Selenious Acid

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.

• 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.

• None. None.contraindicated

• 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. However, based upon clinical requirements, some patients may require a higher dosage: o Adults : 60 mcg/day Pediatric Patients 7 kg and above : 2 mcg/kg/day (up to 60 mcg/day) o Pediatric Patients less than 7 kg : 2 to 4 mcg/kg/day • Monitor selenium concentrations during treatment. 2.1 Important Administration Information Selenious Acid Injection is supplied as a pharmacy bulk package for admixing use only. It is not for direct intravenous infusion . Prior to administration, Selenious Acid Injection must be transferred to a separate parenteral nutrition container, prepared and used as an admixture in parenteral nutrition solutions. The Pharmacy Bulk Package vial of Selenious Acid Injection is intended for dispensing of single doses to multiple patients in a pharmacy admixture program. The final parenteral nutrition solution is for intravenous infusion into a central or peripheral vein. The choice of a central or peripheral venous route should depend on the osmolarity of the final infusate.

• Pulmonary Embolism due to Pulmonary Vascular Precipitates: If signs of pulmonary distress occur, stop the infusion and initiate a medical evaluation. ( 5.1 ) • Vein Damage and Thrombosi s: Solutions with osmolarity of 900 mOsmol/L or more must be infused through a central venous catheter. ( 2.1 , 5.2 ) • Aluminum Toxicity : Increased risk in patients with renal impairment, including preterm infants. ( 5.3 , 5.4 ) • Monitoring and Laboratory Tests : Monitor selenium concentrations, fluid and electrolyte status, serum osmolarity, blood glucose, liver and kidney function, blood count and coagulation parameters throughout treatment. ( 5.4 , 2.5 ) 5.1 Pulmonary Embolism due to Pulmonary Vascular Precipitates Pulmonary vascular precipitates causing pulmonary vascular emboli and pulmonary distress have been reported in patients receiving parenteral nutrition. The cause of precipitate formation has not been determined in all cases; however, in some fatal cases, pulmonary emboli occurred as a result of calcium phosphate precipitates. Precipitation has occurred following passage through an in-line filter; in vivo precipitate formation may also have occurred. If signs of pulmonary distress occur, stop the parenteral nutrition infusion and initiate a medical evaluation. In addition to inspection of the solution [see Dosage and Administration ( 2.2, 2.3 )], the infusion set and catheter should also periodically be checked for precipitates.

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. Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure: • Pulmonary embolism due to pulmonary vascular precipitates [see Warnings and Precautions ( 5.1 )] • Vein damage and thrombosis [see Warnings and Precautions ( 5.2 )] • Aluminum toxicity [see Warnings and Precautions ( 5.3 )] No selenium-related adverse reactions in patients receiving intravenously administered parenteral nutrition solutions containing selenious acid within the recommended dosage range. To report SUSPECTED ADVERSE REACTIONS, contact Gland Pharma Limited at 609-250-7990 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

8.1 Pregnancy Risk Summary Administration of the recommended dose of Selenious Acid Injection in parenteral nutrition is not expected to cause major birth defects, miscarriage, or adverse maternal or fetal outcomes. Animal reproduction studies have not been conducted with intravenous selenious acid. The estimated background risk of major birth defects and miscarriage for the indicated populations are unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Clinical Considerations Disease-associated Maternal and/or Embryo-Fetal Risk Deficiency of trace elements, including selenium, is associated with adverse pregnancy and fetal outcomes. Pregnant women have an increased metabolic demand for trace elements, including selenium. Parenteral nutrition with selenium should be considered if a pregnant woman’s nutritional requirements cannot be fulfilled by oral or enteral intake. 8.2 Lactation Risk Summary Selenium is present in human milk. Administration of the approved recommended dose of Selenious Acid Injection in parenteral nutrition is not expected to cause harm to a breastfed infant. There is no information on the effects of selenious acid on milk production.

Metabolism

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.

There are no known cases of overdosage with intravenous selenious acid in parenteral nutrition. Overdosage has been reported with oral selenium. Available selenium concentrations in these subjects have been reported using various assays and laboratory-based reference ranges over a period of time. Interpret results in the context of current reported ranges. For oral selenium, the Tolerable Upper Limit (UL) is 400 mcg/day and the No Observed Adverse Effect Level (NOAEL) is 800 mcg/day. The estimated oral bioavailability of selenium is approximately 70%. Acute Oral Toxicity Effects Serious adverse events and deaths have been reported with acute oral toxicity, however, there is no clear correlation between the amount ingested, signs and symptoms of toxicity, or selenium blood concentrations. With severe toxicity, the most common presenting symptoms within a few hours post-ingestion of oral doses greater than 1 gram/day of selenium are gastrointestinal (nausea, vomiting, diarrhea, and abdominal pain), altered mental status, and “garlic” breath odor. Death from circulatory collapse has been reported after oral ingestion of 5 to 10 grams of selenium.

