MIDODRINE HYDROCHLORIDE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

MIDODRINE HYDROCHLORIDE (UNII: 59JV96YTXV) (MIDODRINE - UNII:6YE7PBM15H)

Available from:

American Health Packaging

INN (International Name):

MIDODRINE HYDROCHLORIDE

Composition:

MIDODRINE HYDROCHLORIDE 10 mg

Prescription type:

PRESCRIPTION DRUG

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

MIDODRINE HYDROCHLORIDE- MIDODRINE HYDROCHLORIDE TABLET
AMERICAN HEALTH PACKAGING
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MIDODRINE HYDROCHLORIDE TABLETS
8288621/0917OS
RX ONLY
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
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
STRUCTURAL FORMULA:
MOLECULAR FORMULA: C
H
N
O
HCl; Molecular Weight: 290.7
12
18
2
4
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
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION:
Midodrine hydrochloride forms an active metabolite, desglymidodrine,
that is an alpha1-agonist, and
exerts its actions via activation of the alpha-adrenergic receptors of
the arteriolar and ve