BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

BUTALBITAL (UNII: KHS0AZ4JVK) (BUTALBITAL - UNII:KHS0AZ4JVK), ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D), CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E)

Available from:

Actavis Pharma, Inc.

INN (International Name):

BUTALBITAL

Composition:

BUTALBITAL 50 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Butalbital, Acetaminophen and Caffeine Capsules, USP are indicated for the relief of the symptom complex of tension (or muscle contraction) headache. Evidence supporting the efficacy and safety of this combination product in the treatment of multiple recurrent headaches is unavailable. Caution in this regard is required because butalbital is habit-forming and potentially abusable. This product is contraindicated under the following conditions: - Hypersensitivity or intolerance to any component of this product - Patients with porphyria. Butalbital Barbiturates may be habit-forming: Tolerance, psychological dependence, and physical dependence may occur especially following prolonged use of high doses of barbiturates. The average daily dose for the barbiturate addict is usually about 1500 mg. As tolerance to barbiturates develops, the amount needed to maintain the same level of intoxication increases; tolerance to a fatal dosage, however, does not increase more than two-fold. As this occurs, the margin between

Product summary:

Butalbital, Acetaminophen, and Caffeine Capsules USP, 50 mg/300 mg/40 mg Containing 50 mg butalbital, 300 mg acetaminophen, and 40 mg caffeine. Available as hard gelatin capsules with a light blue opaque body and a light blue opaque cap. Cap is imprinted twice with "FIORICET" in black and body is imprinted twice with a three-head profile "" in black. The capsules are supplied in bottles of 100 capsules (NDC 0591-2640-01) and 500 capsules (NDC 0591-2640-05). Store at 20o to 25o C (68o to 77o F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container. Rx only Manufactured by: LGM Pharma Solutions, LLC Irvine, CA 92614 Manufactured for: Teva Pharmaceuticals USA, Inc. Parsippany, NJ 07054 7029-0100-WG-EC Rev. 01/2021

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE- BUTALBITAL, ACETAMINOPHEN,
AND CAFFEINE CAPSULE
ACTAVIS PHARMA, INC.
----------
BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE CAPSULES, USP
RX ONLY
HEPATOTOXICITY
Acetaminophen has been associated with cases of acute liver failure,
at times
resulting in liver transplant and death. Most of the cases of liver
injury are
associated with the use of acetaminophen at doses that exceed 4000
milligrams
per day, and often involve more than one acetaminophen-containing
product.
DESCRIPTION
Butalbital, Acetaminophen, and Caffeine Capsules, USP are supplied in
hard-gelatin
capsule form for oral administration.
Each capsule contains the following active ingredients:
Butalbital, USP……………………50 mg
Acetaminophen, USP…………….300 mg
Caffeine, USP……………………..40 mg
_Inactive Ingredients: _sodium lauryl sulfate, talc, microcrystalline
cellulose, stearic acid,
FD&C red # 40, titanium dioxide, FD&C blue # 1, FD&C yellow # 6,
gelatin.
Butalbital (5-allyl-5-isobutylbarbituric acid) is a short- to
intermediate-acting barbiturate.
It has the following structural formula:
Acetaminophen (4´-hydroxyacetanilide) is a non-opiate, non-salicylate
analgesic and
antipyretic. It has the following structural formula:
Caffeine (1,3,7-trimethylxanthine) is a central nervous system
stimulant. It has the
following structural formula:
CLINICAL PHARMACOLOGY
This combination drug product is intended as a treatment for tension
headache.
It consists of a fixed combination of butalbital, acetaminophen, and
caffeine. The role
each component plays in the relief of the complex of symptoms known as
tension
headache is incompletely understood.
PHARMACOKINETICS
The behavior of the individual components is described below.
_BUTALBITAL_
Butalbital is well absorbed from the gastrointestinal tract and is
expected to distribute to
most tissues in the body. Barbiturates in general may appear in breast
milk and readily
cross the placental barrier. They are bound to plasma and tissue
proteins to a vary