BUTALBITAL, ACETAMINOPHEN AND CAFFEINE capsule

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

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

Disponible des:

Seton Pharmaceuticals LLC

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

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 than two-fold. As this occurs, the margin between an intoxication dosage and fatal dosage becomes smaller. The lethal dose of a barbiturate is far less if alcohol is also ingested. Major withdrawal symptoms (convulsions and delirium) may occur within 16 hours and last up to 5 days after abrupt cessation of these drugs. Intensity of withdrawal symptoms gradually declines over a period of approximately 15 days. Treatment of barbiturate dependence consists of cautious and gradual withdrawal of the drug. Barbiturate-dependent patients can be withdrawn by using a number of different withdrawal regimens. One method involves initiating treatment at the patient's regular dosage level and gradually decreasing the daily dosage as tolerated by the patient.

Resumen del producto:

Butalbital, acetaminophen and caffeine capsules, USP containing butalbital 50 mg (Warning: May be habit-forming) , acetaminophen 325 mg and caffeine 40 mg, are supplied as White to off-white powder filled in a hard gelatin capsule with a white opaque cap and body, imprinted with "A30" on cap and body in black ink. They are available as:             Bottles of 100 with child-resistant closure: NDC 13925-536-01 Butalbital, acetaminophen and caffeine capsules, USP containing butalbital 50 mg (Warning: May be habit-forming) , acetaminophen 300 mg and caffeine 40 mg, are supplied as White to off-white powder filled in a hard gelatin capsule with a Light Blue opaque cap and body, imprinted with "A3l" on cap and body in black ink. They are available as:             Bottles of 100 with child-resistant closure: NDC 13925-535-01 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. Rx only Manufactured by: Aavis Pharmaceuticals, Hoschton, GA 30548 Marketed by: Seton Pharmaceuticals LLC Wall, NJ 07719 USA 1-800-510-3401 Code. L7042/01 Rev. 05/2022

Estat d'Autorització:

Abbreviated New Drug Application

Fitxa tècnica

BUTALBITAL, ACETAMINOPHEN AND CAFFEINE - BUTALBITAL, ACETAMINOPHEN AND
CAFFEINE CAPSULE
SETON PHARMACEUTICALS LLC
----------
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE CAPSULES USP, 50 MG/325 MG/40
MG
AND 50 MG/300 MG/40 MG
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 capsule form
for oral
administration.
Each 50 mg/325 mg/40 mg capsule contains:
Butalbital ................... 50 mg
WARNING: May be habit-forming.
Acetaminophen ........ 325 mg
Caffeine ...................... 40 mg
Each 50 mg/300 mg/40 mg capsule contains:
Butalbital ................... 50 mg
WARNING: May be habit-forming.
Acetaminophen ........ 300 mg
Caffeine ...................... 40 mg
In addition, each capsule contains the following inactive ingredients:
Microcrystalline
Cellulose, Croscarmellose Sodium, Colloidal Silicon Dioxide, Magnesium
Stearate,
Pregelatinized starch, Povidone, Crospovidone, Stearic Acid with 50
mg/325 mg/40 mg
capsule shell composed of gelatin and titanium dioxide and 50 mg/300
mg/40 mg
capsule shell composed of gelatin, titanium dioxide, FD&C Yellow 6,
FD&C blue 1 and
FD&C Red 40. Imprinting ink composed of Black Iron Oxide, Butyl
Alcohol, Dehydrated
Alcohol, Isopropyl Alcohol, Potassium Hydroxide, Propylene Glycol,
Shellac and Strong
Ammonia Solution.
Butalbital (5-allyl-5-isobutylbarbituric acid), a slightly bitter,
white, odorless, crystalline
powder, is a short to intermediate-acting barbiturate. It has the
following structural
formula:
C
H
N O
MW = 224.26
Acetaminophen (4'-hydroxyacetanilide), a slightly bitter, white,
odorless, crystalline
powder, is a nonopiate, non-salicylate analgesic and antipyretic. It
has the following
structural formula:
C H NO
MW = 151.16
11
16