Retinol 1514 views0 applications

Australian approved name (AAN): Retinol

Common names and synonyms: Retinol anhydrous; Vitamin A alcohol; Retinyl; Vitamin A

Molecular formula: C20H30O

Molecular weight: 286.45

Conversions per unit:
1mg = 1mgRE
1mg = 3333IU
1IU = 0.3µgRE
1µgRE = 1µg

RDI as retinol equivalents per NHMRC:
Infants – 0-6 months – 250µg/day retinol (as retinyl esters) (AI)
Infants – 7-12 months – 430µg/day RE (AI)
Children – 1-3 years – 300µg/day
Children – 4-8 years – 400µg/day
Children – 9-13 years – 600µg/day
Boys – 14-18 years – 900µg/day
Girls – 14-18 years – 700µg/day
Men – 900µg/day
Women – 700µg/day
Pregnancy – 14-18 years – 700µg/day
Pregnancy – 19-50 years – 800µg/day
Lactation – 1100µg/day

Mandatory component: Vitamin A

Maximum daily dose: When for internal use the MRDD must be no more than 3000µg RE of Vitamin A. When for topical use the concentration of Vitamin A in the medicine must be no more than 1%.

Warnings and Restrictions: When preparations for internal use in adults contain more than 33 micrograms of retinol equivalents per dosage unit in divided preparations or per gram of an undivided preparation, the medicine requires the following warning statements on the medicine label:
VITA2 – WARNING: If you are pregnant – or considering becoming pregnant – do not take Vitamin A supplements without consulting your doctor or pharmacist [or words to that effect]. NOTE: Position this warning at the beginning of the directions for use.
VITA4 – WARNING – When taken in excess of 3000 micrograms retinol equivalents – Vitamin A can cause birth defects. NOTE: Position this warning at the beginning of the directions for use.
VITA3 – The recommended daily amount of Vitamin A from all sources is 700 micrograms retinol equivalents for women and 900 micrograms retinol equivalents for men.

When used as an active ingredient and the route of administration is oral or sublingual, the medicine requires the following warning statement on the medicine label:
VIT – Vitamins can only be of assistance if the dietary vitamin intake is inadequate. or Vitamin supplements should not replace a balanced diet.

Allowable purpose of the ingredient: Active. Excipient

TGA reference: British Approved Name issued by the British Pharmacopoeia Commission

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