BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE capsule

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

Bryant Ranch Prepack

INN (Nome Internazionale):

BUTALBITAL

Composizione:

BUTALBITAL 50 mg

Via di somministrazione:

ORAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

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 adeno

Dettagli prodotto:

NDC: 63629-3152-1: 20 Capsules in a BOTTLE NDC: 63629-3152-2: 90 Capsules in a BOTTLE NDC: 63629-3152-3: 30 Capsules in a BOTTLE NDC: 63629-3152-4: 60 Capsules in a BOTTLE NDC: 63629-3152-5: 100 Capsules in a BOTTLE NDC: 63629-3152-6: 15 Capsules in a BOTTLE NDC: 63629-3152-7: 18 Capsules in a BOTTLE

Stato dell'autorizzazione:

New Drug Application Authorized Generic

Foglio illustrativo

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

Scheda tecnica

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, INCLU