1. DRUG ACTION
Midodrine hydrochloride is a pro-drug of desglymidodrine. Desglymidodrine is a sympathomimetic agent which acts on peripheral alpha-adrenergic receptors to increase arterial resistance, resulting in an increase in blood pressure.
2. INDICATIONS AND DOSE
2.1 Severe orthostatic hypotension due to autonomic dysfunction
When corrective factors have been ruled out and other forms of treatment are inadequate
2.1.1 Adult:
Initially 2.5 mg 3 times a day, increased if necessary up to 10 mg 3 times a day. Dose to be increased at weekly intervals according to blood pressure measurements. Usual maintenance is 10 mg 3 times a day. Avoid administration at night; the last daily dose should be taken at least 4 hours before bedtime.
3. CONTRA-INDICATIONS
- Aortic aneurysm
- Blood vessel spasm
- Bradycardia
- Cardiac conduction disturbances
- Cerebrovascular occlusion
- Congestive heart failure
- Hypertension
- Hyperthyroidism
- Myocardial infarction
- Narrow-angle glaucoma
- Phaeochromocytoma
- Proliferative diabetic retinopathy
- Serious obliterative blood vessel disease
- Serious prostate disorder
- Urinary retention
4. CAUTIONS
- Atherosclerotic cardiovascular disease (especially with symptoms of intestinal angina or claudication of the legs)
- Autonomic dysfunction
- Elderly (manufacturer recommends cautious dose titration)
- Prostate disorders
5. SIDE-EFFECTS
5.1 Common or Very Common
- Chills
- Flushing
- Gastrointestinal discomfort
- Headache
- Nausea
- Paraesthesia
- Piloerection
- Scalp pruritus
- Skin reactions
- Stomatitis
- Supine hypertension (dose-dependent)
- Urinary disorders
5.2 Uncommon
- Anxiety
- Arrhythmias
- Irritability
- Sleep disorders
5.3 Rare or Very Rare
- Hepatic function abnormal
- Palpitations
5.4 Frequency Not Known
- Confusion
- Diarrhoea
- Vomiting
5.5 Side-Effects Further Information
Manufacturer advises that treatment must be stopped if supine hypertension is not controlled by reducing the dose.
6. CONCEPTION AND CONTRACEPTION
Manufacturer recommends effective contraception during treatment in women of childbearing potential.
7. PREGNANCY
Manufacturer advises avoidance due to toxicity in animal studies.
8. BREAST FEEDING
Manufacturer advises avoidance due to lack of information available.
9. RENAL IMPAIRMENT
Manufacturer advises avoidance in severe or acute impairment.
10. MONITORING REQUIREMENTS
- Manufacturer advises measuring hepatic and renal function before treatment and at regular intervals during treatment.
- Manufacturer advises regular monitoring of supine and standing blood pressure due to the risk of hypertension in the supine position.
11. PATIENT AND CARER ADVICE
Manufacturer advises that patients report symptoms of supine hypertension (such as chest pain, palpitations, shortness of breath, headache, and blurred vision) immediately. The risk of supine hypertension at night can be reduced by raising the head of the bed.
12. MEDICINAL FORMS
There can be variation in the licensing of different medicines containing the same drug.
12.1 Tablet
12.1.1 Midodrine hydrochloride (Non-proprietary)
- Midodrine hydrochloride 2.5 mg
- Midodrine 2.5mg tablets | 100 tablets
- Midodrine hydrochloride 5 mg
- Midodrine 5mg tablets | 100 tablets
12.1.2 Bramox (Brancaster Pharma Ltd)
- Midodrine hydrochloride 2.5 mg
- Bramox 2.5mg tablets | 100 tablets
- Midodrine hydrochloride 5 mg
- Bramox 5mg tablets | 100 tablets
- Midodrine hydrochloride 10 mg
- Bramox 10mg tablets | 100 tablets