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:

Golden State Medical Supply, Inc.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Midodrine hydrochloride tablets are indicated for the treatment of symptomatic orthostatic hypotension (OH). Because midodrine hydrochloride 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 hydrochloride tablets' 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 hydrochloride 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 hydrochloride tablets. After initiation of treatment, midodrine hydrochloride tablets should be continued only for patients who repo

Product summary:

Midodrine Hydrochloride Tablets, USP are available containing 2.5 mg, 5 mg or 10 mg of midodrine hydrochloride, USP. The 2.5 mg tablets are round, white scored tablet with C/149 on the upper side; and plain on the lower side. They are available as follows: NDC 51407-388-90 Bottle of 90 Tablets The 5 mg are tablets round, white scored tablet with C/150 on the upper side; and plain on the lower side. They are available as follows: NDC 51407-389-90 Bottle of 90 Tablets The 10 mg tablets are round, white scored tablet with C/151 on the upper side; and plain on the lower side. They are available as follows: NDC 51407-390-90 Bottle of 90 Tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Manufactured for: Xiromed, LLC. Florham Park, NJ 07932 PI-159-00 Rev.: 07/2019 Marketed by: GSMS, Inc. Camarillo, CA USA 93012

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

MIDODRINE HYDROCHLORIDE- MIDODRINE HYDROCHLORIDE TABLET
GOLDEN STATE MEDICAL SUPPLY, INC.
----------
MIDODRINE HCL TABLETS.
MIDODRINE HYDROCHLORIDE
TABLETS, USP
2.5 MG, 5 MG AND 10 MG
WARNING
BECAUSE MIDODRINE HYDROCHLORIDE TABLETS 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 TABLETS 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 TABLETS, PRINCIPALLY IMPROVED
ABILITY
TO CARRY OUT ACTIVITIES OF DAILY LIVING, HAVE NOT BEEN VERIFIED.
DESCRIPTION
Midodrine hydrochloride is a vasopressor/antihypotensive. The chemical
name for
midodrine hydrochloride is acetamide, 2-amino-
_N_-[2-(2,5-dimethoxyphenyl)-2-
hydroxyethyl]-, monohydrochloride, (±)-. The molecular weight of
midodrine
hydrochloride is 290.7. Its structural formula and molecular formula
are:
Midodrine hydrochloride, USP is an odorless, white, crystalline
powder. It is soluble in
water and sparingly soluble in methanol and has a pKa of 7.8 (0.3%
aqueous solution)
and a pH of 3.5 to 5.5 (5% aqueous solution). It has a melting range
of 200° to 203°C.
Each midodrine hydrochloride tablet, USP for oral administration
contains 2.5 mg, 5 mg
or 10 mg of midodrine hydrochloride, USP. In addition, each tablet
contains the following
inactive ingredients: magnesium stearate, microcrystalline cellulose,
and pregelatinized
starch.
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
Midodrine hydrochloride tablets form an active metabolite,
desglymidodrine, that is an
alpha
-agonist, and exerts its actions via activation of the
alpha-adrenergic receptors of
the arteriolar and venous vasculature, producing an increase in
vascular tone and