(VYE ta min aye)
Treatment and prevention of vitamin A deficiency; parenteral (IM) route is indicated when oral administration is not feasible or when absorption is insufficient (malabsorption syndrome); dietary supplement (OTC)
Hypersensitivity to vitamin A or any component of the formulation; hypervitaminosis A; pregnancy (dose exceeding RDA); intravenous administration of Aquasol A � �
Dietary Reference Intake for vitamin A (presented as retinol activity equivalent [RAE]) (IOM, 2000): Oral:
Recommended dietary allowance (RDA):
Males: 900 mcg/day (3000 units/day)
Females: 700 mcg/day (2330 units/day)
Pregnant females ≥19 years: 770 mcg/day (2560 units/day)
Lactating females ≥19 years: 1300 mcg/day (4330 units/day)
Deficiency (manufacturer recommendation): IM: Note: IM route is indicated when oral administration is not feasible or when absorption is insufficient (malabsorption syndrome): 100,000 units/day for 3 days, followed by 50,000 units/day for 2 weeks
Note: Follow-up therapy with an oral therapeutic multivitamin (containing additional vitamin A) is recommended: Oral: 10,000-20,000 units/day for 2 months
High-dose supplementation in patients at high risk for deficiency (off-label dose) (eg, persons living in developing areas of the world where deficiency is a public health problem, especially persons with severe infectious disease or malnutrition): Oral:
Adults: 200,000 units/dose every 6 months (WHO, 2008)
Pregnant females: Maximum 10,000 units daily or 25,000 units once weekly. Administer for a minimum of 12 weeks during pregnancy or until delivery (WHO, 2008; WHO, 2011c)
Postpartum females: 200,000 units at delivery or within 8 weeks of delivery (WHO, 2008)
Treatment of xerophthalmia (off-label use): Oral:
Adults (except females of reproductive age): 200,000 units once daily for 2 days; repeat with single dose after 2 weeks (WHO, 2008)
Females of reproductive age (WHO, 1997; WHO, 2008):
With night blindness or Bitot 's spots (less severe xerophthalmia): 5000-10,000 units daily (maximum 10,000 units/day) or ≤25,000 units once weekly for ≥4 weeks
Severe xerophthalmia: Refer to adult dosing.
Refer to adult dosing.
Dietary Reference Intake for vitamin A (presented as retinol activity equivalent [RAE]) (IOM, 2000): Oral:
Adequate intake (AI):
1-6 months: 400 mcg/day (1330 units/day)
7-12 months: 500 mcg/day (1670 units/day)
Recommended dietary allowance (RDA):
1-3 years: 300 mcg/day (1000 units/day)
4-8 years: 400 mcg/day (1330 units/day)
9-13 years: 600 mcg/day (2000 units/day)
Males >13 years: 900 mcg/day (3000 units/day)
Females >13 years: 700 mcg/day (2330 units/day)
Pregnant females 14-18 years: 750 mcg/day (2500 units/day)
Lactating females 14-18 years: 1200 mcg/day (4000 units/day)
Deficiency (manufacturer recommendation): IM: Note: IM route is indicated when oral administration is not feasible or when absorption is insufficient (malabsorption syndrome):
Infants: 7500-15,000 units/day for 10 days
Children 1-8 years: 17,500-35,000 units/day for 10 days
Children >8 years: Refer to adult dosing.
Note: Follow-up therapy with an oral therapeutic multivitamin (containing additional vitamin A) is recommended: Oral:
Low Birth Weight Infants: Additional vitamin A is recommended; however, no dosage amount has been established.
Children ≤8 years: 5000-10,000 units/day for 2 months
Children >8 years: Refer to adult dosing.
High-dose supplementation in patients at high risk for deficiency (off-label dose) (eg, persons living in developing areas of the world where deficiency is a public health problem, especially persons with severe infectious disease or malnutrition): Oral:
Infants <6 months: Not recommended (WHO, 2011a)
Infants 6-12 months: 100,000 units/dose; repeat every 4-6 months, but do not readminister within 30 days of previous dose (WHO, 1997; WHO, 2010)
Children >1 year: 200,000 units/dose; repeat every 4-6 months, but do not readminister within 30 days of previous dose (WHO, 1997; WHO, 2010)
Treatment of measles (off-label use) (WHO, 2004; WHO, 2010): Oral: Note: Repeat with single dose in 2-4 weeks if severe malnutrition exists or ophthalmic evidence of a vitamin deficiency is present:
Infants <6 months: 50,000 units once daily for 2 days
Infants 6-11 months: 100,000 units once daily for 2 days
Children >11 months to 5 years: 200,000 units once daily for 2 days
Treatment of xerophthalmia (off-label use): Oral:
Infants <6 months: 50,000 units once daily for 2 days; repeat with single dose after 2 weeks (WHO, 2010)
Infants 6-12 months: 100,000 units once daily for 2 days; repeat with single dose after 2 weeks (WHO, 2010)
Children >1 year (except females of reproductive age): 200,000 units once daily for 2 days; repeat with single dose after 2 weeks (WHO, 2008)
Females of reproductive age: Refer to adult dosing.
May be administered orally or IM. Note: IV administration is contraindicated.
Dairy products, fish, and liver are common dietary sources of vitamin A; broccoli, cantaloupe, carrots, peas, spinach, and squash are sources of beta-carotene (which is converted to vitamin A) (IOM, 2000)
Injection: Store at 2 � �C to 8 � �C (36 � �F to 46 � �F); do not freeze. Protect from light. The following stability information has also been reported for Aquasol A � � injection: May be stored at room temperature for up to 4 weeks (Cohen, 2007).
