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完整处方资料：http://www.info.pmda.go.jp/go/pack/2189019M1020_1_03/
Lotriga will be the first prescription medicine in Japan that contains both EPA-E and DHA-E.
The results of the Phase III clinical trial conducted in Japan evaluated the efficacy and safety of Lotriga for Japanese patients with hypertriglyceridemia [baseline triglyceride level, 150 to 750 mg/dL], in comparison with an active comparator EPA (eicosapentaenoic acid, 0.6g thrice daily, recommended daily dose) product.
The trial demonstrated that 2g (once daily) of Lotriga was equally, and 4g (2g twice daily) of Lotriga was statistically superior to the EPA, in lowering the percent change from baseline in triglycerides. Lotriga was safe and well tolerated, with a safety profile comparable to the EPA.
According to the Takeda website, the recommended dosage of Lotriga in adults is 2g of Omega-3-acid ethyl esters is orally administered immediately after meals once a day. In the case of high triglyceride level, the dose can be increased to 2g twice a day.
Brand name : Lotriga 2g
Active ingredient: Omega-3-Acid ethyl esters
Dosage form: colorless to light-yellow clear spherical capsule, major axis 4 mm
Print on wrapping: (Face)ロトリガ粒状カプセル2g, 2g, 2001, (Back)LOTRIGA 2g
Effects of this medicine
This medicine inhibits lipid (triglyceride) secretion from the liver and promotes disappearance of triglyceride from the blood, to lower the blood level of triglycerides.
Usually, used for treatment of hyperlipidemia.
Before using this medicine, be sure to tell your doctor and pharmacist
•If you have previously experienced any allergic reactions (itch, rash, etc.) to any medicines.
If you have bleeding (hemophilia, capillary fragility, urinary tract bleeding, gastrointestinal ulceration, hemoptysis, vitreous hemorrhage, ets.).
If you are scheduled for surgery.
•If you are pregnant or breastfeeding.
•If you are taking any other medicinal products. (Some medicines may interact to enhance or diminish medicinal effects. Beware of over-the-counter medicines and dietary supplements as well as other prescription medicines.)
Dosing schedule (How to take this medicine)
•Your dosing schedule prescribed by your doctor is <<to be written by a healthcare professional>>
•In general, for adults, take 1 pack at a time per day, just after a meal. The dosage should be increased according to triglyceride level, but 1 pack at a time, twice a day, is the upper limit of dosage. Strictly follow the instructions.
•You should take this medicine just after a meal because its absorption is decreased by taking on an empty stomach.
•You should take this medicine without chewing.
•If you miss a dose, skip the missed dose and continue your regular dosing schedule. You should never take two doses at one time.
•If you accidentally take more than your prescribed dose, consult with your doctor or pharmacist.
•Do not stop taking this medicine unless your doctor instructs you to do so.
Precautions while taking this medicine
•Strictly adhere to dietary instructions given and to kinesitherapy prescribed.
Possible adverse reactions to this medicine
The most commonly reported adverse reactions include diarrhea, rash, and itching. If any of these symptoms occur, consult with your doctor or pharmacist.
The symptoms described below are rarely seen as initial symptoms of the adverse reactions indicated in brackets. If any of these symptoms occur, stop taking this medicine and see your doctor immediately.
No pertinent entries.
The above symptoms do not describe all the adverse reactions to this medicine. Consult with your doctor or pharmacist if you notice any symptoms of concern other than those listed above.
Storage conditions and other information
•Keep out of the reach of children. Store away from direct sunlight, heat and moisture.
•Discard the remainder. Do not store them.
Internal
Published: 1/2013
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