Drugs List

Therapeutic Indications

Uses

Vitamin deficiency - prophylaxis

Prevention of vitamin deficiency in conditions such as galactosaemia, disaccharide intolerance, phenylketonuria and other disorders of carbohydrate or amino acid metabolism, as well as in patients who are on restricted, specialised or synthetic diets.

Contraindications

History of hypervitaminosis A or D
Hypercalcaemia

Precautions and Warnings

Breastfeeding
Pregnancy

Contains hydroxybenzoate
Neonate exposed in utero: High doses of vitamin A may be harmful
Prolonged use or excessive doses may cause hypervitaminosis
Patients should not exceed recommended dose

Pregnancy and Lactation

Pregnancy

Vitamins are essential for human life. Preparations containing multiple vitamins are used in pregnant women, however, the practice of supplementation varies from country to country. 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.

Some authorities advise that women who are, or who wish to become, pregnant should not routinely take vitamin A supplements.

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 (Briggs, 2008). Normal doses of Vitamin D have shown no human teratogenic effect.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

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 breast feeding.

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

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Side Effects

None Known

Presentation

Sugar free oral emulsion containing vitamin A (as palmitate), vitamin D2 (ergocalciferol), cyanocobalamin and choline chloride.

Drugs List

Therapeutic Indications

Uses

Vitamin deficiency - prophylaxis

Prevention of vitamin deficiency in conditions such as galactosaemia, disaccharide intolerance, phenylketonuria and other disorders of carbohydrate or amino acid metabolism, as well as in patients who are on restricted, specialised or synthetic diets.

Dosage

Adults

Elderly

Children

Additional Dosage Information

Contraindications

History of hypervitaminosis A or D
Hypercalcaemia

Precautions and Warnings

Breastfeeding
Pregnancy

Contains hydroxybenzoate
Neonate exposed in utero: High doses of vitamin A may be harmful
Prolonged use or excessive doses may cause hypervitaminosis
Patients should not exceed recommended dose

Pregnancy and Lactation

Pregnancy

Vitamins are essential for human life. Preparations containing multiple vitamins are used in pregnant women, however, the practice of supplementation varies from country to country. 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.

Some authorities advise that women who are, or who wish to become, pregnant should not routinely take vitamin A supplements.

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 (Briggs, 2008). Normal doses of Vitamin D have shown no human teratogenic effect.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

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 breast feeding.

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

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Side Effects

None Known

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 ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Further Information

Last Full Review Date: August 2013

Reference Sources

British National Formulary, 65th Edition (March - September 2013) Pharmaceutical Press, London.

BNF for Children (2013-2014) Pharmaceutical Press, London.

Dietary Supplements, 3rd edition (2007) ed. Mason, P. Pharmaceutical Press, London.

Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 2nd edition (2007) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.

Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 9th edition (2011) ed. Briggs, G., Freeman, R. and Yaffe, S. Lippincott Williams & Wilkins, Philadelphia.

Summary of Product Characteristics: Ketovite liquid. Essential Pharmaceuticals Ltd. June 2012.