"The U.S. Food and Drug Administration today proposed to withdraw approval of the drug midodrine hydrochloride, used to treat the low blood pressure condition orthostatic hypotension, because required post-approval studies that verify the clinical"...
The most frequent adverse reactions seen in controlled trials were supine and sitting hypertension; paresthesia and pruritus, mainly of the scalp; goosebumps; chills; urinary urge; urinary retention and urinary frequency.
The frequency of these events in a 3-week placebo-controlled trial is shown in the following table:
|Event||# of reports||% of patients||# of reports||% of patients|
|Total # of reports||22||77|
| 1Includes hyperesthesia and scalp
2Includes dysuria (1), increased urinary frequency (2), impaired urination (1), urinary retention (5), urinary urgency (2)
3Includes scalp pruritus
4Includes patients who experienced an increase in supine hypertension
5Includes abdominal pain and pain increase
Less frequent adverse reactions were headache; feeling of pressure/fullness in the head; vasodilation/flushing face; confusion/thinking abnormality; dry mouth; nervousness/anxiety and rash. Other adverse reactions that occurred rarely were visual field defect; dizziness; skin hyperesthesia; insomnia; somnolence; erythema multiforme; canker sore; dry skin; dysuria; impaired urination; asthenia; backache; pyrosis; nausea; gastrointestinal distress; flatulence and leg cramps.
The most potentially serious adverse reaction associated with ProAmatine® (midodrine hydrochloride) therapy is supine hypertension. The feelings of paresthesia, pruritus, piloerection and chills are pilomotor reactions associated with the action of midodrine on the alpha-adrenergic receptors of the hair follicles. Feelings of urinary urgency, retention and frequency are associated with the action of midodrine on the alpha-receptors of the bladder neck.
Read the Proamatine (midodrine hydrochloride) Side Effects Center for a complete guide to possible side effects
The use of drugs that stimulate alpha-adrenergic receptors (e.g., phenylephrine, pseudoephedrine, ephedrine, phenylpropanolamine or dihydroergotamine) may enhance or potentiate the pressor effects of ProAmatine® (midodrine hydrochloride) . Therefore, caution should be used when ProAmatine® (midodrine hydrochloride) is administered concomitantly with agents that cause vasoconstriction.
ProAmatine® (midodrine hydrochloride) has been used in patients concomitantly treated with salt-retaining steroid therapy (i.e., fludrocortisone acetate), with or without salt supplementation. The potential for supine hypertension should be carefully monitored in these patients and may be minimized by either reducing the dose of fludrocortisone acetate or decreasing the salt intake prior to initiation of treatment with ProAmatine® (midodrine hydrochloride) . Alpha-adrenergic blocking agents, such as prazosin, terazosin, and doxazosin, can antagonize the effects of ProAmatine® (midodrine hydrochloride) .
Potential for Drug Interaction: It appears possible, although there is no supporting experimental evidence, that the high renal clearance of desyglymidodrine (a base) is due to active tubular secretion by the base-secreting system also responsible for the secretion of such drugs as metformin, cimetidine, ranitidine, procainamide, triamterene, flecainide, and quinidine. Thus there may be a potential for drug-drug interactions with these drugs.
Read the Proamatine Drug Interactions Center for a complete guide to possible interactions
Last reviewed on RxList: 10/25/2010
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