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:

AvKARE

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 an intoxication dosage and fatal dosage becomes smaller. The lethal dose of a barbiturate is far less if alcohol is also ingested. Major withdrawal symptoms (convulsions and delirium) may occur within 16 hours and last up to 5 days after abrupt cessation of these drugs. Intensity of withdrawal symptoms gradually declines over a period of approximately 15 days. Treatment of barbiturate dependence consists of cautious and gradual withdrawal of the drug. Barbiturate-dependent patients can be withdrawn by using a number of different withdrawal regimens. One method involves initiating treatment at the patient’s regular dosage level and gradually decreasing the daily dosage as tolerated by the patient.

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 42291-181-01). Store at 20 to 25 o C (68 to 77 o F) [see USP Controlled Room Temperature.] Dispense in a tight, light-resistant container. Rx only For all medical inquires contact AvKARE at 1-855-361-3993. Manufactured for: AvKARE, Inc. Pulaski, TN 38478 Mfg. Rev. 11/16 AV Rev. 06/18 (P)

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE- BUTALBITAL, ACETAMINOPHEN,
AND CAFFEINE CAPSULE
AVKARE
----------
BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE CAPSULES, USP
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
of molecular weight 224.26. It has the following structural formula:
Acetaminophen (4´-hydroxyacetanilide), is a non-opiate,
non-salicylate analgesic and
antipyretic of molecular weight 151.16. It has the following
structural formula:
Caffeine (1,3,7-trimethylxanthine), is a central nervous system
stimulant of molecular
weight 194.19. 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 bar