Overview
11 DESCRIPTION Selenious Acid Injection, USP is a sterile, non-pyrogenic, clear, colorless solution intended for use as a trace element and additive to intravenous solutions for parenteral nutrition. Each 600 mcg/10 mL Pharmacy Bulk Package vial contains 10 mL of selenious acid solution. None of the presentations contain preservatives.
Mechanism of Action
12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action Selenious acid is converted in vivo to hydrogen selenide via glutathione-involved electron reductions. Hydrogen selenide acts as a selenium pool to form selenoproteins which include, but are not limited to, glutathione peroxidase, iodothyronine deiodinase, peroxidase and thioredoxins. 12.2 Pharmacodynamics Selenious acid exposure-response relationships and the time course of pharmacodynamic responses is unknown. 12.3 Pharmacokinetics Distribution In humans 85% of intravenous administered 75 Se-sodium selenite was protein-bound within 4 to 6 hours and 95% by 24 hours. Elimination Selenium is primarily eliminated in urine.
Indications
- 1 INDICATIONS AND USAGE Selenious Acid Injection is indicated in adult and pediatric patients as a source of selenium for parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. Selenious Acid Injection is a trace element indicated in adult and pediatric patients as a source of selenium for parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated.
Common Doses
- 60 mcg
- 2 mcg
- 4 mcg
- 10 mL
Dosage
2 DOSAGE AND ADMINISTRATION • Pharmacy Bulk Package : Not for direct intravenous infusion . ( 2.1 ) • See full prescribing information for information on preparation, administration, and general dosing considerations. ( 2.1 , 2.2, 2.3 , 2.4 , 2.5 ) Recommended Dosage ( 2.5 ) • Selenious Acid Injection provides 60 mcg/mL of selenium. • Individualize the dosage based upon the patient’s clinical condition, nutritional requirements, and the contribution of oral or enteral selenium intake. The following dosages are general recommendations intended for most patients.
Contraindications
- 4 CONTRAINDICATIONS None. None.
Side Effects
- 6 ADVERSE REACTIONS No selenium-related adverse reactions have been reported in clinical studies or postmarketing reports in patients receiving intravenously administered parenteral nutrition solutions containing selenious acid within the recommended dosage range. The following adverse reactions associated with use of other components of parenteral nutrition solutions were identified in clinical studies or postmarketing reports.
Interactions
- No major interactions listed on the FDA label. Always consult a healthcare professional.