Adult Dosing

Tension headache

• 1-2 Tabs/Caps of aspirin/butalbital/caffeine (325 mg/50 mg/40 mg) PO q4 hrs
• Max: 6 caps/tabs per day

Pediatric Dosing

• Safety and effectiveness in pediatric patients have not been established

[Outline]

• Adult Dosing
• Pediatric Dosing

• Relief of the symptom complex of tension headache

• Hypersensitivity to any of the ingredients of the product
• Hemorrhagic diathesis (hemophilia, hypoprothrombinemia, von Willebrand’s disease, thrombocytopenias, thrombasthenia, hereditary platelet dysfunctions, severe vitamin K deficiency and severe liver damage)
• Aspirin and NSAIDs induced urticaria and bronchospasm
• Aspirin triad
• Peptic ulcer or other serious gastrointestinal lesions
• Porphyria

• N/A

Renal Dose Adjustment

• Severe renal impairment: Caution advised, dose adjustments not defined

Hepatic Dose Adjustment

• Hepatic impairment: Caution advised, dose adjustments not defined
• Severe hepatic impairment: Caution advised, dose adjustments not defined

See Supplemental Patient Information

• Anaphylactic shock and other severe allergic reactions can occur with therapeutic doses aspirin, before starting the treatment it should be ascertained if the patient is allergic to aspirin
• Aspirin can cause significant bleeding in patients with peptic ulcer or other gastrointestinal lesions or with bleeding disorders and also preoperatively administration of aspirin prolong the bleeding time, use aspirin, butalbital and caffeine cautiously in these patients
• Extended use of butalbital, aspirin, and caffeine is not recommended as butalbital is habit-forming and potentially abusable
• Epidemiologic studies indicate an association between aspirin and Reye's Syndrome. Use cautiously in children, including teenagers, with chicken pox or flu

Cautions: Use cautiously in

• Severe renal impairment
• Severe hepatic impairment
• Coagulation disorders
• Head injury
• Elevated intracranial pressure
• Acute abdominal conditions
• Hypothyroidism
• Urethral stricture
• Addison's disease
• Prostatic hypertrophy
• Concomitant anticoagulant therapy
• Hemostatic defects
• History of Peptic ulcer
• Elderly patients
• Debilitated patients
• Children or teenager with chicken pox or flu
• Surgery
• Patient with known allergy
• Uncontrolled hypertension
• G6PD deficiency
• History of drug abuse
• Chronic alcohol use
• History of GI bleed
• Gastroesophageal reflux disease
• Gout

Supplemental Patient Information

• Advise patients to avoid engaging in potentially hazardous tasks such as driving a car or operating a machinery as aspirin/butalbital/caffeine may impair the mental and/or physical abilities
• Advise patients to avoid concomitant use of alcohol and other CNS depressants
• Advise patients to take the drug only for as long as it is prescribed and in the amounts prescribed as butalbital may be habit-forming
• Advise patients to take the drug with food or a full glass of water or milk to minimize gastric irritation caused by aspirin

Pregnancy Category:C

Breastfeeding: Avoid aspirin during breastfeeding, especially with very young infants; although a rare single low dose of aspirin daily is unlikely to cause problems in the infant. The risks with chronic high dose aspirin use are less clear. Monitor infant salicylate serum levels particularly in neonates. Avoid breastfeeding for 1-2 hrs after a dose to minimize antiplatelet effects. As no published data is available with butalbital or combination products containing butalbital during breastfeeding, other agents may be preferred, especially while nursing a newborn or preterm infant. Adverse event like fussiness, jitteriness and poor sleep patterns have been reported in the infants of mothers with very high caffeine intakes equivalent to 10 or more cups of coffee daily. No stimulatory effects on infants 3 wks were observed in mothers taking 5 cups of coffee daily found. Preterm and younger newborn infants metabolize caffeine very slowly and may have serum levels of caffeine and other active caffeine metabolites similar to their mothers. Decreased breastmilk iron concentrations causing mild iron deficiency anemia in some breastfed infants may occur on intake of >450 mL of coffee. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 20 Jan 2011). Based upon data from AAP Policy Guidelines irritability, poor sleeping pattern may occur as caffeine is excreted slowly; no effect were observed with moderate intake of caffeinated beverages (2-3 cups per day). Information (available at http://aappolicy.aappublications.org/cgi/content/full/pediatrics;108/3/776 last accessed 20 January 2011). As per manufacturer data because of potential for serious adverse reactions in nursing infants from butalbital, aspirin, and caffeine, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

