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:

RedPharm Drug, Inc.

Пут администрације:

ORAL

Тип рецептора:

PRESCRIPTION DRUG

Терапеутске индикације:

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. 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. Orphenadrine has been chronically abused for its euphoric effects. The mood elevating effects may occur at therapeutic doses of orphenadrine.

Резиме производа:

Orphenadrine citrate extended-release tablets 100 mg are round, white to off-white tablets, debossed NL4 on one side and plain on the other side and are supplied as: NDC 43386-480-24 in bottles of 100 tablets NDC 43386-480-26 in bottles of 500 tablets NDC 43386-480-28 in bottles of 1000 tablets Storage and Handling Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container. Manufactured by Novel Laboratories, Inc. Somerset, NJ 08873 for GAVIS Pharmaceuticals, LLC 400 Campus Drive Somerset, NJ 08873 GIN-480-01 Rev: 02/2011

Статус ауторизације:

Abbreviated New Drug Application

Карактеристике производа

ORPHENADRINE CITRATE- ORPHENADRINE CITRATE TABLET, EXTENDED RELEASE
REDPHARM DRUG, INC.
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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-⟨-phenylbenzyl)oxy]ethylamine citrate (1:1) having molecular
formula
C18H23NO•C6H8O7 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 cautioned accordingly.
PRECAUTIONS
Confusion, anxiety and