BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE capsule

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

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)

제공처:

LGM Pharma Solutions, LLC

관리 경로:

ORAL

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

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]: Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules are contraindicated for: Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules are also contraindicated in patients with: Risk Summary Prolonged use of opioid analgesics during pregnancy may cause neonatal opioid withdrawal syndrome [see Warnings and Precautions (5.6)] . Available data with Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsu

제품 요약:

Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules are dark blue, opaque cap with a gray, opaque body, and body is imprinted with “B 073” in black ink. Bottles of 100 (NDC 79739-6670-1 ) Store at 20° to 25°C (68° to 77°F); 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.

승인 상태:

Abbreviated New Drug Application

환자 정보 전단

acetaminophen, caffeine, and codeine phosphate capsule
LGM Pharma Solutions, LLC
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Medication Guide
Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules,
CIII
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 right away or call 911if 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 accessibl

제품 특성 요약

BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE-
BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE CAPSULE
LGM PHARMA SOLUTIONS, LLC
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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 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._
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RECENT MAJOR CHANGES
Dosage and Administration
(2.2)
03/2021
Warnings and Precautions
(5.1, 5.3, 5.4)
03/2021
INDICATIONS AND USAGE
Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsule is
a combination product of
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 B