Drugs List

Therapeutic Indications

Uses

Orthostatic hypotension

For the treatment of severe orthostatic hypotension due to autonomic dysfunction when corrective factors have been ruled out and other forms of treatment are inadequate.

Contraindications

Children under 18 years
Acute renal failure
Aortic aneurysm
Bradycardia
Breastfeeding
Cardiac conduction defects
Cerebral arteriosclerosis
Cerebral ischaemia
Congestive cardiac failure
Coronary vasospasm
Deep vein thrombosis
Hypertension
Hyperthyroidism
Myocardial infarction
Narrow angle glaucoma
Occlusive peripheral arterial disease
Phaeochromocytoma
Pregnancy
Proliferative diabetic retinopathy
Renal impairment - creatinine clearance below 30 ml/minute
Severe cardiac disorder
Severe prostatic disorder
Urinary retention

Precautions and Warnings

Elderly
Atherosclerosis
Autonomic dysfunction
Gastrointestinal ischaemia
Intermittent claudication
Prostate disorder

Advise ability to drive/operate machinery may be affected by side effects
Advise patient to take last dose at least 4 hours before bedtime
Monitor renal and hepatic function before and during treatment
Monitor heart rate
Monitor supine and standing blood pressure regularly
Advise patients to report symptoms of supine hypertension immediately
May affect results of some laboratory tests
Discontinue if hypertension develops
Female: Ensure adequate contraception during treatment

Supine hypertension may often be controlled by an adjustment to the dose. If supine hypertension occurs, which is not overcome by reducing the dose, treatment with midodrine must be stopped.

The risk of supine hypertension occurring during the night can be reduced by elevating the head.

In patients suffering from a severe disturbance of the autonomic nervous system, administration of midodrine may lead to a further reduction of blood pressure when standing. If this occurs, further treatment with midodrine should be stopped.

Pregnancy and Lactation

Pregnancy

Midodrine is contraindicated in pregnancy.

At the time of writing there is limited data on the use of midodrine in pregnant women. It is not known if midodrine or its metabolites crosses the human placenta, however the molecular weight is low enough that this would be expected.

Animal studies have shown reproductive toxicity at maternally toxic doses.

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

Midodrine is contraindicated in breastfeeding.

At the time of writing it is unknown whether midodrine and its metabolites are excreted in human milk. The molecular weight suggests the drug will be excreted into the breast milk. Severe systolic hypertension is a potential effect in an infant. Briggs (2015) concludes that women who are taking midodrine should probably not breastfeed.

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 pain
Anxiety
Changes in hepatic function
Chest pain
Chills
Confusion
Diarrhoea
Dizziness
Dyspepsia
Dysuria
Elevation of liver enzymes
Excitability
Flushing
Headache
Hypertension
Insomnia
Irritability
Light-headedness
Nausea
Palpitations
Paraesthesia
Piloerection
Pruritus
Rash
Reflex bradycardia
Restlessness
Sleep disturbances
Stomatitis
Supine hypertension
Tachycardia
Urinary retention
Urinary urgency
Visual disturbances
Vomiting

Presentation

Oral formulations of midodrine hydrochloride.

Drugs List

Therapeutic Indications

Uses

Orthostatic hypotension

For the treatment of severe orthostatic hypotension due to autonomic dysfunction when corrective factors have been ruled out and other forms of treatment are inadequate.

Dosage

A careful evaluation of the response to treatment and of the overall balance of the expected benefits and risks needs to be undertaken before any dose increase and advice to continue therapy for long periods.

The last daily dose should be taken at least 4 hours before bedtime in order to prevent supine hypertension.

Adults

Contraindications

Children under 18 years
Acute renal failure
Aortic aneurysm
Bradycardia
Breastfeeding
Cardiac conduction defects
Cerebral arteriosclerosis
Cerebral ischaemia
Congestive cardiac failure
Coronary vasospasm
Deep vein thrombosis
Hypertension
Hyperthyroidism
Myocardial infarction
Narrow angle glaucoma
Occlusive peripheral arterial disease
Phaeochromocytoma
Pregnancy
Proliferative diabetic retinopathy
Renal impairment - creatinine clearance below 30 ml/minute
Severe cardiac disorder
Severe prostatic disorder
Urinary retention

Precautions and Warnings

Elderly
Atherosclerosis
Autonomic dysfunction
Gastrointestinal ischaemia
Intermittent claudication
Prostate disorder

Advise ability to drive/operate machinery may be affected by side effects
Advise patient to take last dose at least 4 hours before bedtime
Monitor renal and hepatic function before and during treatment
Monitor heart rate
Monitor supine and standing blood pressure regularly
Advise patients to report symptoms of supine hypertension immediately
May affect results of some laboratory tests
Discontinue if hypertension develops
Female: Ensure adequate contraception during treatment

Supine hypertension may often be controlled by an adjustment to the dose. If supine hypertension occurs, which is not overcome by reducing the dose, treatment with midodrine must be stopped.

The risk of supine hypertension occurring during the night can be reduced by elevating the head.

In patients suffering from a severe disturbance of the autonomic nervous system, administration of midodrine may lead to a further reduction of blood pressure when standing. If this occurs, further treatment with midodrine should be stopped.

Pregnancy and Lactation

Pregnancy

Midodrine is contraindicated in pregnancy.

At the time of writing there is limited data on the use of midodrine in pregnant women. It is not known if midodrine or its metabolites crosses the human placenta, however the molecular weight is low enough that this would be expected.

Animal studies have shown reproductive toxicity at maternally toxic doses.

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

Midodrine is contraindicated in breastfeeding.

At the time of writing it is unknown whether midodrine and its metabolites are excreted in human milk. The molecular weight suggests the drug will be excreted into the breast milk. Severe systolic hypertension is a potential effect in an infant. Briggs (2015) concludes that women who are taking midodrine should probably not breastfeed.

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 pain
Anxiety
Changes in hepatic function
Chest pain
Chills
Confusion
Diarrhoea
Dizziness
Dyspepsia
Dysuria
Elevation of liver enzymes
Excitability
Flushing
Headache
Hypertension
Insomnia
Irritability
Light-headedness
Nausea
Palpitations
Paraesthesia
Piloerection
Pruritus
Rash
Reflex bradycardia
Restlessness
Sleep disturbances
Stomatitis
Supine hypertension
Tachycardia
Urinary retention
Urinary urgency
Visual disturbances
Vomiting

Effects on Laboratory Tests

Patients taking midodrine may have falsely elevated plasma metadrenaline levels as a result of analytical interference when measured by HILIC-based HPLC-MS/MS. This potential for interference should be considered in cases where patients taking midodrine require biochemical investigation for potential phaeochromocytomas and paragangliomas.

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: April 2018

Reference Sources

Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 3rd edition (2015) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.
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.
Summary of Product Characteristics: Bramox 2.5mg tablets. Brancaster Pharma Ltd. Revised October 2018.
Summary of Product Characteristics: Bramox 5mg tablets. Brancaster Pharma Ltd. Revised October 2018.
Summary of Product Characteristics: Bramox 10mg tablets. Brancaster Pharma Ltd. Revised January 2021.
Summary of Product Characteristics: Midotense 2.5mg tablets. Transdermal Ltd. Revised May 2017.

NICE Evidence Services Available at: www.nice.org.uk Last accessed: 15 July 2021