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:

Bryant Ranch Prepack

INN (International Name):

ORPHENADRINE CITRATE

Composition:

ORPHENADRINE CITRATE 100 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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.

Product summary:

Product: 63629-1564 NDC: 63629-1564-0 56 TABLET, EXTENDED RELEASE in a BOTTLE NDC: 63629-1564-8 14 TABLET, EXTENDED RELEASE in a BOTTLE NDC: 63629-1564-1 20 TABLET, EXTENDED RELEASE in a BOTTLE NDC: 63629-1564-6 28 TABLET, EXTENDED RELEASE in a BOTTLE NDC: 63629-1564-5 30 TABLET, EXTENDED RELEASE in a BOTTLE NDC: 63629-1564-7 45 TABLET, EXTENDED RELEASE in a BOTTLE NDC: 63629-1564-2 60 TABLET, EXTENDED RELEASE in a BOTTLE NDC: 63629-1564-4 90 TABLET, EXTENDED RELEASE in a BOTTLE NDC: 63629-1564-3 100 TABLET, EXTENDED RELEASE in a BOTTLE NDC: 63629-1564-9 120 TABLET, EXTENDED RELEASE in a BOTTLE

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ORPHENADRINE CITRATE- ORPHENADRINE CITRATE TABLET, EXTENDED RELEASE
BRYANT RANCH PREPACK
----------
ORPHENADRINE CITRATE EXTENDED-RELEASE TABLETS
RX ONLY
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-α-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
18
23
6
8
7
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 t