RX ITEM-Lovaza 1 Gm Cap 120 By Glaxosmithkline

LOVAZA- omega-3-acid ethyl esters capsule, liquid filled
GlaxoSmithKline LLC

1 INDICATIONS AND USAGE

LOVAZA� (omega-3-acid ethyl esters) is indicated as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (greater than or equal to 500 mg per dL) hypertriglyceridemia (HTG).

Usage Considerations: 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 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 LOVAZA on the risk for pancreatitis has not been determined.

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

2 DOSAGE AND ADMINISTRATION

�
Assess triglyceride levels carefully before initiating therapy. Identify other causes (e.g., diabetes mellitus, hypothyroidism, medications) of high triglyceride levels and manage as appropriate [see Indications and Usage (1)].
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Patients should be placed on an appropriate lipid-lowering diet before receiving LOVAZA, and should continue this diet during treatment with LOVAZA. In clinical studies, LOVAZA was administered with meals.
The daily dose of LOVAZA 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 LOVAZA capsules whole. Do not break open, crush, dissolve, or chew LOVAZA.

3 DOSAGE FORMS AND STRENGTHS

LOVAZA (omega-3-acid ethyl esters) capsules are supplied as 1-gram transparent, soft-gelatin capsules filled with light-yellow oil and bearing the designation "GS FH2".

4 CONTRAINDICATIONS

LOVAZA is contraindicated in patients with known hypersensitivity (e.g., anaphylactic reaction) to LOVAZA or any of its components.

RX ITEM-Lovaza 1 Gm Cap 120 By Glaxosmit
NDC 00173-0783-02 UPC/GTIN No.3-01730-78302-8 Mfg.Part No.78302

Lovaza 1 Gm Cap 120 By Glaxosmithkline
BRAND: LOVAZA NDC: 00173-0783-02,173078302 UPC: 3-01730-78302-8,301730783028 Glaxosmithkline/Kdc

OMEGA-3 ACID ETHYL ESTERS
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