P15

Selenium:

• Description
• Clinical pharmacology
• Indications and usage
• Contraindications
• Warnings
• Precautions
• Adverse reactions
• Overdosage
• Dosage and administration
• How supplied
• P15 (Selenium) reviews

Rx Only

TRACE ELEMENT ADDITIVE FOR IV USE AFTER DILUTION

DESCRIPTION

P15 (Selenium) Injection is a sterile, nonpyrogenic solution for use as an additive to solutions for Total Parenteral Nutrition (TPN).

Each mL contains Selenious Acid 65.4 mcg (equivalent to elemental P15 (Selenium) 40 mcg/mL) and Water for Injection q.s. pH may be adjusted with nitric acid to 1.8 to 2.4.

CLINICAL PHARMACOLOGY

P15 (Selenium) is part of glutathione peroxidase which protects cell components from oxidative damage due to peroxides produced in cellular metabolism.

Prolonged TPN support in humans has resulted in P15 (Selenium) deficiency symptoms which include muscle pain and tenderness. The symptoms have been reported to respond to supplementation of TPN solutions with P15 (Selenium).

Pediatric conditions, Keshan disease, and Kwashiorkor, have been associated with low dietary intake of P15 (Selenium). The conditions are endemic to geographical areas with low P15 (Selenium) soil content. Dietary supplementation with P15 (Selenium) salts has been reported to reduce the incidence of the conditions among affected children.

Normal blood levels of P15 (Selenium) in different human populations have been found to vary and depend on the P15 (Selenium) content of the food consumed. Results of surveys carried out in some countries are tabulated below:

Plasma P15 (Selenium) levels of 0.3 and 0.9 mcg/100 mL have been reported to produce deficiency symptoms in humans.

P15 (Selenium) is eliminated primarily in urine. However, significant endogenous losses through feces also occur. The rate of excretion and the relative importance of two routes varies with the chemical form of P15 (Selenium) used in supplementation. Ancillary routes of elimination are lungs and skin.

INDICATIONS AND USAGE

P15 (Selenium) Injection is indicated for use as a supplement to intravenous solutions given for total parenteral nutrition (TPN). Administration of P15 (Selenium) in TPN solutions helps to maintain plasma P15 (Selenium) levels and to prevent depletion of endogenous stores and subsequent deficiency symptoms.

CONTRAINDICATIONS

P15 (Selenium) Injection should not be given undiluted by direct injection into a peripheral vein because of the potential for infusion phlebitis.

WARNINGS

P15 (Selenium) Injection can be toxic if given in excessive amounts. Supplementation of TPN solution with P15 (Selenium) should be immediately discontinued if toxicity symptoms are observed. Frequent determination of plasma P15 (Selenium) levels during TPN support and close medical supervision is recommended.

P15 (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 P15 is eliminated in urine and feces, P15 (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 P15 (Selenium) plasma level determinations are suggested as a guideline.

In animals, P15 (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: P15 (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 wellcontrolled studies in pregnant women. P15 (Selenium) Injection should be used during pregnancy only if potential benefit justifies the potential risk to the fetus.

Presence of P15 (Selenium) in placenta and umbilical cord blood has been reported in humans.

ADVERSE REACTIONS

The amount of P15 (Selenium) present in P15 (Selenium) Injection is small. Symptoms of toxicity from P15 (Selenium) are unlikely to occur at the recommended dosage level.

OVERDOSAGE

Chronic toxicity in humans resulting from exposure to P15 (Selenium) in industrial environments, intake of foods grown in seleniferous soils, use of selenium-contaminated water, and application of cosmetics containing P15 (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 P15 (Selenium) compounds has resulted in death with histopathological changes including fulminating peripheral vascular collapse, internal vascular congestion, diffusely hemorrhagic, congested and edematus lungs, brick-red color gastric mucosa. The death was preceded by coma.

No effective antidote to P15 (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

P15 (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, P15 (Selenium) deficiency states resulting from long-term TPN support, P15 (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 P15 (Selenium) Injection to the TPN solution under laminar flow hood is recommended. P15 (Selenium) is physically compatible with the electrolytes and other trace elements usually present in amino-acid/dextrose solution used for TPN. Frequent monitoring of plasma P15 (Selenium) levels is suggested as a guideline for subsequent administration. The normal whole blood range for P15 (Selenium) is approximately 10 to 37 mcg/100 mL.

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

HOW SUPPLIED

P15 (Selenium) Injection containing selenious acid 65.4 mcg/mL (equivalent to elemental P15 (Selenium) 40 mcg/mL).

NDC 0517-6510-25 10 mL Single Dose Vial Packaged in boxes of 25

Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F).

AMERICAN

REGENT, INC.

SHIRLEY, NY 11967

IN6510

Rev. 11/15

PRINCIPAL DISPLAY PANEL - Container

NDC 0517-6510-25

P15 (Selenium) INJECTION

P15 (Selenium) 400 mcg/10 mL

(40 mcg/mL)

10 mL

SINGLE DOSE VIAL

Trace Element Additive

FOR IV USE AFTER DILUTION

PRESERVATIVE FREE

Rx Only

AMERICAN REGENT, INC.

