Dosing & Uses
Dosage Forms & Strengths
capsule
- 7,500 U
- 8000 U
- 10,000 U
- 25,000 U
injectable solution
- 50,000 U/mL
tablet
- 10,000 U
- 15,000 U
RDA
Described as retinol activity equivalent (RAE)
1 RAE = Retinol 1 mcg
Males: 900 mcg/day (3000 U/day)
Females
- 700 mcg/day (2330 U/day)
- >18 years pregnant: 750-770 mcg/day (2500-2600 U/day)
- >18 years breastfeeding: 1300 mcg RAE (4330 U)
Upper Intake Levels
>18 years: 3000 mcg/day RAE (10,000 U)
Pregnancy: 3000 mcg/day RAE (10,000 U)
Lactation: 3000 mcg/day RAE (10,000 U)
Vitamin A Deficiency
Malabsorption or oral administration not feasible: 100,000 U/day IM for 3 days; then 50,000 U/day for 2 weeks; follow with oral therapy.
Oral therapy: Take oral therapeutic multivitamin containing 10,000-20,000 U/day vitamin A for 2 months
Deficiency prophylaxis: 10,000-50,000 U PO qDay
Xerophthalmia (Off-label)
Recommended dose except for females of reproductive age: 200,000 units PO qDay for 2 days; repeat dose again after 2 weeks
Females of reproductive age with night blindness or Bitot's spots: 5000-10,000 units/day; 10,000 units/day maximum or ≤25,000 units once weekly for ≥4 weeks
Bronchopulmonary Dysplasia (Orphan)
Orphan designation of vitamin A palmitate for prevention of bronchopulmonary dysplasia
Sponsors
- Fox Pharma, Inc; 6097 Hidden Valley Drive; Doylestown, PA 18902
- Advent Therapeutics, Inc; 6500 Old Carversville Road; Lumberville, PA 18933-9729
Dosage Forms & Strengths
capsule
- 7,500 U
- 8,000 U
- 10,000 U
- 25,000 U
injectable solution
- 50,000 U/mL
tablet
- 10,000 U
- 15,000 U
RDA
0-6 months: 400 mcg/day RAE (1333 U/day)
6-12 months: 500 mcg/day RAE (1666 U/day)
1-3 years: 300 mcg/day RAE (1000 U/day)
3-8 years: 400 mcg/day RAE (1333 U/day)
8-13 years: 600 mcg/day RAE (2000 U/day)
13-18 years: 900 mcg/day RAE (3000 U/day)
Upper Intake Levels
0-3 years: 600/day mcg RAE (2000 U/day)
3-8 years: 900/day mcg RAE (3000 U/day)
8-13 years: 1700 mcg/day RAE (5667 U/day)
13-18 years: 2800 mcg/day RAE (9333 U/day)
13-18 years pregnant: 2800 mcg/day RAE (9333 U/day)
13-18 years breastfeeding: 2800 mcg/day RAE (9333 U/day)
Deficiency
Use IM route when oral administraiton is not possible or in malabsorption syndrome
Infants: 7500-15000 units/day for 10 days
1-8 years: 17,500-35,000 units/day for 10 days
>8 years
- Malabsorption or oral administration not feasible: 100,000 U/day IM for 3 days; then 50,000 U/day for 2 weeks; follow with oral therapy.
- Oral therapy: Take oral therapeutic multivitamin containing 10,000-20,000 U/day vitamin A for 2 months
- Deficiency prophylaxis: 10,000-50,000 U PO qDay
Xerophthalmia
<6 months: 50,000 units qDay for 2 days; repeat once with single dose after 2 weeks
6-12 months: 100,000 units qDay for 2 days; repeat with single dose after 2 weeks
>1 year except females of reproductive age: 200,000 units qDay for 2 days; repeat with single dose after 2 weeks
Females of reproductive age with night blindness or Bitot's spots: 5000-10,000 units/day; 10,000 units/day maximum or ≤25,000 units once weekly for ≥4 weeks
Retinopathy of Prematurity (Orphan)
Retinol palmitate
Orphan designation for prevention of retinopathy of prematurity (ROP)
Sponsor
- Orphanix GmbH; 41 Peter-Rosegger-Strabe; Ried im Innkreis; Austria
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Adverse Effects
Frequency Not Defined
Anaphylaxsis & death after IV use
Facial dermatitis
Stratum corneum fragility
Conjunctivities
Sticky skin
Granuloma-like lesions in acne
Dry mucus
Paranochia
Corneal opacities
Palmoplanar peeling
Cheilitis
Alopecia
Warnings
Contraindications
Hypersensitivity
IV use
Hypervitaminosis A
Malabasorption syndrome (oral therapy)
Pregnancy (dose >RDA)
Cautions
Use caution if dose >25,000 units/day (monitor closely)
Evaluate additional vitamin deficiencies if diagnosis of vitamin deficiency occurs (single vitamin A deficiency rare)
Caution in renal impairment (toxicity reported)
Monitor prolonged administration over 25,000 units/day; take into account vitamin intake from other dietary and supplement sources
Efficacy of large systemic doses of 100,000 to 300,000 units/day vitamin A for the treatment of acne not established
Pregnancy & Lactation
Pregnancy Category: A (oral); C (doses exceeding RDA); X (>6,000 units/day administered parenterally)
Lactation: Distributed into milk; safe at RDA levels
Pregnancy Categories
A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA:Information not available.
Nutrition
Sources: Liver, butter, eggs, green leafy vegetables, colorful fruits & vegetables (carrots, mango, pumpkin, sweet potatoes)
Functions: Growth & development, maintenance of epithelial tissue
Deficiency: Night blindness, dry eyes, susceptibility to infections, follicular hyperkeratosis
Toxicity: hypervitaminosis A
Acute: Nausea, fatigue, dizziness, dry skin, cerebral edema, increased ICP, skin loss, liver failure
Chronic: Osteoporosis, hair loss, high cholesterol, coma, swelling of the optic eye, rash, mouth sores, liver failure
Teratogenicity: fetal toxicity, birth defects (>10,000 units/day)
Pharmacology
Mechanism of Action
Vitamin A supplementation plays a role in embryonic development, visual adaptation to darkness, immune function, and maintenance of epithelial cells
Pharmacokinetics
Serum concentration: 300-700 ng/mL (adults); 200-500 ng/mL (infants)
Peak plasma time: 4-5 hr (oil solution); 304 hr (water-miscible)
Protein Bound: Retinol binding protein
Distribution: Mainly stored in liver as retinyl palmitate
Metabolism: hepatic glucuronidation, decarboxylation
Metabolites: retinoic acid, retinal
Excretion: Urine and feces (via bile)
