Nchi: Marekani
Lugha: Kiingereza
Chanzo: NLM (National Library of Medicine)
ORPHENADRINE CITRATE (UNII: X0A40N8I4S) (ORPHENADRINE - UNII:AL805O9OG9)
Woodward Pharma Services LLC
ORAL
PRESCRIPTION DRUG
Orphenadrine citrate extended-release tablets are indicated as 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. Safety and effectiveness in pediatric patients have not been established. Orphenadrine citrate has been chronically abused for its euphoric effects. The mood elevating effects may occur at therapeutic doses of orphenadrine.
Orphenadrine Citrate Extended-Release Tablets, for oral administration, are available as 100 mg White to off-white, round tablets debossed 'CL 71' on one side and plain on the other side and supplied as: NDC 69784-905-01 bottles of 100 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense contents in a tight, light-resistant container as defined in the USP with a child-resistant closure. KEEP TIGHTLY CLOSED. To report SUSPECTED ADVERSE REACTIONS, contact Woodward Pharma Services LLC at 1-888-514-4727 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Manufactured for: Woodward Pharma Services LLC Birmingham, MI 48009 Rev. 09/2017 A
Abbreviated New Drug Application
ORPHENADRINE CITRATE- ORPHENADRINE CITRATE TABLET, EXTENDED RELEASE WOODWARD PHARMA SERVICES LLC ---------- ORPHENADRINE CITRATE EXTENDED RELEASE TABLETS, 100 MG ORPHENADRINE CITRATE EXTENDED-RELEASE TABLETS WOODWARD PHARMA SERVICES LLC RX ONLY DESCRIPTION: Orphenadrine citrate is the citrate salt of orphenadrine (2-dimethyl-aminoethyl 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 and has a molecular weight of 461.51. The molecular formula C H NO•C H O is represented by the following structural formula: Each orphenadrine citrate extended-release tablet contains 100 mg orphenadrine citrate, USP. Orphenadrine citrate extended-release tablets also contain: calcium stearate, ethylcellulose, and lactose monohydrate. 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 skeletal muscles in man. Orphenadrine citrate also possesses anti-cholinergic actions. INDICATIONS AND USAGE: Orphenadrine citrate extended-release tablets are indicated as adjunct to rest, physical therapy and other 18 23 6 8 7 measures for the relief of discomfort associated with acute painful musculo 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. PRECAUTIONS Confusion, anxiety Soma hati kamili