ORPHENADRINE CITRATE tablet

Երկիր: Ամերիկայի Միացյալ Նահանգներ

Լեզու: անգլերեն

Աղբյուրը: NLM (National Library of Medicine)

Ակտիվ բաղադրիչ:

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

Հասանելի է:

Carilion Materials Management

Կառավարման երթուղին:

ORAL

Ռեկվիզորի տեսակը:

PRESCRIPTION DRUG

Թերապեւտիկ ցուցումներ:

Orphenadrine citrate extended-release tablets, USP 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]

Ապրանքի ամփոփագիր:

Product: 68151-1463 NDC: 68151-1463-0 1 TABLET in a PACKAGE

Լիազորման կարգավիճակը:

Abbreviated New Drug Application

Ապրանքի հատկությունները

ORPHENADRINE CITRATE- ORPHENADRINE CITRATE TABLET
CARILION MATERIALS MANAGEMENT
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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, USP 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.
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
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23
6
8
7
cautioned accordingly.
PRECAUTIONS
Confusion, anxiety and tremors have been reported in few patients
receiving propoxyphene and
o