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 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’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 tabletsshould be continued only for patients who report signifi

Product summary:

Midodrine Hydrochloride 2.5 mg, 5 mg and 10 mg tablets for oral administration. Midodrine Hydrochloride Tablets, USP 2.5 mg are white to off-white rectangle shaped, flat faced, beveled edge, scored tablets, debossed with “M” above the score and “2.5” below the score on one side of the tablet and “2.5” on the other side.                  Blistercards of 30               NDC 0615-8382-39 Midodrine Hydrochloride Tablets, USP 5 mg are white to off-white round shaped, flat faced, beveled edge, scored tablets, debossed with “M” above the score, “5” below the score on one side and “5” on the other side.                  Blistercards of 30               NDC 0615-8383-39 Midodrine Hydrochloride Tablets, USP 10 mg are white to off-white capsule shaped, flat faced, beveled edge, scored tablets, debossed with “M” on the left of the score and “10” on  right of the score on one side of the tablet and “10” on the other side.                  Blistercards of 30               NDC 0615-8384-39 Store at 20° to 25°C (68° to 77°F) excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Preserve in well-closed containers. Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Manufactured by: Aurobindo Pharma Limited Hyderabad-500 038, India Issued: May 2020

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

MIDODRINE HYDROCHLORIDE- MIDODRINE HYDROCHLORIDE TABLET
NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS
----------
MIDODRINE HYDROCHLORIDE TABLETS, USP
RX ONLY
WARNING: BECAUSE MIDODRINE HYDROCHLORIDECAN 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 HYDROCHLORIDEIN 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, 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: Colloidal silicon dioxide, magnesium stearate,
microcrystalline
cellulose, pregelatinized starch (maize) and talc.
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: White crystalline powder
SOLUBILITY: Freely soluble in formic acid, soluble in water, slightly
soluble in ethanol, very
slightly soluble in glacial acetic acid, sparingly soluble in
methanol, practically insoluble in
ethyl ether.
12
18
2
4
PKA: 7.8 (0.3% aqueous solution)
PH: 4.0 to 5.0 (5% solution in water)
MELTING RANGE: About 200ºC
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION: Midodrine hydrochlorideforms an active
metabolite,
desglymidodrine, that is an alpha -agoni