Midorine Tablets P.L. Special Precautions

Supine hypertension: The most potentially serious adverse reaction associated with midodrine therapy is marked elevation of supine arterial blood pressure (supine hypertension). Systolic pressure of about 200 mmHg were seen overall in about 13.4% of patients given 10 mg of midodrine. Systolic elevations of this degree were most likely to be observed in patients with relatively elevated pretreatment systolic blood pressure (mean, 170 mmHg). Use of midodrine is not recommended in patients with initial supine systolic pressure above 180 mmHg. Sitting blood pressures were also elevated by midodrine therapy. It is essential to monitor supine and sitting blood pressures in patients maintained on midodrine.
Potential for supine and sititng hypertension: The potential for supine and sitting hypertension should be evaluated at the beginning of midodrine therapy. Supine hypertension can often be controlled by preventing the patient from becoming fully supine (ie, sleeping with the head of the bed elevated). The patient should be cautioned to report symptoms of supine hypertension immediately. Symptoms may include cardiac awareness, pounding in the ears, headache, blurred vision, etc. The patient should be advised to discontinue the medication immediately if supine hypertension persists.
Slight slowing of the heart rate: A slight slowing of the heart rate may occur after administration of midodrine, primarily due to vagal reflex. Caution should be exercised when midodrine is used concomitantly with cardiac glycosides (eg, digitalis), psychopharmacologic agents, beta blockers or other agents that directly or indirectly reduce heart rate. Patients who experience any signs or symptoms suggesting bradycardia (pulse slowing, increased dizziness, syncope, cardiac awareness) should be advised to discontinue midodrine and should be reevaluated.
Renal function impairment: Midodrine use has not been studied in patients with renal impairment. Because desglymidodrine is eliminated via the kidneys and higher blood levels would be expected in such patients, midodrine should be used with caution in patients with renal impairment, with a starting dose of 2.5 mg. Renal function should be assessed prior to initial use of midodrine.
Hepatic function impairment: Midodrine use has not been studied in patients with hepatic impairment. Midodrine should be used with caution in patients with hepatic impairment, as the liver has a role in the metabolism of midodrine.
Special risk: Patients with urinary retention problems: Use cautiously in patients with urinary retention problems, as desglymidodrine acts on the alpha-adrenergic receptors of the bladder neck.
Orthostatic hypotensive patients: Use with caution in orthostatic hypotensive patients who are also diabetic, as well as those with a history of visual problems who are also taking fludrocortisone acetate, which is known to cause an increase in intraocular pressure and glaucoma.
Effects on Ability to Drive and Use Machine: No data is available with regard to this.