VANATOL LQ- butalbital, acetaminophen and caffeine syrup

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

GM Pharmaceuticals

INN (Διεθνής Όνομα):

BUTALBITAL

Σύνθεση:

BUTALBITAL 50 mg in 15 mL

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

VANATOL™ LQ 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 : Babiturates 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 d

Περίληψη προϊόντος:

VANATOL™ LQ (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: 1 fl oz physician samples NDC 58809-820-02 16 fl oz NDC 58809-820-16 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 for: GM Pharmaceuticals, Inc. Arlington, TX 76015 Manufactured by: Mikart, Inc. Atlanta, GA 30318 Code 778C00 Rev. 07/17

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Αρχείο Π.Χ.Π.

VANATOL LQ- BUTALBITAL, ACETAMINOPHEN AND CAFFEINE SYRUP
GM PHARMACEUTICALS
----------
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
VANATOL™ LQ (butalbital, acetaminophen and caffeine) is 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 incompletely understood.
PHARMACOKINETICS
The behavior of the individual components is described below.
Butalbital
Butalbital is well absorbed from the gastrointestinal tract and i