Omega-3-acid ethyl esters oral
- Drugs List
- Therapeutic Indications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
Oral formulations of omega-3-acid ethyl esters 90 comprising of eicosapentaenoic acid (EPA) ethyl ester and docosahexaenoic acid (DHA) ethyl ester.
Adjunctive therapy to diet for the reduction of elevated triglycerides
Adjuvant treatment to diet in endogenous hypertriglyceridaemia when dietary measures alone are insufficient to produce an adequate response:
Type IV in monotherapy.
Type IIb/III in combination with statins, when control of triglycerides using statins alone is insufficient.
Initial treatment 2 capsules daily. If adequate response is not obtained, the dose may be increased to 4 capsules daily.
Children under 18 years
Precautions and Warnings
Patients over 70 years
Predisposition to haemorrhage
Adjustment of anticoagulant dose may be necessary during concurrent therapy
Not indicated for treatment of exogenous hypertriglyceridaemia (type 1)
Contains soya or soya derivative
Monitor hepatic function in patients with hepatic impairment
Monitor patients receiving concurrent anticoagulants
Advise patient to take after food to reduce gastro-intestinal disturbances
It has been reported in some patients a small but important increase (within normal values) in aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels. AST and ALT levels should be monitored in patients with any signs of liver damage, in particular in patients taking high doses. There are no data showing an increased risk for patients with hepatic impairment.
Pregnancy and Lactation
Use omega-3-acid ethyl esters 90 with caution during pregnancy.
The manufacturer does not recommend using omega-3-acid ethyl esters 90 during pregnancy unless clearly necessary. At the time of writing there is limited published information regarding the use of omega-3-acid ethyl ester 90 during pregnancy. Potential risks are unknown.
Omega-3-acid ethyl esters 90 is contraindicated during breastfeeding.
The manufacturer contraindicates the use of omega-3-acid ethyl esters 90 when breastfeeding. The presence of omega-3-acid ethyl esters 90 in human breast milk and the effect on exposed infants are unknown.
Gastroesophageal reflux disease
Increase in serum transaminases
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Last Full Review Date: December 2019.
Summary of Product Characteristics: Omacor 1000mg soft capsules. Mylan. Revised July 2019.
Summary of Product Characteristics: Teromeg 1000mg capsules. ADVANZ Pharma. Revised October 2019.
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