ORPHENADRINE CITRATE tablet, extended release

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

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

제공처:

RxChange Co.

INN (International Name):

ORPHENADRINE CITRATE

구성:

ORPHENADRINE CITRATE 100 mg

관리 경로:

ORAL

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

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.

제품 요약:

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 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

승인 상태:

Abbreviated New Drug Application

제품 특성 요약

ORPHENADRINE CITRATE- ORPHENADRINE CITRATE TABLET, EXTENDED RELEASE
RXCHANGE CO.
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ORPHENADRINE CITRATE EXTENDED-RELEASE TABLETS
GAVIS PHARMACEUTICALS, LLC.
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 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
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operating machinery or driving a motor vehicle; ambulatory patients
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