Norflex

INJECTION: Boxes of 6 (NDC 0089-0540-06 ) 2 mL ampuls, each ampul containing 60 mg of orphenadrine citrate in aqueous solution.

Store at controlled room temperature 15°-30°C (59°-86°F).

September 2007. Manufactured for Graceway Pharmaceuticals, LLC Bristol, TN 37620. By Hospira, Inc. Lake Forest, IL 60045. Effective Date: 10/01/2007. FDA Rev date: 2/11/2008

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.

INJECTION: Adults - One 2 mL ampul (60 mg) intravenously or intramuscularly; may be repeated every 12 hours.

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. Norflex (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 should therefore be cautioned accordingly.

Norflex (orphenadrine) Injection contains sodium bisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than nonasthmatic people.

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 has not been established. Therefore, if orphenadrine is prescribed for prolonged use, periodic monitoring of blood, urine and liver function values is recommended.

Pregnancy

Pregnancy Category C. Animal reproduction studies have not been conducted with Norflex (orphenadrine). It is also not know whether Norflex (orphenadrine) can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Norflex (orphenadrine) should be given to a pregnant woman only if clearly needed.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

SIDE EFFECTS

Adverse reactions of orphenadrine are mainly due to the mild anti-cholinergic action of orphenadrine, 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.

Rare instances of anaphylactic reaction have been reported associated with the intramuscular injection of Norflex (orphenadrine) Injection.

Drug Abuse And Dependence

Orphenadrine has been chronically abused for its euphoric effects. The mood elevating effects may occur at therapeutic doses of orphenadrine.

DRUG INTERACTIONS

No information provided.

Pregnancy Category C. Animal reproduction studies have not been conducted with Norflex (orphenadrine). It is also not know whether Norflex (orphenadrine) can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Norflex (orphenadrine) should be given to a pregnant woman only if clearly needed.

Adverse reactions of orphenadrine are mainly due to the mild anti-cholinergic action of orphenadrine, 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.

Rare instances of anaphylactic reaction have been reported associated with the intramuscular injection of Norflex (orphenadrine) Injection.

Drug Abuse And Dependence

Orphenadrine has been chronically abused for its euphoric effects. The mood elevating effects may occur at therapeutic doses of orphenadrine.

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