BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE capsule

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

BUTALBITAL (UNII: KHS0AZ4JVK) (BUTALBITAL - UNII:KHS0AZ4JVK), ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E), CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E), CODEINE PHOSPHATE (UNII: GSL05Y1MN6) (CODEINE ANHYDROUS - UNII:UX6OWY2V7J)

可用日期:

Bryant Ranch Prepack

INN（国际名称）:

BUTALBITAL

组成:

BUTALBITAL 50 mg

给药途径:

ORAL

处方类型:

PRESCRIPTION DRUG

疗效迹象:

ASCOMP with Codeine is 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 ASCOMP with Codeine 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. ASCOMP with Codeine is contraindicated for: - All children younger than 12 years of age [see Warnings and Precautions (5.5)] - Postoperative management in children younger than 18 years of age following tonsillectomy and/or adenoidectomy [see Warnings and Precautions (5.5)] . ASCOMP with Codeine is also contraindicated in patients with: - Significant respiratory depression [se

產品總結:

ASCOMP with Codeine (Butalbital, Aspirin, Caffeine, and Codeine Phosphate Capsules, USP ) have a plain blue opaque cap with a yellow opaque body imprinted with "B 074" in black ink. NDC: 63629-2952-1: 30 Capsules in a BOTTLE NDC: 63629-2952-2: 20 Capsules in a BOTTLE NDC: 63629-2952-3: 90 Capsules in a BOTTLE NDC: 63629-2952-4: 60 Capsules in a BOTTLE NDC: 63629-2952-5: 40 Capsules in a BOTTLE NDC: 63629-2952-6: 18 Capsules in a BOTTLE Store below 25°C (77°F) in a tight, light-resistant container. Protect from moisture. Store ASCOMP with Codeine securely and dispose of properly [see PATIENT COUNSELING INFORMATION (17)]. Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504

授权状态:

Abbreviated New Drug Application

资料单张

BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE- BUTALBITAL,
ASPIRIN,
CAFFEINE AND CODEINE PHOSPHATE CAPSULE
Bryant Ranch Prepack
----------
MEDICATION GUIDE
MEDICATION GUIDE
ASCOMP WITH CODEINE (AZ-KOMP)
(BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE, USP) CAPSULES,
CIII
ASCOMP with Codeine is:
•
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 ASCOMP with Codeine:
•
Get emergency help right away if you take too much ASCOMP with Codeine
(overdose). When
you first start taking ASCOMP with Codeine, 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.
•
Taking ASCOMP with Codeine 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 ASCOMP with Codeine. They could die from
taking it. Selling or
giving away ASCOMP with Codeine is against the law.
•
Store ASCOMP with Codeine securely, out of sight and reach of
children, and in a location not
accessible by others, including visitors to the home.
Important Information Guiding Use in Pediatric Patients:
•
Do not give ASCOMP with Codeine to a child younger than 12 years of
age.
•
Do not give ASCOMP with Codeine to a child younger than 18 years of
age after surgery to
remove the tonsils and/or adenoids.
•
Avoid giving ASCOMP with Codeine to children between 12 to 18 years of
age who have risk
facto

产品特点

BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE- BUTALBITAL,
ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE
BRYANT RANCH PREPACK
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ASCOMP WITH CODEINE
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ASCOMP
WITH CODEINE.
ASCOMP WITH CODEINE (BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE
PHOSPHATE, USP) CAPSULES,
FOR ORAL USE, CIII
INITIAL U.S. APPROVAL: 1990
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; AND INTERACTION WITH DRUGS AFFECTING CYTOCHROME
P450 ISOENZYMES
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
ASCOMP WITH CODEINE EXPOSES 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 ASCOMP WITH CODEINE, ESPECIALLY BY CHILDREN,
CAN RESULT IN
FATAL OVERDOSE. (5.3)
CONCOMITANT USE OF OPIOIDS OR A BARBITURATE WITH BENZODIAZEPINES OR
OTHER CENTRAL
NERVOUS SYSTEM (CNS) DEPRESSANTS, INCLUDING ALCOHOL, MAY RESULT IN
PROFOUND
SEDATION, RESPIRATORY DEPRESSION, COMA, AND DEATH. RESERVE CONCOMITANT
PRESCRIBING FOR USE IN PATIENTS FOR WHOM ALTERNATIVE TREATMENT OPTIONS
ARE
INADEQUATE; LIMIT DOSAGES AND DURATIONS TO THE M