Fludrocortisone for Orthostatic Hypotension

V1.0 Last reviewed: 22/04/2021 Review date: 22/04/2024

FLUDROCORTISONE
for Orthostatic Hypotension
Traffic light classification- Amber 2
Information sheet for Primary Care Prescribers
Key points/interactions
 Fludrocortisone should only be considered when non-pharmacological strategies have failed to
alleviate the patient’s symptoms, unless otherwise considered clinically appropriate by the
specialist.
 The most common side effects are fluid retention/oedema, hypokalaemia, headache and supine
hypertension.
 Fludrocortisone interacts with CYP3A substrates and digoxin (increasing toxicity)

Licensed Indications
Fludrocortisone does not have a marketing authorisation in the UK for treating postural hypotension, so
the use for this indication is unlicensed.

Exclusions
Children under 18 years, pregnancy and lactation. Active infection unless on specific treatment.
Patients for whom rise in BP or increase in fluid retention will cause known risks or worsening of
comorbidity.

Medicines Initiation
Fludrocortisone should be initiated by a consultant geriatrician/cardiologist/neurologist or other
specialist experienced in the management of neurocardiovascular instability. Fludrocortisone should
only be considered when non-pharmacological strategies have failed to alleviate the patient’s
symptoms, unless otherwise deemed clinically appropriate by the specialist. A diagnostic and
management algorithm is included at Appendix II.

Dose Regiment and Route of Administration

Initial dose: 50-100 micrograms once daily in the morning.

The dose may be increased weekly up to 300 micrograms a day, in divided doses if necessary,
depending on the supine and standing blood pressure results. No specific dose adjustment is needed
in renal disease but fludrocortisone may not be appropriate in view of sodium and fluid retention.

Duration of Treatment
Duration of treatment should be determined on an individual basis. For some, treatment can be
weaned and stopped as fluid status or morbidity changes. For others, treatment is likely to be required
long term (e.g. Parkinson’s disease contributing to orthostatic hypotension).

Monitoring Requirements and Responsibilities

 The initiating specialist will be responsible for assessing risk factors or pre-existing conditions that
may be exacerbated by mineralocorticoid therapy (U&E’s, fluid status, lying and standing BP,
assessment of fracture risk in the context of any falls).
 On-going primary care requirements should include monitoring for hypokalaemia, excessive fluid
retention and response to treatment. Additional specific advice should be clearly documented in
any correspondence.

Signs & Symptoms of fluid overload Blood Pressure

U & E’s
or heart failure (Lying & Standing)
 Weekly (first month)  Weekly (first month)
Initiation 
or until stable or until stable
After any dose increase   
Minimum 6 monthly or
  
if symptoms recur
 In addition to absolute values for haematological or biochemical indices, a rapid fall or rise or
consistent downward or upward trend in any value should prompt caution and extra vigilance.

Contraindications
 Hypersensitivity to the active substance or to any of the excipients.
 Systemic infections unless specific anti-infective therapy is employed.

Explicit Criteria for Review and Discontinuation* Action

Symptoms that may indicate supine Check lying and standing blood pressure. If supine
hypertension such as chest pain, palpitations, hypertension present see below.
shortness of breath, headache, blurred vision,
and pounding in the ears

Supine hypertension (systolic BP>160mmHg) Usually dose related but check if the last dose is
taken at least 4 hours before bedtime.
Consider dose reduction or withhold and discuss
with the specialist. If persistent despite dose
reductions, consider discontinuation in consultation
with the specialist.

Lying or standing Blood pressure increases Reduce / withhold and discuss with the specialist
above 180/100 mmHg or is considered clinically team.
significant.

Acute or severe renal impairment Withhold until discussed with the specialist team.
Likely to contribute to fluid retention.

Signs and symptoms of heart failure Withhold and discuss with the specialist team.

Hypokalaemia Correct with supplements. Discuss with the

specialist team if severe or persistent.

