MIDODRINE HCL- 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:

Eon Labs, Inc.

INN (International Name):

MIDODRINE HYDROCHLORIDE

Composition:

MIDODRINE HYDROCHLORIDE 2.5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Midodrine hydrochloride tablets, USP are indicated for the treatment of symptomatic orthostatic hypotension (OH). Because midodrine hydrochloride tablets, USP 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 tablet, USP'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 hydrochloride tablets, USP 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, USP. After initiation of treatment, midodrine hydrochloride tablets, USP should be continue

Product summary:

Midodrine Hydrochloride Tablets, USP, for oral administration, are available as 2.5 mg White, round, flat-faced, bevelled edge, debossed “E ” over “40” on one side and bisected on the other side and supplied as: NDC 0185-0040-01 bottles of 100 NDC 0185-0040-05 bottles of 500 5 mg Reddish-orange, round, flat-faced, bevelled edge, debossed “E ” over “43” on one side and bisected on the other side and supplied as: NDC 0185-0043-01 bottles of 100 NDC 0185-0043-05 bottles of 500 10 mg Blue-grey, round, flat-faced, bevelled edge, debossed, “E ” over “149” on one side and bisected on the other side and supplied as: NDC 0185-0149-01 bottles of 100 NDC 0185-0149-05 bottles of 500 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense contents in a tight, light-resistant container as defined in the USP with a child-resistant closure, as required. Protect from light and moisture. KEEP TIGHTLY CLOSED. To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Manufactured by Sandoz Inc. Princeton, NJ 08540 OS8009 Rev. March 2017 MF0040REV03/17

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

MIDODRINE HCL- MIDODRINE HYDROCHLORIDE TABLET
EON LABS, INC.
----------
MIDODRINE HYDROCHLORIDE TABLETS, USP
RX ONLY
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 agent.
Midodrine hydrochloride is an
odorless, white, crystalline powder, soluble in water and sparingly
soluble in methanol having a pKa of
7.8 (0.3% aqueous solution), a pH of 3.5 to 5.5 (5% aqueous solution)
and a melting range of 200°C to
203°C. It is chemically described as: (1) Acetamide,
2-amino-_N_-[2-(2,5-dimethoxyphenyl)-2-
hydroxyethyl]-monohydrochloride, (±)-; or (2)
(±)-2-amino-_N_-(ß-hydroxy-2,5-
dimethoxyphenethyl)acetamide monohydrochloride. Midodrine
hydrochloride’s molecular formula is
C
H N O HCl, its molecular weight is 290.7 and its structural formula
is:
Each tablet for oral administration contains 2.5 mg, 5 mg or 10 mg of
midodrine hydrochloride and the
following inactive ingredients: pregelatinized starch (corn starch),
microcrystalline cellulose, colloidal
silicon dioxide, magnesium stearate. In addition, the 5 mg tablets
contain FD&C yellow No. 6 aluminum
lake and FD&C red No. 40 aluminum lake and the 10 mg tablets contain
FD&C blue No. 2 aluminum
lake.
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
Midodrine hydrochloride forms an active metabolite, desglymidodrine,
that is an alpha -agonist and
exerts its actio