Valsts: Amerikas Savienotās Valstis
Valoda: angļu
Klimata pārmaiņas: NLM (National Library of Medicine)
ORPHENADRINE CITRATE (UNII: X0A40N8I4S) (ORPHENADRINE - UNII:AL805O9OG9)
Preferred Pharmaceuticals, Inc.
ORPHENADRINE CITRATE
ORPHENADRINE CITRATE 100 mg
ORAL
PRESCRIPTION DRUG
Orphenadrine citrate extended-release tablets are indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute painful musculoskeletal conditions. Orphenadrine citrate extended-release tablets are contraindicated in patients with glaucoma, pyloric or duodenal obstruction, stenosing peptic ulcers, prostatic hypertrophy or obstruction of the bladder neck, cardio-spasm (mega-esophagus) and myasthenia gravis. Orphenadrine citrate tablets are 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 extended-release tablets 100 mg are round, white to off-white tablets, debossed NL4 on one side and plain on the other side and are supplied as: Bottle of 14 - 68788-9138-4 Bottle of 20 - 68788-9138-2 Bottle of 30 - 68788-9138-3 Bottle of 60 - 68788-9138-6 Bottle of 90 - 68788-9138-9 Bottle of 100 - 68788-9138-1 Bottle of 120 - 68788-9138-8 Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container. Manufactured by Novel Laboratories, Inc. Somerset, NJ 08873 Manufactured For Lupin Pharmaceuticals, Inc. Baltimore, MD 21202 PI4800000204 Rev: 06/2017 Repackaged By: Preferred Pharmaceuticals Inc.
Abbreviated New Drug Application
ORPHENADRINE CITRATE- ORPHENADRINE CITRATE TABLET, EXTENDED RELEASE PREFERRED PHARMACEUTICALS, INC. ---------- ORPHENADRINE CITRATE EXTENDED-RELEASE TABLETS RX ONLY DESCRIPTION Orphenadrine citrate is the citrate salt of orphenadrine. It occurs as a white, crystalline powder having a bitter taste. It is practically odorless; sparingly soluble in water, slightly soluble in alcohol. The chemical name of orphenadrine citrate is (±)_-N,N_-Dimethyl-2-[(_o_- methyl-α-phenylbenzyl)oxy]ethylamine citrate (1:1) having molecular formula C H NO•C H O and molecular weight of 461.51. It has the following structural formula: Each tablet for oral administration contains 100 mg orphenadrine citrate. Each Orphenadrine citrate extended- release tablet contains the following inactive ingredients: hydroxypropyl methylcellulose, lactose monohydrate and magnesium stearate. 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 extended-release tablets are indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute painful musculoskeletal conditions. CONTRAINDICATIONS Orphenadrine citrate extended-release tablets are contraindicated in patients with glaucoma, pyloric or duodenal obstruction, stenosing peptic ulcers, prostatic hypertrophy or obstruction of the bladder neck, cardio-spasm (mega-esophagus) and myasthenia gravis. Orphenadrine citrate tablets are contraindicated in patients who have demonstrated a previous hypersensitivity to the drug. 18 23 6 8 7 WARNINGS Some patients may experience transient episodes of light-headedness, dizziness or syncope. Orphenadrine may impair the ability of the patient to engage in potentially hazardous activities such as operating machinery or driving a motor vehicle; ambulatory patients Izlasiet visu dokumentu