SHIRLEY, NY 11967

PRINCIPAL DISPLAY PANEL - Carton

P15 (Selenium) INJECTION

P15 (Selenium) 400 mcg/10 mL

(40 mcg/mL)

Trace Element Additive

NDC 0517-6510-25

25 x 10 mL

SINGLE DOSE VIALS

FOR INTRAVENOUS USE AFTER DILUTION PRESERVATIVE FREE Rx Only

Each mL contains: Selenious Acid 65.4 mcg, Water for Injection q.s.

pH adjusted with Nitric Acid. Sterile, nonpyrogenic.

WARNING: DISCARD UNUSED PORTION. Store at 20°-25°C (68°-77°F); excursions

permitted to 15°-30°C (59°-86°F).

Directions for Use: See Package Insert.

AMERICAN REGENT, INC.

SHIRLEY, NY 11967

Rev. 11/05

Container Carton

Sulfur:

• Dosage & administration
• Purpose
• Indications & usage
• Active ingredients
• Inactive ingredients
• Warnings
• Keep out of reach of children
• P15 (Sulfur) reviews

Dosage & Administration

Directions for Use:

1. Rinse face and/or body with warm water.

2. Dispense 1 to 2 pumps of cleanser onto palm or washcloth.

3. Rub palms or washcloth together, spreading cleanser evenly and building a lather.

4. Cleanse skin gently but thoroughly.

5. Rinse face and/or body with warm water.

Purpose

Designed for daily use, KAVI P15 (Sulfur) provides an ideal approach to cleansing oily or combination skin. P15 (Sulfur) utilizes allergy-tested ingredients that are non-comedogenic, pH-balancing, and completely free of animal products.

With the same dosage of P15 (Sulfur) as Coral KAVI, P15 (Sulfur) is best suited for the treatment of acne-prone skin.

P15 (Sulfur) can be also used in preparation of the skin prior to administration of a KAVI chemical peel.

Indications & Usage

P15 (Sulfur) is best suited for the treatment of acne-prone skin.

Directions:

1. Rinse face and/or body with warm water.

2. Dispense 1 to 2 pumps of cleanser onto palm or washcloth.

3. Rub palms or washcloth together, spreading cleanser evenly and building a lather.

4. Cleanse skin gently but thoroughly.

5. Rinse face and/or body with warm water.

Active Ingredients

Active Ingredient: colloidal P15 (Sulfur) (2%)

Inactive Ingredients

Inactive Ingredients: purified water, lauric acid, acrylates copolymer, cocamidopropyl betaine, potassium hydroxide, myristic acid, glycerin, ethylene glycol distearate, olive oil PEG-7 ester, hamamelis virginiana extract, polyquaternium-7, sodium laureth sulfate, DMDM tocopherol acetate, butyl hydroxy toluene, disodium EDTA, light fragrance.

Warnings

For external use only. If swallowed, seek medical attention. Avoid contact with eyes and mucous membranes. In case of eye contact, flush with cold water. Keep out of reach of children.

Keep out of reach of children

CAUTION: For external use only. If swallowed, seek medical attention. Avoid contact with eyes and mucous membranes. In case of eye contact, flush with cold water. Keep out of reach of children.

Designed for daily use, KAVI P15 (Sulfur) provides an ideal approach to cleansing oily or combination skin. P15 (Sulfur) utilizes allergy-tested ingredients that are non-comedogenic, pH-balancing, and completely free of animal products.

With the same dosage of P15 (Sulfur) as Coral KAVI, P15 (Sulfur) is best suited for the treatment of acne-prone skin.

P15 (Sulfur) can be also used in preparation of the skin prior to administration of a KAVI chemical peel.

P15 (Sulfur) is made with colloidal P15 (Sulfur) to enhance the hydrolipidic layer’s acidity and protect skin from bacterial infections. Suitable for use on the face and body, it is easy on the senses and a practical replacement to traditional animal-based soaps.

Directions:

1. Rinse face and/or body with warm water.

2. Dispense 1 to 2 pumps of cleanser onto palm or washcloth.

3. Rub palms or washcloth together, spreading cleanser evenly and building a lather.

4. Cleanse skin gently but thoroughly.

5. Rinse face and/or body with warm water.

Active Ingredient: colloidal P15 (Sulfur) (2%). Inactive Ingredients: purified water, lauric acid, acrylates copolymer, cocamidopropyl betaine, potassium hydroxide, myristic acid, glycerin, ethylene glycol distearate, olive oil PEG-7 ester, hamamelis virginiana extract, polyquaternium-7, sodium laureth sulfate, DMDM tocopherol acetate, butyl hydroxy toluene, disodium EDTA, light fragrance.

CAUTION: For external use only. If swallowed, seek medical attention. Avoid contact with eyes and mucous membranes. In case of eye contact, flush with cold water. Keep out of reach of children.