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TRACE ELEMENT ADDITIVE FOR IV USE AFTER DILUTION
Selenol 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 Selenol 40 mcg/mL) and Water for Injection q.s. pH may be adjusted with nitric acid to 1.8 to 2.4.
Selenol 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 Selenol deficiency symptoms which include muscle pain and tenderness. The symptoms have been reported to respond to supplementation of TPN solutions with Selenol.
Pediatric conditions, Keshan disease, and Kwashiorkor, have been associated with low dietary intake of Selenol. The conditions are endemic to geographical areas with low Selenol soil content. Dietary supplementation with Selenol salts has been reported to reduce the incidence of the conditions among affected children.
Normal blood levels of Selenol in different human populations have been found to vary and depend on the Selenol content of the food consumed. Results of surveys carried out in some countries are tabulated below:
COUNTRY | Number of Samples | Selenol (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 Selenol levels of 0.3 and 0.9 mcg/100 mL have been reported to produce deficiency symptoms in humans.
Selenol 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 Selenol used in supplementation. Ancillary routes of elimination are lungs and skin.
Selenol Injection is indicated for use as a supplement to intravenous solutions given for total parenteral nutrition (TPN). Administration of Selenol in TPN solutions helps to maintain plasma Selenol levels and to prevent depletion of endogenous stores and subsequent deficiency symptoms.
Selenol Injection should not be given undiluted by direct injection into a peripheral vein because of the potential for infusion phlebitis.
Selenol Injection can be toxic if given in excessive amounts. Supplementation of TPN solution with Selenol should be immediately discontinued if toxicity symptoms are observed. Frequent determination of plasma Selenol levels during TPN support and close medical supervision is recommended.
Selenol 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 Selenol is eliminated in urine and feces, Selenol 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 Selenol plasma level determinations are suggested as a guideline.
In animals, Selenol has been reported to enhance the action of Vitamin E and decrease the toxicity of mercury, cadmium and arsenic.
Pregnancy Category C: Selenol 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. Selenol Injection should be used during pregnancy only if potential benefit justifies the potential risk to the fetus.
Presence of Selenol in placenta and umbilical cord blood has been reported in humans.
The amount of Selenol present in Selenol Injection is small. Symptoms of toxicity from Selenol are unlikely to occur at the recommended dosage level.
Chronic toxicity in humans resulting from exposure to Selenol in industrial environments, intake of foods grown in seleniferous soils, use of selenium-contaminated water, and application of cosmetics containing Selenol 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 Selenol 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 Selenol 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.
Selenol 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, Selenol deficiency states resulting from long-term TPN support, Selenol 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 Selenol Injection to the TPN solution under laminar flow hood is recommended. Selenol is physically compatible with the electrolytes and other trace elements usually present in amino-acid/dextrose solution used for TPN. Frequent monitoring of plasma Selenol levels is suggested as a guideline for subsequent administration. The normal whole blood range for Selenol 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.
Selenol Injection containing selenious acid 65.4 mcg/mL (equivalent to elemental Selenol 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
Selenol INJECTION
Selenol 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
Selenol INJECTION
Selenol 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
Depending on the reaction of the Selenol after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Selenol 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 Selenol 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.
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The information was verified by Dr. Rachana Salvi, MD Pharmacology