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:

Sandoz Inc

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 musculo skeletal conditions. Contraindicated in patients with glaucoma, pyloric or duodenal obstruction, stenosing peptic ulcers, prostatic hypertrophy or obstruction of the bladder neck, cardio-spasm (megaesophagus) and myasthenia gravis. Contraindicated in patients who have demonstrated a previous hypersensitivity to the drug. Safety and effectiveness in pediatric patients have not been established. Orphenadrine citrate has been chronically abused for its euphoric effects.[1] The mood elevating effects may occur at therapeutic doses of orphenadrine.[2]

ملخص المنتج:

Orphenadrine Citrate Extended-Release Tablets, USP, for oral administration, are available as 100 mg White, round-shaped tablets debossed “E ” over “22” on one side and plain on the other side and supplied as: NDC 0185-0022-01 bottles of 100 NDC 0185-0022-10 bottles of 1000 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense contents in a tight, light-resistant container as defined in the USP with a child-resistant closure, as required. KEEP TIGHTLY CLOSED. KEEP OUT OF THE REACH OF CHILDREN. Manufactured by Sandoz Inc. Princeton, NJ 08540 46299664 Rev. May 2022 MF0022REV05/2022

الوضع إذن:

Abbreviated New Drug Application

خصائص المنتج

ORPHENADRINE CITRATE- ORPHENADRINE CITRATE TABLET, EXTENDED RELEASE
SANDOZ INC
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ORPHENADRINE CITRATE EXTENDED-RELEASE TABLETS, USP
RX ONLY
DESCRIPTION
Orphenadrine citrate, USP is the citrate salt of orphenadrine
(2-dimethyl-aminoethyl 2-
methylbenzhydryl ether citrate). It occurs as a white, crystalline
powder having a bitter
taste. It is practically odorless; sparingly soluble in water,
slightly soluble in alcohol and
has a molecular weight of 461.51. The molecular formula C
H
NO • C H O is
represented by the following structural formula:
Each orphenadrine citrate extended-release tablet, USP contains 100 mg
orphenadrine
citrate, USP. Orphenadrine citrate extended-release tablets, USP also
contain: calcium
stearate, ethylcellulose and lactose monohydrate.
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 skeletal 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 musculo skeletal conditions.
CONTRAINDICATIONS
Contraindicated in patients with glaucoma, pyloric or duodenal
obstruction, stenosing
peptic ulcers, prostatic hypertrophy or obstruction of the bladder
neck, cardio-spasm
(megaesophagus) and myasthenia gravis.
Contraindicated in patients who have demonstrated a previous
hypersensitivity to the
drug.
18
23
6
8
7
drug.
WARNINGS
Some patients may experience transient episodes of light-headedness,
dizziness or
syncope. Orphenadrine citrate 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 tremors have been reported in few patients
receiving
propoxyphene and