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Fludrocortisone tablets


Oral formulation of fludrocortisone acetate

Drugs List

  • fludrocortisone 100microgram tablets
  • Therapeutic Indications


    Addison's disease
    Adrenal insufficiency - cortical
    Adrenogenital syndrome

    Unlicensed Uses

    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
    Exanthematous disorder
    Family history of diabetes mellitus
    Family history of glaucoma
    History of allergies including anaphylaxis
    Postmenopausal females
    Acute glomerulonephritis
    Acute psychosis
    Chronic nephritis
    Congestive cardiac failure
    Diabetes mellitus
    Epileptic disorder
    Glucose-galactose malabsorption syndrome
    Hepatic cirrhosis
    Hepatic impairment
    History of peptic ulcer
    History of severe affective disorders
    History of steroid myopathy
    History of steroid-induced psychosis
    Lactose intolerance
    Latent or healed tuberculosis
    Metastatic carcinoma
    Myasthenia gravis
    Ocular herpes simplex infection
    Peptic ulcer
    Recent gastrointestinal anastomosis
    Recent myocardial infarction
    Renal impairment
    Severe affective disorders
    Thromboembolic disorder
    Ulcerative colitis

    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
    Contains lactose
    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 ( ) or if this is unavailable at the backup site ( ).


    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

    Side Effects

    Abdominal distension
    Acne-like eruptions
    Aggravation of pre-existing psychiatric conditions
    Aggravation of schizophrenia
    Anaphylactoid reaction
    Aseptic necrosis
    Avascular osteonecrosis
    Behavioural disturbances
    Cardiac arrhythmias
    Cognitive impairment
    Congestive cardiac failure
    Corneal thinning
    Cushingoid changes
    Delayed healing of fracture
    ECG changes
    Emotional lability
    Exacerbation of epilepsy
    Exacerbation of ophthalmic fungal disease
    Exacerbation of ophthalmic viral disease
    Fluid retention
    Hypokalaemic acidosis
    Impaired carbohydrate tolerance, increased need for anti-diabetic therapy
    Increased appetite
    Increased calcium excretion
    Increased intra-ocular pressure
    Increased susceptibility and severity of infections
    Increased sweating
    Lupus erythematosus-like syndrome
    Menstrual disturbances
    Muscle weakness
    Necrotising angiitis
    Negative calcium balance
    Negative protein balance
    Opportunistic infections
    Peptic ulceration with perforation and haemorrhage
    Posterior subcapsular cataracts
    Potassium loss
    Precipitation of diabetes
    Psychological dependence
    Psychotic reactions
    Raised intracranial pressure
    Recurrence of dormant tuberculosis
    Reduced muscle mass
    Scleral thinning
    Secondary adrenocortical and pituitary unresponsiveness
    Sleep disturbances
    Sodium retention
    Suicidal tendencies
    Suppression of growth in children and adolescents
    Suppression of reactions to skin tests
    Tendon rupture
    Thinning of skin
    Ulcerative oesophagitis
    Vertebral and long bone fractures
    Vertebral compression fractures
    Weight gain
    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 ( ) or if this is unavailable at the backup site ( ).

    Further Information

    Last Full Review Date: December 2014

    Reference Sources

    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:
    Last accessed: 30 June 2017.

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