Orphenadrine and Aspirin (Systemic)
VA CLASSIFICATION
Primary: MS200
Commonly used brand name(s): N3 Gesic; N3 Gesic Forte; Norgesic; Norgesic Forte; Norphadrine; Norphadrine Forte; Orphenagesic; Orphenagesic Forte.
Note: For a listing of dosage forms and brand names by country availability, see Dosage Forms section(s).
Category:
Analgesic–skeletal muscle relaxant—
Indications
Accepted
Spasm, skeletal muscle, accompanied by pain (treatment)—Indicated as an adjunct to other measures, such as rest and physical therapy, for relief of pain and muscle spasm associated with acute painful musculoskeletal conditions{01}.
Pharmacology/Pharmacokinetics
Orphenadrine—See Skeletal Muscle Relaxants (Systemic).
Aspirin—See Salicylates (Systemic).
Caffeine—See Caffeine (Systemic).
Precautions to Consider
Orphenadrine—See Skeletal Muscle Relaxants (Systemic).
Aspirin—See Salicylates (Systemic).
Caffeine—See Caffeine (Systemic).
Side/Adverse Effects
Orphenadrine—See Skeletal Muscle Relaxants (Systemic).
Aspirin—See Salicylates (Systemic).
Caffeine—See Caffeine (Systemic).
Overdose
For specific information on the agents used in the management of orphenadrine and aspirin overdose, see: • Charcoal, Activated (Oral-Local) monograph; and/or
• Vitamin K 1—Phytonadione in Vitamin K (Systemic) monograph.
For more information on the management of overdose or unintentional ingestion, contact a Poison Control Center (see Poison Control Center Listing ).
Treatment of overdose
For aspirin:
To decrease absorption—Emptying the stomach via induction of emesis or gastric lavage.
Administering activated charcoal.
To enhance elimination—Inducing forced alkaline diuresis to increase salicylate excretion.{02} However, bicarbonate should not be administered orally for this purpose because salicylate absorption may be increased.{02} Also, if acetazolamide is used, the increased risk of severe metabolic acidosis and salicylate toxicity (caused by increased penetration of salicylate into the brain because of metabolic acidosis) must be considered.{02} Some emergency care practitioners recommend that acetazolamide not be used at all in the treatment of salicylate overdose.{02} Others state that acetazolamide may be used, provided that precautions are taken to prevent systemic metabolic acidosis, such as concurrent administration of an alkaline intravenous solution, e.g., one that contains sodium bicarbonate or sodium lactate.{02}
Institution of exchange transfusion, hemodialysis, peritoneal dialysis, or hemoperfusion as needed in severe overdose.
Monitoring—Monitoring serum salicylate concentration until it is apparent that the concentration is decreasing to the nontoxic range. Salicylate concentrations of 50 mg per 100 mL 2 hours after ingestion indicate serious toxicity{02}; salicylate concentrations above 80 mg per 100 mL 2 hours after ingestion indicate possible fatality. In addition, prolonged monitoring may be necessary in massive overdosage because absorption may be delayed; if a determination performed prior to 6 hours after ingestion fails to show a toxic salicylate concentration, the determination should be repeated.{02} Salicylate concentrations of 45 to 65 mg per 100 mL 6 hours after ingestion or 35 to 55 mg per 100 mL 12 hours after ingestion indicate a mild degree of toxicity; salicylate concentrations of 65 to 90 mg per 100 mL 6 hours after ingestion or 55 to 75 mg per 100 mL 12 hours after ingestion indicate a moderate degree of toxicity; and salicylate concentrations of 90 mg (or more) per 100 mL 6 hours after ingestion or 75 mg (or more) per 100 mL 12 hours after ingestion indicate a severe degree of toxicity.{02}{03}{04}{05}
Monitoring for pulmonary edema and instituting appropriate therapy if required.
Specific treatment—Administering blood or vitamin K 1 if necessary to treat hemorhaging. See the package insert or Vitamin K (Systemic) for specific dosing guidelines for use of this product.
Supportive care—Correcting hyperthermia; fluid, electrolyte, and acid-base imbalances; ketosis; and plasma glucose concentration as needed. Monitoring and supporting vital functions. Patients in whom intentional overdose is known or suspected should be referred for psychiatric consultation.
For orphenadrine:
To decrease absorption—Emptying the stomach via induction of emesis or gastric lavage.
To enhance elimination—Maintaining a high-volume urinary output. Hemodialysis or peritoneal dialysis may be of some benefit if the serum concentration is greater than 4 mcg per mL.
Monitoring the patient and administering supportive treatment of observed symptoms.
Supportive care—Administering intravenous fluids and circulatory support as required. Patients in whom intentional overdose is known or suspected should be referred for psychiatric consultation.
Patient Consultation
As an aid to patient consultation, refer to Advice for the Patient, Orphenadrine and Aspirin (Systemic).
