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Orphengesic® Forte (Orphenadrine 50 mg, Aspirin 770 mg, Caffeine 60 mg)
Non-Opioid
Noncontrolled
Relief of mild to moderate acute muscle aches and pains

Orphengesic® Forte is indicated as an adjunct to rest, physical therapy, and other measures to relieve acute musculoskeletal pain. Orphengesic® Forte does not directly relax muscles. The mechanism of action of orphenadrine is not clearly identified, but may be related to its analgesic properties.

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 with 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.
  • Use of NSAIDs, including aspirin, can cause premature closure of the fetal ductus arteriosus and fetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment. Because of these risks, limit Orphengesic® Forte use between about 20 and 30 weeks of gestation, and avoid use at about 30 weeks of gestation and later in pregnancy.
  • Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) has been reported in patients taking NSAIDs such as aspirin. Advise patients to stop taking the medication immediately if they develop any type of rash or fever and to contact their healthcare provider as soon as possible.
  • The safe and effective use in children has not been established; Usage in children under 12 is not recommended.
  • 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.
  • Confusion, anxiety, and tremors have been reported with concomitant propoxyphene and orphenadrine.

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, and rarely, urticaria and other dermatosis.

For more details, please read the Full Prescribing Information for Orphengesic® Forte.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.



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