MIDODRINE HYDROCHLORIDE tablet

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

MIDODRINE HYDROCHLORIDE (UNII: 59JV96YTXV) (MIDODRINE - UNII:6YE7PBM15H)

Mevcut itibaren:

Alembic Pharmaceuticals Inc.

Uygulama yolu:

ORAL

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

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 hydrochloride tablets. After initiation of treatment, midodrine hydrochloride tablets should be continued only for patients who report significant symptom

Ürün özeti:

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. Bottle of 100 tabletswith child resistant closure, NDC 62332-338-31 Bottle of 500 tablets                                              NDC 62332-338-71 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. Bottle of 100 tabletswith child resistant closure, NDC 62332-339-31 Bottle of 500 tablets                                              NDC 62332-339-71 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. Bottle of 100 tabletswith child resistant closure, NDC 62332-340-31 Bottle of 500 tablets                                              NDC 62332-340-71 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       

Yetkilendirme durumu:

Abbreviated New Drug Application

Ürün özellikleri

MIDODRINE HYDROCHLORIDE - MIDODRINE HYDROCHLORIDE TABLET
ALEMBIC PHARMACEUTICALS INC.
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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
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 increase in
vascular tone and
elevation of blood pressure. Desglymidodrine d