BUTALBITAL ACETAMINOPHEN AND CAFFEINE- butalbital acetaminophen and caffeine tablet

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

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

Sẵn có từ:

Lake Erie Medical DBA Quality Care Products LLC

INN (Tên quốc tế):

BUTALBITAL

Thành phần:

BUTALBITAL 50 mg

Tuyến hành chính:

ORAL

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

Butalbital, Acetaminophen, and Caffeine Tablets USP is 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 is contraindicated under the following conditions: – Hypersensitivity or intolerance to any component of this product – Patients with porphyria.

Tóm tắt sản phẩm:

Butalbital, Acetaminophen, and Caffeine Tablets USP Containing 50 mg butalbital, 325 mg acetaminophen, and 40 mg caffeine. Available as white, round uncoated tablets, engraved WATSON on one side and 3369 on other side supplied in bottles of 100 and 500. Bottles of 100 are supplied with child-resistant closures. Store below 30°C (86°F); dispense in a tight container.

Tình trạng ủy quyền:

Abbreviated New Drug Application

Đặc tính sản phẩm

BUTALBITAL ACETAMINOPHEN AND CAFFEINE- BUTALBITAL ACETAMINOPHEN AND
CAFFEINE TABLET
LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC
REFERENCE LABEL SET ID: 418054C3-D8C8-49B0-93A5-A53FD0C5018F
----------
BUTALBITAL-ACETAMINOPHEN-CAFFEINE 50MG/325MG/40MG
DESCRIPTION
Butalbital, Acetaminophen, and Caffeine Tablets USP is 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:
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:
_Inactive Ingredients: _crospovidone, magnesium stearate,
microcrystalline cellulose, povidone,
pregelatinized starch, and stearic acid.
CLINICAL PHARMACOLOGY
Butalbital, Acetaminophen, and Caffeine Tablets USP 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
binding increases directly as a function
of lipid solubility.
Elimination of butalbital is primarily via the kidney (59% to 88% of
the dose) as unchanged drug or
metabolites. The plasma half-life is about 35 hours. Urinary excretion
products include parent dr