ADVERSE REACTIONS SECTION.

ADVERSE REACTIONS. Side effects of Orphenadrine Citrate, Aspirin, and Caffeine Tablets are those seen with aspirin and caffeine or those usually associated with mild anticholinergic agents. These may include tachycardia, palpitation, urinary hesitancy or retention, dry mouth, blurred vision, dilation of the pupil, increased intraocular tension, weakness, nausea, vomiting, headache, dizziness, constipation, drowsiness, and rarely, urticaria and other dermatoses. Infrequently, an elderly patient may experience some degree of confusion. Mild central excitation and occasional hallucinations may be observed. These mild side effects can usually be eliminated by reduction in dosage. One case of aplastic anemia associated with the use of Orphenadrine Citrate, Aspirin, and Caffeine Tablets has been reported. No causal relationship has been established. Rare G.I. hemorrhage due to aspirin content may be associated with the administration of Orphenadrine Citrate, Aspirin, and Caffeine Tablets. Some patients may experience transient episodes of lightheadedness, dizziness or syncope.

CLINICAL PHARMACOLOGY SECTION.

CLINICAL PHARMACOLOGY. Orphenadrine citrate is centrally acting (brain stem) compound which in animals selectively blocks facilitatory functions of the reticular formulation. Orphenadrine does not produce myoneural block, nor does it affect crossed extensor reflexes. Orphenadrine prevents nicotine-induced convulsions but not those produced by strychnine.Chronic administration of Orphenadrine Citrate, Aspirin, and Caffeine to dogs and rats has revealed no drug-related toxicity. No blood or urine changes were observed, nor were there any macroscopic or microscopic pathological changes detected. Extensive experience with combinations containing aspirin and caffeine has established them as safe agents. The addition of orphenadrine citrate does not alter the toxicity of aspirin and caffeine.The mode of therapeutic action of orphenadrine has not been clearly identified, but may be related to its analgesic properties. Orphenadrine citrate also possesses anticholinergic actions.

CONTRAINDICATIONS SECTION.

CONTRAINDICATIONS. Because of the mild anti-cholinergic effect of orphenadrine, Orphenadrine Citrate, Aspirin, and Caffeine Tablets should not be used in patients with glaucoma, pyloric or duodenal obstruction, achalasia, prostatic hypertrophy, or obstructions at the bladder neck. Orphenadrine Citrate, Aspirin, and Caffeine Tablets are also contraindicated in patients with myasthenia gravis and in patients known to be sensitive to aspirin or caffeine.The drug is contraindicated in patients who have demonstrated previous hypersensitivity to the drug.

DESCRIPTION SECTION.

DESCRIPTION. Each tablet, for oral administration, contains Orphenadrine Citrate USP, 25 mg or 50 mg, Aspirin USP, 385 mg or 770 mg, Caffeine USP, 30 mg or 60 mg.Orphenadrine citrate, N, N-Dimethyl-2-[(o-methyl--phenylbenzyl)oxy]ethylamine citrate (1:1), is centrally acting (brain stem) compound. It occurs as white, practically odorless, crystalline powder, having bitter taste. Its molecular formula is C18H23NO.C6H8O7 with molecular weight of 461.51. The structural formula is shown below.Aspirin, salicylic acid acetate, is non-opiate analgesic, anti-inflammatory and antipyretic agent. It occurs as white, crystalline tabular or needle like powder and is odorless or has faint odor. Its molecular formula is C9H8O4, with molecular weight of 180.16. The structural formula is shown below.Caffeine, 1,3,7-trimethylxanthine, is central nervous system stimulant which occurs as white powder or white glistening needles. It also has bitter taste. Its molecular formula is C8H1 0N4O2, with molecular weight of 194.19. The structural formula is shown below.Each tablet contains the following inactive ingredients: colloidal silicon dioxide, corn starch, croscarmellose sodium, FD&C Blue No. 1, FD&C Yellow No. 10, anhydrous lactose, microcrystalline cellulose, povidone, pregelatinized starch, stearic acid, and sodium lauryl sulfate.. Orphenadrine Citrate Chemical Structure. Aspirin Chemical Structure. Caffeine Chemical Structure.

