MIDODRINE HYDROCHLORIDE tablet

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

TruPharma, LLC

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Midodrine Hydrochloride Tablets, USP are indicated for the treatment of symptomatic orthostatic hypotension (OH). Because Midodrine Hydrochloride Tablets, USP 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, USP 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, USP 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, USP. After initiation of treatment, Midodrine Hydrochloride Tablets, USP should be continued

Produkt oppsummering:

Midodrine Hydrochloride Tablets, USP 2.5mg, 5mg and 10mg tablets for oral administration. Midodrine Hydrochloride Tablets, USP 2.5mg are white to off white, round beveled edge, scored tablets debossed with " ^ " above the score line on one side and "040" on other side. Bottles of 100 tablets: NDC 52817-323-10 Midodrine Hydrochloride Tablets, USP 5mg are white to off white, round beveled edge, scored tablets debossed with " ^ " above the score line on one side and "041" on other side. Bottles of 100 tablets: NDC 52817-324-10 Midodrine Hydrochloride Tablets, USP 10mg are white to off white, round beveled edge, scored tablets debossed with " ^ " above the score line on one side and "042" on other side. Bottles of 100 tablets: NDC 52817-325-10 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]. Dispense in a tight, light-resistant container as defined in the USP, using a child-resistant closure. To report SUSPECTED ADVERSE REACTIONS, contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Distributed By TruPharma, LLC Tampa, FL 33609 Manufactured by: Rubicon Research Private Limited Ambernath, Dist: Thane, 421506 India Rx Only Rev.00, 09/2019

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

MIDODRINE HYDROCHLORIDE- MIDODRINE HYDROCHLORIDE TABLET
TRUPHARMA, LLC
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MIDODRINE HYDROCHLORIDE TABLETS, USP
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, 2.5 mg, 5 mg and 10 mg
INACTIVE INGREDIENTS: Colloidal Silicone Dioxide, Croscarmellose
sodium, Magnesium Stearate,
Microcrystalline Cellulose, Pregelatinised Starch, Sodium Lauryl
Sulphate
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 crystalline powder
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 hydrochloride forms an active
metabolite, desglymidodrine, that is
an alpha1-agonist, and exerts its actions via activation of the
alpha-adrenergic receptors of the arteriolar
12
18
2
4
an alpha1-agonist, and exerts its actions via activati