Drugplain

Midodrine Hydrochloride 5 mg/1

Midodrine Hydrochloride · TABLET · Bryant Ranch Prepack

1 Recall on Record
Plain English

Midodrine hydrochloride is an oral tablet used to treat low blood pressure, particularly in patients who experience dizziness or fainting when standing up. It works by narrowing blood vessels to help raise blood pressure.

Key Facts

Brand Name
Midodrine Hydrochloride
Generic Name
Midodrine Hydrochloride
NDC Code (Product)
71335-1433
Manufacturer
Bryant Ranch Prepack
Strength
5 mg/1
Dosage Form
TABLET
Route
ORAL
Marketing Status
Application #
ANDA077746
Marketing Start
09/12/2006

Recall History

1 Recall on Record
Class II02/17/2026

The Harvard Drug Group LLC

Defective container; inadequately sealed blister packaging.

OngoingVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

nausea351 reports
hypotension348 reports
dyspnoea340 reports
headache332 reports
death310 reports
diarrhoea298 reports
fatigue294 reports
dizziness282 reports
fall271 reports
vomiting195 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

INDICATIONS AND USAGE Midodrine hydrochloride tablets are indicated for the treatment of symptomatic orthostatic hypotension (OH). Because midodrine hydrochloride tablets can cause marked elevation of supine blood pressure (BP>200 mmHg systolic), it should be used in patients whose lives are considerably impaired despite standard clinical care, including non-pharmacologic treatment (such as support stockings), fluid expansion, and lifestyle alterations. The indication is based on midodrine’s effect on increases in 1-minute standing systolic blood pressure, a surrogate marker considered likely to correspond to a clinical benefit. At present, however, clinical benefits of midodrine hydrochloride tablets, principally improved ability to perform life activities, have not been established. Further clinical trials are underway to verify and describe the clinical benefits of midodrine hydrochloride tablets. After initiation of treatment, midodrine hydrochloride tablets should be continued only for patients who report significant symptomatic improvement.

Dosage & Administration

DOSAGE AND ADMINISTRATION The recommended dose of midodrine hydrochloride tablet is 10 mg, 3 times daily. Dosing should take place during the daytime hours when the patient needs to be upright, pursuing the activities of daily living. A suggested dosing schedule of approximately 4-hour intervals is as follows: shortly before, or upon arising in the morning, midday and late afternoon (not later than 6 P.M.). Doses may be given in 3-hour intervals, if required, to control symptoms, but not more frequently. Single doses as high as 20 mg have been given to patients, but severe and persistent systolic supine hypertension occurs at a high rate (about 45%) at this dose. In order to reduce the potential for supine hypertension during sleep, midodrine hydrochloride tablets should not be given after the evening meal or less than 4 hours before bedtime. Total daily doses greater than 30 mg have been tolerated by some patients, but their safety and usefulness have not been studied systematically or established. Because of the risk of supine hypertension, midodrine hydrochloride tablets should be continued only in patients who appear to attain symptomatic improvement during initial treatment. T…

Warnings

WARNINGS 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 pre-treatment systolic blood pressures (mean 170 mmHg). There is no experience in patients with initial supine systolic pressure above 180 mmHg, as those patients were excluded from the clinical trials. Use of midodrine in such patients is not recommended. Sitting blood pressures were also elevated by midodrine therapy. It is essential to monitor supine and sitting blood pressures in patients maintained on midodrine . Uncontrolled hypertension increases the risk of cardiovascular events, particularly stroke.

Contraindications

CONTRAINDICATIONS Midodrine hydrochloride tablets are contraindicated in patients with severe organic heart disease, acute renal disease, urinary retention, pheochromocytoma or thyrotoxicosis. Midodrine should not be used in patients with persistent and excessive supine hypertension.

Drug Interactions

Drug Interactions When administered concomitantly with midodrine, cardiac glycosides may enhance or precipitate bradycardia, A.V. block or arrhythmia. The risk of hypertension increases with concomitant administration of drugs that increase blood pressure (phenylephrine, pseudoephedrine, ephedrine, dihydroergotamine, thyroid hormones, or droxidopa). Avoid concomitant use of drugs that increase blood pressure. If concomitant use cannot be avoided, monitor blood pressure closely. Avoid use of MAO inhibitors or linezolid with midodrine. Midodrine 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 midodrine. Alpha-adrenergic blocking agents, such as prazosin, terazosin, and doxazosin, can antagonize the effects of midodrine. Potential for Drug Interaction It appears possible, although there is no supporting experimental evidence, that the high renal clearanc…

Adverse Reactions

ADVERSE REACTIONS 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: Adverse Events Placebo n=88 Midodrine n=82 Event # of reports % of patients # of reports % of patients Total # of reports 22 77 Paresthesia 1 4 4.5 15 18.3 Piloerection 0 0 11 13.4 Dysuria 2 0 0 11 13.4 Pruritis 3 2 2.3 10 12.2 Supine hypertension 4 0 0 6 7.3 Chills 0 0 4 4.9 Pain 5 0 0 4 4.9 Rash 1 1.1 2 2.4 1 Includes hyperesthesia and scalp paresthesia 2 Includes dysuria (1), increased urinary frequency (2), impaired urination (1), urinary retention (5), urinary urgency (2) 3 Includes scalp pruritus 4 Includes patients who experienced an increase in supine hypertension 5 Includes 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 we…

Frequently Asked Questions

What is Midodrine Hydrochloride used for?

Midodrine hydrochloride is an oral tablet used to treat low blood pressure, particularly in patients who experience dizziness or fainting when standing up. It works by narrowing blood vessels to help raise blood pressure.

Is Midodrine Hydrochloride a controlled substance?

Midodrine Hydrochloride is not classified as a controlled substance by the DEA.

What is the generic name for Midodrine Hydrochloride?

The generic name for Midodrine Hydrochloride is Midodrine Hydrochloride. There are 4 other brand versions of Midodrine Hydrochloride.

What is the NDC code for Midodrine Hydrochloride 5 mg/1?

The NDC (National Drug Code) for Midodrine Hydrochloride 5 mg/1 is 71335-1433, listed by Bryant Ranch Prepack.

Product NDC

71335-1433

Package NDC

71335-1433-1

Other Midodrine Brands

See all →

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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