Drugs List

Therapeutic Indications

Uses

Addison's disease
Adrenal insufficiency - cortical
Adrenogenital syndrome

Unlicensed Uses

To increase plasma volume in neuropathic postural hypotension

Contraindications

Uncontrolled systemic infection
Galactosaemia

Precautions and Warnings

Children under 18 years
Elderly
Exanthematous disorder
Family history of diabetes mellitus
Family history of glaucoma
History of allergies including anaphylaxis
Postmenopausal females
Acute glomerulonephritis
Acute psychosis
Breastfeeding
Chronic nephritis
Congestive cardiac failure
Diabetes mellitus
Diverticulitis
Epileptic disorder
Glaucoma
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
Hypertension
Hyperthyroidism
Hypothyroidism
Lactose intolerance
Latent or healed tuberculosis
Metastatic carcinoma
Myasthenia gravis
Ocular herpes simplex infection
Osteoporosis
Peptic ulcer
Pregnancy
Recent gastrointestinal anastomosis
Recent myocardial infarction
Renal impairment
Severe affective disorders
Thromboembolic disorder
Thrombophlebitis
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

Pregnancy

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 ).

Lactation

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

Side Effects

Abdominal distension
Acne-like eruptions
Aggravation of pre-existing psychiatric conditions
Aggravation of schizophrenia
Amenorrhoea
Amnesia
Anaphylactoid reaction
Angioedema
Anxiety
Aseptic necrosis
Avascular osteonecrosis
Behavioural disturbances
Candidiasis
Cardiac arrhythmias
Cognitive impairment
Confusion
Congestive cardiac failure
Convulsions
Corneal thinning
Cushingoid changes
Delayed healing of fracture
Depression
Dyspepsia
Ecchymosis
ECG changes
Emotional lability
Erythema
Euphoria
Exacerbation of epilepsy
Exacerbation of ophthalmic fungal disease
Exacerbation of ophthalmic viral disease
Exophthalmos
Fatigue
Fluid retention
Fractures
Glaucoma
Headache
Hiccups
Hirsutism
Hypertension
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
Insomnia
Irritability
Leucocytosis
Lupus erythematosus-like syndrome
Malaise
Menstrual disturbances
Muscle weakness
Myopathy
Nausea
Necrotising angiitis
Negative calcium balance
Negative protein balance
Neuritis
Opportunistic infections
Osteoporosis
Pancreatitis
Papilloedema
Paraesthesia
Peptic ulceration with perforation and haemorrhage
Petechiae
Posterior subcapsular cataracts
Potassium loss
Precipitation of diabetes
Pruritus
Psychological dependence
Psychotic reactions
Purpura
Raised intracranial pressure
Rash
Recurrence of dormant tuberculosis
Reduced muscle mass
Scleral thinning
Secondary adrenocortical and pituitary unresponsiveness
Sleep disturbances
Sodium retention
Striae
Suicidal tendencies
Suppression of growth in children and adolescents
Suppression of reactions to skin tests
Syncope
Tendon rupture
Thinning of skin
Thromboembolism
Thrombophlebitis
Ulcerative oesophagitis
Urticaria
Vertebral and long bone fractures
Vertebral compression fractures
Vertigo
Weight gain
Withdrawal syndrome - see product information
Wound healing retarded

Presentation

Oral formulation of fludrocortisone acetate

Drugs List

Therapeutic Indications

Uses

Addison's disease
Adrenal insufficiency - cortical
Adrenogenital syndrome

Unlicensed Uses

To increase plasma volume in neuropathic postural hypotension

Dosage

Adults

Children

Neonates

Contraindications

Uncontrolled systemic infection
Galactosaemia

Precautions and Warnings

Children under 18 years
Elderly
Exanthematous disorder
Family history of diabetes mellitus
Family history of glaucoma
History of allergies including anaphylaxis
Postmenopausal females
Acute glomerulonephritis
Acute psychosis
Breastfeeding
Chronic nephritis
Congestive cardiac failure
Diabetes mellitus
Diverticulitis
Epileptic disorder
Glaucoma
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
Hypertension
Hyperthyroidism
Hypothyroidism
Lactose intolerance
Latent or healed tuberculosis
Metastatic carcinoma
Myasthenia gravis
Ocular herpes simplex infection
Osteoporosis
Peptic ulcer
Pregnancy
Recent gastrointestinal anastomosis
Recent myocardial infarction
Renal impairment
Severe affective disorders
Thromboembolic disorder
Thrombophlebitis
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

Pregnancy

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 ).

Lactation

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

Side Effects

Abdominal distension
Acne-like eruptions
Aggravation of pre-existing psychiatric conditions
Aggravation of schizophrenia
Amenorrhoea
Amnesia
Anaphylactoid reaction
Angioedema
Anxiety
Aseptic necrosis
Avascular osteonecrosis
Behavioural disturbances
Candidiasis
Cardiac arrhythmias
Cognitive impairment
Confusion
Congestive cardiac failure
Convulsions
Corneal thinning
Cushingoid changes
Delayed healing of fracture
Depression
Dyspepsia
Ecchymosis
ECG changes
Emotional lability
Erythema
Euphoria
Exacerbation of epilepsy
Exacerbation of ophthalmic fungal disease
Exacerbation of ophthalmic viral disease
Exophthalmos
Fatigue
Fluid retention
Fractures
Glaucoma
Headache
Hiccups
Hirsutism
Hypertension
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
Insomnia
Irritability
Leucocytosis
Lupus erythematosus-like syndrome
Malaise
Menstrual disturbances
Muscle weakness
Myopathy
Nausea
Necrotising angiitis
Negative calcium balance
Negative protein balance
Neuritis
Opportunistic infections
Osteoporosis
Pancreatitis
Papilloedema
Paraesthesia
Peptic ulceration with perforation and haemorrhage
Petechiae
Posterior subcapsular cataracts
Potassium loss
Precipitation of diabetes
Pruritus
Psychological dependence
Psychotic reactions
Purpura
Raised intracranial pressure
Rash
Recurrence of dormant tuberculosis
Reduced muscle mass
Scleral thinning
Secondary adrenocortical and pituitary unresponsiveness
Sleep disturbances
Sodium retention
Striae
Suicidal tendencies
Suppression of growth in children and adolescents
Suppression of reactions to skin tests
Syncope
Tendon rupture
Thinning of skin
Thromboembolism
Thrombophlebitis
Ulcerative oesophagitis
Urticaria
Vertebral and long bone fractures
Vertebral compression fractures
Vertigo
Weight gain
Withdrawal syndrome - see product information
Wound healing retarded

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: 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: www.nice.org.uk
Last accessed: 30 June 2017.