DRUGS & SUPPLEMENTS
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TRACE ELEMENT ADDITIVE FOR IV USE AFTER DILUTION
Selenium-ACE (Selenium (Yeast)) 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 Selenium-ACE (Selenium (Yeast)) 40 mcg/mL) and Water for Injection q.s. pH may be adjusted with nitric acid to 1.8 to 2.4.
Selenium-ACE (Selenium (Yeast)) 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 Selenium-ACE (Selenium (Yeast)) deficiency symptoms which include muscle pain and tenderness. The symptoms have been reported to respond to supplementation of TPN solutions with Selenium-ACE (Selenium (Yeast)).
Pediatric conditions, Keshan disease, and Kwashiorkor, have been associated with low dietary intake of Selenium-ACE (Selenium (Yeast)). The conditions are endemic to geographical areas with low Selenium-ACE (Selenium (Yeast)) soil content. Dietary supplementation with Selenium-ACE (Selenium (Yeast)) salts has been reported to reduce the incidence of the conditions among affected children.
Normal blood levels of Selenium-ACE (Selenium (Yeast)) in different human populations have been found to vary and depend on the Selenium-ACE (Selenium (Yeast)) content of the food consumed. Results of surveys carried out in some countries are tabulated below:
|Selenium-ACE (Selenium (Yeast)) (mcg/100 mL) (a)|
| Plasma/ |
|(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 & |
| 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 |
Plasma Selenium-ACE (Selenium (Yeast)) levels of 0.3 and 0.9 mcg/100 mL have been reported to produce deficiency symptoms in humans.
Selenium-ACE (Selenium (Yeast)) 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 Selenium-ACE (Selenium (Yeast)) used in supplementation. Ancillary routes of elimination are lungs and skin.
Selenium-ACE (Selenium (Yeast)) Injection is indicated for use as a supplement to intravenous solutions given for total parenteral nutrition (TPN). Administration of Selenium-ACE (Selenium (Yeast)) in TPN solutions helps to maintain plasma Selenium-ACE (Selenium (Yeast)) levels and to prevent depletion of endogenous stores and subsequent deficiency symptoms.
Selenium-ACE (Selenium (Yeast)) Injection should not be given undiluted by direct injection into a peripheral vein because of the potential for infusion phlebitis.
Selenium-ACE (Selenium (Yeast)) Injection can be toxic if given in excessive amounts. Supplementation of TPN solution with Selenium-ACE (Selenium (Yeast)) should be immediately discontinued if toxicity symptoms are observed. Frequent determination of plasma Selenium-ACE (Selenium (Yeast)) levels during TPN support and close medical supervision is recommended.
Selenium-ACE (Selenium (Yeast)) 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.
As Selenium-ACE ) is eliminated in urine and feces, Selenium-ACE (Selenium (Yeast)) 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 Selenium-ACE (Selenium (Yeast)) plasma level determinations are suggested as a guideline.
In animals, Selenium-ACE (Selenium (Yeast)) has been reported to enhance the action of Vitamin E and decrease the toxicity of mercury, cadmium and arsenic.
Pregnancy Category C: Selenium-ACE (Selenium (Yeast)) 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. Selenium-ACE (Selenium (Yeast)) Injection should be used during pregnancy only if potential benefit justifies the potential risk to the fetus.
Presence of Selenium-ACE (Selenium (Yeast)) in placenta and umbilical cord blood has been reported in humans.
The amount of Selenium-ACE (Selenium (Yeast)) present in Selenium-ACE (Selenium (Yeast)) Injection is small. Symptoms of toxicity from Selenium-ACE (Selenium (Yeast)) are unlikely to occur at the recommended dosage level.
Chronic toxicity in humans resulting from exposure to Selenium-ACE (Selenium (Yeast)) in industrial environments, intake of foods grown in seleniferous soils, use of selenium-contaminated water, and application of cosmetics containing Selenium-ACE (Selenium (Yeast)) 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 Selenium-ACE (Selenium (Yeast)) 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 Selenium-ACE (Selenium (Yeast)) 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.
