Drugs List

Therapeutic Indications

Uses

Prophylaxis of vitamin A and D deficiency.

Administration

For oral administration.

Contraindications

Hypersensitivity to arachis oil (peanuts)

Hypercalcaemia

Metastatic calcification

Severe renal impairment

Precautions and Warnings

Not all available brands are licensed for all age groups

Infants under 1 year: Capsule formulation may not be suitable for this age group

Children: May have increased sensitivity to the effects of vitamin A and D

Patients with renal impairment, calculi or heart disease may be at increased risk of organ damage if hypercalcaemia occurs

Pregnancy (see Pregnancy section)

Lactation (see Lactation section)

Excessive prolonged dosage of vitamin A and D may lead to hypervitaminosis

Patients should not exceed recommended dose

Absorption of vitamin A may be impaired in cholestatic jaundice, fat-malabsorption conditions, hepatic or pancreatic impairment

Patients with hepatic impairment may have enhanced susceptibility to the effects of vitamin A

Plasma calcium levels should be checked regularly in patients receiving pharmacological doses of vitamin D particularly when nausea and vomiting are present

Plasma phosphate concentrations should be controlled during vitamin D therapy to reduce the risk of ectopic calcification

Some formulations may contain arachis oil.

Pregnancy and Lactation

Pregnancy

The fat soluble vitamins A and D may be toxic or teratogenic in high doses. Deficiencies of vitamins may also be teratogenic. Doses in excess of those recommended should be avoided during pregnancy.

Vitamin A

Caution should be used in pregnancy as excessive doses of vitamin A may be teratogenic, especially when taken in the first trimester. Various recommendations concerning dosage of vitamin A in pregnancy have been made but further research is needed to define more clearly the boundary between risk and benefit in vitamin A supplementation. Some authorities advise that women who are, or who wish to become pregnant, should not take vitamin A supplements except on the advice of a doctor or an antenatal clinic.

Vitamin D

High doses of vitamin D have been shown to be teratogenic in animals but there is no conclusive evidence of problems in humans and very high doses of vitamin D used to treat maternal hypoparathyroidism during pregnancy have not been associated with foetal abnormalities.

Lactation

Vitamin A

Is found in the breast milk of lactating mothers and there is therefore a theoretical risk of neonatal toxicity.

Vitamin D

Vitamin D is excreted into breast milk in limited amounts.
Large doses of vitamin D in lactating mothers may cause hypercalcaemia in infants.

Doses in excess of those recommended should be avoided during lactation.

Serum calcium levels of the infant should be monitored if the mother is receiving pharmacological doses.

Side Effects

None in the absence of overdosing.

Presentation

Capsules containing:
Vitamin A 4000 international units (1.2mg)
Vitamin D 400 international units (10 micrograms)

Drugs List

Therapeutic Indications

Uses

Prophylaxis of vitamin A and D deficiency.

Dosage

Adults

Elderly

Children

Patients with Renal Impairment

Administration

For oral administration.

Contraindications

Hypersensitivity to arachis oil (peanuts)

Hypercalcaemia

Metastatic calcification

Severe renal impairment

Precautions and Warnings

Not all available brands are licensed for all age groups

Infants under 1 year: Capsule formulation may not be suitable for this age group

Children: May have increased sensitivity to the effects of vitamin A and D

Patients with renal impairment, calculi or heart disease may be at increased risk of organ damage if hypercalcaemia occurs

Pregnancy (see Pregnancy section)

Lactation (see Lactation section)

Excessive prolonged dosage of vitamin A and D may lead to hypervitaminosis

Patients should not exceed recommended dose

Absorption of vitamin A may be impaired in cholestatic jaundice, fat-malabsorption conditions, hepatic or pancreatic impairment

Patients with hepatic impairment may have enhanced susceptibility to the effects of vitamin A

Plasma calcium levels should be checked regularly in patients receiving pharmacological doses of vitamin D particularly when nausea and vomiting are present

Plasma phosphate concentrations should be controlled during vitamin D therapy to reduce the risk of ectopic calcification

Some formulations may contain arachis oil.

Pregnancy and Lactation

Pregnancy

The fat soluble vitamins A and D may be toxic or teratogenic in high doses. Deficiencies of vitamins may also be teratogenic. Doses in excess of those recommended should be avoided during pregnancy.

Vitamin A

Caution should be used in pregnancy as excessive doses of vitamin A may be teratogenic, especially when taken in the first trimester. Various recommendations concerning dosage of vitamin A in pregnancy have been made but further research is needed to define more clearly the boundary between risk and benefit in vitamin A supplementation. Some authorities advise that women who are, or who wish to become pregnant, should not take vitamin A supplements except on the advice of a doctor or an antenatal clinic.

Vitamin D

High doses of vitamin D have been shown to be teratogenic in animals but there is no conclusive evidence of problems in humans and very high doses of vitamin D used to treat maternal hypoparathyroidism during pregnancy have not been associated with foetal abnormalities.

Lactation

Vitamin A

Is found in the breast milk of lactating mothers and there is therefore a theoretical risk of neonatal toxicity.

Vitamin D

Vitamin D is excreted into breast milk in limited amounts.
Large doses of vitamin D in lactating mothers may cause hypercalcaemia in infants.

Doses in excess of those recommended should be avoided during lactation.

Serum calcium levels of the infant should be monitored if the mother is receiving pharmacological doses.

Effects on Ability to Drive and Operate Machinery

There are no known effects on the ability to drive or operate machinery.

Counselling

Advise patients not to exceed the stated dose.

Side Effects

None in the absence of overdosing.

Overdosage

It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

The following number will direct the caller to the relevant local centre (0844) 892 0111

Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet (https://www.toxbase.org/)

Shelf Life and Storage

Protect from light
Store in a dry place below 25 degrees C

Reference Sources

Summary of Product Characteristics for Vitamins A & D Capsules BPC from RP Scherer Limited dated February 1998

BNF 52 September 2006

BNF for Children 2006

Martindale 35th Edition

Therapeutics in Pregnancy and Lactation
ed. Lee, A et al
Radcliffe Medical Press, Abingdon, 2000

Drugs in Pregnancy and Lactation, 7th edition
ed. Briggs, G et al
Lippincott Williams & Wilkins, Philadelphia 2005

Medicines For Children
RCPCH Publications Ltd, London, 2003

Dietary Supplements, 2nd edition
ed. Mason, P
Pharmaceutical Press, London, 2001