Orphenadrine Citrate

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.

10. Dosage and Administration Section DOSAGE AND ADMINISTRATION Adults Two tablets per day; one in the morning and one in the evening.

4. 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.

ADVERSE REACTIONS Adverse reactions of orphenadrine citrate are mainly due to the mild anti-cholinergic action of orphenadrine citrate and are usually associated with higher dosage. Dryness of the mouth is usually the first adverse effect to appear. When the daily dose is increased, possible adverse effects include tachycardia, palpitation, urinary hesitancy or retention, blurred vision, dilatation of pupils, increased ocular tension, weakness, nausea, vomiting, headache, dizziness, constipation, drowsiness, hypersensitivity reactions, pruritus, hallucinations, agitation, tremor, gastric irritation and rarely urticaria and other dermatoses. Infrequently, an elderly patient may experience some degree of mental confusion. These adverse reactions can usually be eliminated by reduction in dosage. Very rare cases of aplastic anemia associated with the use of orphenadrine tablets have been reported. No causal relationship has been established. To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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-〈-phenylbenzyl)oxy]ethylamine citrate (1:1) having molecular formula C 18 H 23 NO•C 6 H 8 O 7 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. S:\RA\2011 ANDA\Orphenadrine Citrate ER Tablets\CBE - Labeling\Backup\062812\figure-01.jpg

OVERDOSAGE Orphenadrine citrate extended-release tablets are toxic when overdosed and typically induces anti-cholinergic effects.[3] In a review of orphenadrine toxicity, the minimum lethal dose was found to be 2 to 3 grams for adults; however, the range of toxicity is variable and unpredictable.[4] Treatment for orphenadrine citrate extended-release tablets overdose is evacuation of stomach contents (when necessary), charcoal at repeated doses, intensive monitoring and appropriate supportive treatment of any emergent anti-cholinergic effects.[5]

HOW SUPPLIED 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: Product: 63629-1564 NDC: 63629-1564-0 56 TABLET, EXTENDED RELEASE in a BOTTLE NDC: 63629-1564-8 14 TABLET, EXTENDED RELEASE in a BOTTLE NDC: 63629-1564-1 20 TABLET, EXTENDED RELEASE in a BOTTLE NDC: 63629-1564-6 28 TABLET, EXTENDED RELEASE in a BOTTLE NDC: 63629-1564-5 30 TABLET, EXTENDED RELEASE in a BOTTLE NDC: 63629-1564-7 45 TABLET, EXTENDED RELEASE in a BOTTLE NDC: 63629-1564-2 60 TABLET, EXTENDED RELEASE in a BOTTLE NDC: 63629-1564-4 90 TABLET, EXTENDED RELEASE in a BOTTLE NDC: 63629-1564-3 100 TABLET, EXTENDED RELEASE in a BOTTLE NDC: 63629-1564-9 120 TABLET, EXTENDED RELEASE in a BOTTLE Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container. Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504