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DRUGS & SUPPLEMENTS
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E Plex 400 Extra Strength
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E Plex 400 Extra Strength uses
E Plex 400 Extra Strength consists of DL-Methionine, Selenium (Selenium HVP Chelate), Vitamin E (D-Alpha Tocopherol Acid Succinate).Selenium (Selenium HVP Chelate):
- Description
- Clinical pharmacology
- Indications and usage
- Contraindications
- Warnings
- Precautions
- Adverse reactions
- Overdosage
- Dosage and administration
- How supplied
Rx Only
TRACE ELEMENT ADDITIVE FOR IV USE AFTER DILUTION
DESCRIPTION
E Plex 400 Extra Strength (Selenium (Selenium HVP Chelate)) Injection is a sterile, nonpyrogenic solution for use as an additive to solutions for Total Parenteral Nutrition (TPN).
Each mL contains Selenious Acid 65.4 mcg (equivalent to elemental E Plex 400 Extra Strength (Selenium (Selenium HVP Chelate)) 40 mcg/mL) and Water for Injection q.s. pH may be adjusted with nitric acid to 1.8 to 2.4.
CLINICAL PHARMACOLOGY
E Plex 400 Extra Strength (Selenium (Selenium HVP Chelate)) is part of glutathione peroxidase which protects cell components from oxidative damage due to peroxides produced in cellular metabolism.
Prolonged TPN support in humans has resulted in E Plex 400 Extra Strength (Selenium (Selenium HVP Chelate)) deficiency symptoms which include muscle pain and tenderness. The symptoms have been reported to respond to supplementation of TPN solutions with E Plex 400 Extra Strength (Selenium (Selenium HVP Chelate)).
Pediatric conditions, Keshan disease, and Kwashiorkor, have been associated with low dietary intake of E Plex 400 Extra Strength (Selenium (Selenium HVP Chelate)). The conditions are endemic to geographical areas with low E Plex 400 Extra Strength (Selenium (Selenium HVP Chelate)) soil content. Dietary supplementation with E Plex 400 Extra Strength (Selenium (Selenium HVP Chelate)) salts has been reported to reduce the incidence of the conditions among affected children.
Normal blood levels of E Plex 400 Extra Strength (Selenium (Selenium HVP Chelate)) in different human populations have been found to vary and depend on the E Plex 400 Extra Strength (Selenium (Selenium HVP Chelate)) content of the food consumed. Results of surveys carried out in some countries are tabulated below:
| COUNTRY | Number of Samples | E Plex 400 Extra Strength (Selenium (Selenium HVP Chelate)) (mcg/100 mL) (a) | ||
| Whole Blood | Blood Cells | Plasma/ Serum | ||
| (a) Mean values with or without standard deviation in parentheses, all other ranges. | ||||
| (b) Age group unknown. | ||||
| (c) Three children recovered from Kwashiorkor and the other six under treatment for other diseases. | ||||
| (d) Low selenium-content soil area. | ||||
| (e) Well nourished children, three recovered from Kwashiorkor and the other six under treatment for other diseases. | ||||
| (f) Mean values from seven subjects. | ||||
| Canada | 254 Adults | (37.9 ± 7.8) | (23.6 ± 6.0) | (14.4 ± 2.9) |
| England | 8 (b) | 26-37 (32) | -- | -- |
| Guatemala & Southern USA | 10 Adults 9 Children (c) | 19-28 (22) (23 ± 5) | -- (36 ± 12) | -- (15 ± 5) |
| New Zealand (d) | 113 Adults | (5.4 ± 0.1) | (6.6 ± 0.3) | (4.3 ± 0.1) |
| Thailand | 3 Adults 9 Children (e) | 14.4-20.2 (12.0 ± 3.6) (f) | 17.8-35.8 (19.5 ± 8.2) | 8.1-12.5 (8.3 ± 2.2) |
| USA | 210 Adults | 15.7-25.6 (20.6) | -- | -- |
Plasma E Plex 400 Extra Strength (Selenium (Selenium HVP Chelate)) levels of 0.3 and 0.9 mcg/100 mL have been reported to produce deficiency symptoms in humans.
