ORPHENADRINE CITRATE injection, solution

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

orphenadrine citrate (UNII: X0A40N8I4S) (orphenadrine - UNII:AL805O9OG9)

Disponible depuis:

Sagent Pharmaceuticals

DCI (Dénomination commune internationale):

orphenadrine citrate

Composition:

orphenadrine citrate 30 mg in 1 mL

Mode d'administration:

INTRAVENOUS

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

Orphenadrine Citrate Injection is 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. Orphenadrine has been chronically abused for its euphoric effects. The mood elevating effects may occur at therapeutic doses of orphenadrine.

Descriptif du produit:

Orphenadrine Citrate Injection, USP is supplied as follows: Orphenadrine Citrate Injection, USP is an aqueous solution. Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F). [See USP Controlled Room Temperature.] Protect from light. Retain in carton until time of use. Not to be sold in unbroken box. Discard unused portion. Sterile, Nonpyrogenic, Preservative-free. The container closure is not made with natural rubber latex. SAGENT® Mfd. for SAGENT Pharmaceuticals Schaumburg, IL 60195 (USA) Made in India ©2021 Sagent Pharmaceuticals, Inc. Revised: May 2021 SAGENT Pharmaceuticals®

Statut de autorisation:

Abbreviated New Drug Application

Résumé des caractéristiques du produit

ORPHENADRINE CITRATE- ORPHENADRINE CITRATE INJECTION, SOLUTION
SAGENT PHARMACEUTICALS
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ORPHENADRINE CITRATE INJECTION, USP
(FOR INTRAVENOUS OR INTRAMUSCULAR USE)
SAGENT
R only
DESCRIPTION
Orphenadrine citrate is the citrate salt of orphenadrine
(2-dimethylaminoethyl 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.
It has the following structural formula:
The empirical formula is C
H
NO·C H O , representing a molecular weight of 461.50.
Orphenadrine Citrate Injection, USP contains 60 mg of orphenadrine
citrate in aqueous
solution in each vial. Orphenadrine Citrate Injection, USP also
contains: sodium
metabisulfite NF, 2.0 mg; sodium chloride USP, 5.8 mg; sodium
hydroxide NF, to adjust
pH; and water for injection USP, q.s. to 2 mL.
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 Injection is indicated as an adjunct to rest,
physical therapy, and
other measures for the relief of discomfort associated with acute
painful musculo
®
x
18
23
6
8
7
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.
Orphenadrine citrate co