BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE- codeine phosphate, butalbital, caffeine, and acetaminophen capsule c

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CODEINE PHOSPHATE (UNII: GSL05Y1MN6) (CODEINE - UNII:Q830PW7520), BUTALBITAL (UNII: KHS0AZ4JVK) (BUTALBITAL - UNII:KHS0AZ4JVK), CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E), ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)

Available from:

Physicians Total Care, Inc.

INN (International Name):

CODEINE PHOSPHATE

Composition:

CODEINE PHOSPHATE 30 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules is indicated for the relief of the symptom complex of tension (or muscle contraction) headache. Evidence supporting the efficacy and safety of Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules in the treatment of multiple recurrent headaches is unavailable. Caution in this regard is required because codeine and butalbital are habit-forming and potentially abusable. Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules is contraindicated under the following conditions: −  Hypersensitivity or intolerance to acetaminophen, caffeine, butalbital, or codeine. −  Patients with porphyria. Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules is controlled by the Drug Enforcement Administration and is classified under Schedule III. Codeine Codeine can produce drug dependence of the morphine type and, therefore, has the potential for being abused. Psychological dependence, physical dependence,

Product summary:

Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules Dark blue, opaque cap with a white, opaque body. Cap is imprinted with “WATSON” in light blue. Body is imprinted with “3220” in red. Bottles of 10     NDC 54868-5162-1, Bottles of 90     NDC 54868-5162-2, Bottles of 100   NDC 54868-5162-0, Bottles of 30     NDC 54868-5162-3. Below 30°C (86°F); tight container. Rx only

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE - CODEINE
PHOSPHATE, BUTALBITAL, CAFFEINE, AND ACETAMINOPHEN CAPSULE CAPSULE
PHYSICIANS TOTAL CARE, INC.
----------
RX ONLY
DESCRIPTION
Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules is
supplied in capsule form for
oral administration.
Each capsule contains the following active ingredients:
butalbital, USP.......................................50 mg
acetaminophen, USP.........................325 mg
caffeine, USP.........................................40 mg
codeine phosphate, USP.....................30 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:
Codeine phosphate
(7,8-Didehydro-4,5α-epoxy-3-methoxy-17-methylmorphinan-6α-ol
phosphate (1:1)
(salt) hemihydrate) is a narcotic analgesic and antitussive. It has
the following structural formula:
_Inactive Ingredients: _colloidal silicon dioxide, magnesium stearate,
pregelatinized starch.
CLINICAL PHARMACOLOGY
Butalbital, Acetaminophen, Caffeine and Codeine Phosphate Capsules is
a combination drug product
intended as a treatment for tension headache.
Butalbital, Acetaminophen, and Caffeine Tablets, USP consists of a
fixed combination of butalbital 50
mg, acetaminophen 325 mg, and caffeine 40 mg. 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.
Codeine
Codeine is readily absorbed from the gastrointestinal tract. It is
rapidly distributed from the
intravascular spaces to the various body tissues, with preferential
uptake by parenchymatous organs
such as the liver, spleen and kidney. Codeine crosses