E Plex 400 Extra Strength (Selenium (Selenium HVP Chelate)) is eliminated primarily in urine. However, significant endogenous losses through feces also occur. The rate of excretion and the relative importance of two routes varies with the chemical form of E Plex 400 Extra Strength (Selenium (Selenium HVP Chelate)) used in supplementation. Ancillary routes of elimination are lungs and skin.
INDICATIONS AND USAGE
E Plex 400 Extra Strength (Selenium (Selenium HVP Chelate)) Injection is indicated for use as a supplement to intravenous solutions given for total parenteral nutrition (TPN). Administration of E Plex 400 Extra Strength (Selenium (Selenium HVP Chelate)) in TPN solutions helps to maintain plasma E Plex 400 Extra Strength (Selenium (Selenium HVP Chelate)) levels and to prevent depletion of endogenous stores and subsequent deficiency symptoms.
CONTRAINDICATIONS
E Plex 400 Extra Strength (Selenium (Selenium HVP Chelate)) Injection should not be given undiluted by direct injection into a peripheral vein because of the potential for infusion phlebitis.
WARNINGS
E Plex 400 Extra Strength (Selenium (Selenium HVP Chelate)) Injection can be toxic if given in excessive amounts. Supplementation of TPN solution with E Plex 400 Extra Strength (Selenium (Selenium HVP Chelate)) should be immediately discontinued if toxicity symptoms are observed. Frequent determination of plasma E Plex 400 Extra Strength (Selenium (Selenium HVP Chelate)) levels during TPN support and close medical supervision is recommended.
E Plex 400 Extra Strength (Selenium (Selenium HVP Chelate)) Injection is a hypotonic solution and should be administered in admixtures only.
This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum.
Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.
PRECAUTIONS
As E Plex 400 Extra Strength ) is eliminated in urine and feces, E Plex 400 Extra Strength (Selenium (Selenium HVP Chelate)) supplements may be adjusted, reduced or omitted in renal dysfunction and/or gastrointestinal malfunction. In patients receiving blood transfusions, contribution from such transfusions should also be considered. Frequent E Plex 400 Extra Strength (Selenium (Selenium HVP Chelate)) plasma level determinations are suggested as a guideline.
In animals, E Plex 400 Extra Strength (Selenium (Selenium HVP Chelate)) has been reported to enhance the action of Vitamin E and decrease the toxicity of mercury, cadmium and arsenic.
Pregnancy
Teratogenic Effects
Pregnancy Category C: E Plex 400 Extra Strength (Selenium (Selenium HVP Chelate)) at high dose levels (15-30 mcg/egg) has been reported to have adverse embryological effects among chickens. There are however, no adequate and wellcontrolled studies in pregnant women. E Plex 400 Extra Strength (Selenium (Selenium HVP Chelate)) Injection should be used during pregnancy only if potential benefit justifies the potential risk to the fetus.
Presence of E Plex 400 Extra Strength (Selenium (Selenium HVP Chelate)) in placenta and umbilical cord blood has been reported in humans.
ADVERSE REACTIONS
The amount of E Plex 400 Extra Strength (Selenium (Selenium HVP Chelate)) present in E Plex 400 Extra Strength (Selenium (Selenium HVP Chelate)) Injection is small. Symptoms of toxicity from E Plex 400 Extra Strength (Selenium (Selenium HVP Chelate)) are unlikely to occur at the recommended dosage level.
OVERDOSAGE
Chronic toxicity in humans resulting from exposure to E Plex 400 Extra Strength (Selenium (Selenium HVP Chelate)) in industrial environments, intake of foods grown in seleniferous soils, use of selenium-contaminated water, and application of cosmetics containing E Plex 400 Extra Strength (Selenium (Selenium HVP Chelate)) has been reported in literature. Toxicity symptoms include hair loss, weakened nails, dermatitis, dental defects, gastrointestinal disorders, nervousness, mental depression, metallic taste, vomiting, and garlic odor of breath and sweat. Acute poisoning due to ingestion of large amounts of E Plex 400 Extra Strength (Selenium (Selenium HVP Chelate)) compounds has resulted in death with histopathological changes including fulminating peripheral vascular collapse, internal vascular congestion, diffusely hemorrhagic, congested and edematus lungs, brick-red color gastric mucosa. The death was preceded by coma.