• Apr 30, 2019NDANDA209379Am Regent
• Jul 8, 2025ANDAANDA219629Gland

1. 1Plasma Cell Myeloma550%
2. 2Cerebral Palsy110%
3. 3Cholangitis110%
4. 4Circumstance Or Information Capable Of Leading To Medication Error110%
5. 5Diarrhoea110%
6. 6Fatigue110%
7. 7Nausea110%
8. 8Pneumonia110%
9. 9Product Label Confusion110%
10. 10Respiratory Failure110%
11. 11Wrong Dose110%

Recent PubMed references pinned to Selenious Acid as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

• Sodium Selenite Attenuates Monocrotaline-Induced Pulmonary Arterial Hypertension by Upregulating GPX3 and Ameliorating Vascular Remodeling.
  Physiological research · 2026 · Liu Z, Liu X, Mprah R, et al.
  PMID 42187509DOI 10.33549/physiolres.935734
• Integrated multi-omics analysis reveals mechanism of metabolic reprogramming enabling bacterial selenite detoxification and selenium nanoparticles biogenesis by Serratia marcescens HBQT.
  Bioresource technology · 2026 · Zhang Y, Lin J, He M, et al.
  PMID 42162935DOI 10.1016/j.biortech.2026.134925
• Effect of Metal Cations on Selenite Bioreduction by a Consortium of Halophilic/Halotolerant Bacteria and/or Yeast.
  Environmental microbiology reports · 2026 · Lashani E, Moghimi H, Turner RJ, et al.
  PMID 42157070DOI 10.1111/1758-2229.70320
• Effects of the foliar application of selenite at different growth stages on selenium transformation, silage quality and the metabolome of tiger nut (Cyperus esculentus L.).
  Food chemistry · 2026 · Wang K, Gong T, Du X, et al.
  PMID 42081854DOI 10.1016/j.foodchem.2026.149472
• Sodium selenite attenuates hyperglycemia-exacerbated cerebral ischemia/reperfusion injury by inhibiting the Fas/FasL/PUMA apoptotic pathway.
  Pathology, research and practice · 2026 · Yang L, Ding F, Yin X, et al.
  PMID 42061100DOI 10.1016/j.prp.2026.156494
• Sodium selenite synergistic strategy based on myosin structural modification: Achieving soft selenium-enriched gel of large Yellow croaker surimi.
  Food research international (Ottawa, Ont.) · 2026 · Jia A, Xu Y, Guo J, et al.
  PMID 41895966DOI 10.1016/j.foodres.2026.118893
• Funneliformis mosseae and selenite synergistically enhance rice tolerance to soda saline-alkali stress via regulating photosynthetic-ionic homeostasis and GSH-Px/GSH system.
  Plant physiology and biochemistry : PPB · 2026 · Liu F, Shi F, Xu T, et al.
  PMID 41806555DOI 10.1016/j.plaphy.2026.111167
• Selenium modulates the antioxidative response in green microalga Monoraphidium cf. contortum.
  Environmental toxicology and pharmacology · 2026 · Špoljarić Maronić D, Štolfa Čamagajevac I, Žuna Pfeiffer T, et al.
  PMID 41672254DOI 10.1016/j.etap.2026.104958

The 10 most recently updated of 16 ClinicalTrials.gov registrations naming Selenious Acid as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Tralement Versus a Fixed-dose Trace Element Combination Product to Evaluate Manganese Safety
  Withdrawn · Phase 4 · Interventional · 0 enrolled · American Regent, Inc.
  NCT05661682updated 2025-02-12
• Tralement vs. Fixed-dose Trace Element Combination Product in Patients >3 to 17 Years of Age Requiring Long-term PN
  Withdrawn · Phase 4 · Interventional · 0 enrolled · American Regent, Inc.
  NCT05677126updated 2024-11-15
• Sodium Selenite and Radiation Therapy in Treating Patients With Metastatic Cancer
  Completed · Phase 1 · Interventional · 15 enrolled · Stanford University
  NCT02184533updated 2024-05-28
• High Dose Inorganic Selenium for Preventing Chemotherapy Induced Peripheral Neuropathy
  Unknown · Phase 3 · Interventional · 68 enrolled · Seoul National University Hospital
  NCT04201561updated 2023-06-26
• Study Evaluating Sodium Selenite in Combination With Abiraterone in Castrate Resistant Prostate Cancer Progressing on Abiraterone
  Withdrawn · Phase 1 · Interventional · 0 enrolled · Stanford University
  NCT04296578updated 2021-08-12
• Selenium as a Potential Treatment for Moderately-ill, Severely-ill, and Critically-ill COVID-19 Patients.
  Unknown · Phase 2 · Interventional · 100 enrolled · CHRISTUS Health
  NCT04869579updated 2021-08-03
• SodiUm SeleniTe Adminstration IN Cardiac Surgery (SUSTAIN CSX®-Trial).
  Unknown · Phase 3 · Interventional · 1,400 enrolled · Daren K. Heyland
  NCT02002247updated 2021-06-01
• Peripartum Cardiomyopathy in Nigeria Registry
  Completed · Phase 4 · Interventional · 100 enrolled · Aminu Kano Teaching Hospital
  NCT03081949updated 2021-01-22
• High-dose Selenium Supplementation in Patients With Left Ventricular Assist
  Completed · Phase 3 · Interventional · 21 enrolled · RWTH Aachen University
  NCT02530788updated 2018-02-07
• Selenium to Improve Neurological Outcome After Cardiac Arrest
  Withdrawn · Phase 2 · Interventional · 0 enrolled · Medical University of Graz
  NCT01390506updated 2017-12-13

Frequently asked questions

How does Selenious Acid work?

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.

What is Selenious Acid used for?

According to FDA labeling, Selenious Acid carries indications including: 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.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Selenious Acid?

Selenious Acid is classified as Physiochemical Activity, Cellular Degradation/Digestion Alteration, Increased Glutathione Concentration.

What are the brand names for Selenious Acid?

Selenious Acid is marketed under brand names including Multitrace-5, Multrys, Tralement.

What are the contraindications for Selenious Acid?

Selenious Acid labeling lists contraindications including: None. None.. Always consult the full prescribing information and a clinician.