• EENT: Tinnitus
• CNS: Dizziness, drowsiness, lightheadedness
• GI: Nausea, vomiting, flatulence, GI ulcer, GI bleeding, dyspepsia, abdominal pain, constipation, hepatotoxicity
• RESP: Bronchospasm
• DERM: Toxic epidermal necrolysis, erythema multiforme, rash, ecchymosis, Stevens–Johnson syndrome
• HEMA: Bone marrow suppression causing pancytopenia, thrombocytopenia, agranulocytosis, aplastic anemia, hypoprothrombinemia, bleeding, disseminated intravascular coagulation, hyperuricemia
• MISC: Anaphylactic/anaphylactoid reaction, photosensitivity

Aspirin

• Salicylates; precise mechanism of action unknown; inhibits prostaglandin synthesis, exhibits analgesic, anti-inflammatory and antipyretic activity, and 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 (3% unchanged)
• Half-life: 3 hrs

Butalbital

• Barbiturates; act as nonselective depressants of the central nervous system (CNS), by binding at a distinct binding site associated with a Cl^-ionopore at the GABAA receptor, increasing the duration of time for which the Cl^- ionopore is open
• Well absorbed from the gastrointestinal tract
• Metabolized by liver
• Renally excreted 59%-88% (3.6% unchanged)
• Half-life: 35 hrs

US Trade Name(s)

• Fiorinal
• Lanorinal

US Availability

aspirin/butalbital/caffeine (generic)

• TABS: 325 mg/50 mg/40 mg

Lanorina, Fiorinal (aspirin/butalbital/caffeine )

• CAPS: 325 mg/50 mg/40 mg

Canadian Trade Name(s)

• Fiorinal
• Pronal
• Ratio-Tecnal
• Trianal

Canadian Availability

Fiorinal (aspirin/butalbital/caffeine )

• CAPS: 330 mg/50 mg/40 mg

Pronal, Ratio-Tecnal, Trianal (aspirin/butalbital/caffeine )

• CAPS: 330 mg/50 mg/40 mg
• TABS: 330 mg/50 mg/40 mg

UK Trade Name(s)

• N/A

UK Availability

• N/A

Australian Trade Name(s)

• N/A

Australian Availability

• N/A

[Outline]

Analgesics

Analgesics; Combinations

Pricing data from www.DrugStore.com in U.S.A.

• Fiorinal 50-325-40 MG CAPS [Bottle] (WATSON LABS)
  100 mg = $228.94
  200 mg = $440.71

Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.

• Aspirin 325 MG / butalbital 50 MG / Caffeine 40 MG Oral Capsule (Lannett Company, Inc.)
• Aspirin 325 MG / butalbital 50 MG / Caffeine 40 MG Oral Capsule (MUTUAL PHARMACEUTICAL COMPANY, INC.)
• Aspirin 325 MG / butalbital 50 MG / Caffeine 40 MG Oral Capsule (Watson Laboratories, Inc.)
• Aspirin 325 MG / butalbital 50 MG / Caffeine 40 MG Oral Tablet (Actavis Elizabeth LLC)
• Aspirin 325 MG / butalbital 50 MG / Caffeine 40 MG Oral Tablet (Goldline Laboratories, Inc.)
• Aspirin 325 MG / butalbital 50 MG / Caffeine 40 MG Oral Tablet (Qualitest)
• Aspirin 325 MG / butalbital 50 MG / Caffeine 40 MG Oral Tablet (West-ward Pharmaceutical Corp.)
• Fiorinal Oral Capsule (Watson Pharma, Inc.)