"June 10, 2015 -- A new class of medications can lower "bad" LDL cholesterol to unheard-of levels, and it may be on the horizon.
The new class is called PCSK9 inhibitors. An FDA advisory panel on Tuesday recommended that the agency approve t"...
OMTRYG™ (omega-3-acid ethyl esters A) is indicated as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe ( ≥ 500 mg/dL) hypertriglyceridemia.
Patients should be placed on an appropriate lipid-lowering diet before receiving OMTRYG and should continue this diet during treatment with OMTRYG.
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
DOSAGE AND ADMINISTRATION
- Assess triglyceride levels carefully before initiating therapy. Identify other causes (e.g., diabetes mellitus, hypothyroidism, or medications) of high triglyceride levels and manage as appropriate. [see INDICATIONS AND USAGE].
- Patients should be placed on an appropriate lipid-lowering diet before receiving OMTRYG and should continue this diet during treatment with OMTRYG.
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. [see CLINICAL PHARMACOLOGY]
Patients should be advised to swallow OMTRYG capsules whole. Do not break open, crush, dissolve or chew OMTRYG.
Dosage Forms And Strengths
OMTRYG (omega-3-acid ethyl esters A) capsules are supplied as 1.2-gram, transparent, soft-gelatin capsules filled with light-yellow oil and bearing the designation TP0001.
Storage And Handling
OMTRYG (omega-3-acid ethyl esters A) capsules, 1.2 grams, are supplied as transparent soft-gelatin capsules filled with light-yellow oil and bearing the designation TP0001.
Bottles of 120: NDC 61112-001-01
Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Do not freeze. Keep out of reach of children.
Inactive Ingredients: alpha-tocopherol (in sunflower oil), gelatin, glycerol, purified water
Manufactured for: Trygg Pharma Inc. 1001 North 19th St. Suite 1200 Arlington, VA 22209. Revised: Apr 2014This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 5/5/2014
Additional Omtryg Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Tips to keep it under control.