Norgesic

Name: Norgesic

Side effects

Side effects of Norgesic (orphenadrine citrate with aspirin and caffeine) or Norgesic (orphenadrine citrate with aspirin and caffeine) Forte are those seen with aspirin and caffeine or those usually associated with mild anticholinergic agents. These may include tachycardia, palpitation, urinary hesitancy or retention, dry mouth, blurred vision, dilatation of the pupil, increased intraocular tension, weakness, nausea, vomiting, headache, dizziness, constipation, drowsiness, and rarely, urticaria and other dermatoses. Infrequently, an elderly patient may experience some degree of confusion. Mild central excitation and occasional hallucinations may be observed. These mild side effects can usually be eliminated by reduction in dosage. One case of aplastic anemia associated with the use of Norgesic (orphenadrine citrate with aspirin and caffeine) has been reported. No causal relationship has been established. Rare G.I. hemorrhage due to aspirin content may be associated with the administration of Norgesic (orphenadrine citrate with aspirin and caffeine) or Norgesic (orphenadrine citrate with aspirin and caffeine) Forte. Some patients may experience transient episodes of light-headedness, dizziness or syncope.

Overdose

No information provided.

What is the most important information i should know about aspirin/caffeine/orphenadrine (norgesic, norgesic forte)?

Use caution when driving, operating machinery, or performing other hazardous activities. Aspirin/caffeine/orphenadrine may cause dizziness or drowsiness. If you experience dizziness or drowsiness, avoid these activities.

Use alcohol cautiously. Alcohol may increase drowsiness and dizziness while taking aspirin/caffeine/orphenadrine. Also, in combination with aspirin, alcohol can be damaging to the stomach.

Call your doctor immediately if you experience a rash, itching, a fever, or nasal congestion during treatment with aspirin/caffeine/orphenadrine.

Watch for bloody, black, or tarry stools or bloody vomit. This could indicate damage to the stomach.

Do not take more of this medication than is prescribed. If the pain is not being adequately treated, talk to your doctor.

Norgesic Drug Class

Norgesic is part of the drug classes:

  • Other agents for local oral treatment

  • Platelet aggregation inhibitors excl. heparin

  • Salicylic acid and derivatives

  • Antihistamine Like Musculoskeletal Relaxants

Commonly used brand name(s)

In the U.S.

  • Norgesic
  • Norgesic Forte
  • Orphenadrine w/A.C.
  • Orphengesic
  • Orphengesic Forte

Available Dosage Forms:

  • Tablet

Therapeutic Class: Skeletal Muscle Relaxant, Centrally Acting/Salicylate, Aspirin Combination

Pharmacologic Class: Orphenadrine

Chemical Class: Salicylate, Aspirin

Norgesic Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose in children
  • Changes in behavior
  • drowsiness or tiredness (severe)
  • fast or deep breathing
  • Any loss of hearing
  • bloody urine
  • confusion
  • convulsions (seizures)
  • diarrhea
  • dizziness or lightheadedness (severe)
  • drowsiness (severe)
  • excitement or nervousness (severe)
  • fast or deep breathing
  • hallucinations (seeing, hearing, or feeling things that are not there)
  • headache (severe or continuing)
  • increased sweating
  • nausea or vomiting (severe or continuing)
  • ringing or buzzing in the ears (continuing)
  • uncontrollable flapping movements of the hands, especially in elderly patients
  • unexplained fever
  • unusual thirst
  • vision problems

Check with your doctor as soon as possible if any of the following side effects occur:

Less common or rare
  • Abdominal or stomach pain, cramping, or burning (severe)
  • bloody or black, tarry stools
  • decreased urination
  • eye pain
  • fainting
  • fast or pounding heartbeat
  • shortness of breath, troubled breathing, tightness in chest, or wheezing
  • skin rash, hives, itching, or redness
  • sores, ulcers, or white spots on lips or in mouth
  • swollen and/or painful glands
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • vomiting of blood or material that looks like coffee grounds

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Abdominal or stomach cramps, pain, or discomfort (mild to moderate)
  • dryness of mouth
  • heartburn or indigestion
  • nausea or vomiting (mild)
Less common
  • Blurred or double vision or other vision problems
  • confusion
  • constipation
  • difficult urination
  • dizziness or lightheadedness
  • drowsiness
  • excitement, nervousness, or restlessness
  • headache
  • muscle weakness
  • trembling
  • unusually large pupils of eyes

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

Actions

Orphenadrine citrate is a centrally acting (brain stem) compound which in animals selectively blocks facilitatory functions of the reticular formation. Orphenadrine does not produce myoneural block, nor does it affect crossed extensor reflexes. Orphenadrine prevents nicotine-induced convulsions but not those produced by strychnine.

Chronic administration of Norgesic to dogs and rats has revealed no drug-related toxicity. No blood or urine changes were observed, nor were there any macroscopic or microscopic pathological changes detected. Extensive experience with combinations containing aspirin and caffeine has established them as safe agents. The addition of orphenadrine citrate does not alter the toxicity of aspirin and caffeine.

The mode of therapeutic action of orphenadrine has not been clearly identified, but may be related to its analgesic properties. Orphenadrine citrate also possesses anticholinergic actions.

Warnings

Reye's Syndrome may develop in individuals who have chicken pox, influenza, or flu symptoms. Some studies suggest a possible association between the development of Reye's Syndrome and the use of medicines containing salicylate or aspirin. Norgesic and Norgesic Forte contain aspirin and therefore are not recommended for use in patients with chicken pox, influenza, or flu symptoms.

Norgesic and Norgesic Forte 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.

Usage in pregnancy

Since safety of the use of this preparation in pregnancy, during lactation, or in the childbearing age has not been established, use of the drug in such patients requires that the potential benefits of the drug be weighed against its possible hazard to the mother and child.

Adverse Reactions

Side effects of Norgesic or Norgesic Forte are those seen with aspirin and caffeine or those usually associated with mild anticholinergic agents. These may include tachycardia, palpitation, urinary hesitancy or retention, dry mouth, blurred vision, dilatation of the pupil, increased intraocular tension, weakness, nausea, vomiting, headache, dizziness, constipation, drowsiness, and rarely, urticaria and other dermatoses. Infrequently, an elderly patient may experience some degree of confusion. Mild central excitation and occasional hallucinations may be observed. These mild side effects can usually be eliminated by reduction in dosage. One case of aplastic anemia associated with the use of Norgesic has been reported. No causal relationship has been established. Rare G.I. hemorrhage due to aspirin content may be associated with the administration of Norgesic or Norgesic Forte. Some patients may experience transient episodes of light-headedness, dizziness or syncope.

(web3)