Proamatine
ProAmatine®
(midodrine hydrochloride) Tablets
Because ProAmatine® 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® 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® , principally improved ability to carry out activities of daily living, have not been verified.
DRUG DESCRIPTION
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
Structural formula:
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Molecular formula: C12H18N2O4HCl; 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
Generic Name: Midodrine Hydrochloride
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Proamatine
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