Clarion Max Omega Fish Oil Capsules

CLARION MAX OMEGA
(FISH OIL CAPSULES)

For the use of a Registered Medical Practitioner or a Hospital or a Laboratory only.

 

Composition

Each soft gelatin capsule contains:

Fish Oil, Rich in Omega-3-Acid BP containing

Eicosapentaenoic Acid 180mg

Docosahexaenoic Acid 120mg

 

Product Description

Natural coloured, oblong shaped transparent soft gelatin capsules containing pale yellow oily liquid.

 

Indications And Usage

Fish oils may primarily be indicated to lower triglyceride levels in those with hypertriglyceridemia. Another important indication may be to prevent death in those who have suffered myocardial infarctions. Fish oils are used to decrease clotting tendencies of the blood. They may also be indicated for lowering blood pressure, for preventing restenosis following coronary angioplasty, for alleviating some of the symptoms of rheumatoid arthritis and ulcerative colitis and for helping to prevent relapse in Crohn’s disease. They may help stabilize mood in bipolar disorder and may have beneficial effects in IgA nephropathy.

 

Pharmacodynamic/Pharmacokinetics

Mechanism of Action

EPA and DHA lower elevated triglyceride levels. In the cardiovascular system, EPA and DHA have anti-arrythmic properties. EPA and DHA have anti-inflammatory and immune-modulating properties and are beneficial for the musculoskeletal, gastrointestinal and immune systems. EPA and DHA are also important for maintenance of normal blood flow as they lower fibrinogen levels and prevent platelets from sticking to each other. DHA is vital for normal brain development for the fetus and infant and for the maintenance of normal brain function throughout life. DHA appears to be a major determinant of membrane fluidity in brain cells, and this could play a major role in the maintenance of normal cognition and mood. The triglyceride-lowering effect of EPA and DHA appears to result from the combined effects of inhibition of lipogenesis and stimulation of fatty acid oxidation in liver. EPA and DHA inhibit the transcription of genes coding for lipogenesis enzymes and increase the transcription of the regulatory enzymes of fatty acid oxidation. Stimulation of fatty acid oxidation is through activation of PPAR (peroxisome proliferator-activated receptor)- alpha. Inhibition of lipogenesis is through down-regulation of SREBP (sterol regulatory element binding protein) -1c messenger RNA. Several mechanisms are believed to account for the anti-inflammatory activity of EPA and DHA. The two competitively inhibit the conversion of arachidonic acid to the pro-inflammatory eicosanoids PG (prostaglandin)E2 and LT(leukotriene)B4, thus reducing their synthesis. EPA and DHA also inhibit the synthesis of the inflammatory cytokines TNF (tumor necrosis factor)-alpha and IL(interleukin)-1 beta in both healthy volunteers and rheumatoid arthritis patients. EPA and DHA inhibit the 5-LOX (lipoxygenase) pathway responsible for the conversion of arachidonic acid to inflammatory leukotrienes in neutrophils and monocytes and can suppress phopholipase C-mediated signal transduction, also involved in inflammatory events.

EPA and DHA may possess disease-modifying activity. Incorporation of EPA and DHA into articular cartilage chondrocyte membranes results in a dose-dependent reduction in the expression and activity of the proteoglycan-degrading enzymes known as aggrecanases. This similarly results in decreased expression of interleukin IL-1 alpha and TNF-alpha as well as COX (cyclooxygenase) -2, but not COX-1. EPA and DHA have both similar and dissimilar physiologic roles. EPA appears to be more important in those roles where the eicosanoids are involved, whereas DHA seems to play its most important roles in the membranes of CNS cells and in the PPAR system. EPA is the precursor to series-3 prostaglandins (PG), the series-5 leukotrienes (LT) and the series- 3 thromboxanes (TX).

Specifically, EPA is the precursor of TXA3 and LTB5, eicosanoids, which reduce platelet aggregation and increase vasodilation. This could account in part for those fish oil effects that may lead to reduced clotting activity and decreased blood pressure. Fish oils appear to have mood-stabilizing properties when used in the treatment of bipolar disorder. Overactive cell- signaling pathways may be involved in the pathophysiology of bipolar disorder. EPA and DHA may dampen signal transduction associated with phosphatidylinositol and arachidonic acid. These LCPUFAs, especially DHA, are incorporated into the phospholipids of the membranes of cells involved in cell-signaling pathways. The mechanism by which fish oils appear to prevent cardiac arrythmia is unclear but also may have something to do with the incorporation of these LCPUFAs into the cell membranes of the heart. Fish oils may have cancer chemopreventive effects, but clinical chemoprevention studies are needed to determine if this is the case. In vitro and animal studies have shown EPA and DHA to suppress neoplastic transformation, inhibit cancer growth, enhance apoptosis or programmed cell death and to have anti-angiogenic activity. A common mechanism underlying all of the above activity could be the role of the LCPUFAs in modulating eicosanoid production and activity. Fats other than from fish sources are known risk factors for cancer as well as cardiovascular disease. Those fats may direct the eicosanoid pathways toward situations in which cancer cells can flourish, whereas the opposite may be the case for the fish oils.