Persistently labile blood pressure after the initial Discuss with the specialist team.
titration

* Glucocorticoid effects are expected to be minimal at recommended doses but as a precaution withdrawal after
prolonged therapy should be gradual. Seek specialist advice if withdrawal is considered urgent.

Precautions (for a full list, see manufacturer’s guidance available here)

 Hypokalaemia may be additive with other medicines and may pose concerns with those that
predispose to cardiac dysrhythmias.
 Sodium and fluid retention may precipitate or exacerbate heart failure.
 Corticosteroid effects can be minimised by using the lowest possible dose.
 Glucocorticoid related side effects are considered very rare and generally well tolerated at
therapeutic doses.
 A patient steroid treatment card should be supplied at the point of dispensing to every patient. This
gives a clear guidance on the precautions to be taken to minimise risk of potential infection and
adrenal suppression, and provides details of prescriber, medication, dosage and the duration of
treatment.

V1.0 Fludrocortisone for Orthostatic Hypotension

Authors: Emma Grace – Lead Clinical Pharmacist, HCOP and Stroke Services 2
Shary Walker – Specialist Interface and Formulary Pharmacist
Review date: April 2024
Key Medication Interactions (for a full list, see manufacturer’s guidance available here)
Antihypertensive, including diuretics Fludrocortisone antagonises the effects of
antihypertensive and diuretics. The hypokalaemic
effect of diuretics, including acetazolamide, is
enhanced

Response to anticoagulants may be altered by

Anticoagulants corticosteroids (but this may be less pronounced
with the small doses used)

Co-treatment with CYP3A inhibitors, including

CYP3A inhibitors cobicistat-containing products, is expected to
increase the risk of systemic side-effects.

Co-administration may enhance the possibility of

Digitalis glycosides (e.g. Digoxin) digitalis toxicity.

There may be increased metabolic clearance of

Hepatic Enzyme Inducers (e.g. barbiturates,
Fludrocortisone. Patients should be carefully
carbamazepine, phenytoin, primidone, rifabutin,
observed for possible diminished effects, and the
rifampicin)
dosage should be adjusted accordingly.

Corticosteroids may increase GI bleeding and

ulceration associated with NSAIDS. They can
reduce serum salicylate levels. Stopping
NSAIDS corticosteroids when on high-dose NSAIDS may
result in salicylate toxicity and additive fluid
retention.

Metabolic clearance of adrenocorticoids is

decreased in hypothyroid patients and increased
Thyroid medications in hyperthyroid patients. Changes in thyroid status
of the patient may necessitate adjustments in
adrenocorticoid dosage.
For advice and queries please contact the original prescriber. For a more complex patient review (e.g.
comorbidities and very frail patient), consider referral to a local community geriatrician via the
appropriate pathway.

References
1. APC. Midodrine Information Sheet. 2018. [Online]. Available at: https://www.nottsapc.nhs.uk/. Last
updated on December 2018. Accessed 07/10/2020.
2. Lanier J B et al (2011): Evaluation and Management of Orthostatic Hypotension Am Fam
Physician. Sep 1; 84(5):527-536.
3. Martindale: The complete reference. Fludrocortisone. [Online]. Available at:
www.medicinescomplete.com. Last revised on 24/06/2010.
4. NICE Evidence summary [ESUOM20]. Postural hypotension in adults: fludrocortisone. 2013.
[Online]. Available at: https://www.nice.org.uk/advice/esuom20/chapter/Key-points-from-the-
evidence. October 2013. Accessed 07/10/2020.
5. Ashley C., Dunleavy A., et.al. The Renal Drug Database. 2014. [Online]. Available at:
www.renaldrugdatabse.com. Last reviewed on 29/06/2017. Accessed 07/10/2020.
6. Summary of Product Characteristics. Fludrocortisone Acetate, Aspen. 2017. [Online]. Available at:
www.medicines.org.uk. Last updated on 03/06/2020. Accessed 07/10/2020.

