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:

Lifestar Pharma LLC

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'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 repor

Product summary:

Midodrine hydrochloride tablets, USP are supplied as 2.5 mg, 5 mg and 10 mg tablets for oral administration. 2.5 mg tablets are white to off white, round tablets, scored on one side and debossed with 'LS' on the other side. NDC 70756-010-11                Bottle of 100 tablets with child-resistant closure. 5 mg tablets are white to off white, round tablets, scored on one side and debossed with 'L49' on the other side. NDC 70756-049-11                Bottle of 100 tablets with child-resistant closure. 10 mg tablets are white to off white, round tablets, scored on one side and debossed with 'L50' on the other side. NDC 70756-050-11                Bottle of 100 tablets with child-resistant closure. Store at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Manufactured for: Lifestar Pharma LLC 1200 MacArthur Blvd. Mahwah, NJ 07430 USA Product of Italy Revised: November 2023, V-04

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

MIDODRINE HYDROCHLORIDE- MIDODRINE HYDROCHLORIDE TABLET
LIFESTAR PHARMA LLC
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MIDODRINE HYDROCHLORIDE TABLETS, USP
RX ONLY
BOXED WARNING
WARNING: BECAUSE MIDODRINE HYDROCHLORIDE 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 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, 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 (corn), 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: 290.75
ORGANOLEPTIC PROPERTIES: White to off-white crystalline powder
SOLUBILITY: Water: Soluble
PKA: 7.8 (0.3% aqueous solution)
PH: 4.0 to 5.0
MELTING RANGE: 192°C to 203°C
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
Midodrine hydrochloride 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 pressure. Desglymido