Indications
MaxOmega is indicated as an adjunct to diet to reduce very
high (>500mg/dl) triglyceride (TG) levels in adult patients and as an
adjunct in secondary prevention in those who have had a myocardial infarction
in the preceding 3 months. It is also indicated to help reduce the joint
inflammation associated with mild arthritis, mood disorders & impulse
control, age-related macular degeneration.
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চিকিৎসকের পরামর্শ মোতাবেক ঔষধ সেবন করুন'
Composition
Each Soft Gelatin Capsule Contains Omega-3-Acid Ethyl Esters
BP 1000 mg. A combination of-
Eicosapentaenoic Acid BP 80 mg
Docosahexaenoic Acid BP 120 mg
Pharmacology
Omega-3-acid ethyl esters reduce triglyceride production by
the liver but this mechanism is not well understood. Omega-3-acid ethyl esters
inhibit acyl-CoA: 1,2-diacylglycerol acyltransferase, reducing triglyceride
synthesis and increasing paroxysmal beta-oxidation, which increases fatty aside
metabolism. Omega-3-acid ethyl esters also inhibit the release of fatty acids
by competing for enzymes involved in the synthesis of triglycerides, increase
triglyceride clearance by increasing the activity of lipoprotein lipase, and
decrease production of VLDL-C.
Dosage & Administration
In hypertriglyceridaemia: it can be taken as a single dose
of 4 capsules (4 gm) or 2 capsules (2 gm) twice daily.
In previously myocardial infarction patients: It can be
taken 1 capsule (1 gm ) daily with food. Patients should be placed on an
appropriate lipid lowering diet before receiving Omega-3 Acid Ethyl Esters and
should continue this diet during treatment.
In joint inflammation associated with mild arthritis: The
dose is 2.7 gm daily.
In mood disorders & impulse control and age-related
macular degeneration: The dose is 1 capsule (1 gm) per day. Or, as directed by
the registered physician.
* রেজিস্টার্ড
চিকিৎসকের পরামর্শ মোতাবেক ঔষধ সেবন করুন'
Interaction
MaxOmega-acid ethyl esters has been given in conjunction
with warfarin without haemorrhagic complications. However, the prothrombin time
must be checked when MaxOmega-acid ethyl esters is combined with warfarin or
when treatment with MaxOmega-acid ethyl esters is stopped.
Contraindications
It is contraindicated in patients who exhibit
hypersensitivity to any component of this medication.
Side Effects
Immune system disorders: Rare- hypersensitivity;
Metabolism and nutrition disorders: Uncommon-hyperglycaemia,
gout;
Nervous system disorders: Uncommon- dizziness, dysgeusia,
headache;
Vascular disorders: Uncommon- hypotension;
Respiratory thoracic and mediastinal disorders: Uncommon-
epistaxis;
Gastrointestinal disorders: Common- gastrointestinal
disorders (including abdominal distension, abdominal pain, constipation,
diarrhoea, dyspepsia, flatulence, eructation, gastro-oesophageal reflux
disease, nausea or vomiting), Uncommon- gastrointestinal haemorrhage;
Hepatobiliary disorders: Rare- liver disorders (including
transaminases increased, alanine aminotransferase increased and aspartate
aminotransferase increased);
Skin and subcutaneous tissue disorders: Uncommon- rash,
Rare-urticarial.
Pregnancy & Lactation
Omega-3-acid ethyl esters should be used during pregnancy
only if the potential benefit justifies the potential risk to the fetus. It is
not known whether it is excreted in human milk. Caution should be exercised
when Omega-3-acid ethyl esters are administered to a lactating mother.
Precautions & Warnings
Because of the moderate increase in bleeding time (with the
high dosage, i.e. 4 capsules), patients receiving anti-coagulant therapy must
be monitored and the dosage of anti-coagulant adjusted if necessary. Use of
this medication does not eliminate the need for the surveillance usually
required for patients of this type. Make allowance for the increased bleeding
time in patients at high risk of haemorrhage (because of severe trauma,
surgery, etc). In the absence of efficacy and safety data, use of this
medication in children is not recommended. During treatment with MaxOmega-acid
ethyl esters, there is a fall in thromboxane A2 production. No significant
effect has been observed on the other coagulation factors. Some studies with
omega-3-acids demonstrated a prolongation of bleeding time, but the bleeding
time reported in these studies has not exceeded normal limits and did not
produce clinically significant bleeding episodes. In some patients a small but
significant increase (within normal values) in ASAT and ALAT was reported, but
there are no data indicating an increased risk for patients with hepatic
impairment. ALAT and ASAT levels should be monitored in patients with any signs
of liver damage (in particular with the high dosage, i.e. 4 capsules).
MaxOmega-acid ethyl esters is not indicated in exogenous hypertriglyceridaemia
(type 1 hyperchylomicronaemia). There is only limited experience in secondary
endogenous hypertriglyceridaemia (especially uncontrolled diabetes). There is
no experience regarding hypertriglyceridaemia in combination with fibrates.
Therapeutic Class
Other lipid regulating drugs
Storage Conditions
Store below 25°C in a dry & cool place.
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