Version Control- Fludrocortisone for Orthostatic Hypotension

Version Author(s) Date Changes
1.0 Emma Grace
Shary Walker
V1.0 Fludrocortisone for Orthostatic Hypotension
Authors: Emma Grace – Lead Clinical Pharmacist, HCOP and Stroke Services 3
Shary Walker – Specialist Interface and Formulary Pharmacist
Review date: April 2024
Appendix I – Lying and Standing Blood Pressure Measurement

Automated equipment can be used but where measurements are difficult it will be necessary to use a
manual sphygmomanometer. Ascertain if the patient is able and safe to stand. Illness may impair their
ability to bear weight and severe symptoms resulting from a profound fall in blood pressure on standing
could lead to a fall. Sitting blood pressure can be taken however this can reduce the sensitivity of the
test.

Explain Measure blood Look for symptoms

pressure

•Inform patient of the •Ask patient to lie •Notice and

investigation down for at least 5 document symptoms
mins – measure BP •Dizziness
•Ideally use manual •Light-headedness
sphygmomanometer •Ask patient to stand •Vagueness
– measure BP within •Pallor
1 minute of standing
•Visual disturbances
•Feeling of
•If patient is able, weakness
measure again after
•Palpitations
3 mins of standing

 Ask or assist the patient to stand up or sit on the edge of the bed if the patient is unable to stand
 Stop if the patient is unable to stand/sit unsupported or is at risk of falling
 Keep the patient standing/sitting for the full 3 minutes

Postural hypotension is said to be present if:

 Systolic Blood Pressure falls (SBP) by ≥ 20mmHg on standing (with or without symptoms)
 SBP falls to below 90mmHg on standing (even if the drop is less than 20mmHg with or without
symptoms)
 Diastolic Blood Pressure falls by ≥10mmHg on standing with symptoms (although clinically much
less significant than a drop in systolic BP)

V1.0 Fludrocortisone for Orthostatic Hypotension

Authors: Emma Grace – Lead Clinical Pharmacist, HCOP and Stroke Services 4
Shary Walker – Specialist Interface and Formulary Pharmacist
Review date: April 2024
Fludrocortisone for Orthostatic Hypotension
V1.0 Last reviewed: 22/04/2021 Review date: 22/04/2024

Appendix II – Management of Orthostatic Hypotension Algorithm

• Secondary (and otherwise

• Symptomatic treatable) causes excluded and
• Orthostatic Hypotension medications reviewed
• Neurally-mediated
vasodepressor syncope
Hydration advice:
Midodrine*: • Increase fluid intake between
2.5mg three times a day. 08:00 and 18:00
NB: - The third dose of the day should • No more than 4 caffeinated
be by (or before) 17:00 to avoid supine Monitor: drinks per 24 hours
hypertension. • Symptoms (abolition or • >65 years and no systemic
Example: Midodrine 2.5mg at 7:00, improvement in presyncopal hypertension – Additional table
12:00 and 17:00. symptoms or no episodes of salt in diet
syncope) NB: Caution in heart failure or
Depending on the results of supine and • Lying/standing BP volume overload
standing blood pressure recordings and
tolerability, this dose may be increased
weekly up to a dose of 10mg three times
a day. Fludrocortisone may also be Venous compression:
continued in combination. Volume Expansion: Graded compression hosiery
Fludrocortisone 100 micrograms (If tolerated and practicable) – NOT
in the morning initially TEDS
(50 micrograms if >65 years) NB – not to be used in the presence
Titrate dose according to of significant peripheral vascular
response to a maximum of 300
* Refer to APC Midodrine disease or in patients with broken
micrograms daily in 2 or 3 divided
Information Sheet skin or ulceration.
doses.

Monitor electrolytes weekly until stable and after any dose

change, minimum 6 monthly thereafter. Monitor for signs of
developing heart failure or volume overload.
Salt restriction and/or Potassium supplements may be
necessary.
Withdraw slowly to avoid the effects of adrenal suppression.