See Supplemental Patient Information
- Cases of acute liver failure, occasionally resulting in liver transplant and death, have been reported with acetaminophen therapy. These events are mostly associated with acetaminophen doses >4000 mg/day and often involve more than one acetaminophen-containing product. Patients with underlying liver disease and those who ingest alcohol during therapy are at a greater risk for developing acute liver failure [US Black Box Warning]
- Extended use of butalbital is not recommended as it is habit-forming and potentially abusable
- There have been post-marketing reports of hypersensitivity and anaphylaxis associated with acetaminophen use
- Therapy may impair mental and/or physical abilities required for the performance of hazardous activities such as driving a car or operating machinery
- Alcohol and other CNS depressants should be avoided during therapy as they may produce an additive CNS depression
Cautions: Use cautiously in
- Severe renal impairment
- Severe hepatic impairment
- Acute abdominal conditions
- Alcohol use
- History of drug abuse
- CNS depressant use
- Pregnancy
- Elderly or debilitated patients
Supplemental Patient Information
- Advise patients receiving treatment to refrain from any hazardous activity such as driving a motor vehicle or operating machinery until it is confirmed that they are not adversely affected
- Instruct patients to avoid concomitant use of this drug with alcohol or other CNS depressants
- Instruct patients not to take acetaminophen >4000 mg/day or use more than one product that contains acetaminophen
- Advise patients to discontinue therapy and promptly consult their physician if they develop signs or symptoms of allergy including rash, hives, pruritus, urticaria, swelling of the face/mouth/throat, vomiting, or difficulty breathing
Pregnancy Category:C
Breastfeeding: Acetaminophen is a good choice for analgesia and fever reduction in nursing mothers. Amounts excreted in milk are much less than doses usually given to infants. Adverse effects in breastfed infants appear to be rare. Maternal medication is usually compatible with breastfeeding; no observable change was seen in the nursing infant while the mother was ingesting the compound. As no published experience is available with butalbital or combination products containing butalbital during breastfeeding, other agents may be preferred, especially while nursing a newborn or preterm infant. Caffeine appears in breastmilk rapidly after maternal ingestion. Adverse events 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. 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. Irritability, poor sleeping pattern may occur as caffeine is excreted slowly; no effect were observed with moderate intake of caffeinated beverages (2-3 cups/day). This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT and http://aappolicy.aappublications.org/cgi/content/full/pediatrics;108/3/776/T6 last accessed 31 May 2011)As per manufacturer's data, because of potential for serious adverse reactions in nursing infants from acetaminophen, butalbital, 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)
- Esgic-Plus
- Fioricet
- Orbivan
US Availability
acetaminophen/butalbital/caffeine (generic)
- CAPS
- 500 mg/50 mg/40 mg
- 300 mg/50 mg/40 mg
- 325 mg/50 mg/40 mg
- TABS
- 500 mg/50 mg/40 mg
- 750 mg/50 mg/40 mg
- 325 mg/50 mg/40 mg
- SOLN
- [325 mg/50 mg/40 mg]/15 mL
Esgic-Plus (acetaminophen/butalbital/caffeine)
- CAPS: 500 mg/50 mg/40 mg
- TABS: 500 mg/50 mg/40 mg
Fioricet (acetaminophen/butalbital/caffeine)
Orbivan (acetaminophen/butalbital/caffeine)
Canadian Trade Name(s)
Canadian Availability
UK Trade Name(s)
UK Availability
Australian Trade Name(s)
Australian Availability
[Outline]
Pricing data from www.DrugStore.com in U.S.A.
- Esgic-Plus 50-500-40 MG TABS [Bottle] (FOREST)
30 mg = $61.72
90 mg = $175.24 - Fioricet 50-325-40 MG TABS [Bottle] (WATSON LABS)
30 mg = $72.23
90 mg = $188.07
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.
