Epadel S900 Dosage & Drug Information

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Special Precautions Use In Pregnancy & Lactation Adverse Reactions Drug Interactions Caution For Usage Storage MIMS Class ATC Classification Thai FDA Category Presentation/Packing Local Product Insert

Concise Prescribing Info

Contents

Ethyl icosapentate

Indications/Uses

Hypertriglyceridemia. Adjunct in hypercholesterolemia w/ effective antihypercholesterolemia drug; to maximally tolerated statin therapy to reduce risk of MI, stroke, coronary revascularization & unstable angina requiring hospitalization in adults w/ elevated triglyceride (TG) levels (>200 mg/dL) & established CV disease or DM & ≥2 additional risk factors for CV disease; to diet in reducing TG levels in adults w/ severe hypertriglyceridemia (≥500 mg/dL).

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Dosage/Direction for Use

Adult 1 sachet bid. Abnormalities in TG May increase dose to 1 sachet tid.

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Overdosage

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Administration

Should be taken with food: Take immediately after meals. Do not chew.

Contraindications

Hemorrhage eg, hemophilia, capillary fragility, GI ulcer, urinary tract & vitreous hemorrhage, hemoptysis.

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Special Precautions

Discontinue if there is no response to treatment. Cerebral haemorrhage in patient w/ poorly controlled HTN. Patients menstruating; w/ bleeding tendency; scheduled to undergo surgery. Perform test to confirm hyperlipidemia; diet & exercise therapy or reduction of risk factors for ischemic heart disease eg, HTN & smoking, before initiating treatment. Regularly measure blood lipid level during treatment. Concomitant use w/ anticoagulants or antiplatelets. Pregnancy. Avoid breastfeeding during treatment. Low birth wt infants, infants, neonates. Childn.

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Use In Pregnancy & Lactation

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Adverse Reactions

Rash, pruritus; anaemia; nausea, abdominal discomfort & pain, diarrhoea, heartburn; hepatic function disorder including increased AST (GOT), ALT (GPT), alkaline phosphatase, γ-glutamyl transpeptidase, LDH & bilirubin; increased creatine kinase (creatine phosphokinase).

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Drug Interactions

Increased bleeding tendency w/ anticoagulants (eg, warfarin) & drugs that inhibit platelet aggregation (eg, aspirin, indomethacin, ticlopidine HCl, cilostazol).

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Caution For Usage

For caution against possible variation of physical aspect of medicine... Click to view Epadel S900 detailed prescribing information

Storage

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Description

View Epadel S900 description for details of the chemical structure and excipients (inactive components).

Action

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MIMS Class

Dyslipidaemic Agents

ATC Classification

C10AX06 - omega-3-triglycerides incl. other esters and acids ; Belongs to the class of other lipid modifying agents.

Thai FDA Category

Presentation/Packing

Form

Epadel S900 soft cap 900 mg

Packing/Price

84 × 45's

Epadel S900

icosapent ethyl

Manufacturer:

Catalent Japan

Distributor:

DKSH

Marketer:

Meiji