Adult Dosing

Mild-moderate pain of acute musculoskeletal disorders

• 1-2 tabs of (aspirin/caffeine/orphenadrine) 385 mg/30 mg/25 mg PO tid-qid
• 1/2-1 tabs of (aspirin/caffeine/orphenadrine) 770 mg/60 mg/50 mg PO tid-qid

Pediatric Dosing

• Safety and effectiveness in pediatric patients have not been established

[Outline]

• Adult Dosing
• Pediatric Dosing

• Symptomatic relief of mild-moderate pain of acute musculoskeletal disorders
• 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

• Hypersensitivity to any of the ingredients of the product
• Patients with glaucoma
• Pyloric or duodenal obstruction
• Achalasia
• Prostatic hypertrophy
• Obstructions at the bladder neck
• Myasthenia gravis

• N/A

Renal Dose Adjustment (Based on CrCl)

• Renal impairment: Dose adjustments not defined

Hepatic Dose Adjustment

• Hepatic impairment: Dose adjustments not defined

See Supplemental Patient Information

• Individuals having chicken pox, influenza, or flu symptoms are prone to Reye’s syndrome. Avoid therapy in such patients
• Safety of continuous prolong therapy with aspirin/caffeine/orphenadrine tablets have not been established; on prescribing for prolong use, periodically monitor blood, urine and liver function values
• Avoid concomitant use of propoxyphene and orphenadrine because there is an increased risk of confusion, anxiety and tremors; dose reduction and/or discontinuation of one or both agents is recommended

Cautions: Use cautiously in

• Peptic ulcers
• Coagulation abnormalities

Supplemental Patient Information

• Advise patients to avoid engaging in activities requiring mental alertness such as operating a hazardous machinery and driving a automobile

Pregnancy Category:NR

Breastfeeding: No stimulatory effects on infants 3 wks were observed in mothers taking 5 cups of coffee daily. Preterm and younger newborn infants metabolize caffeine very slowly and may have serum levels of caffeine and other active caffeine metabolites similar to their mother's. Decreased breastmilk iron concentrations; mild iron deficiency anemia in some breastfed infants may occur on intake of >450 mL of coffee. Based on data from AAP Policy Guidelines, irritability, poor sleeping pattern may occur as caffeine is excreted slowly; no effects were observed with moderate intake of caffeinated beverages (2-3 cups per day). Available at (available at http://aappolicy.aappublications.org/cgi/content/full/pediatrics;108/3/776 last accessed 30 December 2010). Safety of the use of this preparation in pregnancy, during lactation, or in the child-bearing age has not been established. Manufacturer advises to use this drug only after assessing benefit/risk.This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT).

• CV: Tachycardia, palpitation
• GU: Urinary hesitancy, urinary retention
• GI: Dry mouth, nausea, constipation, vomiting, GI hemorrhage
• EENT: Blurred vision, dilation of the pupil, increased intraocular tension
• CNS: Weakness, headache, dizziness, drowsiness, confusion, central excitation, hallucinations, lightheadedness, dizziness, syncope
• DERM: Urticaria
• HEMA: Aplastic anemia

Aspirin

• Salicylates; inhibits prostaglandin synthesis, exhibits analgesic, anti-inflammatory activity; inhibits platelet aggregation by irreversible inhibition of platelet cyclooxygenase and thereby inhibiting the generation of thromboxane A2
• Hydrolyzed in gut and plasma (aspirin) and metabolized by liver (salicylic acid); CYP450: Unknown
• Excreted in urine
• Half life: 12 mins (aspirin), 3 hrs (salicylic acid)

Caffeine

• Analeptic; precise mechanism of action unknown; produces constriction of cerebral blood vessels, antagonizes adenosine A1 and A2 receptors
• Rapidly absorbed
• Metabolized by liver; CYP450: CYP1A2
• Excreted in urine (1% unchanged)
• Half life: 3-7 hrs

Orphenadrine

• Skeletal muscle relaxant; binds to both histamine H1 receptors and NMDA receptors, restores the motor disturbances induced by neuroleptics, relaxes skeletal muscle spasms and exhibits a mood elevating effect
• Complete absorption from GI tract
• Metabolized by liver; CYP450: Unknown
• Half life: 14 hrs

US Trade Name(s)

• Invagesic (Discontinued)
• Invagesic forte (Discontinued)
• Norgesic
• Norgesic forte

US Availability

aspirin/caffeine/orphenadrine (generic)

• TABS:
• 385 mg/30 mg/25 mg
• 770 mg/60 mg/50 mg

Invagesic, Norgesic (aspirin/caffeine/orphenadrine)

• TABS: 385 mg/30 mg/25 mg

Invagesic forte, Norgesic forte (aspirin/caffeine/orphenadrine)

• TABS: 770 mg/60 mg/50 mg

Canadian Trade Name(s)

• N/A

Canadian Availability

• N/A

UK Trade Name(s)

• N/A

UK Availability

• N/A

Australian Trade Name(s)

• N/A

Australian Availability

• N/A

[Outline]

Analgesics

Analgesics; Combinations

• Aspirin 385 MG / Caffeine 30 MG / Orphenadrine Citrate 25 MG Oral Tablet (Sandoz Inc)
• Aspirin 770 MG / Caffeine 60 MG / Orphenadrine Citrate 50 MG Oral Tablet (Sandoz Inc)
• Norgesic 25/385/30 (orphenadrine / aspirin / caffeine) Oral Tablet (3M Pharmaceuticals)
• Norgesic forte 50/770/60 (orphenadrine / aspirin / caffeine) Oral Tablet (3M Pharmaceuticals)