Drugs List

Therapeutic Indications

Uses

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.

Contraindications

Children under 18 years
Breastfeeding

Precautions and Warnings

Patients over 70 years
Predisposition to haemorrhage
Hepatic impairment
Pregnancy
Renal impairment

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

Hepatic impairment
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

Pregnancy

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.

Lactation

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.

Side Effects

Abdominal distension
Abdominal pain
Constipation
Diarrhoea
Dizziness
Dysgeusia
Dyspepsia
Epistaxis
Eructation
Flatulence
Gastro-intestinal disturbances
Gastro-intestinal haemorrhage
Gastroesophageal reflux disease
Gout
Headache
Hepatic disorders
Hyperglycaemia
Hypersensitivity reactions
Hypotension
Increase in serum transaminases
Nausea
Pruritus
Rash
Urticaria
Vomiting

Presentation

Oral formulations of omega-3-acid ethyl esters 90 comprising of eicosapentaenoic acid (EPA) ethyl ester and docosahexaenoic acid (DHA) ethyl ester.

Drugs List

Therapeutic Indications

Uses

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.

Dosage

Adults

Contraindications

Children under 18 years
Breastfeeding

Precautions and Warnings

Patients over 70 years
Predisposition to haemorrhage
Hepatic impairment
Pregnancy
Renal impairment

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

Hepatic impairment
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

Pregnancy

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.

Lactation

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.

Side Effects

Abdominal distension
Abdominal pain
Constipation
Diarrhoea
Dizziness
Dysgeusia
Dyspepsia
Epistaxis
Eructation
Flatulence
Gastro-intestinal disturbances
Gastro-intestinal haemorrhage
Gastroesophageal reflux disease
Gout
Headache
Hepatic disorders
Hyperglycaemia
Hypersensitivity reactions
Hypotension
Increase in serum transaminases
Nausea
Pruritus
Rash
Urticaria
Vomiting

Overdosage

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 ).

Further Information

Last Full Review Date: December 2019.

Reference Sources

Summary of Product Characteristics: Omacor 1000mg soft capsules. Mylan. Revised July 2019.

Summary of Product Characteristics: Teromeg 1000mg capsules. ADVANZ Pharma. Revised October 2019.