Vitamin a palmitate

What is Vitamin a palmitate?

• Vitamin a palmitate (Aquasol A) provides 50,000 USP Units of vitamin A per mL as retinol (C20H30O) in the form of vitamin A palmitate.

Retinyl palmitate

Retinyl palmitate spacefill

What are the uses of this medicine?

• Vitamin a palmitate (Aquasol A) 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.

How does this medicine work?

• Beta-carotene, retinol, and retinal have effective and reliable vitamin A activity.
• 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.

Who Should Not Use this medicine ?

This medicine cannot be used in patients:

• with sensitivity to any of the ingredients in this preparation
• intravenous administration
• Hypervitaminosis A

What drug interactions can this medicine cause?

• Tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.

Be sure to mention any of the following:

• oral contraceptives

Is this medicine FDA approved?

• Yes, it was FDA approved.

How should this medicine be used?

Recommended dosage: Adults:

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

Pediatric patients 1 to 8 years old:

• 17,500 to 35,000 Units daily for 10 days.

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.

Administration:

• This product must be administrated as intramuscular injection.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Parenteral (water-miscible vitamin A Palmitate) injection 50,000 USP units/mL
• (15 mg retinol/mL)

This medicine is available in fallowing brand namesː

• Aquasol A

What side effects can this medication cause?

The most common side effects of this medicine include:

• Anaphylactic shock
• Allergic reactions
• Hypervitaminosis A Syndrome: Fatigue, malaise, lethargy, abdominal discomfort, anorexia, and vomiting

What special precautions should I follow?

• Avoid overdosage. Keep out of the reach of children.
• Polysorbates have been associated with E-Ferol syndrome (thrombocytopenia, renal dysfunction, hepatomegaly, cholestasis, ascites, hypotension and metabolic acidosis) in low birthweight infants.
• Protect from light.
• Prolonged daily dose administration over 25,000 Units vitamin A should be under close supervision.
• Women on oral contraceptives have shown a significant increase in plasma vitamin A levels.
• The U.S. Recommended Daily Allowance (RDA) of vitamin A (5,000 Units) is recommended for nursing mothers.
• Anaphylactic shock and death have been reported using the intravenous route.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

Hypervitaminosis A Syndrome:

General manifestations:

• Fatigue, malaise, lethargy, abdominal discomfort, anorexia, and vomiting.

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.

Management of overdosage:

• The treatment of hypervitaminosis A consists of immediate withdrawal of the vitamin along with symptomatic and supportive treatment.

Can this medicine be used 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.

Can this medicine be used in children?

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

What are the active and inactive ingredients in this medicine?

Active:

• VITAMIN A PALMITATE

Inactives:

• CHLOROBUTANOL
• POLYSORBATE 80
• CITRIC ACID MONOHYDRATE
• SODIUM HYDROXIDE

Who manufactures and distributes this medicine?

• Casper Pharma LLC

What should I know about storage and disposal of this medication?

• Store at 2–8°C (36–46°F).
• Do not freeze.

• Dailymed label info on Vitamin a palmitate
• FDA Vitamin a palmitate

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