Orphenadrine Citrate

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.

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.

DESCRIPTION Orphenadrine citrate, USP 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 18 H 23 NO • C 6 H 8 O 7 is represented by the following structural formula: Each orphenadrine citrate extended-release tablet, USP contains 100 mg orphenadrine citrate, USP. Orphenadrine citrate extended-release tablets, USP also contain: calcium stearate, ethylcellulose and lactose monohydrate. Image-01

DOSAGE AND ADMINISTRATION Adults-Two tablets per day; one in the morning and one in the evening.

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 musculo skeletal conditions.

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.

DRUG ABUSE AND DEPENDENCE Orphenadrine citrate has been chronically abused for its euphoric effects. [1] The mood elevating effects may occur at therapeutic doses of orphenadrine. [2]

OVERDOSAGE Orphenadrine citrate is toxic when overdosed and typically induces anticholinergic 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 overdose is evacuation of stomach contents (when necessary), charcoal at repeated doses, intensive monitoring and appropriate supportive treatment of any emergent anticholinergic effects. [5]

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Orphenadrine Citrate Orphenadrine Citrate ORPHENADRINE CITRATE ORPHENADRINE CALCIUM STEARATE ETHYLCELLULOSE, UNSPECIFIED LACTOSE MONOHYDRATE WHITE ROUND E;22

ANDA040327

Orphenadrine Citrate

Orphenadrine Citrate

0185-0022

HUMAN PRESCRIPTION DRUG

ORAL

Orphenadrine Citrate Extended-Release Tablets, USP, 100 mg x 100 Tablets - Label NDC 0185-0022-01 Orphenadrine Citrate Extended-Release Tablets, USP 100 mg Rx only 100 Tablets Sandoz Image-02

Rx Only

PEDIATRIC USE Safety and effectiveness in pediatric patients have not been established.

PREGNANCY Animal reproduction studies have not been conducted with orphenadrine citrate. It is also not known whether orphenadrine citrate can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Orphenadrine citrate should be given to a pregnant woman only if clearly needed.

HOW SUPPLIED Orphenadrine Citrate Extended-Release Tablets, USP, for oral administration, are available as 100 mg White, round-shaped tablets debossed “ E ” over “22” on one side and plain on the other side and supplied as: NDC 0185-0022-01 bottles of 100 NDC 0185-0022-10 bottles of 1000 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, as required. KEEP TIGHTLY CLOSED. KEEP OUT OF THE REACH OF CHILDREN. Manufactured by Sandoz Inc. Princeton, NJ 08540 46299664 Rev. May 2022 MF0022REV05/2022

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. Orphenadrine citrate should be used with caution in patients with tachycardia, cardiac decompensation, coronary insufficiency, cardiac arrhythmias. Safety of continuous long-term therapy with orphenadrine citrate has not been established. Therefore, if orphenadrine citrate is prescribed for prolonged use, periodic monitoring of blood, urine and liver function values is recommended.