BUTALBITAL-ACETAMINOPHEN-CAFFE (Generic for ESGIC)

Butalbital 50mg, Acetaminophen 325mg, Caffeine 40mg, Oral tablet

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.

Butalbital 50mg, Acetaminophen 325mg, Caffeine 40mg, Oral tablet

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 325mg, Caffeine 40mg, Oral tablet

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 325mg, Caffeine 40mg, Oral tablet

Tobacco

· Severity: Moderate

· Notes for Consumers: Tobacco smoke contains substances that may speed the removal of Caffeine from the body. If you start smoking Caffeine may become less effective. Tobacco smokers often drink several caffeinated beverages daily. Just the opposite occurs when someone stops smoking tobacco; if you stop smoking this may increase the amount of Caffeine in the blood and side effects from Caffeine may get worse. Too much Caffeine can cause nausea, nervousness, or sleeplessness, and occasionally other effects like tremor. If you stop smoking tobacco, you may need to lower your Caffeine intake.

· Notes for Professionals: Inducers of the hepatic CYP450 isoenzyme CYP1A2 may induce the hepatic oxidative metabolism of caffeine. Tobacco smoke contains hydrocarbons that induce hepatic CYP450 microsomal enzymes (e.g., CYP1A1, CYP1A2, CYP2E1). The increased clearance of caffeine by smokers may contribute to the higher consumption of caffeinated beverages reported to occur in this group. Because the effect on hepatic microsomal enzymes is not related to the nicotine component of tobacco, the sudden cessation of tobacco smoking may result in a reduced clearance of caffeine, despite the initiation of a nicotine replacement product. Following several days of abstinence from chronic tobacco smoking, caffeine clearance may decrease by roughly 40%, leading to the possible occurrence of caffeine-related side effects like nausea, nervousness, irritability, tremors, or insomnia, if caffeine use remains the same.

Butalbital 50mg, Acetaminophen 325mg, Caffeine 40mg, Oral tablet

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.

<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>