Selenious Acid 40 ug/mL
Selenious Acid · INJECTION, SOLUTION · Pangea Pharmaceuticals, LLC
Selenious Acid is a injection, solution containing selenious acid at 40 ug/mL, taken intravenous. Manufactured by Pangea Pharmaceuticals, LLC.
Key Facts
- Brand Name
- Selenious Acid
- Generic Name
- Selenious Acid
- NDC Code (Product)
81279-106- Manufacturer
- Pangea Pharmaceuticals, LLC
- Strength
- 40 ug/mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Marketing Status
- Marketing Start
- 05/20/2024
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
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.
Dosage & Administration
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. 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 so…
Contraindications
4 CONTRAINDICATIONS None. None.
Adverse Reactions
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. 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
Frequently Asked Questions
What is Selenious Acid used for?
Selenious Acid contains Selenious Acid. It is a injection, solution taken intravenous. Consult your doctor for specific uses.
Is Selenious Acid a controlled substance?
Selenious Acid is not classified as a controlled substance by the DEA.
What is the generic name for Selenious Acid?
The generic name for Selenious Acid is Selenious Acid. There are no other listed brand versions of Selenious Acid.
What is the NDC code for Selenious Acid 40 ug/mL?
The NDC (National Drug Code) for Selenious Acid 40 ug/mL is 81279-106, listed by Pangea Pharmaceuticals, LLC.
Other Selenious Acid Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)