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《LOVAZA (omega-3-acid ethyl esters) Capsules》.pdf
1 PRESCRIBING INFORMATION
2 LOVAZA®
3 (omega-3-acid ethyl esters)
4 Capsules
5 DESCRIPTION
6 LOVAZA, a lipid-regulating agent, is supplied as a liquid-filled gel capsule for oral
7 administration. Each 1-gram capsule of LOVAZA (omega-3-acid ethyl esters) contains at least
8 900 mg of the ethyl esters of omega-3 fatty acids. These are predominantly a combination of
9 ethyl esters of eicosapentaenoic acid (EPA - approximately 465 mg) and docosahexaenoic acid
10 (DHA - approximately 375 mg).
11 The structural formula of EPA ethyl ester is:
O
O
12
13 The empirical formula of EPA ethyl ester is C H O , and the molecular weight of EPA
22 34 2
14 ethyl ester is 330.51.
15 The structural formula of DHA ethyl ester is:
O
16 O
17 The empirical formula of DHA ethyl ester is C H O , and the molecular weight of DHA
24 36 2
18 ethyl ester is 356.55.
19 LOVAZA capsules also contain the following inactive ingredients: 4 mg α-tocopherol (in a
20 carrier of partially hydrogenated vegetable oils including soybean oil), and gelatin, glycerol, and
21 purified water (components of the capsule shell).
22 CLINICAL PHARMACOLOGY
23 Mechanism of Action: The mechanism of action of LOVAZA is not completely understood.
24 Potential mechanisms of action include inhibition of acyl CoA:1,2-diacylglycerol
25 acyltransferase, increased mitochondrial and peroxisomal β-oxidati
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