No effective antidote to E Plex 400 Extra Strength (Selenium (Selenium HVP Chelate)) poisoning in humans is known. Animal studies have shown casein and linseed oil in feeds, reduced glutathione, arsenic, magnesium sulfate, and bromobenzene to afford limited protection.
DOSAGE AND ADMINISTRATION
E Plex 400 Extra Strength (Selenium (Selenium HVP Chelate)) Injection provides 40 mcg selenium/mL. For metabolically stable adults receiving TPN, the suggested additive dosage level is 20 to 40 mcg selenium/day. For pediatric patients, the suggested additive dosage level is 3 mcg/kg/day.
In adults, E Plex 400 Extra Strength (Selenium (Selenium HVP Chelate)) deficiency states resulting from long-term TPN support, E Plex 400 Extra Strength (Selenium (Selenium HVP Chelate)) as selenomethionine or selenious acid, administered intravenously at 100 mcg/day for a period of 24 and 31 days, respectively, has been reported to reverse deficiency symptoms without toxicity.
Aseptic addition of E Plex 400 Extra Strength (Selenium (Selenium HVP Chelate)) Injection to the TPN solution under laminar flow hood is recommended. E Plex 400 Extra Strength (Selenium (Selenium HVP Chelate)) is physically compatible with the electrolytes and other trace elements usually present in amino-acid/dextrose solution used for TPN. Frequent monitoring of plasma E Plex 400 Extra Strength (Selenium (Selenium HVP Chelate)) levels is suggested as a guideline for subsequent administration. The normal whole blood range for E Plex 400 Extra Strength (Selenium (Selenium HVP Chelate)) is approximately 10 to 37 mcg/100 mL.
Parenteral drug products should be inspected visually for particulate matter and discoloration, whenever solution and container permit.
HOW SUPPLIED
E Plex 400 Extra Strength (Selenium (Selenium HVP Chelate)) Injection containing selenious acid 65.4 mcg/mL (equivalent to elemental E Plex 400 Extra Strength (Selenium (Selenium HVP Chelate)) 40 mcg/mL).
NDC 0517-6510-25 10 mL Single Dose Vial Packaged in boxes of 25
Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F).
AMERICAN
REGENT, INC.
SHIRLEY, NY 11967
IN6510
Rev. 11/15
PRINCIPAL DISPLAY PANEL - Container
NDC 0517-6510-25
E Plex 400 Extra Strength (Selenium (Selenium HVP Chelate)) INJECTION
E Plex 400 Extra Strength (Selenium (Selenium HVP Chelate)) 400 mcg/10 mL
(40 mcg/mL)
10 mL
SINGLE DOSE VIAL
Trace Element Additive
FOR IV USE AFTER DILUTION
PRESERVATIVE FREE
Rx Only
AMERICAN REGENT, INC.
SHIRLEY, NY 11967
PRINCIPAL DISPLAY PANEL - Carton
E Plex 400 Extra Strength (Selenium (Selenium HVP Chelate)) INJECTION
E Plex 400 Extra Strength (Selenium (Selenium HVP Chelate)) 400 mcg/10 mL
(40 mcg/mL)
Trace Element Additive
NDC 0517-6510-25
25 x 10 mL
SINGLE DOSE VIALS
FOR INTRAVENOUS USE AFTER DILUTION PRESERVATIVE FREE Rx Only
Each mL contains: Selenious Acid 65.4 mcg, Water for Injection q.s.
pH adjusted with Nitric Acid. Sterile, nonpyrogenic.
WARNING: DISCARD UNUSED PORTION. Store at 20°-25°C (68°-77°F); excursions
permitted to 15°-30°C (59°-86°F).
