Butalbital, Acetaminophen and Caffeine Oral Solution 50 mg/325 mg/40 mg per 15 mL

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

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

Mevcut itibaren:

Mikart, LLC

INN (International Adı):

BUTALBITAL

Kompozisyon:

BUTALBITAL 50 mg in 15 mL

Uygulama yolu:

ORAL

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

Butalbital, acetaminophen and caffeine oral solution is 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

Ürün özeti:

Butalbital, Acetaminophen and Caffeine Oral Solution is an orange, tropical fruit punch flavored liquid containing butalbital 50 mg (Warning: May be habit-forming), acetaminophen 325 mg and caffeine 40 mg per 15 mL, with 7.368% alcohol. It is supplied in containers as follows: 16 fl oz NDC 46672-633-16 128 fl oz NDC 46672-633-28 Storage: Store at 20° to 25°C (68° to 77°F)[See USP Controlled Room Temperature). Dispense in a tight, light-resistant container with a child-resistant closure. Store at 20° to 25°C (68° to 77°F)[See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container with a child-resistant closure. Rx only Manufactured by: MIKART, LLC Atlanta, GA 30318 Code 778Z00 Rev. 06/20

Yetkilendirme durumu:

Abbreviated New Drug Application

Ürün özellikleri

BUTALBITAL, ACETAMINOPHEN AND CAFFEINE- BUTALBITAL, ACETAMINOPHEN AND
CAFFEINE SYRUP
MIKART, LLC
----------
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE ORAL SOLUTION
50 MG/325 MG/40 MG PER 15 ML
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 are supplied in liquid form for
oral administration.
Each 15 mL contains:
Butalbital USP......................................................50
mg
WARNING: May be habit forming.
Acetaminophen USP............................................325 mg
Caffeine USP........................................................40
mg
Alcohol
..................................................................7.368%
In addition, this drug product contains the following inactive
ingredients: citric acid, ethyl maltol, liquid
glucose, glycerin, methylparaben, propylene glycol, propylparaben,
purified water, saccharin sodium,
sorbitol solution, sucrose, with FD&C yellow #6 as coloring, and
natural and artificial flavoring
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 not completely understood.
PHARMACOKINETICS
The behavior of the individual components is desc