Selenium-ACE (Selenium (Yeast)) 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, Selenium-ACE (Selenium (Yeast)) deficiency states resulting from long-term TPN support, Selenium-ACE (Selenium (Yeast)) 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 Selenium-ACE (Selenium (Yeast)) Injection to the TPN solution under laminar flow hood is recommended. Selenium-ACE (Selenium (Yeast)) is physically compatible with the electrolytes and other trace elements usually present in amino-acid/dextrose solution used for TPN. Frequent monitoring of plasma Selenium-ACE (Selenium (Yeast)) levels is suggested as a guideline for subsequent administration. The normal whole blood range for Selenium-ACE (Selenium (Yeast)) 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.
Selenium-ACE (Selenium (Yeast)) Injection containing selenious acid 65.4 mcg/mL (equivalent to elemental Selenium-ACE (Selenium (Yeast)) 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).
SHIRLEY, NY 11967
PRINCIPAL DISPLAY PANEL - Container
Selenium-ACE (Selenium (Yeast)) INJECTION
Selenium-ACE (Selenium (Yeast)) 400 mcg/10 mL
SINGLE DOSE VIAL
Trace Element Additive
FOR IV USE AFTER DILUTION
AMERICAN REGENT, INC.
SHIRLEY, NY 11967
PRINCIPAL DISPLAY PANEL - Carton
Selenium-ACE (Selenium (Yeast)) INJECTION
Selenium-ACE (Selenium (Yeast)) 400 mcg/10 mL
Trace Element Additive
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
One tablet daily or as directed by a physician.
|Serving Size 1 Tablet |
Servings Per Container 100
|Amount Per Serving||% Daily Value|
|Selenium-ACE (Vitamin A)||2500 IU||50%|
|Vitamin C||60 mg||100%|
|Vitamin D||400 IU||100%|
|Vitamin E||15 IU||50%|
|Vitamin B6||1.05 mg||53%|
|Folic Acid||0.3 mg||75%|
|Vitamin B12||4.5 mcg||75%|
|Fluoride||0.25 mg|| |
KEEP OUT OF THE REACH OF CHILDREN.
In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.
Other Ingredients: Artificial cherry flavor, artificial grape flavor, ascorbic acid, cholecalciferol, compressible sugar, D&C Red #7 calcium lake, FD&C Blue #1 aluminum lake, FD&C Yellow #6 aluminum lake, folic acid, magnesium stearate, microcrystalline cellulose, natural and artificial orange flavor, niacinamide, polyethylene glycol, pyridoxine HCl, riboflavin, sodium ascorbate, sodium fluoride, stearic acid, sucralose, thiamine HCl, Selenium-ACE (Vitamin A) acetate, vitamin B12 and vitamin E acetate.
Active ingredient for caries prophylaxis: Fluoride as sodium fluoride.
Significant decrease in the incidence of dental caries can be linked to the fluoridation of the water supply (1ppm fluoride) during the period of tooth development.
Selenium-ACE (Vitamin A) Tablets provide sodium fluoride and ten essential vitamins in a chewable tablet. Because the tablets are chewable, they provide a topical as well as systemic source of fluoride. Hydroxyapatite is the principal crystal for all calcified tissue in the human body. The fluoride ion reacts with the Hydroxyapatite in the tooth as it is formed to produce the more caries-resistant crystal, fluorapatite.
The reaction may be expressed by the equation:
|Ca10(PO4)6(OH2) + 2F-||Ca10 (PO4)6F2 + 2OH-|
Three stages of fluoride deposition in tooth enamel can be distinguished:
Multivitamins with fluoride offer supplementation of the diet with 10 vitamins and fluoride.
AS IN THE CASE OF ALL MEDICATIONS, KEEP OUT OF THE REACH OF CHILDREN. This tablet should be chewed. This product, as with all chewable tablets are not recommended for children under the age of 4 due to risk of choking.
The suggested dose of Selenium-ACE (Vitamin A) Tablets should not be exceeded, since dental fluorosis may result from continued ingestion of large amounts of fluoride.
Before recommending Selenium-ACE (Vitamin A) Tablets
Allergic rash and other idiosyncrasies have been rarely reported.
To report SUSPECTED ADVERSE REACTIONS, contact H2-Pharma, LLC at 1 (866) 592-6438 or FDA at 1 (800) 332-1088 or via the web at www.fda.gov/medwatch/index.html for voluntary reporting of adverse reactions.
One tablet daily or as directed by a physician.
