ORPHENADRINE CITRATE- orphenadrine citrate tablet

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

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

Disponible depuis:

Preferred Pharmaceuticals, Inc.

Mode d'administration:

ORAL

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

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 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]

Descriptif du produit:

Orphenadrine Citrate Extended-Release Tablets, for oral administration, are available as 100 mg White, round-shaped tablets debossed “E” over “22” on one side and plain on the other side and supplied as: Bottle of 14 - 68788-9306-4 Bottle of 20 - 68788-9306-2 Bottle of 30 - 68788-9306-3 Bottle of 60 - 68788-9306-6 Bottle of 90 - 68788-9306-9 Bottle of 100 - 68788-9306-1 Bottle of 120 - 68788-9306-8 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, as required. KEEP TIGHTLY CLOSED. KEEP THIS ANDALL 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. Manufactured by Sandoz Inc. Princeton, NJ 08540 OS8870 Rev. May 2016 MF0022REV05/16 Repackaged By: Preferred Pharmaceuticals Inc.

Statut de autorisation:

Abbreviated New Drug Application

Résumé des caractéristiques du produit

ORPHENADRINE CITRATE- ORPHENADRINE CITRATE TABLET
PREFERRED PHARMACEUTICALS, INC.
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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 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 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
cautioned accordingly.
18
23
6
8
7
PRECAUTIONS
Confusion, anxiety and tremors have been reported in few patients
receiving propoxyphene and
orphenadrine concomitantly. A