Directions for Use: See Package Insert.
AMERICAN REGENT, INC.
SHIRLEY, NY 11967
Rev. 11/05
Container Carton
Vitamin E (D-Alpha Tocopherol Acid Succinate):
A generic descriptor for all tocopherols and tocotrienols that exhibit alpha-tocopherol activity. By virtue of the phenolic hydrogen on the 2H-1-benzopyran-6-ol nucleus, these compounds exhibit varying degree of antioxidant activity, depending on the site and number of methyl groups and the type of isoprenoids.
Indication: E Plex 400 Extra Strength (Vitamin E (D-Alpha Tocopherol Acid Succinate)), known for its antioxidant activities, is protective against cardiovascular disease and some forms of cancer and has also demonstrated immune-enhancing effects. It may be of limited benefit in some with asthma and rheumatoid arthritis. It may be helpful in some neurological diseases including Alzheimer's, some eye disorders including cataracts, and diabetes and premenstrual syndrome. It may also help protect skin from ultraviolet irradiation although claims that it reverses skin aging, enhances male fertility and exercise performance are poorly supported. It may help relieve some muscle cramps.
E Plex 400 Extra Strength (Vitamin E (D-Alpha Tocopherol Acid Succinate)) has antioxidant activity. It may also have anti-atherogenic, antithrombotic, anticoagulant, neuroprotective, antiviral, immunomodulatory, cell membrane-stabilizing and antiproliferative actions. E Plex 400 Extra Strength (Vitamin E (D-Alpha Tocopherol Acid Succinate)) is a collective term used to describe eight separate forms, the best-known form being alpha-tocopherol. E Plex 400 Extra Strength (Vitamin E (D-Alpha Tocopherol Acid Succinate)) is a fat-soluble vitamin and is an important antioxidant. It acts to protect cells against the effects of free radicals, which are potentially damaging by-products of the body's metabolism. E Plex 400 Extra Strength (Vitamin E (D-Alpha Tocopherol Acid Succinate)) is often used in skin creams and lotions because it is believed to play a role in encouraging skin healing and reducing scarring after injuries such as burns. There are three specific situations when a E Plex 400 Extra Strength (Vitamin E (D-Alpha Tocopherol Acid Succinate)) deficiency is likely to occur. It is seen in persons who cannot absorb dietary fat, has been found in premature, very low birth weight infants (birth weights less than 1500 grams, or 3½ pounds), and is seen in individuals with rare disorders of fat metabolism. A E Plex 400 Extra Strength (Vitamin E (D-Alpha Tocopherol Acid Succinate)) deficiency is usually characterized by neurological problems due to poor nerve conduction. Symptoms may include infertility, neuromuscular impairment, menstrual problems, miscarriage and uterine degradation. Preliminary research has led to a widely held belief that E Plex 400 Extra Strength (Vitamin E (D-Alpha Tocopherol Acid Succinate)) may help prevent or delay coronary heart disease. Antioxidants such as E Plex 400 Extra Strength (Vitamin E (D-Alpha Tocopherol Acid Succinate)) help protect against the damaging effects of free radicals, which may contribute to the development of chronic diseases such as cancer. It also protects other fat-soluble vitamins (A and B group vitamins) from destruction by oxygen. Low levels of E Plex 400 Extra Strength (Vitamin E (D-Alpha Tocopherol Acid Succinate)) have been linked to increased incidence of breast and colon cancer.
E Plex 400 Extra Strength pharmaceutical active ingredients containing related brand and generic drugs:
E Plex 400 Extra Strength available forms, composition, doses:
Composition is the list of ingredients which combinedly form a medicine. Both active ingredients and inactive ingredients form the composition. The active ingredient gives the desired therapeutic effect whereas the inactive ingredient helps in making the medicine stable.
Doses are various strengths of the medicine like 10mg, 20mg, 30mg and so on. Each medicine comes in various doses which is decided by the manufacturer, that is, pharmaceutical company. The dose is decided on the severity of the symptom or disease.