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:

Cardinal Health 107, LLC

INN (International Name):

MIDODRINE HYDROCHLORIDE

Composition:

MIDODRINE HYDROCHLORIDE 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 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 report significant symptomatic improvement. Midodrine hydrochloride tablets are contraindicated in patients with severe organic heart disease, acute renal disease, urinary retention, pheochromocytoma or thyrotoxicosis. Midodrine hydrochloride tablets should not be used in patients with persistent and excessive supine hypertension.

Product summary:

Midodrine Hydrochloride Tablets, USP are available containing 5 mg of midodrine hydrochloride, USP. The 5 mg tablets are white to off-white, round, scored tablets debossed with MH above the score and 2 below the score on one side of the tablet and M on the other side. They are available as follows: Overbagged with 10 tablets per bag, NDC 55154-5696-0 Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Manufactured by: ALPHAPHARM PTY LTD 15 Garnet Street Carole Park QLD 4300 Australia Distributed by: Mylan Institutional Inc. Rockford, IL 61103 U.S.A. Distributed by: Cardinal Health Dublin, OH 43017 L41541000124 S-12776 2/22

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

MIDODRINE HYDROCHLORIDE- MIDODRINE HYDROCHLORIDE TABLET
CARDINAL HEALTH 107, LLC
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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: colloidal silicon dioxide, croscarmellose
sodium, magnesium
stearate, microcrystalline cellulose, pregelatinized starch (corn) and
sodium lauryl
sulfate.
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
elevation of