Aksoderm Forte

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.

For intramuscular use.

I. Adults

100,000 Units daily for three days followed by 50,000 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.

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 over-dosage in several species. Malformations of the central nervous system, the eye, the palate, and the urogenital tract are recorded. Vitamin Ain excess of the recommended dietary allowance is contraindicated in women who are or may become pregnant. If vitamin Ais 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.

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 birth-weight infants.

PRECAUTIONS

General: Protect from light. Prolonged daily dose administration over 25,000 Units vitamin Ashould 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.

See OVERDOSAGE section. Anaphylactic shock and death have been reported using the intravenous route. Allergic reactions have been reported rarely with administration of Aksoderm Forte® Parenteral (vitamin a) including one case of an anaphylactoid type reaction.

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.