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EICOSAPENTAENOIC ACID DOCOSAHEXAENOIC ACID Omacor® 460 milligrams / 380 milligrams

EICOSAPENTAENOIC ACID DOCOSAHEXAENOIC ACID

Omacor®

Generic Name: EICOSAPENTAENOIC ACID DOCOSAHEXAENOIC ACID
Brand Name: Omacor®
Dosage Strength: 460 milligrams / 380 milligrams
Dosage Form: Softgel Capsule

WHAT IS THE MEDICINE USED FOR?

(Indication) Hypertriglyceridemia in patient at risk of ischemic heart disease &/or pancreatitis. Supplement to diet when appropriate & assiduous dietary measures alone are insufficient to produce an adequate response.

HOW MUCH AND HOW OFTEN SHOULD YOU USE THIS MEDICINE?

(Dosage) 4 caps. This may be administered in 2 doses/day. The capsules should be taken with meals in order to avoid gastrointestinal disturbances.

(Contraindications) Allergy to any ingredients of Omacor.

(Precautions) Risk of Hemorrhage: Because of the moderate increase in bleeding time, patients receiving anticoagulant therapy must be monitored and the dosage of anticoagulant adjusted if necessary (see Interactions). Use of Omacor does not eliminate the need for surveillance usually required for patients of this type.
Make allowance for the increased bleeding time in patients at high risk of hemorrhage (because of severe trauma, surgery, etc).
Omacor is not indicated in exogenous hypertriglyceridemia (type I hyperchylomicronemia).
There is only limited experience in secondary endogenous hypertriglyceridemia (especially uncontrolled diabetes).
There is no experience in combination with other lipid-lowering agents.
Regular monitoring of hepatic function (ASAT and ALAT) is required in patients with hepatic impairment.
Use in pregnancy & lactation: No teratogenic effect has been observed in animal studies. As there is no information on its effects on human pregnancy, however, Omacor should not be used during pregnancy or lactation unless absolutely necessary.
Use in children: In the absence of efficacy and safety data, use of Omacor in children is not recommended.

(Adverse Reactions) The most frequently reported undesirable clinical effects are gastrointestinal disturbances, eg reflux or eructation with an odor or taste of fish, nausea, vomiting, distension, diarrhea or constipation.
There have also been rare reports of eczema and acne.
Moderate elevation of the hepatic transaminases (ASAT and ALAT) has been reported.

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