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, LLC dba Vangard Labs

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 tablet scan 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’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, 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 symptoma

Product summary:

Midodrine hydrochloride tablets, USP are available as 2.5 mg, 5 mg and 10 mg tablets for oral administration. Midodrine hydrochloride tablets USP, 2.5 mg having functional scoring are white to off-white round, flat-faced, beveled edge, scored tablets debossed with ‘L’ above the score and plain on below the score on one side of the tablet and ‘584’ on the other side. Blistercard of 30 tablets                                            NDC 0615-8443-39 Midodrine hydrochloride tablets USP, 5 mg having functional scoring are white to off-white round, flat-faced, beveled edge, scored tablets debossed with ‘L’ above the score and plain on below the score on one side of the tablet and ‘585’ on the other side. Blistercard of 30 tablets                                            NDC 0615-8444-39 Midodrine hydrochloride tablets USP, 10 mg having functional scoring are white to off-white round, flat-faced, beveled edge, scored tablets debossed with ‘L’ above the score and plain on below the score on one side of the tablet and ‘586’ on the other side. Blistercard of 30 tablets                                            NDC 0615-8445-39 Blistercard of 15 tablets                                            NDC 0615-8445-05 Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Rx only Manufactured by: Alembic Pharmaceuticals Limited    (Formulation Division), Panelav 389350, Gujarat, India Manufactured for: Alembic Pharmaceuticals, Inc. Bedminster, NJ 07921, USA Revised: 09/2021 20034003

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

MIDODRINE HYDROCHLORIDE- MIDODRINE HYDROCHLORIDE TABLET
NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS
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MIDODRINE HYDROCHLORIDE TABLETS, USP
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
NAME: Midodrine hydrochloride tablets, USP
DOSAGE FORM: 2.5 mg, 5 mg and 10 mg tablets for oral administration
ACTIVE INGREDIENT: Midodrine hydrochloride, USP 2.5 mg, 5 mg and 10 mg
INACTIVE INGREDIENTS: Microcrystalline cellulose, crospovidone,
hydroxypropyl
cellulose, colloidal silicon dioxide and magnesium stearate.
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-(ß-hydroxy-2,5-dimethoxyphenethyl)acetamide
monohydrochloride
BAN, INN, JAN: Midodrine
STRUCTURAL FORMULA:
MOLECULAR FORMULA: C
H
N O HCl
MOLECULAR WEIGHT: 290.7
ORGANOLEPTIC PROPERTIES: Odorless, white to off-white powder
12
18
2
4
ORGANOLEPTIC PROPERTIES: Odorless, white to off-white powder
SOLUBILITY: Soluble in water, sparingly soluble in methanol
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 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 i