Drugs List

Therapeutic Indications

Uses

Foetal neural tube defects in women of high risk: prevention
Folate deficiency anaemia
Haemolytic anaemia (autoimmune)
Prevention of first occurrence of neural tube defects

Unlicensed Uses

Folic acid supplement for neonates
Prevention of methotrexate toxicity in juvenile idiopathic arthritis
Prevention of methotrexate toxicity in severe psoriasis or Crohn's disease
Prevention of methotrexate-induced adverse effects in rheumatic disease

Contraindications

None known

Precautions and Warnings

Folate dependent neoplasms
Haemodialysis
Malignant neoplasm
Phenylketonuria
Vitamin B12 deficiency

Not for monotherapy in pernicious anaemia or vitamin B12 deficiency
Establish definite diagnosis before prescribing
Some formulations contain hydroxybenzoate
Some formulations contain propylene glycol
Some products may contain phenylalanine
Perform cobalamin absorption test in elderly before long term therapy
May reduce intestinal absorption of zinc

Folic acid should not be administered alone for the treatment of Addisonian pernicious anaemia or other vitamin B12 deficiency states as it may precipitate the development of subacute combined degeneration of the spinal cord.

Folic acid is removed by haemodialysis.

Patients should be advised to take antacids at least two hours after administration of folic acid.

Pregnancy and Lactation

Pregnancy

Folic acid is considered safe for use in pregnancy.

Folic acid supplements are often beneficial during pregnancy.

Folate deficiency is related to the occurrence of birth defects and some neural tube defects. Lack of folic acid may also be responsible for cases of spontaneous abortion and intrauterine growth restriction (Briggs, 2015).

Folic acid deficiency during pregnancy and especially multiple pregnancy may lead to the appearance of foetal malformations. Imbalance in folate requiring trophoblast cells may also lead to detachment of the placenta.

Very high doses of folic acid have been shown to cause foetal abnormalities in animal studies, however, harmful effects on the human foetus, mother or the pregnancy have not been reported for the ingestion of folic acid.

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

Folic acid is considered safe for use in breastfeeding.

Folic acid is excreted in breast milk. There are no known harmful effects.

Accumulation of folate in milk takes precedence over maternal folate needs.

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

Abdominal distension
Allergic reaction
Anorexia
Decreased appetite
Flatulence
Gastro-intestinal disturbances
Nausea

Presentation

Oral solution containing folic acid

Drugs List

Therapeutic Indications

Uses

Foetal neural tube defects in women of high risk: prevention
Folate deficiency anaemia
Haemolytic anaemia (autoimmune)
Prevention of first occurrence of neural tube defects

Unlicensed Uses

Folic acid supplement for neonates
Prevention of methotrexate toxicity in juvenile idiopathic arthritis
Prevention of methotrexate toxicity in severe psoriasis or Crohn's disease
Prevention of methotrexate-induced adverse effects in rheumatic disease

Dosage

Adults

Children

Neonates

Contraindications

None known

Precautions and Warnings

Folate dependent neoplasms
Haemodialysis
Malignant neoplasm
Phenylketonuria
Vitamin B12 deficiency

Not for monotherapy in pernicious anaemia or vitamin B12 deficiency
Establish definite diagnosis before prescribing
Some formulations contain hydroxybenzoate
Some formulations contain propylene glycol
Some products may contain phenylalanine
Perform cobalamin absorption test in elderly before long term therapy
May reduce intestinal absorption of zinc

Folic acid should not be administered alone for the treatment of Addisonian pernicious anaemia or other vitamin B12 deficiency states as it may precipitate the development of subacute combined degeneration of the spinal cord.

Folic acid is removed by haemodialysis.

Patients should be advised to take antacids at least two hours after administration of folic acid.

Pregnancy and Lactation

Pregnancy

Folic acid is considered safe for use in pregnancy.

Folic acid supplements are often beneficial during pregnancy.

Folate deficiency is related to the occurrence of birth defects and some neural tube defects. Lack of folic acid may also be responsible for cases of spontaneous abortion and intrauterine growth restriction (Briggs, 2015).

Folic acid deficiency during pregnancy and especially multiple pregnancy may lead to the appearance of foetal malformations. Imbalance in folate requiring trophoblast cells may also lead to detachment of the placenta.

Very high doses of folic acid have been shown to cause foetal abnormalities in animal studies, however, harmful effects on the human foetus, mother or the pregnancy have not been reported for the ingestion of folic acid.

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

Folic acid is considered safe for use in breastfeeding.

Folic acid is excreted in breast milk. There are no known harmful effects.

Accumulation of folate in milk takes precedence over maternal folate needs.

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

Abdominal distension
Allergic reaction
Anorexia
Decreased appetite
Flatulence
Gastro-intestinal disturbances
Nausea

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: February 2017

Reference Sources

Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 10th edition (2015) ed. Briggs, G., Freeman, R. Wolters Kluwer Health, Philadelphia.

Martindale: The Complete Drug Reference. 38th Edition. London: Brayfield A (ed). Pharmaceutical Press; 2014.

Summary of Product Characteristics: Folic acid 2.5mg/5ml oral solution. Wockhardt UK Ltd. Revised May 2016.

Summary of Product Characteristics: Folic acid Colonis 1 mg/ml oral solution. Colonis Pharma Ltd. Revised October 2016.

Summary of Product Characteristics: Lexpec 2.5mg/5ml oral solution. Rosemont Pharmaceuticals Ltd. Revised July 2013.

NICE - Evidence Services
Available at: www.nice.org.uk
Last accessed: 29 June 2017.