swallow OMTRYG capsules whole. Do not break open, crush, dissolve or chew OMTRYG.


What interacts with Omtryg?

Sorry No Records found


What are the warnings of Omtryg?

Sorry No Records found


What are the precautions of Omtryg?

Sorry No Records found


What are the side effects of Omtryg?

Sorry No records found


What should I look out for while using Omtryg?

OMTRYG is contraindicated in patients with known hypersensitivity (e.g., anaphylactic reaction) to omega-3-acid ethyl esters or any component of OMTRYG.


What might happen if I take too much Omtryg?

Sorry No Records found


How should I store and handle Omtryg?

Inspect parenteral drug products visually for particulate matter and discoloration prior to administration, whenever solution and container permit. The product may be filtered using a sterile filter if particles are seen subsequent to opening of the ampoule.OPC ampoule: to open, turn so that the point faces upward and break off the neck with a downward movement.ArrayInspect parenteral drug products visually for particulate matter and discoloration prior to administration, whenever solution and container permit. The product may be filtered using a sterile filter if particles are seen subsequent to opening of the ampoule.OPC ampoule: to open, turn so that the point faces upward and break off the neck with a downward movement.ArrayInspect parenteral drug products visually for particulate matter and discoloration prior to administration, whenever solution and container permit. The product may be filtered using a sterile filter if particles are seen subsequent to opening of the ampoule.OPC ampoule: to open, turn so that the point faces upward and break off the neck with a downward movement.ArrayOMTRYG (omega-3-acid ethyl esters) capsules, USP, 1.2 grams, are supplied as type A transparent soft-gelatin capsules filled with light-yellow oil and bearing the designation TP0001.Bottles of 120: NDC 61112-001-01Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Do not freeze. Dispense in a tight, light-resistant container.OMTRYG (omega-3-acid ethyl esters) capsules, USP, 1.2 grams, are supplied as type A transparent soft-gelatin capsules filled with light-yellow oil and bearing the designation TP0001.Bottles of 120: NDC 61112-001-01Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Do not freeze. Dispense in a tight, light-resistant container.OMTRYG (omega-3-acid ethyl esters) capsules, USP, 1.2 grams, are supplied as type A transparent soft-gelatin capsules filled with light-yellow oil and bearing the designation TP0001.Bottles of 120: NDC 61112-001-01Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Do not freeze. Dispense in a tight, light-resistant container.OMTRYG (omega-3-acid ethyl esters) capsules, USP, 1.2 grams, are supplied as type A transparent soft-gelatin capsules filled with light-yellow oil and bearing the designation TP0001.Bottles of 120: NDC 61112-001-01Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Do not freeze. Dispense in a tight, light-resistant container.


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Clinical Information

Chemical Structure

No Image found
Clinical Pharmacology

The mechanism of action of OMTRYG is not completely understood. Potential mechanisms of action include inhibition of acyl-CoA:1,2-diacylglycerol acyltransferase, increased mitochondrial and peroxisomal ß-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.

Non-Clinical Toxicology
OMTRYG is contraindicated in patients with known hypersensitivity (e.g., anaphylactic reaction) to omega-3-acid ethyl esters or any component of OMTRYG.









Table 2 summarizes the results and magnitude of the pertinent drug interactions assessed with rifabutin. The clinical relevance of these interactions and subsequent dose modifications should be judged in light of the population studied, severity of the disease, patient's drug profile, and the likely impact on the risk/benefit ratio.





In patients with hepatic impairment, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels should be monitored periodically during therapy with OMTRYG. In some patients, increases in ALT levels without a concurrent increase in AST levels were observed.

In some patients, OMTRYG increases LDL-cholesterol levels. LDL-cholesterol levels should be monitored periodically during therapy with OMTRYG.

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Interactions

Interactions

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