Šalis: Jungtinės Valstijos
kalba: anglų
Šaltinis: NLM (National Library of Medicine)
ORPHENADRINE CITRATE (UNII: X0A40N8I4S) (ORPHENADRINE - UNII:AL805O9OG9)
H.J. Harkins Company, Inc.
ORPHENADRINE CITRATE
ORPHENADRINE CITRATE 100 mg
ORAL
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 the 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. Contraindicated in patients with glaucoma, pyloric or duodenal obstruction, stenosing peptic ulcers, prostatic hypertrophy or obstruction of the bladder neck, cardiospasm (megaesophagus) and myasthenia gravis. Contraindicated in patients who have demonstrated a previous hypersensitivity to the drug.
Tablets 100 mg-Each round, white, convex tablet imprinted with "G" on one side and "2011" on the other side. Bottles of 100 NDC 0115-2011-01 Bottles of 500 NDC 0115-2011-02 Store at controlled room temperature 15° to 30°C (59° to 86°F). Dispense in tightly-closed, light-resistant container (USP).
Abbreviated New Drug Application
ORPHENADRINE CITRATE - ORPHENADRINE CITRATE TABLET, EXTENDED RELEASE H.J. HARKINS COMPANY, INC. ---------- ORPHENADRINE CITRATE EXTENDED-RELEASE TABLETS, 100 MG RX ONLY DESCRIPTION Orphenadrine citrate is the citrate salt of orphenadrine (2-dimethylaminoethyl 2-methyl-benzhydryl 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. Each orphenadrine citrate tablet contains 100 mg orphenadrine citrate, USP. Orphenadrine citrate tablets also contain ethylcellulose NF, povidone USP, lactose monohydrate NF, and magnesium stearate NF. ACTIONS The mode of therapeutic action has not been clearly identified, but may be related to its analgesic properties. Orphenadrine citrate also possesses anticholinergic actions. INDICATIONS 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 the 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 Contraindicated in patients with glaucoma, pyloric or duodenal obstruction, stenosing peptic ulcers, prostatic hypertrophy or obstruction of the bladder neck, cardiospasm (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. PREGNANCY PREGNANCY CATEGORY C Safe use of orphenadrine citrate has not been established with respect to adverse effects upon fetal development. Therefore, orphenadrine citrate should be used in Perskaitykite visą dokumentą