BUTALBITAL/ACETAMINOPHEN/CAFFEINE capsule

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

Advanced Rx Pharmacy of Tennessee, LLC

Via di somministrazione:

ORAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

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. Abuse and Dependence 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

Dettagli prodotto:

Butalbital, Acetaminophen , and Caffeine Capsules USP , 50 mg /300 mg/40 mg Each butalbital, acetaminophen and caffeine capsule contain butalbital 50 mg, acetaminophen 300 mg and caffeine 40 mg. Capsules are blue opaque cap printed with "GPI (over) 50/300/40 (over) mg" and blue opaque body printed with "044" contains white to off-white blend and are available in bottles of: Bottles of 30 NDC: 80425-0215-01 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight container as defined in the USP. Rx only Manufactured by: Granules Pharmaceuticals Inc. Chantilly, VA 20151 Distributed by: Advanced Rx Pharmacy of Tennessee, LLC Rev 04/2022

Stato dell'autorizzazione:

Abbreviated New Drug Application

Scheda tecnica

BUTALBITAL/ACETAMINOPHEN/CAFFEINE-
BUTALBITAL/ACETAMINOPHEN/CAFFEINE CAPSULE
ADVANCED RX PHARMACY OF TENNESSEE, LLC
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BUTALBITAL, ACETAMINOPHEN AND CAFFEINE 50MG/300MG/40MG CAPSULES
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 , FD&C Blue #1, FD&C Red #3,
gelatin,
microcrystalline cellulose, povidone, pregelatinized starch, sodium
lauryl sulfate, stearic
acid, talc and titanium dioxide. In addition, capsule printing ink
contains ammonium
hydroxide, black iron oxide, propylene glycol and shellac glaze.
Butalbital
Butalbital (5-allyl-5-isobutylbarbituric acid), is a short to
intermediate-acting barbiturate
of molecular weight 224.26. It has the following structural formula:
Butalbital
Acetaminophen
Acetaminophen (4´-hydroxyacetanilide), is a non-opiate,
non-salicylate analgesic and
antipyretic of molecular weight 151.16. It has the following
structural formula:
Acetaminophen
Caffeine
Caffeine (1,3,7-trimethylxanthine), is a central nervous system
stimulant of molecular
weight 194.19. It has the following structural formula:
Caffeine
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 varying
degree and bindin