ORPHENADRINE CITRATE tablet extended release

Држава: Сједињене Америчке Државе

Језик: Енглески

Извор: NLM (National Library of Medicine)

Активни састојак:

ORPHENADRINE CITRATE (UNII: X0A40N8I4S) (ORPHENADRINE - UNII:AL805O9OG9)

Доступно од:

Unit Dose Services

INN (Међународно име):

ORPHENADRINE CITRATE

Састав:

ORPHENADRINE CITRATE 100 mg

Тип рецептора:

PRESCRIPTION DRUG

Статус ауторизације:

Abbreviated New Drug Application

Карактеристике производа

ORPHENADRINE CITRATE- ORPHENADRINE CITRATE TABLET, EXTENDED RELEASE
UNIT DOSE SERVICES
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ORPHENADRINE CITRATE EXTENDED-RELEASE TABLETS
RX ONLY
DESCRIPTION
Orphenadrine citrate is the citrate salt of orphenadrine. It occurs as
a white, crystalline powder having a
bitter taste. It is practically odorless; sparingly soluble in water,
slightly soluble in alcohol. The
chemical name of orphenadrine citrate is
(±)_-N,N_-Dimethyl-2-[(_o_-methyl-α-phenylbenzyl)oxy]ethylamine
citrate (1:1) having molecular formula C
H NO•C H O and molecular weight of 461.51. It has the
following structural formula:
Each tablet for oral administration contains 100 mg orphenadrine
citrate. Each Orphenadrine citrate
extended- release tablet contains the following inactive ingredients:
hydroxypropyl methylcellulose,
lactose monohydrate and magnesium stearate.
CLINICAL PHARMACOLOGY
The mode of therapeutic action has not been clearly identified, but
may be related to its analgesic
properties. Orphenadrine citrate does not directly relax tense muscles
in man. Orphenadrine citrate also
possesses anti-cholinergic actions.
INDICATIONS AND USAGE
Orphenadrine citrate extended-release tablets are indicated as an
adjunct to rest, physical therapy, and
other measures for the relief of discomfort associated with acute
painful musculoskeletal conditions.
CONTRAINDICATIONS
Orphenadrine citrate extended-release tablets are contraindicated in
patients with glaucoma, pyloric or
duodenal obstruction, stenosing peptic ulcers, prostatic hypertrophy
or obstruction of the bladder neck,
cardio-spasm (mega-esophagus) and myasthenia gravis. Orphenadrine
citrate tablets are contraindicated
in patients who have demonstrated a previous hypersensitivity to the
drug.
WARNINGS
Some patients may experience transient episodes of light-headedness,
dizziness or syncope.
Orphenadrine may impair the ability of the patient to engage in
potentially hazardous activities such as
operating machinery or driving a motor vehicle; ambulatory patients
should therefore be cauti