Dosage Forms
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
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 [DSC]) [fragrance free; contains benzyl alcohol, cetyl alcohol, disodium edta, methylparaben, peg-10 soya sterol, trolamine (triethanolamine)]
AFirm 2X: 0.3% (30 g [DSC]) [fragrance free; contains benzyl alcohol, cetyl alcohol, disodium edta, methylparaben, peg-10 soya sterol, trolamine (triethanolamine)]
AFirm 3X: 0.6% (30 g [DSC]) [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, 3840 mL)
Solution, Intramuscular:
Aquasol A: 50,000 units/mL (2 mL) [contains chlorobutanol (chlorobutol), polysorbate 80]
Tablet, Oral:
Generic: 10,000 units, 15,000 units, Vitamin A 10000 units and beta carotene 1000 units [DSC]
Pharmacology
Mechanism of Action
Vitamin A is a fat soluble vitamin needed for visual adaptation to darkness, maintenance of epithelial cells, immune function and embryonic development.
Pharmacokinetics/Pharmacodynamics
Absorption
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
Distribution
Large amounts concentrate for storage in the liver
Metabolism
Converted in the small intestine to retinol and further metabolized in the liver; conjugated with glucuronide; undergoes enterohepatic recirculation
Excretion
Feces; urine
Use: Labeled Indications
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)
Use: Off Label
Xerophthalmia caused by vitamin A deficiencyyes
Based on the World Health Organization (WHO) Model Formulary, vitamin A given for the treatment of xerophthalmia caused by vitamin A deficiency is effective and recommended in the management of this condition.
Contraindications
Hypersensitivity to vitamin A or any component of the formulation; hypervitaminosis A; pregnancy (dose exceeding RDA); intravenous administration of Aquasol A
Dosage and Administration
Dosing: Adult
Note: Oral OTC supplements containing vitamin A may express the amount as mcg (retinol activity equivalents [RAE]) instead of (or in addition to) units; 1 unit = 0.3 mcg (RAE) = 0.3 mcg retinol (ASPEN [Vanek 2012]; IOM 2001).
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 (30,000 mcg)/day for 3 days, followed by 50,000 units (15,000 mcg)/day for 2 weeks
Note: Follow-up therapy with an oral therapeutic multivitamin (containing additional vitamin A) is recommended: Oral: 10,000 to 20,000 units (3,000 to 6,000 mcg)/day for 2 months
Deficiency (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 (60,000 mcg)/dose every 6 months (WHO 2008)
Pregnant females: Maximum 10,000 units (3,000 mcg)/day or 25,000 units (7,500 mcg) once weekly. Administer for a minimum of 12 weeks during pregnancy or until delivery (WHO 2008; WHO 2011c)
Postpartum females: 200,000 units (60,000 mcg) at delivery or within 8 weeks of delivery (WHO 2008)
Xerophthalmia, treatment (off-label use): Oral:
Adults (except females of reproductive age): 200,000 units (60,000 mcg) 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): 5,000 to 10,000 units (1,500 to 3,000 mcg)/day (maximum 10,000 units [3,000 mcg]/day) or ≤25,000 units (≤7,500 mcg) once weekly for ≥4 weeks
Severe xerophthalmia: Refer to adult dosing.
Dosing: Geriatric
Refer to adult dosing.
Dosing: Pediatric
Note: Vitamin A products may express the amount as mcg (retinol activity equivalents [RAE]) instead of (or in addition to) units; 1 unit retinol = 0.3 mcg RAE = 0.3 mcg retinol (NIH 2019).
Cystic fibrosis supplementation: Note: Typically administered as part of a fixed dosage product with other fat-soluble vitamins (eg, ADEK); however, some patients may require higher doses based on condition (CF liver disease [Debray 2011]); doses presented are in addition to usual RDA for age.
Infants: Oral: 1,500 units/day (450 mcg RAE/day) (Borowitz 2002; Borowitz 2009).
Children 1 to 3 years: Oral: 5,000 units/day (1,500 mcg RAE/day) (Borowitz 2002; Lahiri 2016).
Children 4 to 8 years: Oral: 5,000 to 10,000 units/day (1,500 to 3,000 mcg RAE/day) (Borowitz 2002; Lahiri 2016).
Children ≥9 years and Adolescents: Oral: 10,000 units/day (3,000 mcg RAE/day) (Borowitz 2002); some data suggest that dose should be individualized based on patient serum concentrations. Based on current US recommendations, some available multivitamin products may be excessive based on patient's needs, particularly in preadolescent patients (Bonifant 2014; Brei 2013; Graham-Maar 2006).
Malabsorption (eg, cholestasis, biliary atresia); supplementation: Limited data available: Children and Adolescents: Note: Specific dose should be based on serum markers and clinical condition; dose should be individualized: Oral: 5,000 to 15,000 units/day (1,500 to 4,500 mcg RAE/day) of water miscible product (eg, Aquasol A); begin at low end of the range for younger patients (Kelly 2007; Kliegman 2020).
