A single or multiple drug overdose with this combination product is a potentially lethal polydrug overdose, and consultation with a regional poison control center is recommended. Immediate treatment includes support of cardiorespiratory function and measures to reduce drug absorption.
Oxygen, intravenous fluids, vasopressors, and other supportive measures should be employed as indicated. Assisted or controlled ventilation should also be considered.
Gastric decontamination with activated charcoal should be administered just prior to N-acetylcysteine (NAC) to decrease systemic absorption if acetaminophen ingestion is known or suspected to have occurred within a few hours of presentation. Serum acetaminophen levels should be obtained immediately if the patient presents 4 hours or more after ingestion to assess potential risk of hepatotoxicity; acetaminophen levels drawn less than 4 hours post-ingestion may be misleading. To obtain the best possible outcome, NAC should be administered as soon as possible where impending or evolving liver injury is suspected. Intravenous NAC may be administered when circumstances preclude oral administration.
Vigorous supportive therapy is required in severe intoxication. Procedures to limit the continuing absorption of the drug must be readily performed since the hepatic injury is dose dependent and occurs early in the course of intoxication.
Oral: one capsule every four hours. Total daily dosage should not exceed 6 capsules.
Extended and repeated use of this product is not recommended because of the potential for physical dependence.
ZEBUTAL® Capsules brand of butalbital 50 mg, acetaminophen 500 mg and caffeine 40 mg are supplied as salmon/red capsules printed “170″ in white ink and are available in:
NDC 68453-170-10 Bottles of 100 capsules.
Store at 20-25o C (68-77o F) [See USP Controlled Room Temperature]. Protect from light and moisture.
Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.
Victory Pharma, Inc.
San Diego, CA 92130
West-ward Pharmaceutical Corp.
Eatontown, NJ 07724
Revised May 2011
ZEBUTAL® Butalbital, Acetaminophen, Caffeine Capsules, USP
| BUTALBITAL, ACETAMINOPHEN AND CAFFEINE |
butalbital, acetaminophen and caffeine capsule
|Labeler — Victory Pharmaceutical (143180318)|
|West-ward Pharmaceutical Corp||001230762||MANUFACTURE|
Revised: 07/2011 Victory Pharmaceutical
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