Држава: Сједињене Америчке Државе
Језик: Енглески
Извор: NLM (National Library of Medicine)
ORPHENADRINE CITRATE (UNII: X0A40N8I4S) (ORPHENADRINE - UNII:AL805O9OG9)
Actavis Pharma, Inc.
INTRAMUSCULAR
PRESCRIPTION DRUG
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. Orphenadrine citrate is contraindicated in patients with glaucoma, pyloric or duodenal obstruction, stenosing peptic ulcers, prostatic hypertrophy or obstruction at the bladder neck, cardiospasm (megaesophagus) and myasthenia gravis. Orphenadrine citrate is contraindicated in patients who have demonstrated a previous hypersensitivity to the drug.
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
Abbreviated New Drug Application
ORPHENADRINE CITRATE- ORPHENADRINE CITRATE INJECTION ACTAVIS PHARMA, INC. ---------- ORPHENADRINE CITRATE INJECTION, USP RX ONLY 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. CLINICAL PHARMACOLOGY The mode of action has not been clearly identified but may be related to analgesic properties. Orphenadrine citrate possesses anticholinergic actions. 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. CONTRAINDICATIONS Orphenadrine citrate is contraindicated in patients with glaucoma, pyloric or duodenal obstruction, stenosing peptic ulcers, prostatic hypertrophy or obstruction at the bladder neck, cardiospasm (megaesophagus) and myasthenia gravis. Orphenadrine citrate is contraindicated in patients who have demonstrated a previous hypersensitivity to the drug. WARNINGS 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 p Прочитајте комплетан документ