ORPHENADRINE CITRATE tablet, extended release

Страна: САЩ

Език: английски

Източник: NLM (National Library of Medicine)

Активна съставка:

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

Предлага се от:

Proficient Rx LP

INN (Международно Name):

ORPHENADRINE CITRATE

Композиция:

ORPHENADRINE CITRATE 100 mg

Начин на приложение:

ORAL

Вид предписание :

PRESCRIPTION DRUG

Терапевтични показания:

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, 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 extended-release tablets have been chronically abused for their euphoric effects.[1] The mood elevating effects may occur at therapeutic doses of orphenadrine.[2]

Каталог на резюме:

Orphenadrine Citrate Extended-Release Tablets, 100 mg, white, round-shaped tablets debossed “E” over “22” on one side and plain on the other side and supplied as: NDC 63187-632-30 bottles of 30 NDC 63187-632-60 bottles of 60 NDC 63187-632-90 bottles of 90 Store at 20° to 25°C (68° to 77°F)[see USP Controlled Room Temperature]. Dispense in tight, light-resistant containers as defined in the USP, with a child-resistant closure as required. KEEP TIGHTLY CLOSED. KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN. To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Sandoz Inc. Princeton, NJ 08540 OS8870 Rev. 09/09 MF0022REV09/09 MG #14534 Repackaged by: Proficient Rx LP Thousand Oaks, CA 91320

Статус Оторизация:

Abbreviated New Drug Application

Данни за продукта

ORPHENADRINE CITRATE- ORPHENADRINE CITRATE TABLET, EXTENDED RELEASE
PROFICIENT RX LP
----------
ORPHENADRINE CITRATE EXTENDED-RELEASE TABLETS
RX ONLY
DESCRIPTION
Orphenadrine citrate 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 contains 100 mg
orphenadrine citrate. Orphenadrine
citrate extended-release tablets 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 extended-release tablets do not
directly relax tense skeletal muscles in
man. Orphenadrine citrate extended-release tablets also possess
anti-cholinergic 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, 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 extended-release tablets may impair the ability
of the patient to engage in
potentially hazardous activities such as operating machinery or
drivin