Midodrine Hydrochloride Recall
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Questions & Answers
Side Effects & Adverse Reactions
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 HCl. 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 HCl tablets in such patients is not recommended. Sitting blood pressures were also elevated by midodrine HCl therapy. It is essential to monitor supine and sitting blood pressures in patients maintained on midodrine HCl.
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FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Midodrine hydrochloride tablets are indicated for the treatment of symptomatic orthostatic hypotension (OH). Because midodrine HCl 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 HCl'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 HCl, 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 HCl.
After initiation of treatment, midodrine HCl tablets should be continued only for patients who report significant symptomatic improvement.
There is currently no drug history available for this drug.
Name: Midodrine Hydrochloride Tablets
Dosage Form: 2.5 mg, 5 mg and 10 mg tablets for oral administration
Active Ingredient: Midodrine hydrochloride
Inactive Ingredients: Microcrystalline Cellulose, NF; Corn Starch, NF; Colloidal Silicon Dioxide, NF; Magnesium Stearate, NF; Talc, USP; FD&C Yellow No. 6 (5 mg tablet); Lake Blend Green (10 mg tablet).
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-((beta)-hydroxy-2,5-dimethoxyphenethyl)acetamide monohydrochloride BAN, INN, JAN: Midodrine
Molecular Formula: C12H18N2O4 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
Midodrine Hydrochloride Manufacturers
American Health Packaging
Physicians Total Care, Inc.
Upsher-smith Laboratories Inc.
Ncs Healthcare Of Ky, Inc Dba Vangard Labs
Global Pharmaceuticals, Division Of Impax Laboratories Inc.
Mylan Pharmaceuticals Inc.
Carilion Materials Management
Mylan Institutional Inc.
American Health Packaging
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