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:

Impax Generics

INN (International Name):

MIDODRINE HYDROCHLORIDE

Composition:

MIDODRINE HYDROCHLORIDE 2.5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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. Midodrine hydrochloride tablets are contra

Product summary:

Midodrine hydrochloride is supplied as 2.5 mg, 5 mg and 10 mg tablets for oral administration. Each 2.5 mg tablet is white, round, with "G" bisect "421" engraved on one side and plain on the other side. Each 5 mg tablet is light orange, round, with "G" bisect "422" engraved on one side and plain on the other side. Each 10 mg tablets is light green, round, with "G" bisect "423" engraved on one side and plain on the other side. Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature]. Dispense in a tightly-closed, light-resistant container as defined in the USP, with a child-resistant closure, as required.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

MIDODRINE HYDROCHLORIDE- MIDODRINE HYDROCHLORIDE TABLET
IMPAX GENERICS
----------
MIDODRINE HYDROCHLORIDE TABLETS,
2.5 MG, 5 MG AND 10 MG
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 venous
v