DOSAGE & ADMINISTRATION SECTION.

DOSAGE AND ADMINISTRATION. Orphenadrine Citrate, Aspirin, and Caffeine Tablets, 25 mg/385 mg/30 mg: Adults to tablets to times daily. Orphenadrine Citrate, Aspirin, and Caffeine Tablets, 50 mg/770 mg/60 mg: Adults 1/2 to tablet to times daily.

HOW SUPPLIED SECTION.

HOW SUPPLIED. Orphenadrine Citrate, Aspirin, and Caffeine Tablets, 50 mg/770 mg/60 mg are scored, capsule-shaped, layered tablets colored white and green, imprinted SZ 491 and are supplied as:NDC 21695-726-30 bottles of 30NDC 21695-726-45 bottles of 45. Storage. Store at 20-25C (68-77 F) (see USP Controlled Room Temperature).Protect from moisture.

INDICATIONS & USAGE SECTION.

INDICATIONS AND USAGE. Symptomatic relief of mild to moderate pain of acute musculoskeletal disorders.The orphenadrine component is indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute painful musculoskeletal conditions.The mode of action of orphenadrine has not been clearly identified, but may be related to its analgesic properties. Orphenadrine Citrate, Aspirin, and Caffeine Tablets do not directly relax tense skeletal muscles in man. Symptomatic relief of mild to moderate pain of acute musculoskeletal disorders.. The orphenadrine component is indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute painful musculoskeletal conditions.The mode of action of orphenadrine has not been clearly identified, but may be related to its analgesic properties. Orphenadrine Citrate, Aspirin, and Caffeine Tablets do not directly relax tense skeletal muscles in man.

PRECAUTIONS SECTION.

PRECAUTIONS. Confusion, anxiety and tremors have been reported in few patients receiving propoxyphene and orphenadrine concomitantly. As these symptoms may be simply due to an additive effect, reduction of dosage and/or discontinuation of one or both agents is recommended in such cases.Safety of continuous long term therapy with Orphenadrine Citrate, Aspirin, and Caffeine Tablets has not been established; therefore, if Orphenadrine Citrate, Aspirin, and Caffeine Tablets are prescribed for prolonged use, periodic monitoring of blood, urine and liver function values is recommended.

SPL UNCLASSIFIED SECTION.

Usage in Pregnancy. Since safety of the use of this preparation in pregnancy, during lactation, or in the child-bearing age has not been established, use of the drug in such patients requires that the potential benefits of the drug be weighed against its possible hazard to the mother and child.

WARNINGS SECTION.

WARNINGS. Reyes Syndrome may develop in individuals who have chicken pox, influenza, or flu symptoms. Some studies suggest possible association between the development of Reyes Syndrome and the use of medicines containing salicylate or aspirin. Orphenadrine Citrate, Aspirin, and Caffeine Tablets contain aspirin and therefore are not recommended for use in patients with chicken pox, influenza, or flu symptoms. Orphenadrine Citrate, Aspirin, and Caffeine Tablets may impair the ability of the patient to engage in potentially hazardous activities such as operating machinery or driving motor vehicle: ambulatory patients should therefore be cautioned accordingly. Aspirin should be used with extreme caution in the presence of peptic ulcers and coagulation abnormalities.. Usage in Pregnancy. Since safety of the use of this preparation in pregnancy, during lactation, or in the child-bearing age has not been established, use of the drug in such patients requires that the potential benefits of the drug be weighed against its possible hazard to the mother and child.. Usage in Children. The safe and effective use of this drug in children has not been established. Usage of this drug in children under 12 years of age is not recommended.