ORPHENADRINE CITRATE tablet, extended release

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

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

متاح من:

DIRECT RX

طريقة التعاطي:

ORAL

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الخصائص العلاجية:

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.

ملخص المنتج:

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: 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 Manufactured For Lupin Pharmaceuticals, Inc. Baltimore, MD 21202 PI4800000204 Rev: 06/2017

الوضع إذن:

Abbreviated New Drug Application

خصائص المنتج

ORPHENADRINE CITRATE- ORPHENADRINE CITRATE TABLET, EXTENDED RELEASE
DIRECT RX
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ORPHENADRINE CITRATE
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
C18H23NO•C6H8O7 and
molecular weight of 461.51. It has the following structural formula:
[Image]
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.
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.
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.
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.
Confusion, anxiety and tremors have been reported in few patients
receiving propoxyphene and
orphen