Aquasol A

The following amounts have been found to be toxic orally. Toxicity manifestations depend on the age, dosage, size, and duration of administration.

Acute toxicity - single dose (25,000 Units/kg body weight)

Infant: 350,000 Units

Adult: Over 2 million Units

Chronic toxicity (4,000 Units/kg body weight for 6 to 15 months)

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.

Hypervitaminosis A Syndrome

1. General manifestations:
   Fatigue, malaise, lethargy, abdominal discomfort, anorexia, and vomiting.
2. Specific manifestations:
   1. 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.
   2. Central Nervous System: irritability, headache, and increased intracranial pressure as manifested by bulging fontanels, papilledema, and exophthal-mos.
   3. Dermatologic: fissures of the lips, drying and cracking of the skin, alopecia, scaling, massive desquamation, and increased pigmentation.
   4. 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.

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 epithe-lial 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 chy-lomicron fraction of the lymph. Vitamin Ais 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.

Before using vitamin A, talk to your doctor, pharmacist, herbalist, or other healthcare provider. You may not be able to use vitamin A if you have certain medical conditions.

Do not take vitamin A without medical advice if you are pregnant. Although some vitamin A is needed for the normal development of a baby, vitamin A can cause birth defects if taken in large doses. You may need to use a prenatal vitamin specially formulated for pregnant women.

Ask your doctor about taking vitamin A if you are breast-feeding a baby. Your dose needs may be different while you are nursing.

In the U.S.

• Aquasol A
• Palmitate-A

Available Dosage Forms:

• Capsule, Liquid Filled
• Capsule
• Tablet
• Liquid
• Solution
• Tablet, Chewable

Therapeutic Class: Nutritive Agent

Pharmacologic Class: Vitamin A (class)

Vitamin A is stored in the body; therefore, when you take more than the body needs, it will build up in the body. This may lead to poisoning and even death. Problems are more likely to occur in:

• Adults taking 7500 RE (25,000 Units) a day for 8 months in a row, or 450,000 RE (1,500,000 Units) all at once; or
• Children taking 5400 RE (18,000 Units) to 15,000 RE (50,000 Units) a day for several months in a row, or 22,500 RE (75,000 Units) to 105,100 RE (350,000 Units) all at once.
• Pregnant women taking more than 1800 RE (6000 Units) a day.

Remember that the total amount of vitamin A you get every day includes what you get from foods that you eat and what you take as a supplement.

High doses and/or prolonged use of vitamin A may cause bleeding from the gums; dry or sore mouth; or drying, cracking, or peeling of the lips.

AQUASOL ATM Parenteral (water-miscible vitamin A Palmitate) provides 50,000 USP Units of vitamin A per mL as retinol (C20H30O) 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.

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.

Avoid taking orlistat (alli, Xenical) or mineral oil while you are taking vitamin A.