 

Pharmacokinetics

EPA- and DHA-laden triacylglycerols, following ingestion, undergo hyrolysis via lipases to form monoglycerides and free fatty acids. In the enterocytes, reacylation takes place reforming TAGs, which are then assembled with phospholipids, cholesterol and apoproteins into chylomicrons. The chylomicrons are released into the lymphatics from whence they are transported to the systemic circulation. In the circulation, the chylomicrons are degraded by lipoprotein lipase, and EPA and DHA are transported by the circulation to various tissues of the body where they are used mainly for the synthesis of phospholipids.

 

Drug Interactions

Interactions may occur between fish oil supplements and aspirin and other non-steroidal anti-inflammatory drugs and herbs such as garlic (Allium sativum) and ginkgo (Ginkgo biloba). Such interactions might be manifested by increased susceptibility to bruising, nosebleeds, hemoptysis, hematemesis, hematuria and blood in the stool. Most who take fish oil supplements and the above drugs or herbs do not suffer from these problems, and, if they occur, they are rare. If they do occur, the dose should be lowered or discontinued.

 

Dosage

A common amount of omega-3 fatty acids in fish oil capsules is 0.18 grams (180 mg) of EPA and 0.12 grams (120 mg) of DHA. Five grams of fish oil contains approximately 0.17 – 0.56 grams (170 -560 mg) of EPA and 0.072 – 0.31 grams (72 – 310 mg) of DHA. Different types of fish contain variable amounts of omega-3 fatty acids, and different types of nuts or oil contain variable amounts of LNA. Fish oils contain approximately 9 calories per gram of oil.

 

Children (18 years and younger)

There is no established dose for children. Omega-3 fatty acids are used in some infant formulas. Fish oil capsules should not be used in children except under the direction of a health care provider. Children should avoid eating fish that may be high in mercury, such as shark, swordfish, king mackerel, and tilefish. (See Precautions section).

 

Adults

Do not take more than 3 grams daily of omega-3 fatty acids from capsules without the supervision of a health care provider, due to an increased risk of bleeding.
For healthy adults with no history of heart disease: The American Heart Association recommends eating fish at least 2 times per week.

For adults with coronary heart disease: The American Heart Association recommends an omega-3 fatty acid supplement (as fish oils), 1 gram daily of EPA and DHA. It may take 2-3 weeks for benefits of fish oil supplements to be seen.

For adults with high cholesterol levels: The American Heart Association recommends an omega-3 fatty acid supplement (as fish oils), 2-4 grams daily of EPA and DHA. It may take 2-3 weeks for benefits of fish oil supplements to be seen.

 

Mode of Administration

By oral route. Should be taken with water.

 

Pregnancy and Lactation

Some fish may contain potentially harmful contaminants, such as heavy metals (including mercury), dioxins, and polychlorinated biphenyls (PCBs). For sport-caught fish, the U.S. Environmental Protection Agency (EPA) recommends that pregnant or nursing women eat no more than a single 6-ounce meal per week, and young children less than 2 ounces per week. For farm-raised, imported, or marine fish, the U.S. Food and Drug Administration recommends that pregnant or nursing women and young children avoid eating types with higher levels of mercury (such as mackerel, shark, swordfish, or tilefish), and eat up to 12 ounces per week of other fish types.

 

Side Effects

There are some side effects of fish oil. If you take large doses of supplements which contain high level of vitamins (especially vitamin D) in addition to Omega 3 fatty acids, the risk is possibility of vitamin poisoning. Vitamin poisoning is a condition can lead to toxic symptoms. For this reason, you should take fish body oil instead of fish liver based oil.

 

Contraindications

Cautions should be taken in patients scheduled for surgery or taking anticoagulant drugs, since large doses may cause increased bleeding tendency. Elevations in blood sugar and cholesterol levels may occur in rare cases in some individuals who take fish oil. Fish oil is easily damaged by oxygen, so vitamin E should be included in all fish oil supplements. In addition, people who supplement with fish oil should take additional vitamin E supplements to protect EPA and DHA within the body from oxidative damage. Some individuals will have digestive difficulties or repeat unpleasant fish odour. following ingestion of concentrated fish oil supplements. In these cases, an enteric coated, delayed release formulation is indicated.

 

Warnings and Precautions

Fish oil supplements should be used by children, pregnant women and nursing mothers only if recommended and monitored by a physician. Because of the possible anti-thrombotic effect of fish oil supplements, hemophiliacs and those taking warfarin (Coumadin) should exercise caution in their use. Fish oil supplements should be stopped before any surgical procedure.

Conflicting results have been reported regarding the effects of fish oil supplements on glycemic control in those with glucose intolerance including type 2 diabetics.

It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly to lower triglyceride levels and to decide if you should continue to take it.

 

Storage

Store in a cool y place not exceeding 30°C and protect from light.

 

Presentation

CLARION MAX OMEGA CAPSULES available in 3 x 10’s in blister pack.

 

MANUFACTURED IN INDIA BY

SOFTGEL HEALTHCARE PVT. LIMTTED

Survey No. 20/1,Vandalur- Kelambakknm Road,

Pudupakkam Village, Kancheepuram District,

Tamilnadu -603103.

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