BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE capsule

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

BUTALBITAL (UNII: KHS0AZ4JVK) (BUTALBITAL - UNII:KHS0AZ4JVK), ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D), CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E), CODEINE PHOSPHATE (UNII: GSL05Y1MN6) (CODEINE ANHYDROUS - UNII:UX6OWY2V7J)

Disponible desde:

Bryant Ranch Prepack

Designación común internacional (DCI):

BUTALBITAL

Composición:

BUTALBITAL 50 mg

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules are indicated for the management of the symptom complex of tension (or muscle contraction) headache when non-opioid analgesic and alternative treatments are inadequate. Limitations of Use Because of the risks of addiction, abuse, and misuse with opioids and butalbital, even at recommended doses [see Warnings and Precautions (5.1)], reserve Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules for use in patients for whom alternative treatment options [e.g., non-opioid, non-barbiturate analgesics]: - Have not been tolerated, or are not expected to be tolerated, - Have not provided adequate analgesia or are not expected to provide adequate analgesia. Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules are contraindicated for: - All children younger than 12 years of age [see Warnings and Precautions (5.5)] . - Post-operative management in children younger than 18 years of age following tonsillectomy and/or adenoide

Resumen del producto:

Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules are dark blue, opaque cap with a gray, opaque body. The body is imprinted with "B 073" in black ink. Rx only Keep this and all medication out of the reach of children. NDC: 71335-0194-1: 20 Capsules in a BOTTLE NDC: 71335-0194-2: 90 Capsules in a BOTTLE NDC: 71335-0194-3: 30 Capsules in a BOTTLE NDC: 71335-0194-4: 60 Capsules in a BOTTLE NDC: 71335-0194-5: 100 Capsules in a BOTTLE NDC: 71335-0194-6: 15 Capsules in a BOTTLE NDC: 71335-0194-7: 18 Capsules in a BOTTLE Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]; and Dispense in a tight, light-resistant container. Store Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules securely and dispose of properly [see PATIENT COUNSELING INFORMATION (17)]. Rx only Keep this and all medication out of the reach of children. Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504

Estado de Autorización:

Abbreviated New Drug Application

Información para el usuario

ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE
Bryant Ranch Prepack
----------
MEDICATION GUIDE
Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules, C
III
Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules
are:
•
A strong prescription pain medicine that contains an opioid (narcotic)
that is indicated for the
relief of the symptom complex of tension (or muscle contraction)
headache, when other pain
treatments such as non-opioid pain medicines do not treat your pain
well enough or you cannot
tolerate them.
•
An opioid pain medicine that can put you at risk for overdose and
death. Even if you take your
dose correctly as prescribed you are at risk for opioid addiction,
abuse, and misuse that can lead
to death.
Important information about Butalbital, Acetaminophen, Caffeine, and
Codeine Phosphate Capsules:
•
Get emergency help or call 911 right away if you take too much
Butalbital, Acetaminophen,
Caffeine, and Codeine Phosphate Capsules (overdose). When you first
start taking Butalbital,
Acetaminophen, Caffeine, and Codeine Phosphate Capsules, when your
dose is changed, or if you
take too much (overdose), serious or life-threatening breathing
problems that can lead to death
may occur. Talk to your healthcare provider about naloxone, a medicine
for the emergency
treatment of an opioid overdose.
•
Taking Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate
Capsules with other opioid
medicines, benzodiazepines, alcohol, or other central nervous system
depressants (including street
drugs) can cause severe drowsiness, decreased awareness, breathing
problems, coma, and death.
•
Never give anyone else your Butalbital, Acetaminophen, Caffeine, and
Codeine Phosphate
Capsules. They could die from taking it. Selling or giving away
Butalbital, Acetaminophen,
Caffeine, and Codeine Phosphate Capsules is against the law.
•
Store Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate
Capsules securely, out of
sight and reach of children, and in a location not accessible by

Ficha técnica

BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE-
BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE
BRYANT RANCH PREPACK
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
BUTALBITAL,
ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE CAPSULES SAFELY AND
EFFECTIVELY.
SEE FULL PRESCRIBING INFORMATION FOR BUTALBITAL, ACETAMINOPHEN,
CAFFEINE, AND CODEINE
PHOSPHATE CAPSULES.
BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE CAPSULES
FOR ORAL
USE, CIII
INITIAL U.S. APPROVAL: 1992
WARNING: ADDICTION, ABUSE, AND MISUSE; RISK EVALUATION AND MITIGATION
STRATEGY (REMS); LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL
INGESTION; RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER
CNS
DEPRESSANTS; ULTRA-RAPID METABOLISM OF CODEINE AND OTHER RISK FACTORS
FOR
LIFE-THREATENING RESPIRATORY DEPRESSION IN CHILDREN; NEONATAL OPIOID
WITHDRAWAL SYNDROME; INTERACTIONS WITH DRUGS AFFECTING CYTOCHROME P450
ISOENZYMES; AND HEPATOTOXICITY
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE CAPSULES
EXPOSE USERS
TO THE RISKS OF ADDICTION, ABUSE, AND MISUSE, WHICH CAN LEAD TO
OVERDOSE AND DEATH.
ASSESS PATIENT'S RISK BEFORE PRESCRIBING AND MONITOR REGULARLY FOR
THESE BEHAVIORS
AND CONDITIONS. (5.1)
TO ENSURE THAT THE BENEFITS OF OPIOID ANALGESICS OUTWEIGH THE RISKS OF
ADDICTION,
ABUSE, AND MISUSE, THE FOOD AND DRUG ADMINISTRATION (FDA) HAS REQUIRED
A RISK
EVALUATION AND MITIGATION STRATEGY (REMS) FOR THESE PRODUCTS. (5.2)
SERIOUS, LIFE-THREATENING, OR FATAL RESPIRATORY DEPRESSION MAY OCCUR.
MONITOR CLOSELY,
ESPECIALLY UPON INITIATION OR FOLLOWING A DOSE INCREASE. (5.3)
ACCIDENTAL INGESTION OF BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND
CODEINE PHOSPHATE
CAPSULES, ESPECIALLY BY CHILDREN, CAN RESULT IN FATAL OVERDOSE. KEEP
OUT OF REACH OF
CHILDREN. (5.3)
CONCOMITANT USE OF OPIOIDS OR A BARBITURATE WITH BENZODIAZEPINES OR
OTHER CENTRAL
NERVOUS SYSTEM (CNS) DEPRESSANTS, INCLUDI