NDC code for selenious acid

CONTRAINDICATIONS

Selenium Injection should not be given undiluted by direct injection into a peripheral vein
because of the potential for infusion phlebitis.

WARNING

Selenium Injection can be toxic if given in excessive amounts. Supplementation of TPN
solution with selenium should be immediately discontinued if toxicity symptoms are
observed. Frequent determination of plasma selenium levels during TPN support and
close medical supervision is recommended.

Selenium 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.

PRECAUTIONS

As selenium is eliminated in urine and feces, selenium 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 selenium plasma level determinations are suggested as a guideline.

In animals, selenium has been reported to enhance the action of Vitamin E and decrease
the toxicity of mercury, cadmium and arsenic.

Pregnancy

Teratogenic Effects

Pregnancy Category C: Selenium at high dose levels (15-30 mcg/egg) has been reported
to have adverse embryological effects among chickens. There are however, no adequate
and well controlled studies in pregnant women. Selenium Injection should be used during
pregnancy only if potential benefit justifies the potential risk to the fetus.

Presence of selenium in placenta and umbilical cord blood has been reported in humans.

ADVERSE REACTIONS

The amount of selenium present in Selenium Injection is small. Symptoms of toxicity
from selenium are unlikely to occur at the recommended dosage level. To report
SUSPECTED ADVERSE REACTIONS, FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

OVERDOSAGE

Chronic toxicity in humans resulting from exposure to selenium in industrial
environments, intake of foods grown in seleniferous soils, use of selenium-contaminated
water, and application of cosmetics containing selenium 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
selenium compounds has resulted in death with histopathological changes including
fulminating peripheral vascular collapse, internal vascular congestion, diffusely
hemorrhagic, congested and edematous lungs, brick-red color gastric mucosa. The death
was preceded by coma.

No effective antidote to selenium 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.

DOSAGE AND ADMINISTRATION

Selenium 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, selenium deficiency states resulting from long-term TPN support, selenium 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 Selenium Injection to parenteral nutrition solutions under laminar flow
hood is recommended. Selenium is physically compatible with the electrolytes and other
trace elements usually present in parenteral nutrition formulations. Frequent monitoring
of plasma selenium levels is suggested as a guideline for subsequent administration. The
normal whole blood range for selenium is approximately 10 to 37 mcg/100 mL.

Do not directly mix ascorbic acid injection with selenium containing parenteral products
in the same syringe or vial, as this admixture may cause the formation of an insoluble
precipitate.

Parenteral drug products should be inspected visually for particulate matter and
discoloration prior to administration, whenever solution and container permit.

Vial labelcarton labelPRINICIPAL DISPLAY PANEL - Vial Labeling

NDC 87944-001-01
20 mL Single Use Vial
Rx Only