Vitamin A

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.

Vitamin A is found in foods such as liver, milk, cheese, eggs, carrots, squash, dark green and yellow vegetables, and fruits such as cantaloupe or apricots. Vitamin A is important for the eyes and skin, and for normal growth.

Vitamin A is used to treat vitamin A deficiency.

Vitamin A may also be used for purposes not listed in this medication guide.

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Vitamin A is found in foods such as liver, milk, cheese, eggs, carrots, squash, dark green and yellow vegetables, and fruits such as cantaloupe or apricots. Vitamin A is important for the eyes and skin, and for normal growth.

Vitamin A is used to treat vitamin A deficiency.

Vitamin A may also be used for purposes not listed in this medication guide.

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Avoid taking orlistat (alli, Xenical) or mineral oil while you are taking vitamin A.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Less serious side effects are more likely to occur, and you may have none at all.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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.

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.

Frequency not defined: Hypersensitivity: Anaphylactic shock (following IV administration), hypersensitivity reaction (rare)