ORPHENADRINE CITRATE- orphenadrine citrate tablet, extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

H.J. Harkins Company, Inc.

INN (International Name):

ORPHENADRINE CITRATE

Composition:

ORPHENADRINE CITRATE 100 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Orphenadrine citrate is indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute painful musculo-skeletal conditions. The mode of action of the drug has not been clearly identified, but may be related to its analgesic properties. Orphenadrine citrate does not directly relax tense skeletal muscles in man. Contraindicated in patients with glaucoma, pyloric or duodenal obstruction, stenosing peptic ulcers, prostatic hypertrophy or obstruction of the bladder neck, cardiospasm (megaesophagus) and myasthenia gravis. Contraindicated in patients who have demonstrated a previous hypersensitivity to the drug.

Product summary:

Tablets 100 mg-Each round, white, convex tablet imprinted with "G" on one side and "2011" on the other side. Bottles of 100 NDC 0115-2011-01 Bottles of 500 NDC 0115-2011-02 Store at controlled room temperature 15° to 30°C (59° to 86°F). Dispense in tightly-closed, light-resistant container (USP).

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ORPHENADRINE CITRATE - ORPHENADRINE CITRATE TABLET, EXTENDED RELEASE
H.J. HARKINS COMPANY, INC.
----------
ORPHENADRINE CITRATE
EXTENDED-RELEASE TABLETS, 100 MG
RX ONLY
DESCRIPTION
Orphenadrine citrate is the citrate salt of orphenadrine
(2-dimethylaminoethyl 2-methyl-benzhydryl 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. Each orphenadrine
citrate tablet contains 100 mg
orphenadrine citrate, USP. Orphenadrine citrate tablets also contain
ethylcellulose NF, povidone USP,
lactose monohydrate NF, and magnesium stearate NF.
ACTIONS
The mode of therapeutic action has not been clearly identified, but
may be related to its analgesic
properties. Orphenadrine citrate also possesses anticholinergic
actions.
INDICATIONS
Orphenadrine citrate is indicated as an adjunct to rest, physical
therapy, and other measures for the relief
of discomfort associated with acute painful musculo-skeletal
conditions. The mode of action of the
drug has not been clearly identified, but may be related to its
analgesic properties. Orphenadrine citrate
does not directly relax tense skeletal muscles in man.
CONTRAINDICATIONS
Contraindicated in patients with glaucoma, pyloric or duodenal
obstruction, stenosing peptic ulcers,
prostatic hypertrophy or obstruction of the bladder neck, cardiospasm
(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
cautioned accordingly.
PREGNANCY
PREGNANCY CATEGORY C
Safe use of orphenadrine citrate has not been established with respect
to adverse effects upon fetal
development. Therefore, orphenadrine citrate should be used in