ORPHENADRINE CITRATE tablet, extended release

Држава: Сједињене Америчке Државе

Језик: Енглески

Извор: NLM (National Library of Medicine)

Активни састојак:

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

Доступно од:

Woodward Pharma Services LLC

Пут администрације:

ORAL

Тип рецептора:

PRESCRIPTION DRUG

Терапеутске индикације:

Orphenadrine citrate extended-release tablets are indicated as 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. The mood elevating effects may occur at therapeutic doses of orphenadrine.

Резиме производа:

Orphenadrine Citrate Extended-Release Tablets, for oral administration, are available as 100 mg White to off-white, round tablets debossed 'CL 71' on one side and plain on the other side and supplied as: NDC 69784-905-01 bottles of 100 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. KEEP TIGHTLY CLOSED. To report SUSPECTED ADVERSE REACTIONS, contact Woodward Pharma Services LLC at 1-888-514-4727 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Manufactured for: Woodward Pharma Services LLC Birmingham, MI 48009 Rev. 09/2017 A

Статус ауторизације:

Abbreviated New Drug Application

Карактеристике производа

ORPHENADRINE CITRATE- ORPHENADRINE CITRATE TABLET, EXTENDED RELEASE
WOODWARD PHARMA SERVICES LLC
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ORPHENADRINE CITRATE EXTENDED RELEASE TABLETS, 100 MG
ORPHENADRINE CITRATE EXTENDED-RELEASE TABLETS
WOODWARD PHARMA SERVICES LLC
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, USP.
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 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 adjunct
to rest, physical therapy and other
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6
8
7
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
cautioned accordingly.
PRECAUTIONS
Confusion, anxiety