Aquasol A - Vitamin A Palmitate injection, Solution
(Vitamin A Palmitate)Aquasol A - Vitamin A Palmitate injection, Solution Prescribing Information
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.
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.
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.
The intravenous administration. Hypervitaminosis A. Sensitivity to any of the ingredients in this preparation.
See
The following amounts have been found to be toxic orally. Toxicity manifestations depend on the age, dosage, size, and duration of administration.
Infant: 350,000 Units
Adult: Over 2 million Units
Infants 3 to 6 months old: 18,500 Units (water dispersed)/day for 1 to 3 months.
Adult: 1 million Units daily for three days; 50,000 Units daily for longer than 18 months; 500,000 Units daily for two months.
1.000000000000000e+00 General manifestations:Fatigue, malaise, lethargy, abdominal discomfort, anorexia, and vomiting.2.000000000000000e+00 Specific manifestations:a. Skeletal: hepatotoxicity, hard tender cortical thickening over the radius and tibia, migratory arthralgia, slow growth, and premature closure of the epiphysis leading to arrested bone growth in children.
b. Central Nervous System: irritability, headache, and increased intracranial pressure as manifested by bulging fontanels, papilledema, and exophthalmos.
c. Dermatologic: fissures of the lips, drying and cracking of the skin, alopecia, scaling, massive desquamation, and increased pigmentation.
d. Systemic: hypomenorrhea, hepatosplenomegaly, hepatotoxicity, jaundice, leukopenia, vitamin A plasma level over 1,200 Units/100 mL.
The treatment of hypervitaminosis A consists of immediate withdrawal of the vitamin along with symptomatic and supportive treatment.
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.
Beta-carotene, retinol, and retinal have effective and reliable vitamin A activity. Retinal and retinol are in chemical equilibrium in the body and have equivalent antixerophthalmic activity. Retinal combines with the rod pigment, opsin, in the retina to form rhodopsin, necessary for visual dark adaptation. Vitamin A prevents retardation of growth and preserves the epithelial cells' integrity. Normal adult liver storage is sufficient to satisfy two years' requirements of vitamin A.
Vitamin A is readily absorbed from the gastrointestinal tract, where the biosynthesis of vitamin A from beta-carotene takes place. Vitamin A absorption requires bile salts, pancreatic lipase, and dietary fat. It is transported in the blood to the liver by the chylomicron fraction of the lymph. Vitamin A is stored in Kupffer cells of the liver mainly as the palmitate. Normal serum vitamin A is 80–300 Units per 100 mL (plasma range is 30–70 mcg per dl) and for carotenoids 270–753 Units per 100 mL. The normal adult liver contains approximately 100 to 300 micrograms per gram, mostly as retinol palmitate.
*Oil-soluble vitamin A water solubilized with polysorbate 80.