orphenadrine citrate

FDA Drug Profile — Orphenadrine Citrate

orphenadrine citrate is listed in the FDA National Drug Code directory with 1 NDC code, marketed under brand name including Orphenadrine Citrate. Available dosage form: injection, solution.

Drug Details

Generic Name
orphenadrine citrate
Brand Names
Orphenadrine Citrate
Application Number
ANDA090585
Sponsor
Sagent Pharmaceuticals
NDC Codes
1
Dosage Forms
INJECTION, SOLUTION
Routes
INTRAMUSCULAR, INTRAVENOUS
Active Ingredients
ORPHENADRINE CITRATE

Indications and Usage

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 skeletal conditions.

Warnings

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 contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than nonasthmatic people.