Measles infection, supplementation: Limited data available (WHO 2004; WHO 2010; WHO 2017): Therapy should be initiated immediately upon diagnoses irrespective of previous doses (WHO 2017).
Infants <6 months: Oral: 50,000 units/day (15,000 mcg RAE/day) for 2 days.
Infants 6 to 11 months: Oral: 100,000 units/day (30,000 mcg RAE/day) for 2 days.
Infants ≥12 months and Children: Oral: 200,000 units/day (60,000 mcg RAE/day) for 2 days.
Note: If severe malnutrition or ophthalmologic evidence of vitamin A deficiency is present, administer a third dose 4 to 6 weeks after the second dose (WHO 2017); earlier administration of the third dose at 2 to 4 weeks following the second dose has also been suggested (AAP [Redbook 2018]; WHO 2004; WHO 2010).
Vitamin A deficiency; prevention for geographical at-risk populations: Note: Supplementation recommended in areas where vitamin A deficiency is a public health problem, including local prevalence of night blindness ≥1% in ages 24 to 59 months or prevalence of serum retinol ≤0.7 mmol/L is ≥20% in ages 6 to 59 months (WHO 2011).
Infants ≥6 months: Oral: 100,000 units/dose (30,000 mcg RAE/dose) administered once.
Children <5 years: Oral: 200,000 units/dose (60,000 mcg RAE/dose) administered as a single dose every 4 to 6 months.
Vitamin A deficiency, treatment:
Initial:
Infants: IM: 7,500 to 15,000 units/dose (2,250 to 4,500 mcg RAE/dose) once daily for 10 days followed by oral supplementation.
Children 1 to 8 years: IM: 17,500 to 35,000 units/dose (5,250 to 10,500 mcg RAE/dose) once daily for 10 days followed by oral supplementation.
Children >8 years and Adolescents: IM: 100,000 units/dose (30,000 mcg RAE/dose) once daily for 3 days; then 50,000 units/dose (15,000 mcg RAE/dose) once daily for 14 days followed by oral supplementation.
Maintenance oral supplementation: After completion of an IM course to correct deficiency, patient should continue on an oral supplementation for 2 months with a multivitamin preparation that contains: Infants and children <8 years: 5,000 to 10,000 units/day (1,500 to 3,000 mcg RAE/day); children ≥8 years and adolescents: 10,000 to 20,000 units/day (3,000 to 6,000 mcg RAE/day).
Xerophthalmia: Limited data available (WHO 1997; WHO 2010):
Infants <6 months: Oral: 50,000 units (15,000 mcg RAE) administered as a single dose; repeat the next day and again after at least 2 weeks for a total of 3 doses.
Infants 6 to 12 months: Oral: 100,000 units (30,000 mcg RAE) administered as a single dose; repeat the next day and again after at least 2 weeks for a total of 3 doses.
Children and Adolescents: Oral: 200,000 units (60,000 mcg RAE) administered as a single dose; repeat the next day and again after at least 2 weeks for a total of 3 doses.
Administration
May be administered orally or IM. Note: IV administration is contraindicated.
Dietary Considerations
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)
Dietary reference Intake (presented as retinol activity equivalent [RAE]) (IOM 2001):
1 to 6 months: Adequate intake: 400 mcg/day (1,330 units/day)
7 to 12 months: Adequate intake: 500 mcg/day (1,670 units/day)
1 to 3 years: RDA: 300 mcg/day (1,000 units/day)
4 to 8 years: RDA: 400 mcg/day (1,330 units/day)
9 to 13 years: RDA: 600 mcg/day (2,000 units/day)
>13 years: RDA: Females: 700 mcg/day (2,330 units/day); Males: 900 mcg/day (3,000 units/day)
Pregnancy: RDA: 14 to 18 years: 750 mcg/day (2,500 units/day); ≥19 years: 770 mcg/day (2,560 units/day)
Lactation: RDA: 14 to 18 years: 1,200 mcg/day (4,000 units/day); ≥19 years: 1,300 mcg/day (4,330 units/day)
Storage
Injection: Store at 2°C to 8°C (36°F to 46°F); do not freeze. Protect from light. Extended storage information at room temperature may be available; contact product manufacturer to obtain current recommendations.
Drug Interactions
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
Adverse Reactions
Frequency not defined: Hypersensitivity: Anaphylactic shock (following IV administration), hypersensitivity reaction (rare), intracranial hypertension (Tan 2019)
Warnings/Precautions
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.
Monitoring Parameters
Serum retinol
Pregnancy
Pregnancy Considerations
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 >6,000 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).
Patient Education
What is this drug used for?
- It is used to treat or prevent vitamin A deficiency.
- It is used to treat some skin problems.
Other side effects of this drug: Talk with your doctor right away if you have any of these signs of:
- A significant reaction like 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. Talk to your doctor if you have questions.
Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.