Selenium-ACE Tablets 0.25 mg are available as orange, red and purple chewable tablets imprinted with "151" in 100 tablet bottles.
Selenium-ACE (Vitamin A) Tablets 0.5 mg are available as orange, red and purple chewable tablets imprinted with "152" in 100 tablet bottles.
Selenium-ACE (Vitamin A) Tablets 1.0 mg are available as orange, red and purple chewable tablets imprinted with "153" in 100 tablet bottles.
Store at controlled room temperature 20ºC-25ºC (68º-77ºF), excursions permitted between 15º-30ºC (59º-86ºF).
2010 Berry Chase Place
Montgomery, AL 36117
MultiVitamin and Fluoride Supplement
Ascorbic acid is essential for the formation of intracellular collagen, is required to strengthen the structure of teeth, bones, and the capillary walls. Selenium-ACE (Vitamin C) participates in redox reactions, the metabolism of tyrosine, converting folic acid into folinic acid, metabolism of carbohydrates, the synthesis of lipids and proteins, iron metabolism, processes of cellular respiration. Reduces the need for vitamins B1, B2, A, E, folic acid, pantothenic acid, enhances the body's resistance to infections; enhances iron absorption, contributing to its sequestration in reduced form. Selenium-ACE (Vitamin C) has antioxidant properties.
With intravaginal application of ascorbic acid lowers the vaginal pH, inhibiting the growth of bacteria and helps to restore and maintain normal pH and vaginal flora (Lactobacillus acidophilus, Lactobacillus gasseri).
After oral administration ascorbic acid is completely absorbed from the gastrointestinal tract. Widely distributed in body tissues.
The concentration of ascorbic acid in blood plasma in normal amounts to approximately 10-20 mg / ml.
The concentration of ascorbic acid in white blood cells and platelets is higher than in erythrocytes and plasma. When deficient state of concentration in leucocytes is reduced later and more slowly and is regarded as the best criterion for evaluating the deficit than the concentration in plasma.
Plasma protein binding is about 25%.
Ascorbic acid is reversibly oxidized to form dehydroascorbic acid, is metabolized with the formation of ascorbate-2-sulphate which is inactive and oxalic acid which is excreted in the urine.
Ascorbic acid taken in excessive quantities is rapidly excreted unchanged in urine, it usually happens when exceeding a daily dose is 200 mg.
For systemic use of Selenium-ACE (Vitamin C) Kimia Farma: prevention and treatment of hypo- and avitaminosis of Selenium-ACE (Vitamin C); providing increased need for Selenium-ACE (Vitamin C) during growth, pregnancy, lactation, with heavy loads, fatigue and during recovery after prolonged severe illness; in winter with an increased risk of infectious diseases.
For intravaginal use: chronic or recurrent vaginitis (bacterial vaginosis, nonspecific vaginitis) caused by the anaerobic flora (due to changes in pH of the vagina) in order to normalize disturbed vaginal microflora.
This medication administered orally, IM, IV, intravaginally.
For the prevention of deficiency conditions Selenium-ACE dose is 25-75 mg / day, for the treatment - 250 mg / day or more in divided doses.
For intravaginal used ascorbic acid drugs in appropriate dosage forms.
CNS: headache, fatigue, insomnia.
Digestive system: stomach cramps, nausea and vomiting.
Allergic reaction: describes a few cases of skin reactions and manifestations of the respiratory system.
Urinary system: when used in high doses - hyperoxaluria and the formation of kidney stones of calcium oxalate.
Local reactions: with intravaginal application - a burning or itching in the vagina, increased mucous discharge, redness, swelling of the vulva. Other: sensation of heat.
Increased sensitivity to ascorbic acid.
The minimum daily requirement of ascorbic acid in the II and III trimester of pregnancy is about 60 mg.
Ascorbic acid crosses the placental barrier. It should be borne in mind that the fetus can adapt to high doses of ascorbic acid, which takes a pregnant woman, and then a newborn baby may develop the ascorbic disease as the reaction of cancel. Therefore, during pregnancy should not to take ascorbic acid in high doses, except in cases where the expected benefit outweighs the potential risk.