In providing consultation, consider emphasizing the following selected information (» = major clinical significance):
Before using this medication
» Conditions affecting use, especially:
Allergic reaction to orphenadrine, aspirin, or nonsteroidal anti-inflammatory drugs (NSAIDs), history of
Pregnancy—High-dose chronic use or abuse of aspirin in third trimester may be hazardous to the mother as well as the fetus and/or neonate, causing heart problems in fetus or neonate and/or bleeding in mother, fetus, or neonate; high-dose chronic use or abuse may also prolong and complicate labor and delivery; not taking aspirin in third trimester unless prescribed by physician
Use in children and teenagers—Checking with physician before giving to children or teenagers with symptoms of acute febrile illness, especially influenza or varicella, because of the risk of Reye's syndrome; also, increased susceptibility to aspirin toxicity in children, especially with fever and dehydration
Use in the elderly—Increased risk of aspirin toxicity
Other medications, especially anticoagulants, antidiabetic agents (oral), CNS depression–producing medications, those cephalosporins that may cause hypoprothrombinemia, moxalactam, plicamycin, valproic acid, methotrexate, NSAIDs, platelet aggregation inhibitors, probenecid, sulfinpyrazone, urinary alkalizers, vancomycin, and zidovudine
Other medical problems, especially achalasia, bladder neck obstruction, coagulation or platelet function disorders, gastrointestinal problems such as ulceration or erosive gastritis (especially a bleeding ulcer or a stenosing peptic ulcer), glaucoma (or predisposition to), myasthenia gravis, prostatic hypertrophy, and pyloric or duodenal obstruction
Proper use of this medication
» Taking with food or full glass (240 mL) of water to minimize stomach irritation
» Not taking medication if it has a strong vinegar-like odor
» Importance of not taking more medication than the amount prescribed
» Proper dosing
Missed dose: Taking if remembered within an hour; not taking if not remembered until later; not doubling doses
» Proper storage
Precautions while using this medication
Regular visits to physician to check progress during prolonged therapy
» Caution if other medications containing aspirin or other salicylates or orphenadrine are used
Not taking acetaminophen or ibuprofen or other nonsteroidal anti-inflammatory analgesics concurrently for more than a few days unless directed by physician
Diabetics: May cause false urine sugar test results
Caution if any kind of surgery is required; aspirin should be discontinued 5 days prior to surgery
» Avoiding use of alcohol or other central nervous system (CNS) depressants unless prescribed or otherwise approved by physician
Alcohol consumption may increase probability of stomach problems
» Caution if blurred vision, drowsiness, dizziness, lightheadedness, or faintness occurs
Possible dryness of mouth; using sugarless gum or candy, ice, or saliva substitute for relief; checking with dentist if dry mouth continues for more than 2 weeks
» Suspected overdose: Getting emergency help at once
Side/adverse effects
Signs and symptoms of possible side effects, especially allergic reactions (including anaphylaxis and angioedema), blood dyscrasias, fainting, fast or pounding heartbeat, gastrointestinal toxicity, and hallucinations
General Dosing Information
This medication should be administered with food or a full glass (240 mL) of water to lessen gastric irritation.
In general, it is recommended that aspirin therapy be discontinued 5 days before surgery to prevent possible occurrence of bleeding problems.
Oral Dosage Forms
ORPHENADRINE CITRATE, ASPIRIN, AND CAFFEINE TABLETS
Usual adult and adolescent dose
Oral, 1 or 2 tablets containing 25 mg of orphenadrine citrate three or four times a day; or
Oral, 1/2 or 1 tablet containing 50 mg of orphenadrine citrate three or four times a day.{01}
Usual pediatric dose
Dosage has not been established.
Strength(s) usually available
U.S.—
25 mg of orphenadrine citrate, 385 mg of aspirin, and 30 mg of caffeine (Rx) [Norgesic] [Norphadrine] [N3 Gesic] [Orphenagesic]
{01}
50 mg of orphenadrine citrate, 770 mg of aspirin, and 60 mg of caffeine (Rx) [Norgesic Forte] [Norphadrine Forte] [N3 Gesic Forte] [Orphenagesic Forte]
{01}
Canada—
25 mg of orphenadrine citrate, 385 mg of ASA, and 30 mg of caffeine (OTC) [Norgesic]
{06}
50 mg of orphenadrine citrate, 770 mg of ASA, and 60 mg of caffeine (OTC) [Norgesic Forte]
{06}
Note: Aspirin is a brand name in Canada; acetylsalicylic acid is the generic name. ASA, a commonly used designation for aspirin (or acetylsalicylic acid) in both the U.S. and Canada, is the term used in Canadian product labeling.
Packaging and storage:
Store below 30 °C (86 °F), in a tight, light-resistant container, unless otherwise specified by manufacturer.
Auxiliary labeling:
• May cause drowsiness.
• Avoid alcoholic beverages.
• Take with food or with a full glass of water.
Revised: 08/11/1994
References
- Orphenadrine (Norgesic). In: PDR Physicians' desk reference. 53rd ed. 1999. Montvale, NJ: Medical Economics Data; 1999. p. 1662-3.
- Panelist Comment, Salicylates (Systemic) monograph revision of 1990.
- Committee on accident and poison prevention, American Academy of Pediatrics. Salicylates. In: Aronow R, editor. Handbook of common poisonings in children. Evanston, IL: American Academy of Pediatrics; 1983. p. 126-30.
- Anonymous. Salicylate. In: The British Columbia drug and poison information centre poison management manual. Ottawa, Canada: Canadian Pharmaceutical Association; 1984. p. 289-91.
- Dugandzic RM, Tierney MG, Dickinson GE, et al. Evaluation of the validity of the Dome nomogram in the management of acute salicylate intoxication. Ann Emerg Med 1989 Nov; 18: 1186-90.
- Orphenadrine (Norgesic, 3M Pharmaceuticals). In: Krogh CME, editor. CPS Compendium of pharmaceuticals and specialties. 33rd ed. Ottawa: Canadian Pharmaceutical Association; 1998. p. 1132.
