VITAMIN A: 680 Adverse Event Reports & Safety Profile

DESCRIPTION AQUASOL A TM Parenteral (water-miscible vitamin A Palmitate) provides 50,000 USP Units of vitamin A per mL as retinol (C 20 H 30 O) in the form of vitamin A palmitate, a light yellow to amber oil.

Contains

0.5% chlorobutanol as preservative; 12% polysorbate 80, 0.1% citric acid, and sodium hydroxide to adjust pH. The structural formula of retinol is: Ordinarily oil-soluble, the vitamin A in this product has been water solubilized by special processing* and is available in a water solution for intramuscular injection. One USP Unit is equivalent to one international unit (IU) and to 0.3 mcg of retinol or 0.6 mcg of betacarotene.

Structural

Formula for AQUASOL

INDICATIONS Vitamin A injection is effective for the treatment of vitamin A deficiency. The parenteral administration is indicated when the oral administration is not feasible as in anorexia, nausea, vomiting, pre- and postoperative conditions, or it is not available as in the "Malabsorption Syndrome" with accompanying steatorrhea.

Pediatric

Use: Vitamin A treatment for deficiency states has been recognized as an especially effective and important therapy in the pediatric population. Vitamin A supplementation for deficiency states in this population has been addressed by the Committee on Clinical Practice Issues of the American Society for Clinical Nutrition, by the American Society for Parenteral and Enteral Nutrition, and by the World Health Organization.

DOSAGE AND ADMINISTRATION For intramuscular use. I.

Adults

100,000 Units daily for three days followed by 50,000 Units daily for two weeks. II. Pediatric patients 1 to 8 years old 17,500 to 35,000 Units daily for 10 days. III.

Infants

7,500 to 15,000 Units daily for 10 days. Follow-up therapy with an oral therapeutic multivitamin preparation, containing 10,000 to 20,000 Units vitamin A for adults and for pediatric patients over 8 years old, and 5,000 to 10,000 Units for infants and other pediatric patients under 8 years old, is recommended daily for two months. Low birth-weight infants may require additional vitamin A though the exact dosing in these pediatric patients has not been established. In malabsorption, the parenteral route must be used for an equivalent preparation. Poor dietary habits should be corrected and an abundant and well-balanced dietary intake should be prescribed.

CONTRAINDICATIONS The intravenous administration. Hypervitaminosis A. Sensitivity to any of the ingredients in this preparation. Use in Pregnancy: Safety of amounts exceeding 6,000 Units of vitamin A daily during pregnancy has not been established at this time. The use of vitamin A in excess of the recommended dietary allowance may cause fetal harm when administered to a pregnant woman. Animal reproduction studies have shown fetal abnormalities associated with overdosage in several species. Malformations of the central nervous system, the eye, the palate, and the urogenital tract are recorded. Vitamin A in excess of the recommended dietary allowance is contraindicated in women who are or may become pregnant. If vitamin A is used during pregnancy, or if the patient becomes pregnant while taking vitamin A, the patient should be apprised of the potential hazard to the fetus.

ADVERSE REACTIONS See OVERDOSAGE section. Anaphylactic shock and death have been reported using the intravenous route. Allergic reactions have been reported rarely with administration of AQUASOL A TM Parenteral including one case of an anaphylactoid type reaction.

WARNINGS Avoid overdosage. Keep out of the reach of children.

Pediatric

Use: Polysorbates have been associated with E-Ferol syndrome (thrombocytopenia, renal dysfunction, hepatomegaly, cholestasis, ascites, hypotension and metabolic acidosis) in low birthweight infants.

PRECAUTIONS General: Protect from light. Prolonged daily dose administration over 25,000 Units vitamin A should be under close supervision. Blood level assays are not a direct measure of liver storage. Liver storage should be adequate before discontinuing therapy. Single vitamin A deficiency is rare. Multiple vitamin deficiency is expected in any dietary deficiency.

Drug

Interactions: Women on oral contraceptives have shown a significant increase in plasma vitamin A levels. Carcinogenesis: There are no studies that show that administration of vitamin A will cause or prevent cancer. Pregnancy: See CONTRAINDICATIONS section.

Nursing

Mothers: The U.S.

Recommended Daily

Allowance (RDA) of vitamin A (5,000 Units) is recommended for nursing mothers.

Active ingredient Purpose Vitamin A 0.01% --------------------- Skin protectant

Inactive ingredients (INCI) of Skintex® Slimming/R6: Butyrospermum Parkii (Shea Butter) Extract, Caffeine, Caprylic/Capric Triglyceride - Gelidium Cartilagineum Extract, Ethylhexylglycerin, Parfum, Phenoxyethanol, Potassium Oleate, Prunus Armeniaca (Apricot)

Kernel

Oil, Rosa Canina Seed Extract, Seed Oil, Simmondsia Chinensis (Jojoba), Sodium Ascorbate, Sodium Polyacrylate, Tocopherol, Tocopheryl Acetate, Urea