FIORICET

Butalbital 50mg, Acetaminophen 300mg, Caffeine 40mg, Oral capsule

Tobacco

· Severity: Moderate

· Notes for Consumers: If you are a tobacco smoker, use of Acetaminophen can increase the risk of liver side effects. Immediately tell your doctor if you get severe abdominal pain, nausea, vomiting, or yellowing of the skin. Do not exceed 4 g acetaminophen/day in adults. Tell your doctor if Acetaminophen does not help your headache or other pain. Tobacco smoke may reduce the effectiveness of Acetaminophen.

· Notes for Professionals: Tobacco smoking induces the cytochrome P450 isoenzyme CYP1A2 and may potentially increase the risk for acetaminophen-induced hepatotoxicity during overdose via enhanced generation of acetaminophen's hepatotoxic metabolite, NAPQI. In one study, current tobacco smoking was found to be very frequent in patients admitted with acetaminophen poisoning. Tobacco smoking appears to be an independent risk factor of severe hepatotoxicity, acute liver failure and death following acetaminophen overdose.

Butalbital 50mg, Acetaminophen 300mg, Caffeine 40mg, Oral capsule

Grapefruit juice

· Severity: Mild

· Notes for Consumers: Do not significantly alter your grapefruit juice intake while taking medicines containing caffeine. Some reports suggest that intake of grapefruit juice can increase side effects from caffeine. Too much Caffeine can cause effects like nausea, tremor, nervousness, or sleeplessness. If these occur, consider ingesting less caffeine daily.

· Notes for Professionals: Data are limited and conflicting as to whether grapefruit juice significantly alters the serum concentrations and/or AUC of caffeine. Caffeine is primarily a CYP1A2 substrate, and grapefruit juice appears to have but a small effect on this enzyme in vivo. One report suggests that grapefruit juice decreases caffeine elimination by inhibition of flavin-containing monooxygenase, a P450 independent system. This interaction might increase caffeine levels and mildly potentiate the clinical effects and common side effects of caffeine. If side effects appear, patients may need to limit either caffeine or grapefruit juice intake.

Butalbital 50mg, Acetaminophen 300mg, Caffeine 40mg, Oral capsule

Caffeine-containing Foods/Beverages

· Severity: Moderate

· Notes for Consumers: Caffeine may cause sleeplessness, so if you are taking a Barbiturate to help you sleep, you may wish to avoid taking caffeine and caffeine-containing foods like colas, coffee, teas, or chocolates within several hours prior to bedtime. Barbiturates may also decrease the actions of Caffeine; if you have a high intake of caffeinated foods or beverages you may experience a headache or irritability from decreased caffeine levels while taking these drugs until your body adjusts. If you take Caffeine for other purposes, notify your health care provider if you think Caffeine is not working as well for you.

· Notes for Professionals: Caffeine has been reported to increase the metabolism of barbiturates, and barbiturates increase caffeine elimination. Higher caffeine doses may be needed after barbiturate administration.

Butalbital 50mg, Acetaminophen 300mg, Caffeine 40mg, Oral capsule

Marijuana

· Severity: Moderate

· Notes for Consumers: The effects of marijuana may be decreased if combined with this medicine. Do not drive or operate machinery until you know how this combination will affect you. Contact your health care provider right away if you notice slurred speech, confusion, severe drowsiness, increased heart rate, or any other new or unusual side effects.

· Notes for Professionals: The incidence of marijuana associated adverse effects may change following coadministration with barbiturates. Barbiturates are inducers of CYP2C9 and CYP3A4, two isoenzymes responsible for the metabolism of marijuana's most psychoactive compound, delta-9-tetrahydrocannabinol (Delta-9-THC). When given concurrently with barbiturates, the amount of Delta-9-THC converted to the active metabolite 11-hydroxy-delta-9-tetrahydrocannabinol (11-OH-THC) may be increased. These changes in Delta-9-THC and 11-OH-THC plasma concentrations may result in an altered marijuana adverse event profile.

Butalbital 50mg, Acetaminophen 300mg, Caffeine 40mg, Oral capsule

Alcohol

· Severity: Major

· Notes for Consumers: Patients who drink more than 3 alcoholic drinks a day and take Acetaminophen are at increased risk of developing liver side effects. Limit alcohol intake while taking Acetaminophen. Avoid alcoholic drinks if you are taking Acetaminophen on a regular basis.

· Notes for Professionals: The risk of developing hepatotoxicity from acetaminophen appears to be increased in patients who regularly consume ethanol. Patients who drink more than 3 alcoholic drinks a day and take acetaminophen are at increased risk of developing hepatotoxicity. Acute or chronic ethanol use increases acetaminophen-induced hepatotoxicity by inducing cytochrome P450 CYP 2E1 leading to increased formation of the hepatotoxic metabolite of acetaminophen. Also, chronic alcohol use can deplete liver glutathione stores. Administration of acetaminophen should be limited or avoided altogether in patients with alcoholism or patients who consume ethanol regularly.

<b>DISCLAIMER:</b><em> This drug information content is provided for informational purposes only and is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Patients should always consult their physician with any questions regarding a medical condition and to obtain medical advice and treatment. Drug information is sourced from GSDD (Gold Standard Drug Database ) provided by Elsevier.</em>