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midodrine hcl 10 mg tablet

In stock Manufacturer APOTEX CORP 60505132501
$0.63 / Tablet

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Orthostatic Hypotension

Midodrine hydrochloride is used in the management of symptomatic orthostatic hypotension; the drug is designated an orphan drug by the US Food and Drug Administration (FDA) for such use. This indication is based on the drug's effect on increases in 1-minute standing systolic blood pressure, a surrogate marker considered likely to correspond to a clinical benefit; however, clinical benefits of midodrine (principally improved ability to perform activities of daily living) have not been established. The drug should only be continued in patients who report substantial symptomatic improvement after initiation of treatment. Midodrine should be used only after nondrug therapies (e.g., support hose, increased sodium intake, life-style modifications) and fluid expansion have failed.

Clinical studies indicate that midodrine is more effective than placebo and at least as effective as ephedrine, fludrocortisone, or dihydroergotamine in the management of orthostatic hypotension. However, despite comparable increases in blood pressure, midodrine may be more effective than comparative drugs (e.g., ephedrine) in managing postural symptoms.

In 1996, FDA approved use of midodrine for treatment of symptomatic orthostatic hypotension under its accelerated approval regulations, which permit approval of drugs used to treat serious or life-threatening diseases or conditions based upon a surrogate end point (e.g., positive effect on blood pressure) that is believed to predict actual clinical benefits such as improved survival or decreased severity of the disease. Pharmaceutical manufacturers that obtain approval under this program are required to conduct additional clinical trials after approval to confirm the drug's benefit; if those trials fail to confirm clinical benefit to patients or if the companies do not pursue the required confirmatory trials with due diligence, FDA can withdraw approval of the drug using expedited procedures. In August 2010, FDA proposed to withdraw approval of midodrine hydrochloride because required postapproval studies verifying the clinical benefit of the drug had not been done. FDA stated that neither the original manufacturer (Shire) nor any generic manufacturer has demonstrated the drug's clinical benefit. Although the company has conducted several clinical studies of the drug and literature regarding its efficacy has been published, the data submitted to the agency at that time had not verified the clinical benefit that the drug was expected to have. In September 2010, FDA clarified that its proposal was part of the regulatory process and that midodrine could remain on the market as that process moves forward. Subsequently, FDA's Center for Drug Evaluation and Research (CDER) and Shire reached an agreement that Shire would conduct 2 additional clinical studies to verify the clinical benefit of midodrine in patients with symptomatic orthostatic hypotension. In February 2012, FDA announced that the proposal to withdraw approval of midodrine will be deferred until these studies have been conducted; meanwhile, the drug remains approved and available on the US market. In September 2014, FDA approved an extended deadline until March 31, 2015 for final submission of study results and analyses for FDA review.

Midodrine increases supine, sitting, and standing diastolic and systolic blood pressures, and may attenuate postural symptoms (e.g., dizziness, lightheadedness, syncope, impaired ability to stand). In several clinical studies, midodrine decreased supine and standing pulse rates in patients with orthostatic hypotension; however, the manufacturer states that clinically important changes in pulse rates generally do not occur in patients with impaired autonomic function receiving the drug. There is some evidence that efficacy of midodrine is related to autonomic function; patients with less severe autonomic dysfunction may benefit from midodrine therapy to a greater extent than those with severe autonomic dysfunction.

The most potentially serious adverse effect of midodrine is supine hypertension (systolic blood pressure of 180 mm Hg or higher), reported in up to 25% of patients receiving the usual dosage (10 mg 3 times daily) of midodrine hydrochloride and in up to 50% of patients receiving 20-mg doses of the drug in clinical studies. Patients should be advised to report promptly to their clinician symptoms of supine hypertension (e.g., cardiac awareness, pounding in the ears, headache, blurred vision). If supine hypertension occurs, the dosage of midodrine may be reduced; withdrawal of the drug may be necessary, particularly if supine hypertension persists. Sleeping with the head of the bed elevated may relieve supine hypertension in some patients.

