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:

NCS HealthCare of KY, Inc dba Vangard Labs

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 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 white to off-white, round, scored tablets debossed with MH above the score and 1 below the score on one side of the tablet and M on the other side. They are available as follows: NDC 0615-7566-39 blisterpacks of 30 tablets 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: NDC 0615-5647-39 blisterpacks of 30 tablets The 10 mg tablets are white to off-white, round, scored tablets debossed with MH above the score and 3 below the score on one side of the tablet and M on the other side. They are available as follows: NDC 0615-7559-39 blisterpacks of 30 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.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

MIDODRINE HYDROCHLORIDE- MIDODRINE HYDROCHLORIDE TABLET
NCS HEALTHCARE OF KY, INC DBA VANGARD LABS
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MIDODRINE HYDROCHLORIDE TABLETS, USP
2.5 MG, 5 MG AND 10 MG
RX ONLY
WARNING
BECAUSE MIDODRINE 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 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,
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 and sodium lauryl sulfate.
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
Midodrine forms 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 blood pres