ORPHENADRINE CITRATE- orphenadrine citrate tablet, extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Lake Erie Medical DBA Quality Care Products LLC

INN (International Name):

ORPHENADRINE CITRATE

Composition:

ORPHENADRINE CITRATE 100 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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.

Product summary:

Orphenadrine citrate extended-release tablets 100 mg are round, white tablets, debossed GG 931 on one side and plain on the reverse side and are supplied as: 49999-046-14 49999-046-30 49999-046-60 Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container. 01-2010M 8100 GIN-480-00 Manufactured by Sandoz Inc. Princeton, NJ 08540 for GAVIS Pharmaceuticals, LLC 400 Campus Drive Somerset, NJ 08873

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ORPHENADRINE CITRATE - ORPHENADRINE CITRATE TABLET, EXTENDED RELEASE
LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC
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ORPHENADRINE CITRATE EXTENDED-RELEASE TABLETS
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
18
23
6
8
7
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