Drugs List

Contraindications

History of hypervitaminosis A or D
Sarcoidosis hypercalcaemia
Hypercalcaemia
Abnormal metabolic sensitivity to vitamin D
Renal osteodystrophy with hyperphosphataemia
Hereditary fructose intolerance

Precautions and Warnings

Oral administration of vitamins is not suitable where vitamin deficiency is due to malabsorption syndromes.

Renal impairment
Pregnancy ( see Pregnancy )
High doses of vitamin A in pregnancy increase risk of damage to foetus
Lactation ( see Lactation )
Excessive prolonged dosage of vitamin A and D may lead to hypervitaminosis

Patients should not exceed recommended dose

The following groups of patients may be at increased risk of hypervitaminosis A:
Severe hypertriglyceridaemia associated with Type V hyperlipoproteinaemia
Children
Liver impairment where liver function compromised by drugs, viral hepatitis or protein-energy malnutrition Pregnancy - all trimesters

Vitamin A absorption may be reduced in :
Cystic fibrosis
Hepatic disease
Pancreatic dysfunction
Intestinal infection

The following groups of patients should avoid increased intake of ascorbic acid:
Glucose-6-phosphate deficiency - ascorbic acid may denature haemoglobin and reduce the erythrocyte glutathione level.
Advanced cancer: tumour haemorrhage and necrosis reported

Vitamin E (alpha tocopheryl) supplements should be avoided in:
Patients taking oral anticoagulants (large doses may increase bleeding tendency)
Iron deficiency anaemia
Hyperthyroidism

Presentations with sorbitol unsuitable in hereditary fructose intolerance.

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.

Vitamin A: several cases of teratogenicity associated with vitamin A have been observed. 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 routinely take vitamin A supplements.
Vitamin D: high doses of vitamin D during pregnancy may induce spontaneous abortion or a severe form of idiopathic hypercalcaemia and a clinical entity in the newborn comprising valvular stenosis of the aorta, peculiar faces, mental retardation and abnormal tooth formation. Genetic factors may play a role. Vitamin D may induce maternal neonatal hypocalcaemia tetany.

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 14-17 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 E is excreted into breast-milk . This may influence calcium metabolism in the infant.
Vitamin A: is found in the breast milk of lactating mothers and there is therefore a theoretical risk of neonatal toxicity.
Vitamin D: in nursing mothers, maternal hypercalcaemia may result in neonatal hypercalcaemia as calcium and vitamin D are excreted in breast milk.

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

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

Hypersensitivity reactions
Increase in plasma cholesterol
Elevated triglyceride levels
Hypercalcaemia
Irritability
Vomiting
Decreased appetite
Skin reactions
Raised intracranial pressure

Symptoms of hypercalcaemia include:
Anorexia
Nausea
Constipation
Abdominal pain
Muscle weakness
Thirst
Polyuria
Drowsiness
Confusion
Nephrocalcinosis
Kidney stones
Coma
Cardiac arrest

Adverse effects are generally only likely when doses in excess of those recommended are taken or when supplements are taken for prolonged periods.

Drugs List

Dosage

Adults

Elderly

Children

Contraindications

History of hypervitaminosis A or D
Sarcoidosis hypercalcaemia
Hypercalcaemia
Abnormal metabolic sensitivity to vitamin D
Renal osteodystrophy with hyperphosphataemia
Hereditary fructose intolerance

Precautions and Warnings

Oral administration of vitamins is not suitable where vitamin deficiency is due to malabsorption syndromes.

Renal impairment
Pregnancy ( see Pregnancy )
High doses of vitamin A in pregnancy increase risk of damage to foetus
Lactation ( see Lactation )
Excessive prolonged dosage of vitamin A and D may lead to hypervitaminosis

Patients should not exceed recommended dose

The following groups of patients may be at increased risk of hypervitaminosis A:
Severe hypertriglyceridaemia associated with Type V hyperlipoproteinaemia
Children
Liver impairment where liver function compromised by drugs, viral hepatitis or protein-energy malnutrition Pregnancy - all trimesters

Vitamin A absorption may be reduced in :
Cystic fibrosis
Hepatic disease
Pancreatic dysfunction
Intestinal infection

The following groups of patients should avoid increased intake of ascorbic acid:
Glucose-6-phosphate deficiency - ascorbic acid may denature haemoglobin and reduce the erythrocyte glutathione level.
Advanced cancer: tumour haemorrhage and necrosis reported

Vitamin E (alpha tocopheryl) supplements should be avoided in:
Patients taking oral anticoagulants (large doses may increase bleeding tendency)
Iron deficiency anaemia
Hyperthyroidism

Presentations with sorbitol unsuitable in hereditary fructose intolerance.

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.

Vitamin A: several cases of teratogenicity associated with vitamin A have been observed. 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 routinely take vitamin A supplements.
Vitamin D: high doses of vitamin D during pregnancy may induce spontaneous abortion or a severe form of idiopathic hypercalcaemia and a clinical entity in the newborn comprising valvular stenosis of the aorta, peculiar faces, mental retardation and abnormal tooth formation. Genetic factors may play a role. Vitamin D may induce maternal neonatal hypocalcaemia tetany.

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 14-17 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 E is excreted into breast-milk . This may influence calcium metabolism in the infant.
Vitamin A: is found in the breast milk of lactating mothers and there is therefore a theoretical risk of neonatal toxicity.
Vitamin D: in nursing mothers, maternal hypercalcaemia may result in neonatal hypercalcaemia as calcium and vitamin D are excreted in breast milk.

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

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

Hypersensitivity reactions
Increase in plasma cholesterol
Elevated triglyceride levels
Hypercalcaemia
Irritability
Vomiting
Decreased appetite
Skin reactions
Raised intracranial pressure

Symptoms of hypercalcaemia include:
Anorexia
Nausea
Constipation
Abdominal pain
Muscle weakness
Thirst
Polyuria
Drowsiness
Confusion
Nephrocalcinosis
Kidney stones
Coma
Cardiac arrest

Adverse effects are generally only likely when doses in excess of those recommended are taken or when supplements are taken for prolonged periods.

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: November 2010

Reference Sources

British National Formulary, 60th Edition (2010) Pharmaceutical Press, London.

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

Drugs in Pregnancy and Lactation, 6th edition ed. Briggs, G et al Lippincott Williams & Wilkins, Philadelphia 2002

Martindale: The Complete Drug Reference, 36th edition (2009) ed. Sweetman, S. Pharmaceutical Press, London.

Medicines For Children RCPCH Publications Ltd, London, 1999

Meyler's Side Effects of Drugs, 14th edition ed. Dukes, M and Aronson, J Elsevier, Amsterdam, 2000

Summary of Product Characteristics: Concavit capsules. Wallace Manufacturing Chemists Ltd. Revised April 2009.

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