Queratal

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 Queratal® 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.

• R52.1 – Chronic intractable pain
• R52.2 – Other chronic pain
• R52.9 – Unspecified pain

• R52.1 – Chronic intractable pain
• R52.2 – Other chronic pain
• R52.9 – Unspecified pain

• R52.1 – Chronic intractable pain
• R52.2 – Other chronic pain
• R52.9 – Unspecified pain