BUTALBITAL, ACETAMINOPHEN AND CAFFEINE tablet

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:

Strides Pharma Inc.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Butalbital, acetaminophen and caffeine tablets, USP are indicated for the relief of the symptom complex of tension (or muscle contraction) headache. Evidence supporting the efficacy and safety of Butalbital, acetaminophen, and caffeine tablets, USP in the treatment of multiple recurrent headaches is unavailable. Caution in this regard is required because butalbital is habit-forming and potentially abusable. Butalbital, acetaminophen and caffeine tablets, USP are 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 n

Product summary:

Containing 50 mg butalbital, 325 mg acetaminophen, and 40 mg caffeine. Available as white to off-white tablets with a "P580" debossed on one side. NDC 42543-094-01: Bottles of 100 supplied with child-resistant closures. NDC 42543-094-05: Bottles of 500. Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Dispense in a tight container. Keep out of reach of children. Rx only For all medical inquiries contact: Vensun Pharmaceuticals, Inc. Yardley, PA 19067 1-800-385-1540 Manufactured for: Vensun Pharmaceuticals, Inc Yardley, PA 19067 Manufactured by: Pharmaceutics International, Inc Hunt Valley, MD 21031 Rev. 00, May 2017

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

BUTALBITAL, ACETAMINOPHEN AND CAFFEINE- BUTALBITAL, ACETAMINOPHEN AND
CAFFEINE TABLET
STRIDES PHARMA INC.
----------
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLETS, 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 tablets, USP are supplied in
tablet form for oral
administration.
Each tablet contains the following active ingredients:
butalbital, USP . . . . . . . . . . 50 mg
acetaminophen, USP . . . . 325 mg
caffeine, USP …………… 40 mg
Butalbital (5-allyl-5-isobutylbarbituric acid) is a short-to
intermediate-acting barbiturate. It
has the following structural formula:
C
H
N O Mol. wt. 224.26
Acetaminophen (4′-hydroxyacetanilide) is a non-opiate,
non-salicylate analgesic and
antipyretic. It has the following structural formula:
C H NO Mol. wt. 151.16
Caffeine (1, 3, 7-trimethylxanthine) is a central nervous system
stimulant. It has the
following structural formula:
11
16
2
3
8
9
2
C H
N O Mol. wt. 194.19
_Inactive Ingredients:_ colloidal silicon dioxide, croscarmellose
sodium, microcrystalline
cellulose, povidone, pregelatinized starch, crospovidone and stearic
acid.
CLINICAL PHARMACOLOGY
Butalbital, acetaminophen and caffeine tablets, USP are 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 placen