ORPHENADRINE CITRATE tablet, extended release

Country: Amerika Syarikat

Bahasa: Inggeris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Boleh didapati daripada:

Aidarex Pharmaceuticals LLC

INN (Nama Antarabangsa):

ORPHENADRINE CITRATE

Komposisi:

ORPHENADRINE CITRATE 100 mg

Laluan pentadbiran:

ORAL

Jenis preskripsi:

PRESCRIPTION DRUG

Tanda-tanda terapeutik:

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.

Ringkasan produk:

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: NDC 33261-088-07  in bottles of 7 tablets NDC 33261-088-14  in bottles of 7 tablets NDC 33261-088-20  in bottles of 7 tablets NDC 33261-088-28  in bottles of 7 tablets NDC 33261-088-30  in bottles of 7 tablets NDC 33261-088-60  in bottles of 7 tablets NDC 33261-088-84  in bottles of 7 tablets NDC 33261-088-90  in bottles of 7 tablets NDC 33261-088-120in bottles of 7 tablets 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 Repackaged By: Aidarex Pharmaceuticals, LLC. Corona, CA 92880

Status kebenaran:

Abbreviated New Drug Application

Ciri produk

ORPHENADRINE CITRATE- ORPHENADRINE CITRATE TABLET, EXTENDED RELEASE
AIDAREX PHARMACEUTICALS 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 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 caut