Šalis: Jungtinės Valstijos
kalba: anglų
Šaltinis: NLM (National Library of Medicine)
orphenadrine citrate (UNII: X0A40N8I4S) (orphenadrine - UNII:AL805O9OG9)
Sagent Pharmaceuticals
orphenadrine citrate
orphenadrine citrate 30 mg in 1 mL
INTRAVENOUS
PRESCRIPTION DRUG
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.
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®
Abbreviated New Drug Application
ORPHENADRINE CITRATE- ORPHENADRINE CITRATE INJECTION, SOLUTION SAGENT PHARMACEUTICALS ---------- 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 Perskaitykite visą dokumentą