Norgesic

Brand Name: Norgesic

Generic Name: orphenadrine citrate, aspirin and caffeine

Drug Class: Skeletal Muscle Relaxants

What is Norgesic, and what is it used for?

Norgesic is a prescription medicine used to treat the symptoms of musculoskeletal pain. Norgesic may be used alone or with other medications.

Norgesic belongs to a class of drugs called Analgesics, Other Combos.

It is not known if Norgesic is safe and effective in children younger than 12 years of age.

Warnings

  • Because of the mild anti-cholinergic effect of orphenadrine, Norgesic and Norgesic Forte Tablets should not be used in patients with glaucoma, pyloric or duodenal obstruction, achalasia, prostatic hypertrophy, or obstructions at the bladder neck. Norgesic and Norgesic Forte 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 a previous hypersensitivity to the drug.
  • Reye’s Syndrome may develop in individuals who have chicken pox, influenza, or flu symptoms. Some studies suggest possible association between the development of Reye’s Syndrome and the use of medicines containing salicylate or aspirin. Norgesic (25mg/385mg/30mg) and Norgesic Forte Tablets (50mg/770mg/60mg) contain aspirin and therefore are not recommended for use in patients with chicken pox, influenza, or flu symptoms.
  • Norgesic and Norgesic Forte Tablets 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.
  • Aspirin should be used with extreme caution in the presence of peptic ulcers and coagulation abnormalities.
  • Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) has been reported in patients taking NSAIDs such as Norgesic and Norgesic Forte. Some of these events have been fatal or life-threatening.
    • DRESS typically, although not exclusively, presents with fever, rash, lymphadenopathy, and/or facial swelling.
    • Other clinical manifestations may include hepatitis, nephritis, hematological abnormalities, myocarditis, or myositis. Sometimes symptoms of DRESS may resemble an acute viral infection. Eosinophilia is often present.
    • Because this disorder is variable in its presentation, other organ systems not noted here may be involved.
    • It is important to note that early manifestations of hypersensitivity, such as fever or lymphadenopathy, may be present even though rash is not evident. If such signs or symptoms are present, discontinue Norgesic or Norgesic Forte and evaluate the patient immediately.
  • Confusion, anxiety and tremors have been reported in a 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 Norgesic and Norgesic Forte Tablets has not been established; therefore, if Norgesic and Norgesic Forte Tablets are prescribed for prolonged use, periodic monitoring of blood, urine and liver function values is recommended.

What are the side effects of Norgesic?

Norgesic may cause serious side effects including:

  • mood changes,
  • confusion,
  • anxiety,
  • hallucinations,
  • nervousness,
  • agitation,
  • shaking,
  • fast, pounding or irregular heartbeats,
  • hearing changes (ringing in your ears, difficulty hearing),
  • difficulty urinating,
  • easy bruising or bleeding,
  • black stools,
  • vomit that looks like coffee grounds,
  • persistent stomach or abdominal pain,
  • fainting,
  • eye pain,
  • unusual tiredness,
  • change in the amount of urine,
  • yellowing of the eyes or skin (jaundice), and
  • dark urine

Get medical help right away, if you have any of the symptoms listed above.

The most common side effects of Norgesic include:

Tell the doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Norgesic. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the dosage for Norgesic?

Norgesic Tablets: Adults 1 or 2 tablets 3 to 4 times daily.

Norgesic Forte Tablets: Adults ½ to 1 tablet 3 to 4 times daily.

What drugs interact with Norgesic?

Currently there is no information available on drug interactions with Norgesic.

Is Norgesic safe to use while pregnant or breastfeeding?

  • 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 dose and duration of Norgesic and Norgesic Forte use between about 20 and 30 weeks of gestation, and avoid Norgesic and Norgesic Forte use at about 30 weeks of gestation and later in pregnancy.
  • No information is provided regarding the effects of Norgesic on lactating women or breastfeeding infants.

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Summary

Norgesic is a prescription medicine used to treat the symptoms of musculoskeletal pain (muscle spasms). Serious side effects of Norgesic include mood changes, confusion, anxiety, hallucinations, nervousness, agitation, shaking, fast, pounding or irregular heartbeats, hearing changes (ringing in your ears, difficulty hearing), difficulty urinating, easy bruising or bleeding, black stools, vomit that looks like coffee grounds, and others.

Treatment & Diagnosis

Medications & Supplements

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Report Problems to the Food and Drug Administration

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

References
All sections courtesy of the U.S. Food and Drug Administration