DOSAGE FORM OF OMEGA-3

LOVAZA or generically called Omega-3-Acid Ethyl Esters is the indicated as and adjunct
to diet to reduce triglyceride (TG) levels in adult patients with severe ( > 500 mg/dL)
hypertriglyceride (HTG). Omega-3-Acid Ethyl Esters, USP, a lipid-regulating agent, are
supplied as a liquid-filled gel capsule for oral administration. They are available as
follows: bottles of 60: NDC 65162-034-06, bottles of 120: NDC 65162-034-16, bottles of
360: NDC 65162-034-32. Store at 20 to 25C (68 to 77F); excursions permitted to 15
to 30C (59 to 86F) [See USP Controlled Room Temperature]. Do not freeze. Protect
from light. Keep out of reach of children. Each 1 gram capsule of Omega-3-Acid Ethyl
Esters, 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).Omega-3-Acid Ethyl Esters capsules, USP are supplied as 1 gram transparent, softgelatin capsules filled with light-yellow oil and imprinted with AN34, with a daily dose
of 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), as written in www.drugs.com.
Patients should be advised to swallow LOVAZA capsules whole. Do not break open,
crush, dissolve, or chew LOVAZA. Some usage considerations stated in www.rxlist.com
follows, Patients should be placed on an appropriate lipid-lowering diet before receiving
LOVAZA and should continue this diet during treatment with LOVAZA. Laboratory
studies should be done to ascertain that the lipid levels are consistently abnormal before
instituting therapy with LOVAZA. 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 asdiabetes 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. Its has also contradictions, Omega3-Acid Ethyl Esters capsules, USP are contraindicated in patients with known
hypersensitivity (e.g., anaphylactic reaction) to Omega-3-Acid Ethyl Esters, USP or any
of its components, stated in www.drugs.com. There are also additional adverse effects,
like constipation, gastrointestinal disorder and vomiting, increased ALT and increased
AST, pruritus and rash. The effect of LOVAZA on the risk for pancreatitis has not been
determined. The effect of LOVAZA on cardiovascular mortality and morbidity has not
been determined. Omega-3-Acid Ethyl Esters do not have any known drug abuse or
withdrawal effects.

References:
Rxlist (2014, July 6). Lovaza. Retrieved from http://www.rxlist.com/lovazadrug/indications-dosage.htm
Medscape. omega 3 fatty acids (Rx). Retrieved from
http://reference.medscape.com/drug/lovaza-omega-3-fatty-acids-342455
Amneal Pharmaceuticals of New York, LLC (2015, June). Omega-3-Acid Ethyl Esters.
Retrieved from http://www.drugs.com/pro/omega-3-acid-ethyl-esters.html