- Drugs List
- Therapeutic Indications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
Oral formulation of fludrocortisone acetate
Adrenal insufficiency - cortical
To increase plasma volume in neuropathic postural hypotension
50 micrograms to 300 micrograms. To obtain an enhanced glucocorticoid effect, cortisone or hydrocortisone may be administered orally concurrently.
Neuropathic postural hypotension (unlicensed)
100 micrograms to 400 micrograms daily.
Children aged 1 month to 18 years
Initially, 50 micrograms to 100 micrograms once daily.
Maintenance dose: 50 micrograms to 300 micrograms once daily, titrated according to age and weight of child and clinical response.
Initially, 50 micrograms once daily, titrated according to response.
Maintenance dose: 50 micrograms to 200 micrograms daily. Higher doses may be required.
Uncontrolled systemic infection
Precautions and Warnings
Children under 18 years
Family history of diabetes mellitus
Family history of glaucoma
History of allergies including anaphylaxis
Congestive cardiac failure
Glucose-galactose malabsorption syndrome
History of peptic ulcer
History of severe affective disorders
History of steroid myopathy
History of steroid-induced psychosis
Latent or healed tuberculosis
Ocular herpes simplex infection
Recent gastrointestinal anastomosis
Recent myocardial infarction
Severe affective disorders
Consider reintroducing steroids temporarily during illness/trauma/surgery
Exposure to measles may require prophylaxis with normal immunoglobulin
May mask symptoms or signs of infections
Passive immunisation of chicken pox / herpes zoster may be required
Diabetic control may need adjustment
Frequent review needed to titrate dose to disease activity
If growth in children is slowed, consider referral to a paediatrician
Monitor electrolyte balance during prolonged continuous therapy
Monitor regularly the height of children receiving prolonged treatment
Psychological changes may occur during initiation & withdrawal of treatment
Antibody response to vaccines may be reduced
Corticosteroids may cause growth retardation in children under 18 years
Oversuppression of immune system may increase susceptibility to infection
Patient should report worrying psychological changes esp. suicidal thoughts
Withdraw gradually after long-term use
Maintain treatment at the lowest effective dose
Advise patient not to take St John's wort concurrently
Dietary salt restriction may be necessary
Advise patient that menstrual irregularities may occur
Advise patient to avoid exposure to measles
Advise patient to seek urgent medical attention if exposed to measles
Advise those on systemic corticosteroids to avoid chickenpox/H zoster
Ensure patient receives Steroid Treatment/Steroid Emergency Card
If exposed to chickenpox or Herpes zoster seek urgent medical attention
Pregnancy and Lactation
Use fludrocortisone with caution in pregnancy.
The manufacturer states that animal studies have shown harmful effects in pregnancy, however the CSM has concludes that there is no convincing evidence that systemic corticosteroids increase the incidence of congenital abnormalities such as cleft palate or lip. Prolonged or repeated administration of corticosteroids during pregnancy may increase the risk of intra-uterine growth retardation. Any adrenal suppression in the neonate following prenatal exposure usually resolves spontaneously after birth and is rarely clinically important.
If fludrocortisone is administered during pregnancy, it is advised that the infant is monitored for signs of hypoadrenalism. Pregnant mothers with fluid retention or pregnancy induced hypertension will require close monitoring. Patients being treated with fludrocortisone during a normal pregnancy may be treated as if they were in the non-gravid state.
There are no references specific to the use of fludrocortisone in pregnancy in standard reference works. However, Schaefer advises that replacement therapy with glucocorticoids as a group can and should be conducted throughout pregnancy.
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 ).
Use fludrocortisone with caution in breastfeeding.
It is not known whether fludrocortisone is excreted in breast milk, however, other corticosteroids are known to be excreted in milk. It is considered unlikely (Hale) that the amounts of fludrocortisone that may be present in milk will be clinically relevant unless maternal doses are extremely high. Caution is however recommended if fludrocortisone is administered during breastfeeding. If fludrocortisone is administered in breastfeeding mothers, the nursing infant should be monitored for signs of hypoadrenalism.
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
Aggravation of pre-existing psychiatric conditions
Aggravation of schizophrenia
Congestive cardiac failure
Delayed healing of fracture
Exacerbation of epilepsy
Exacerbation of ophthalmic fungal disease
Exacerbation of ophthalmic viral disease
Impaired carbohydrate tolerance, increased need for anti-diabetic therapy
Increased calcium excretion
Increased intra-ocular pressure
Increased susceptibility and severity of infections
Lupus erythematosus-like syndrome
Negative calcium balance
Negative protein balance
Peptic ulceration with perforation and haemorrhage
Posterior subcapsular cataracts
Precipitation of diabetes
Raised intracranial pressure
Recurrence of dormant tuberculosis
Reduced muscle mass
Secondary adrenocortical and pituitary unresponsiveness
Suppression of growth in children and adolescents
Suppression of reactions to skin tests
Thinning of skin
Vertebral and long bone fractures
Vertebral compression fractures
Withdrawal syndrome - see product information
Wound healing retarded
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 ).
Last Full Review Date: December 2014
Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 2nd edition (2007) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.
Medications and Mothers' Milk, 14th Edition (2010) Hale, T. Hale Publishing, Amarillo, Texas.
Summary of Product Characteristics: Florinef 0.1mg Tablets. E.R. Squibb. Revised July 2014.
NICE - Evidence Services
Available at: www.nice.org.uk
Last accessed: 30 June 2017.
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Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
FDB Disclaimer : FDB Multilex is intended for the use of healthcare professionals and is provided on the basis that the healthcare professionals will retain FULL and SOLE responsibility for deciding what treatment to prescribe or dispense for any particular patient or circumstance.