Nulacta Plus Untuk Ibu

Uses

Fish oil is a source of essential fatty acids used as a source of calories in parenteral nutrition and as a dietary supplement.

Under FDA approval, fish oil pharmaceuticals are typically products consisting of a combination of the omega-3-fatty acids eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) and are indicated primarily as an adjunct to diet to reduce triglyceride levels in adult patients with severe (>=500 mg/dL) hypertriglyceridemia .

Under EMA approval, such fish oil pharmaceuticals comprised of virtually the same fish and fish oil derived omega-3-fatty acids EPA and DHA are indicated specifically for (a) adjuvant treatment in secondary prevention after myocardial infarction, in addition to other standard therapy (ie. statins, antiplatelet medicinal products, beta blockers, ACE inhibitors), and (b) as a supplement to diet when dietary measures alone are insufficient to produce an adequate response, particularly with type IV hypertriglyceridemia in monotherapy or type IIb/III in combination with statins, when control of triglycerides is insufficient . In addition, prescribing information for EMA approved fish oil pharmaceuticals are also indicated as an adjunct to diet to reduce very high (>=500 mg/dL) triglyceride levels in adult patients, much like similar FDA approved indications .

As a dietary supplement:

• Vitamin E deficiency resulting from impaired absorption.
• Increased requirements due to diet rich in polyunsaturated fats.
• For healthy hair & skin
• As an Antioxidant
• Hemolytic anemia due to Vitamin E deficiency

Therapeutic use

: Heavy metal poisoning, Hepatotoxin poisoning, Hemolytic anemia, Oxygen therapy and replacement therapy in nutritional deficiency states for the betterment of skin and hair.

Nulacta Plus Untuk Ibu is also used to associated treatment for these conditions: Dietary and Nutritional Therapies, Nutritional supplementation, Parenteral NutritionVitamin Deficiency, Long-chain omega-3 fatty acid supplementation, Dietary supplementation

How Nulacta Plus Untuk Ibu works

The specific mechanism of action by which the fish oil EPA and DHA acids are capable of reducing serum triglyceride levels is not yet fully understood . Nevertheless, it is proposed that such omega-3-fatty acids may not be the preferred substrates of the enzyme diacylglycerol O-acyltransferase that participates in the generation of triglycerides; that they might interact with nuclear transcription factors that manage lipogenesis; or that their presence and increase in levels can cause cellular metabolism to subsequently shift toward a decrease in triglyceride synthesis and an increase in fatty acid oxidation . Moreover, the EPA and DHA acids are also believed to be able to promote apolipoprotein B degradation in the liver through the stimulation of an autophagic process . It may also be possible that these fish oil acids can accelerate the clearance of very-low-density lipoprotein (VLDL) particles and chylomicron . The combination of all these actions results in fewer VLDL particles being assembled and secreted, which is of considerable importance as VLDL particles are the major endogenous source of triglycerides .

Moreover, new paradigms of how inflammation is contained and dissipated involve various newly discovered chemical mediators, resolvins, and protectins . Such agents are believed to be directly involved in blocking neutrophil migration, infiltration, recruitment, as well as blocking T-cell migration and promoting T-cell apoptosis . Additionally, such protectins can also reduce tumor necrosis factor and interferon secretion . Of particular importance, however, is the fact that protectins and resolvins are exclusively derived from omega-3-fatty acids and that EPA is the substrate of the resolvins family and DHA can be converted to both resolvins and protectins . It is believed that these effects of such fish oil acids underlie the actions that fish oil have demonstrated on eliciting stability for vulnerable inflammatory plaques .

Finally, fish oil acids have demonstrated certain direct electrophysiological effects on the myocardium . In animal studies, it was shown that the ventricular fibrillation threshold could be increased in both animals fed or infused with omega-3-fatty acids . Further studies subsequently revealed that such fatty acids could reduce both sodium currents and L-type calcium currents on a cellular and ion channel level . It is consequently hypothesized that during ischemia, a reduction in the sodium ion current protects hyperexcitable tissue, and a reduction in the calcium ion current could reduce arrhythmogenic depolarizing currents - and that perhaps the use of EPA and DHA fish oil acids could facilitate such activity . For the time being, however, omega-3-fatty acids in pharmaceutical supplement form have not been shown to elicit such protection against heart conditions .

The mechanism of action for most of vitamin E's effects are still unknown. Vitamin E is an antioxidant, preventing free radical reactions with cell membranes. Though in some cases vitamin E has been shown to have pro-oxidant activity.

