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Omega-3-Acid Ethyl Esters
Overview
What is Omega-3-Acid Ethyl Esters?
Omega-3-acid ethyl esters, USP, a lipid-regulating agent, is supplied as a liquid-filled gel capsule for oral administration. Each 1 gram capsule of omega-3-acid ethyl esters contains at least 900 mg of the ethyl esters of omega-3 fatty acids. These are predominantly a combination of ethyl esters of eicosapentaenoic acid (EPA - approximately 465 mg) and docosahexaenoic acid (DHA - approximately 375 mg).
The structural formula of EPA ethyl ester is:
CHO M.W. 330.51
The structural formula of DHA ethyl ester is:
CHO M.W. 356.55
Omega-3-acid ethyl esters capsules USP also contain the following inactive ingredients: 4 mg alpha-tocopherol, gelatin, glycerin, hypromellose, propylene glycol, and titanium dioxide.
What does Omega-3-Acid Ethyl Esters look like?
What are the available doses of Omega-3-Acid Ethyl Esters?
Capsules: 1 gram ()
What should I talk to my health care provider before I take Omega-3-Acid Ethyl Esters?
How should I use Omega-3-Acid Ethyl Esters?
Omega-3-acid ethyl esters capsules are indicated as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (≥ 500 mg/dL) hypertriglyceridemia (HTG).
Usage Considerations:
Laboratory studies should be done to ascertain that the lipid levels are consistently abnormal before instituting therapy with omega-3-acid ethyl esters capsules. 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 on the risk for pancreatitis has not been determined.
The effect of omega-3-acid ethyl esters capsules on cardiovascular mortality and morbidity has not been determined.
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.
What interacts with Omega-3-Acid Ethyl Esters?
Sorry No Records found
What are the warnings of Omega-3-Acid Ethyl Esters?
Sorry No Records found
What are the precautions of Omega-3-Acid Ethyl Esters?
Sorry No Records found
What are the side effects of Omega-3-Acid Ethyl Esters?
Sorry No records found
What should I look out for while using Omega-3-Acid Ethyl Esters?
Omega-3-acid ethyl esters capsules are contraindicated in patients with known hypersensitivity (e.g., anaphylactic reaction) to omega-3-acid ethyl esters or any of its components.
What might happen if I take too much Omega-3-Acid Ethyl Esters?
Sorry No Records found
How should I store and handle Omega-3-Acid Ethyl Esters?
Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Omega-3-acid ethyl esters capsules USP are available as follows:1 gram – slightly yellow to yellow liquid, oblong, clear, soft gel capsules, imprinted with “TV 5401” in white ink, in bottles of 28 (NDC 42708-067-28).Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Do not freeze. Keep out of reach of children.Omega-3-acid ethyl esters capsules USP are available as follows:1 gram – slightly yellow to yellow liquid, oblong, clear, soft gel capsules, imprinted with “TV 5401” in white ink, in bottles of 28 (NDC 42708-067-28).Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Do not freeze. Keep out of reach of children.Omega-3-acid ethyl esters capsules USP are available as follows:1 gram – slightly yellow to yellow liquid, oblong, clear, soft gel capsules, imprinted with “TV 5401” in white ink, in bottles of 28 (NDC 42708-067-28).Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Do not freeze. Keep out of reach of children.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
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.
Non-Clinical Toxicology
Omega-3-acid ethyl esters capsules are contraindicated in patients with known hypersensitivity (e.g., anaphylactic reaction) to omega-3-acid ethyl esters or any of its components.Furosemide may increase the ototoxic potential of aminoglycoside antibiotics, especially in the presence of impaired renal function. Except in life-threatening situations, avoid this combination.
Furosemide should not be used concomitantly with ethacrynic acid because of the possibility of ototoxicity. Patients receiving high doses of salicylates concomitantly with furosemide, as in rheumatic disease, may experience salicylate toxicity at lower doses because of competitive renal excretory sites.
There is a risk of ototoxic effects if cisplatin and furosemide are given concomitantly. In addition, nephrotoxicity of nephrotoxic drugs such as cisplatin may be enhanced if furosemide is not given in lower doses and with positive fluid balance when used to achieve forced diuresis during cisplatin treatment.
Furosemide has a tendency to antagonize the skeletal muscle relaxing effect of tubocurarine and may potentiate the action of succinylcholine.
Lithium generally should not be given with diuretics because they reduce lithium's renal clearance and add a high risk of lithium toxicity.
Furosemide combined with angiotensin converting enzyme inhibitors or angiotensin II receptor blockers may lead to severe hypotension and deterioration in renal function, including renal failure. An interruption or reduction in the dosage of furosemide, angiotensin converting enzyme inhibitors, or angiotensin receptor blockers may be necessary.
Potentiation occurs with ganglionic or peripheral adrenergic blocking drugs.
Furosemide may decrease arterial responsiveness to norepinephrine. However, norepinephrine may still be used effectively.
Simultaneous administration of sucralfate and furosemide tablets may reduce the natriuretic and antihypertensive effects of furosemide. Patients receiving both drugs should be observed closely to determine if the desired diuretic and/or antihypertensive effect of furosemide is achieved. The intake of furosemide and sucralfate should be separated by at least two hours.
In isolated cases, intravenous administration of furosemide within 24 hours of taking chloral hydrate may lead to flushing, sweating attacks, restlessness, nausea, increase in blood pressure, and tachycardia. Use of furosemide concomitantly with chloral hydrate is therefore not recommended.
Phenytoin interferes directly with renal action of furosemide. There is evidence that treatment with phenytoin leads to decrease intestinal absorption of furosemide, and consequently to lower peak serum furosemide concentrations.
Methotrexate and other drugs that, like furosemide, undergo significant renal tubular secretion may reduce the effect of furosemide. Conversely, furosemide may decrease renal elimination of other drugs that undergo tubular secretion. High-dose treatment of both furosemide and these other drugs may result in elevated serum levels of these drugs and may potentiate their toxicity as well as the toxicity of furosemide.
Furosemide can increase the risk of cephalosporin-induced nephrotoxicity even in the setting of minor or transient renal impairment.
Concomitant use of cyclosporine and furosemide is associated with increased risk of gouty arthritis secondary to furosemide-induced hyperurecemia and cyclosporine impairment of renal urate excretion.
High doses (> 80 mg) of furosemide may inhibit the binding of thyroid hormones to carrier proteins and result in transient increase in free thyroid hormones, followed by an overall decrease in total thyroid hormone levels.
One study in six subjects demonstrated that the combination of furosemide and acetylsalicylic acid temporarily reduced creatinine clearance in patients with chronic renal insufficiency. There are case reports of patients who developed increased BUN, serum creatinine and serum potassium levels, and weight gain when furosemide was used in conjunction with NSAIDs.
Literature reports indicate that coadministration of indomethacin may reduce the natriuretic and antihypertensive effects of furosemide in some patients by inhibiting prostaglandin synthesis. Indomethacin may also affect plasma renin levels, aldosterone excretion, and renin profile evaluation. Patients receiving both indomethacin and furosemide should be observed closely to determine if the desired diuretic and/or antihypertensive effect of furosemide is achieved.
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. In some patients, increases in ALT levels without a concurrent increase in AST levels were observed.
In some patients, omega-3-acid ethyl esters increases 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.
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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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. 315.72Tips
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