Drug Catalog - Product Detail
ORPHENADRINE CITRATE FOR INJECTION INJECT. 30MG/ML 10X2ML
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 00591-3222-47 | ACTAVIS PHARMA | 2 | 30MG/ML | SOLUTION |
PACKAGE FILES
Generic Name
ORPHENADRINE CITRATE
Substance Name
ORPHENADRINE CITRATE
Product Type
HUMAN PRESCRIPTION DRUG
Route
INTRAMUSCULAR
Application Number
ANDA084779
Description
DESCRIPTION Orphenadrine Citrate Injection is a sterile aqueous solution of orphenadrine citrate. It is intended for intravenous or intramuscular administration. Orphenadrine citrate is the citrate salt of orphenadrine and occurs as a white, crystalline powder having a bitter taste. It is practically odorless, sparingly soluble in water and slightly soluble in alcohol. It has the following structural formula: N,N-Dimethyl-2-[( o -methyl-α-phenylbenzyl)oxy]ethylamine Citrate (1:1). Each mL contains: Orphenadrine Citrate 30 mg, Sodium Metabisulfite 0.91 mg, Sodium Chloride 2.9 mg, in Water for Injection q.s. Sodium Hydroxide and/or Hydrochloric Acid may have been used to adjust pH. structural formula for orphenadrine citrate
How Supplied
HOW SUPPLIED Orphenadrine Citrate Injection USP, 30 mg/mL is available in 2 mL ampules in cartons of 10. Store at 20º to 25ºC (68º to 77ºF) [See USP Controlled Room Temperature.] PROTECT FROM LIGHT. DO NOT USE IF PRECIPITATE OCCURS. Literature revised: July 2016 Product No.: 1108-82 Mfd. by: Hikma Farmaceutica (Portugal) S.A. 2705-906 Terrugem SNT, Portugal Dist. by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA
Indications & Usage
INDICATIONS AND USAGE 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 this 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.
Dosage and Administration
DOSAGE AND ADMINISTRATION Adults: 2 mL (60 mg) intravenously or intramuscularly - May be repeated every 12 hours. Relief may be maintained by one (100 mg) orphenadrine citrate tablet twice daily. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever the solution and container permit.