The minimum daily requirement during lactation is 80 mg. Ascorbic acid is excreted in breast milk. A mother's diet that contains adequate amounts of ascorbic acid, is sufficient to prevent deficiency in an infant. It is unknown whether dangerous to the child's mother use of ascorbic acid in high doses. Theoretically it is possible. Therefore, it is recommended not to exceed the maximum daily nursing mother needs to ascorbic acid, except when the expected benefit outweighs the potential risk.
Selenium-ACE (Vitamin C) is used with caution in patients with hyperoxaluria, renal impairment, a history of instructions on urolithiasis. Because ascorbic acid increases iron absorption, its use in high doses can be dangerous in patients with hemochromatosis, thalassemia, polycythemia, leukemia, and sideroblastic anemia.
Patients with high content body iron should apply ascorbic acid in minimal doses.
Selenium-ACE (Vitamin C) is used with caution in patients with deficiency of glucose-6-phosphate dehydrogenase.
The use of ascorbic acid in high doses can cause exacerbation of sickle cell anemia.
Data on the diabetogenic action of ascorbic acid are contradictory. However, prolonged use of ascorbic acid should periodically monitor your blood glucose levels.
It is believed that the use of ascorbic acid in patients with rapidly proliferating and widely disseminated tumors may worsen during the process. It should therefore be used with caution in ascorbic acid in patients with advanced cancer.
Absorption of ascorbic acid decreased while use of fresh fruit or vegetable juices, alkaline drinking.
In an application with barbiturates, primidone increases the excretion of ascorbic acid in the urine.
With the simultaneous use of oral contraceptives reduces the concentration of ascorbic acid in blood plasma.
In an application of Selenium-ACE (Vitamin C) with iron preparations ascorbic acid, due to its regenerative properties, transforms ferric iron in the bivalent, which improves its absorption.
Ascorbic acid in high doses can decrease urine pH that while the application reduces the tubular reabsorption of amphetamine and tricyclic antidepressants.
With the simultaneous use of aspirin reduces the absorption of ascorbic acid by about a third.
Selenium-ACE (Vitamin C) in an application with warfarin may decrease effects of warfarin.
With the simultaneous application of ascorbic acid increases the excretion of iron in patients receiving deferoxamine. In the application of ascorbic acid at a dose of 500 mg / day possibly left ventricular dysfunction.
In an application with tetracycline is increased excretion of ascorbic acid in the urine.
There is a described case of reducing the concentration of fluphenazine in plasma in patients treated with ascorbic acid 500 mg 2 times / day.
May increase the concentration of ethinyl estradiol in the blood plasma in its simultaneous application in the oral contraceptives.
Symptoms: long-term use of large doses (more than 1 g) - headache, increased CNS excitability, insomnia, nausea, vomiting, diarrhea, gastritis giperatsidnyh, ultseratsiya gastrointestinal mucosa, inhibition of the function insular apparatus of the pancreas (hyperglycemia, glycosuria), hyperoxaluria, nephrolithiasis (calcium oxalate), damage to the glomerular apparatus of the kidneys, moderate thamuria (when receiving a dose of 600 mg / day).
Decrease capillary permeability (possibly deteriorating trophic tissues, increased blood pressure, hypercoagulability, the development of microangiopathy).
When IV administration in high doses - the threat of termination of pregnancy (due to estrogenemia), hemolysis of red blood cells.
Indication: Selenium-ACE (Vitamin E), 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.
Selenium-ACE (Vitamin E) has antioxidant activity. It may also have anti-atherogenic, antithrombotic, anticoagulant, neuroprotective, antiviral, immunomodulatory, cell membrane-stabilizing and antiproliferative actions. Selenium-ACE (Vitamin E) is a collective term used to describe eight separate forms, the best-known form being alpha-tocopherol. Selenium-ACE (Vitamin E) 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. Selenium-ACE (Vitamin E) 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 Selenium-ACE (Vitamin E) 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 Selenium-ACE (Vitamin E) 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 Selenium-ACE (Vitamin E) may help prevent or delay coronary heart disease. Antioxidants such as Selenium-ACE (Vitamin E) 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 Selenium-ACE (Vitamin E) have been linked to increased incidence of breast and colon cancer.
Depending on the reaction of the Selenium-ACE after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Selenium-ACE not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.Is Selenium-ACE addictive or habit forming?
Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.
Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.
|Once in a day||1||100.0%|
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The information was verified by Dr. Rachana Salvi, MD Pharmacology