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:

Upsher-Smith laboratories, LLC

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'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. After initiation of treatment, midodrine hydrochloride tablets should be continued only for patients who report significant symptomatic improvement. Midod

Product summary:

Midodrine hydrochloride tablets, USP are supplied as 2.5 mg, 5 mg and 10 mg tablets for oral administration. The 2.5 mg tablet is a white, round, uncoated tablet, scored on one side with "US" above and "2.5" below the score and "211" on the other side. They are supplied as follows: The 5 mg tablet is a pink, round, uncoated tablet, scored on one side with "US" above and "5" below the score and "212" on the other side. They are supplied as follows: The 10 mg tablet is a purple, round, uncoated tablet, scored on one side with "US" above and "10" below the score and "213" on the other side. They are supplied as follows: Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Manufactured by UPSHER-SMITH LABORATORIES, LLC Maple Grove, MN 55369 Revised: 06/2020

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

MIDODRINE HYDROCHLORIDE- MIDODRINE HYDROCHLORIDE TABLET
UPSHER-SMITH LABORATORIES, LLC
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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: colloidal silicon dioxide, corn starch, FD&C
Blue No. 1 Lake (10 mg tablets),
FD&C Red No. 40 Lake (5 mg and 10 mg tablets), magnesium stearate,
microcrystalline cellulose 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_-(β-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, crystalline powder
12
18
2
4
SOLUBILITY:
Water:
Soluble
Methanol:
Sparingly soluble
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 increase i