Omacor

/ Abbott

Post Myocardial Infarction: One capsule daily.
Hypertriglyceridemia: Initial treatment is two capsules daily. If adequate response is not obtained, the dose may be increased to four capsules daily. The capsules may be taken with food to avoid gastrointestinal disturbances. There is no information regarding the use of Omacor in children, in elderly patients over 70 years of age, or in patients with hepatic impairment, and only limited information regarding the use in patients with renal impairment.

Post Myocardial Infarction: Adjuvant treatment in secondary prevention after myocardial infarction, in addition to other standard therapy (e.g. statins, antiplatelet drugs, betablockers, ACE inhibitors).
Hypertriglyceridaemia: Endogenous hypertriglyceridaemia as a supplement to diet when dietary measures alone are insufficient to produce an adequate response:
– Type IV hypertruglyceridaemia.
– Type IIb/III in combination with statins, when control of triglycerides is insufficient Omacor is not indicated in exogenous hypertriglyceridaemia (type 1 hyperchylomicronaemia). There is only limited experience in secondary endogenous hypertriglyceridaemia (especially uncontrolled diabetes).

Hypersensitivity to the active substance, or to any of the excipients.

Patients receiving anticoagulant therapy must be monitored and the dosage of anticoagulant adjusted if necessary. Use of this medicdbation does not eliminate the need for the surveillance usually required for patients of this type. Patients at high risk of hemorrhage (because of severe trauma, surgery, etc.). There is no information regarding the use in children, in elderly patients over 70 years of age, or in patients with hepatic impairment, and only limited information regarding the use in patients with renal impairment. Pediatric use is not recommended. Not indicated in exogenous hypertriglyceridemia (type 1 hyperchylomicroanemia). There is only limited experience in secondary endogenous hypertriglyceridemia (especially uncontrolled diabetes). Regular monitoring of hepatic function (ASAT and ALAT) is required in patients with hepatic impairment (in particular with the high dosage, i.e. 4 capsules).

Immune system disorders: Uncommon: hypersensitivity
Metabolism and nutrition disorders: Rare: hyperglycaemia
Nervous system disorders: Uncommon: dizziness, dysgeusia Rare: headache
Respiratory, thoracic and mediastinal disorders: Very rare: nasal dryness
Gastrointestinal disorders: Common: dyspepsia, nausea Uncommon: abdominal pain, gastrointestinal disorders, (gastro-oesophageal reflux disease, eructation, vomiting, or constipation), gastroenteritis.
Skin and subcutaneous tissue disorders: Rare: acne, rash pruritic.
Investigations: Very rare: white blood count increased, blood lactate dehydrogenase increased transaminases increased. The following adverse event has been reported spontaneously during postmarketing use of Omacor (frequency unknown).
Blood and lymphatic system disorder: Haemorrhagic diathesis.
For full details see prescribing information.

Oral anticoagulants: Prothrombin time must be checked when combined with warfarin or when treatment is stopped.

Pregnancy: There are no adequate data from the use of Omacor in pregnant women. The potential risk for humans is unknown. Therefore Omacor should not be used during pregnancy unless clearly necessary.
Lactation: There are no data on the excretion of Omacor in animal and human milk. Omacor should not be used during lactation.

There are no special recommendations. Treatment should be symptomatic.