SELENIOUS ACID injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

SELENIUM (UNII: H6241UJ22B) (SELENIUM - UNII:H6241UJ22B)

Available from:

American Regent, Inc.

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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. None. 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. n 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. 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. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Selenious Acid Injection and any potential adverse effects on the breastfed infant from Selenious Acid Injection or from the underlying maternal condition. Selenious Acid Injection is approved for use in the pediatric population, including neonates, as a source of selenium for parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. Safety and dosing recommendations in pediatric patients are based on clinical experience [see Dosage and Administration (2.5)] . Because of immature renal function, preterm infants receiving prolonged parenteral nutrition treatment with Selenious Acid Injection may be at higher risk of aluminum toxicity [see Warnings and Precautions (5.3)]. Reported clinical experience with intravenous selenious acid has not identified a difference in selenium requirements between elderly and younger patients. In general, dose selection should be individualized based on the patient’s clinical condition, nutritional requirements, and additional nutritional intake provided orally or enterally to the patient.

Product summary:

Selenious Acid Injection, USP is a clear, colorless solution available as: 12 mcg/2 mL (6 mcg/mL) of selenium in a 2 mL single-dose vial. Carton of 10 vials (NDC 0517-6502-10). The vial closure for both presentation is not made with natural rubber latex. Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature] For storage of admixed solution, see Dosage and Administration (2.3).

Authorization status:

New Drug Application

Summary of Product characteristics

SELENIOUS ACID- SELENIOUS ACID INJECTION, SOLUTION
AMERICAN REGENT, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
SELENIOUS ACID
INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
SELENIOUS ACID
INJECTION.
SELENIOUS ACID INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 2019
RECENT MAJOR CHANGES
Dosage and Administration, Preparation Instructions for Admixing Using
a Parenteral Nutrition Container
(2.3) 10/2020
Recommended Dosage and Monitoring in Adult and Pediatric Patients
(2.5)
8/2021
INDICATIONS AND USAGE
Selenious Acid Injectionis 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. (1)
DOSAGE AND ADMINISTRATION
• _Pharmacy Bulk Package or Single-Dose Vial: 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)
Recommended Dosage (2.5)
• Selenious Acid Injection provides 60 mcg/mL of selenium.
• Selenious Acid Injection in a concentration of 6 mcg/mL is
recommended for use in pediatric patients,
particularly those weighing 7 kg or less.
• 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:
○ _Adults: _60 mcg/day
○ _Pediatric Patients 7 kg and above: _2 mcg/kg/day (up to 60
mcg/day)
○ _Pediatric Patients less than 7 kg: _2 to 4 mcg/kg/day
• Monitor selenium concentrations during treatment.
DOSAGE FORMS AND STRENGTHS
Selenious Acid Injection, USP: (3)
Pharmacy Bulk Package: 600 mcg/10 mL (60 mcg/mL) of selenium
Single-Dose Vial: 12 mcg/2 mL (6 mcg/mL) of selenium
CONTRAINDIC