For a Non-opioid, Non-controlled, Multimodal Path to mild to moderate Acute Musculoskeletal Pain Relief...
Orphengesic® Forte

Safety of continuous long term therapy has not been established; therefore, if prescribed for long term use, periodic monitoring of blood, urine and liver function values is recommended.

INDICATIONS AND USAGE

Orphengesic® Forte (Orphenadrine Citrate, Aspirin and Caffeine 50 mg/ 770 mg/ 60 mg) Tablets are indicated in:

1. Symptomatic relief of mild to moderate pain of acute musculoskeletal disorders.
2. 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. Orphengesic® Forte Tablets do not directly relax tense muscles in man.

IMPORTANT SAFETY INFORMATION (ISI)

Contraindications

Orphengesic® Forte is contraindicated in patients with glaucoma, pyloric or duodenal obstruction, achalasia, prostatic hypertrophy, obstructions at the bladder neck, myasthenia gravis, hypersensitivity to the drug, and known sensitivities to aspirin or caffeine.

Warnings and Precautions

  • Orphengesic® Forte is not recommended in patients with chicken pox, influenza, or flu symptoms due to the possible development of Reye’s Syndrome. Reye’s Syndrome is possibly associated with the use of aspirin.
  • Patients should be cautioned on possible impairment of the ability to engage in potentially hazardous activities such as operating machinery or driving a motor vehicle.
  • Aspirin should be used with extreme caution in the presence of peptic ulcers and coagulation.
  • Safety of use of Orphengesic® Forte in pregnancy, during lactation, or in the child-bearing age has not been established; the potential benefits should be weighed against the possible hazard to mother and child.
  • The safe and effective use in children has not been established; Usage in children under 12 is not recommended.
  • Confusion, anxiety, and tremors have been reported with concomitant propoxyphene and orphenadrine.
  • Safety of continuous long term therapy with Orphengesic® Forte has not been established; If prescribed for prolonged use, periodic monitoring of blood, urine, and liver function values is recommended.

Adverse Reactions

The side effects of Orphengesic® Forte are those seen with aspirin and caffeine or those usually associated with mild anti-cholinergic 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, and drowsiness.

For more safety information and the complete list of adverse reactions, please see the Full Prescribing Information for Orphengesic® Forte.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit MedWatch or call 1-800-FDA-1088.