"The U.S. Food and Drug Administration today proposed to withdraw approval of the drug midodrine hydrochloride, used to treat the low blood pressure condition orthostatic hypotension, because required post-approval studies that verify the clinical"...
(midodrine hydrochloride) Tablets
Because ProAmatine® (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 ProAmatine® (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 ProAmatine® (midodrine hydrochloride) , principally improved ability to carry out activities of daily living, have not been verified.
Name: ProAmatine® (midodrine hydrochloride) Tablets
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 NF, Corn Starch NF, FD&C Blue No. 2 Lake (10-mg tablets), FD&C Yellow No. 6 Lake (5-mg tablet), 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
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
What are the possible side effects of midodrine (ProAmatine)?
In some cases, midodrine may cause an excessive increase in blood pressure, especially when lying down. Contact your doctor immediately or seek emergency medical attention if you experience an unusual awareness of heartbeats, pounding in the ears, headache, or blurred vision. These may be signs of increased blood pressure.
In some cases, increased blood pressure may cause a slowed heart rate. Contact your doctor immediately or seek emergency medical attention if you experience decreased pulse rate, increased dizziness, fainting, or an unusual awareness of heartbeats. These may be...
What are the precautions when taking midodrine hydrochloride (Proamatine)?
Before taking midodrine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: high blood pressure, pheochromocytoma, thyroid disease (severe hyperthyroidism), severe difficulty urinating (due to urinary retention or an enlarged prostate).
Before using this drug, tell your doctor your entire medical history, including: heart disease, liver disease, kidney disease, diabetes.
Get up slowly to reduce dizziness when rising from a sitting or...
Last reviewed on RxList: 10/25/2010
This monograph has been modified to include the generic and brand name in many instances.
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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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