Midodrine Hcl Recall
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Questions & Answers
Side Effects & Adverse Reactions
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.
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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 HCl Tablets are indicated for the treatment of symptomatic orthostatic hypotension (OH). Because Midodrine HCl 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 HCl 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.
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 HCl Tablets, USP
Dosage Form: 2.5 mg, 5 mg and 10 mg tablets for oral administration
Active Ingredient: Midodrine Hydrochloride, USP 2.5 mg, 5 mg and 10 mg
Inactive Ingredients: Colloidal Silicon Dioxide NF, Corn Starch NF, FD&C Blue No. 1 Lake (10 mg tablets), FD&C Red No. 40 Lake (5 mg and 10 mg tablets), Magnesium Stearate NF, Microcrystalline Cellulose NF, Talc USP
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-(β-hydroxy-2,5-dimethoxyphenethyl)acetamide monohydrochloride BAN, INN, JAN: Midodrine
Molecular Formula: C12H18N2O4HCl; Molecular Weight: 290.7
Organoleptic Properties: Odorless, white, crystalline powder
pKa: 7.8 (0.3% aqueous solution) pH: 3.5 to 5.5 (5% aqueous solution)
Melting Range: 200 to 203°C
Midodrine Hcl Manufacturers
- Cardinal Health
- Rebel Distributors Corp
- Mckesson Packaging Services A Business Unit Of Mckesson Corporation
- Cardinal Health
- American Health Packaging
- Eon Labs, Inc.
- Cardinal Health
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