One mechanism of vitamin E's antioxidant effect is in the termination of lipid peroxidation. Vitamin E reacts with unstable lipid radicals, producing stable lipids and a relatively stable vitamin E radical. The vitamin E radical is then reduced back to stable vitamin E by reaction with ascorbate or glutathione.

Dosage

Nulacta Plus Untuk Ibu dosage

Betterment of Cardiovascular health: 400 mg - 800 mg / day

Deficiency syndrome in adults: 200 mg - 400 mg / day

Deficiency syndrome in children: 200 mg / day

Thalassemia: 800 mg / day

Sickle-cell anemia: 400 mg / day

Betterment of Skin & Hair: 200 mg - 400 mg / day (Topical use is also established for beautification)

Chronic cold in adults: 200 mg / day

Side Effects

Overdoses (>1g) have been associated with minor side effects, including hypertension, fatigue, diarrhea and myopathy

Toxicity

There have been some concerns that high doses of DHA and/or EPA (in the range of 900mg/day or EPA plus 600 mg/day of DHA or more for several weeks) could potentially reduce an individual's immune function due to the suppression of inflammatory responses . However, according to the European Food Safety Authority, long-term consumption of EPA and DHA supplements at combined doses of up to about 5 g/day appears to be safe .

Commonly reported side effects of omega-3 supplements are usually mild . These include unpleasant taste, bad breath, heartburn, nausea, gastrointestinal discomfort, diarrhea, headache, and odoriferous sweat .

There is no data available for effects in pregnancy, breast feeding, hepatic impairment, or renal impairment. However, it appears that the process of vitamin E elimination is strict and self regulating enough that vitamin E toxicity is exceedingly rare. Studies showing adverse effects from excess vitamin E generally involve people consuming more than 1000mg/day for weeks to months.

Precaution

Vitamin E may enhance the anticoagulant activity of anticoagulant drugs. Caution is advised in premature infants with high dose Vitamin E supplementation, because of reported risk of necrotizing enterocilitis.

Interaction

Vitamin E may impair the absorption of Vitamin A. Vitamin K functions impairement happens at the level of prothrombin formation and potentiates the effect of Warfarin.

Volume of Distribution

The volume of distribution of EPA is documented as being approximately 82 L .

0.41L/kg in premature neonates given a 20mg/kg intramuscular injection.

Elimination Route

The absorption process of fish oil EPA and DHA acids have been documented as being very efficient, with an absorption rate of about 95%, which is similar to that of other ingested fats .

10-33% of deuterium labelled vitamin E is absorbed in the small intestine. Absorption of Vitamin E is dependant upon absorption of the fat in which it is dissolved. For patients with poor fat absorption, a water soluble form of vitamin E may need to be substituted such as tocopheryl polyethylene glycol-1000 succinate.

In other studies the oral bioavailability of alpha-tocopherol was 36%, gamma-tocotrienol was 9%. The time to maximum concentration was 9.7 hours for alpha-tocopherol and 2.4 hours for gamma-tocotrienol.

Half Life

The half-life of EPA is recorded to be about 37 hours while that of DHA is documented to be about 46 hours .

44 hours in premature neonates given a 20mg/kg intramuscular injection. 12 minutes in intravenous injection of intestinal lymph.

Clearance

The clearance of EPA is recorded to be about 548 ml/hr while that of DHA is documented to be about 518 ml/hr hours .

6.5mL/hr/kg in premature neonates given a 20mg/kg intramuscular injection.

Elimination Route

Based on what is known about the elimination of EPA and DHA, it is understood that such fatty acids do not undergo renal excretion .

Alpha tocopherol is excreted in urine as well as bile in the feces mainly as a carboxyethyl-hydrochroman (CEHC) metabolite, but it can be excreted in it's natural form .

Pregnancy & Breastfeeding use

Use in pregnancy: Vitamin E may be used in pregnancy in the normally recommended dose but the safety of high dose therapy has not been established.

Use in lactation: There appears to be no contraindication to breast feeding by mothers taking the normally recommended dose.

Contraindication

No known contraindications found.

Special Warning

Use in Children: Vitamin E is safe for children

Acute Overdose

Large doses of vitamin E (more than 1 gm/day) have been reported to increase bleeding tendency in vitamin K deficient patients such as those taking oral anticoagulants.

Storage Condition

Store at a cool and dry place, Protect from light and moisture.

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