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.
US Trade Name(s)
US Availability
aspirin/butalbital/caffeine (generic)
Lanorina, Fiorinal (aspirin/butalbital/caffeine )
Canadian Trade Name(s)
- Fiorinal
- Pronal
- Ratio-Tecnal
- Trianal
Canadian Availability
Fiorinal (aspirin/butalbital/caffeine )
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)
UK Availability
Australian Trade Name(s)
Australian Availability
[Outline]
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.
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