BUTALBITAL, ACETAMINOPHEN AND CAFFEINE capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Xspire Pharma, LLC

INN (International Name):

CAFFEINE

Composition:

CAFFEINE 40 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Butalbital, Acetaminophen and Caffeine capsules 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 in

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 yellow, opaque body printed with purple ink logo “Tedor 255” and dark green, opaque cap printed with purple ink logo “Tedor 255”. The capsules are supplied in bottles of 100 capsules (NDC 42195-955-10). Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]; Dispense in a tight, light-resistant container.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

BUTALBITAL, ACETAMINOPHEN AND CAFFEINE- BUTALBITAL, ACETAMINOPHEN AND
CAFFEINE CAPSULE
XSPIRE PHARMA, LLC
----------
BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE CAPSULES 50 MG / 300 MG / 40
MG
RX ONLY
BOXED WARNING
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_: crospovidone, microcrystalline cellulose,
povidone, pregelatinized
starch, stearic acid, talc, D&C yellow #10, FD&C yellow #6, FD&C green
#3, FD&C red
#40, gelatin, titanium dioxide, propylene glycol, hypromellose 2910,
FD&C red #3, FD&C
blue #1.
Butalbital (5-allyl-5-isobutylbarbituric acid), is a short to
intermediate-acting barbiturate
of molecular weight 224.26. It has the following structural formula:
C
H
N
O MW = 224.26
11
16
2
3
Acetaminophen (4´-hydroxyacetanilide), is a non-opiate,
non-salicylate analgesic and
antipyretic of molecular weight 151.16. It has the following
structural formula:
C
H
NO MW = 151.16
Caffeine (1,3,7-trimethylxanthine), is a central nervous system
stimulant of molecular
weight 194.19. It has the following structural formula:
C
H
N
O MW = 194.19
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 descri