Midodrine Hydrochloride
FDA Drug Information • Also known as: Midodrine Hydrochloride
- Brand Names
- Midodrine Hydrochloride
- Route
- ORAL
- Dosage Form
- TABLET
- Product Type
- HUMAN PRESCRIPTION DRUG
⚠ Boxed Warning (Black Box)
Warning: Because Midodrine hydrochloride can cause marked elevation of supine blood pressure, it should be used in patients whose lives are considerably impaired despite standard clinical care. The indication for use of Midodrine hydrochloride in the treatment of symptomatic orthostatic hypotension is based primarily on a change in a surrogate marker of effectiveness, an increase in systolic blood pressure measured one minute after standing, a surrogate marker considered likely to correspond to a clinical benefit. At present, however, clinical benefits of Midodrine hydrochloride, principally improved ability to carry out activities of daily living, have not been verified.
Description
DESCRIPTION Name: Midodrine Hydrochloride Tablets, USP Dosage Form: 2.5 mg, 5 mg and 10 mg tablets for oral administration Active Ingredient: Midodrine hydrochloride, 2.5 mg, 5 mg and 10 mg Inactive Ingredients: Colloidal Silicone Dioxide, Croscarmellose sodium, Magnesium Stearate, Microcrystalline Cellulose, Pregelatinised Starch, Sodium Lauryl Sulphate Pharmacological Classification: Vasopressor/Antihypotensive Chemical Names (USAN: Midodrine Hydrochloride): (1) Acetamide, 2-amino-N-[2-(2,5- dimethoxyphenyl)-2-hydroxyethyl]-monohydrochloride, (±)-; (2) (±)-2-amino-N-(ß-hydroxy-2,5-dimethoxyphenethyl)acetamide monohydrochloride BAN, INN, JAN: Midodrine Structural formula: Molecular formula: C 12 H 18 N 2 O 4 HCl; Molecular Weight: 290.7 Organoleptic Properties: Odorless, white crystalline powder Solubility: Water:Soluble Methanol: Sparingly soluble pKa: 7.8 (0.3% aqueous solution) pH: 3.5 to 5.5 (5% aqueous solution) Melting Range: 200 to 203°C Structure
What Is Midodrine Hydrochloride Used For?
INDICATIONS AND USAGE Midodrine Hydrochloride Tablets, USP are indicated for the treatment of symptomatic orthostatic hypotension (OH). Because Midodrine Hydrochloride Tablets, USP 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 Hydrochloride Tablets, USP 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, USP 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, USP. After initiation of treatment, Midodrine Hydrochloride Tablets, USP should be continued only for patients who report significant symptomatic improvement.
Dosage and Administration
DOSAGE AND ADMINISTRATION The recommended dose of Midodrine Hydrochloride Tablets, USP 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, USP 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, USP should be continued only in patients who appear to attain symptomatic improvement during initial treatment. The supine and standing blood pressure should be monitored regularly, and the administration of Midodrine Hydrochloride Tablets, USP should be stopped if supine blood pressure increases excessively. Because desglymidodrine is excreted renally, dosing in patients with abnormal renal function should be cautious; although this has not been systematically studied, it is recommended that treatment of these patients be initiated using 2.5-mg doses. Dosing in children has not been adequately studied. Blood levels of midodrine and desglymidodrine were similar when comparing levels in patients 65 or older vs. younger than 65 and when comparing males vs. females, suggesting dose modifications for these groups are not necessary.
Side Effects (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 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 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 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 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.
Warnings and Precautions
WARNINGS Supine Hypertension: The most potentially serious adverse reaction associated with Midodrine hydrochloride 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 hydrochloride. 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 hydrochloride in such patients is not recommended. Sitting blood pressures were also elevated by Midodrine hydrochloride therapy. It is essential to monitor supine and sitting blood pressures in patients maintained on Midodrine hydrochloride. Uncontrolled hypertension increases the risk of cardiovascular events, particularly stroke.
Contraindications
CONTRAINDICATIONS Midodrine hydrochloride is contraindicated in patients with severe organic heart disease, acute renal disease, urinary retention, pheochromocytoma or thyrotoxicosis. Midodrine hydrochloride should not be used in patients with persistent and excessive supine hypertension.
Overdosage
OVERDOSAGE Symptoms of overdose could include hypertension, piloerection (goosebumps), a sensation of coldness and urinary retention. There are 2 reported cases of overdosage with Midodrine hydrochloride, both in young males. One patient ingested Midodrine hydrochloride drops, 250 mg, experienced systolic blood pressure greater than 200 mmHg, was treated with an IV injection of 20 mg of phentolamine, and was discharged the same night without any complaints. The other patient ingested 205 mg of Midodrine hydrochloride (41 5-mg tablets), and was found lethargic and unable to talk, unresponsive to voice but responsive to painful stimuli, hypertensive and bradycardic. Gastric lavage was performed, and the patient recovered fully by the next day without sequelae. The single doses that would be associated with symptoms of overdosage or would be potentially life-threatening are unknown. The oral LD 5 Desglymidodrine is dialyzable. Recommended general treatment, based on the pharmacology of the drug, includes induced emesis and administration of alpha-sympatholytic drugs (e.g., phentolamine).
How Supplied
HOW SUPPLIED Midodrine Hydrochloride Tablets, USP 2.5mg, 5mg and 10mg tablets for oral administration. Midodrine Hydrochloride Tablets, USP 2.5mg are white to off white, round beveled edge, scored tablets debossed with " ^ " above the score line on one side and "040" on other side. Bottles of 100 tablets: NDC 72888-112-01 Midodrine Hydrochloride Tablets, USP 5mg are white to off white, round beveled edge, scored tablets debossed with " ^ " above the score line on one side and "041" on other side. Bottles of 100 tablets: 72888-113-01 Midodrine Hydrochloride Tablets, USP 10mg are white to off white, round beveled edge, scored tablets debossed with " ^ " above the score line on one side and "042" on other side. Bottles of 100 tablets: NDC 72888-114-01 Store at 20° to 25°C (68° to 77°F) excursions permitted between 15° to 30° C (59° to 86°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, using a child-resistant closure. To report SUSPECTED ADVERSE REACTIONS, contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Distributed By Advagen Pharma Ltd East Windsor, NJ 08520, USA Manufactured by: Rubicon Research Ltd, Thane 421506, India Rx Only Rev. 12/2025
About This Information
This drug information is sourced from FDA-approved labeling via the openFDA database. It is intended for educational and reference purposes only. This is not medical advice. Always consult your healthcare provider before making decisions about medication. Drug information may be updated by the FDA; check with your pharmacist for the most current information.
What are side effects?
Side effects are unwanted reactions that can occur when taking a medication. They range from mild (headache, nausea) to severe (allergic reactions, organ damage). Not everyone experiences side effects, and severity varies. Report any concerning side effects to your doctor.
What are drug interactions?
Drug interactions occur when a medication is affected by another drug, food, or supplement. Interactions can make medications less effective or cause dangerous side effects. Always tell your doctor about all medications and supplements you take.