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Capsule, Oral:
A-25: 25,000 units
Vitamin A Fish: 7500 units
Generic: 10,000 units
Capsule, Oral [preservative free]:
A-25: 25,000 units [dye free]
Generic: 8000 units
Cream, External:
AFirm 1X: 0.15% (30 g) [fragrance free; contains benzyl alcohol, cetyl alcohol, disodium edta, methylparaben, peg-10 soya sterol, trolamine (triethanolamine)]
AFirm 2X: 0.3% (30 g) [fragrance free; contains benzyl alcohol, cetyl alcohol, disodium edta, methylparaben, peg-10 soya sterol, trolamine (triethanolamine)]
AFirm 3X: 0.6% (30 g) [fragrance free; contains benzyl alcohol, cetyl alcohol, disodium edta, methylparaben, peg-10 soya sterol, trolamine (triethanolamine)]
Gordons-Vite A: 100,000 units/g (75 g, 120 g, 480 g, 2400 g)
Lotion, External:
Gordons-Vite A: 100,000 units (120 mL, 4000 mL)
Solution, Intramuscular:
Aquasol A: 50,000 units/mL (2 mL) [contains chlorobutanol (chlorobutol)]
Tablet, Oral:
Generic: 10,000 units, 15,000 units, Vitamin A 10000 units and beta carotene 1000 units
Bexarotene (Topical): Vitamin A may enhance the adverse/toxic effect of Bexarotene (Topical). Management: Limit doses of vitamin A to 5,000 units per day if combined with topical bexarotene. Consider therapy modification
Orlistat: May decrease the serum concentration of Vitamins (Fat Soluble). Management: Administer oral fat soluble vitamins at least 2 hours before or after the administration of orlistat. Similar precautions do not apply to parenterally administered fat soluble vitamins. Consider therapy modification
Retinoic Acid Derivatives: Vitamin A may enhance the adverse/toxic effect of Retinoic Acid Derivatives. Exceptions: Adapalene; Alitretinoin (Topical); Bexarotene (Topical); Tretinoin (Topical). Avoid combination
Frequency not defined: Miscellaneous: Allergic reactions (rare), anaphylactic shock (following IV administration)
Dosage form specific issues:
- Benzyl alcohol and derivatives: Some dosage forms may contain benzyl alcohol; large amounts of benzyl alcohol ( ≥99 mg/kg/day) have been associated with a potentially fatal toxicity ( "gasping syndrome " �) in neonates; the "gasping syndrome " � consists of metabolic acidosis, respiratory distress, gasping respirations, CNS dysfunction (including convulsions, intracranial hemorrhage), hypotension, and cardiovascular collapse (AAP [Inactive" 1997]; CDC, 1982); some data suggests that benzoate displaces bilirubin from protein binding sites (Ahlfors, 2001); avoid or use dosage forms containing benzyl alcohol with caution in neonates. See manufacturer 's labeling.
- Parenteral vitamin A: In low birth weight infants, polysorbates have been associated with thrombocytopenia, renal dysfunction, hepatomegaly, cholestasis, ascites, hypotension, and metabolic acidosis (E-Ferol syndrome).
- Polysorbate 80: Some dosage forms may contain polysorbate 80 (also known as Tweens). Hypersensitivity reactions, usually a delayed reaction, have been reported following exposure to pharmaceutical products containing polysorbate 80 in certain individuals (Isaksson, 2002; Lucente 2000; Shelley, 1995). Thrombocytopenia, ascites, pulmonary deterioration, and renal and hepatic failure have been reported in premature neonates after receiving parenteral products containing polysorbate 80 (Alade, 1986; CDC, 1984). See manufacturer 's labeling.
Other warnings/precautions:
- Appropriate use: Evaluate other sources of vitamin A while receiving this product; patients receiving >25,000 units/day should be closely monitored for toxicity.
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Adverse events have been observed in animal reproduction studies. In humans, the critical period of exposure is the first trimester of pregnancy. Excess vitamin A during pregnancy may cause craniofacial malformations, as well as CNS, heart, and thymus abnormalities. Maternal vitamin A deficiency also causes adverse effects in the fetus, and vitamin A requirements are increased in pregnant women (IOM, 2000). The manufacturer notes that the safety of doses >6000 units/day in pregnant women has not been established and doses greater than the RDA are contraindicated in pregnant women or those who may become pregnant. High doses are used in some areas of the world for supplementation where deficiency is a public health problem (eg, to prevent night blindness); however, single doses >25,000 units should be avoided within 60 days of conception. High-dose supplementation is otherwise not recommended as part of routine antenatal care (WHO, 2011c).
Vitamin A is a fat soluble vitamin needed for visual adaptation to darkness, maintenance of epithelial cells, immune function and embryonic development.
Vitamin A in dosages not exceeding physiologic replacement is well absorbed in the small intestine after oral administration; water miscible preparations are absorbed more rapidly than oil preparations; large oral doses, conditions of fat malabsorption, low protein intake, or hepatic or pancreatic disease reduces oral absorption
Large amounts concentrate for storage in the liver
Converted in the small intestine to retinol and further metabolized in the liver; conjugated with glucuronide; undergoes enterohepatic recirculation
Feces; urine
- Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)
- Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.
Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.