Concomitant use of midodrine and some vasoconstricting agents (e.g., phenylephrine, ephedrine, dihydroergotamine, phenylpropanolamine, pseudoephedrine) may cause an exaggerated hypertensive response. Patients receiving midodrine concomitantly with a vasoconstricting agent should be observed for possible additive hypertensive effects.

Although midodrine used concomitantly with fludrocortisone (with or without sodium supplementation) appears to be well tolerated, patients should be monitored closely for supine hypertension during combination therapy. In addition, caution should be exercised in patients with ocular conditions when midodrine is used concomitantly with fludrocortisone (which can increase intraocular pressure and precipitate or aggravate glaucoma).

Concomitant use of midodrine and agents that can cause bradycardia (e.g., cardiac glycosides, β-adrenergic blocking agents) may cause an exaggerated bradycardic response. Patients receiving midodrine concomitantly with such agents should be observed for possible additive bradycardic effects.

The manufacturer states that midodrine also should be used with caution in patients with diabetes mellitus and in patients with a history of urinary retention.

Dosage and Administration


Midodrine hydrochloride is administered orally, usually in 3 equally divided doses daily. Since food does not appear to affect GI absorption of midodrine hydrochloride, the drug generally can be administered without regard to meals.


Safety and efficacy of midodrine hydrochloride in children younger than 18 years of age have not been established. The manufacturer states that midodrine hydrochloride dosage adjustment based solely on age is not necessary in geriatric patients. Dosage adjustment based solely on gender also is not necessary.

Orthostatic Hypotension

For the management of symptomatic orthostatic hypotension in adults, the recommended initial dosage of midodrine hydrochloride is 10 mg 3 times daily. Alternatively, some clinicians recommend an initial dosage of midodrine hydrochloride of 2.5 mg administered 2 or 3 times daily; this dosage may be gradually increased as needed in increments of 2.5 mg 3 times daily at approximately weekly intervals. Administration of the drug should be during the hours in which the patient is awake, functioning, and pursuing the activities of daily life. For patients who are awake and functioning during daylight hours, a suggested dosing schedule is administering the drug at approximately 4-hour intervals shortly before or upon arising in the morning, midday, and late afternoon, but not later than 6 p.m. If necessary to provide adequate symptomatic relief, the dosing interval may be reduced to 3 hours; shorter intervals are not recommended. Because of the risk of supine hypertension during midodrine therapy, the drug should be continued only in patients who experience symptomatic relief.

Occasionally, midodrine hydrochloride dosages exceeding 30 mg daily (up to a maximum of 40 mg daily) have been tolerated in the management of orthostatic hypotension in adults; however, safety and efficacy of such dosages have not been studied systematically nor established. Although single doses as high as 20 mg have been used in some patients, the risk of severe and persistent systolic supine hypertension is increased substantially with such doses.

To reduce the occurrence of supine hypertension during sleep, midodrine hydrochloride should not be administered after the evening meal nor less than 4 hours before bedtime; a dose also should be avoided if the patient plans to be supine during the day for a length of time. Supine and standing blood pressure should be monitored carefully in all patients receiving midodrine, and dosage should be reduced or therapy with the drug discontinued if supine blood pressure increases excessively.

Dosage in Renal and Hepatic Impairment

The manufacturer recommends that renal function be assessed prior to initiating midodrine therapy. Because the drug's active metabolite (desglymidodrine) is eliminated by renal excretion and because safety and efficacy have not been studied systematically in patients with renal impairment to date, the manufacturer states that midodrine should be dosed cautiously in patients with abnormal renal function. The manufacturer recommends that midodrine hydrochloride therapy be initiated with 2.5-mg doses in such adults. Desglymidodrine is dialyzable.

Midodrine has not been studied systematically in patients with hepatic impairment, and the effect of alterations in hepatic function on the disposition of the drug currently is not known. Therefore, while the manufacturer currently makes no specific recommendations for dosage adjustment in patients with hepatic impairment, midodrine should be used with caution in such patients.

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