MIDODRINE HCL- midodrine hydrochloride tablet

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

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

Disponible depuis:

Cardinal Health

Mode d'administration:

ORAL

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

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 tablet'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

Descriptif du produit:

Midodrine Hydrochloride Tablets, for oral administration, are available as: 5 mg: Reddish-orange, round, flat-faced, bevelled edge, debossed “E “ over “43” on one side and bisected on the other side and supplied as: Overbagged with 10 tablets per bag, NDC 55154-6847-0 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense contents in a tight, light-resistant container as defined in the USP with a child-resistant closure, as required. To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Manufactured by: Sandoz Inc. 506 Carnegie Center Suite 400 Princeton, NJ 08805 Distributed By: McKesson Packaging Services a business unit of McKesson Corporation 7101 Weddington Rd., Concord, NC 28027 IS-4012621 Distributed by: Cardinal Health Dublin, OH 43017 L53163510318 February 2012

Statut de autorisation:

Abbreviated New Drug Application

Résumé des caractéristiques du produit

MIDODRINE HCL- MIDODRINE HYDROCHLORIDE TABLET
CARDINAL HEALTH
----------
MIDODRINE HYDROCHLORIDE TABLETS
RX ONLY
WARNING
BECAUSE MIDODRINE HYDROCHLORIDE TABLETS 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 TABLETS 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 TABLETS,
PRINCIPALLY IMPROVED ABILITY TO CARRY OUT ACTIVITIES OF DAILY LIVING,
HAVE NOT BEEN VERIFIED.
DESCRIPTION
Midodrine hydrochloride is a vasopressor/antihypotensive agent.
Midodrine hydrochloride is an
odorless, white, crystalline powder, soluble in water and sparingly
soluble in methanol having a pKa of
7.8 (0.3% aqueous solution), a pH of 3.5 to 5.5 (5% aqueous solution)
and a melting range of 200°C to
203°C. It is chemically described as: (1) Acetamide,
2-amino-_N_-[2-(2,5-dimethoxyphenyl)-2-
hydroxyethyl]-monohydrochloride, (±)-; or (2)
(±)-2-amino-_N_-(ß-hydroxy-2,5-
dimethoxyphenethyl)acetamide monohydrochloride. Midodrine
Hydrochloride’s molecular formula is
C
H N O HCl, its molecular weight is 290.7 and its structural formula
is:
Each tablet for oral administration contains 2.5 mg, 5 mg or 10 mg of
midodrine hydrochloride and the
following inactive ingredients: pregelatinized starch,
microcrystalline cellulose, colloidal silicon
dioxide, magnesium stearate. In addition, the 5 mg tablets contain
FD&C yellow No. 6 aluminum lake and
FD&C red No. 40 aluminum lake and the 10 mg tablets contain FD&C blue
No. 2 aluminum lake.
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
Midodrine hydrochloride forms an active metabolite, desglymidodrine,
that is an alpha -agonist and
exerts its actions via activation