BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE capsule

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Aktív összetevők:

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)

Beszerezhető a:

Nexgen Pharma, Inc.

INN (nemzetközi neve):

BUTALBITAL

Összetétel:

BUTALBITAL 50 mg

Az alkalmazás módja:

ORAL

Recept típusa:

PRESCRIPTION DRUG

Terápiás javallatok:

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

Termék összefoglaló:

Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules 50 mg/300 mg/ 40 mg/30 mg with a dark green opaque body and a black opaque cap. Cap is imprinted with “AP” and “661” in white. Bottles of 100 (NDC 0722-7028-01) Bottles of 500 (NDC 0722-7028-05) Store at 20° to 25C (68° to 77F). [See USP Controlled Room Temperature.]; and dispense in a tight container. Store Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules securely and dispose of properly [see Patient Counseling Information (17)] .

Engedélyezési státusz:

Abbreviated New Drug Application

Betegtájékoztató

ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE CAPSULE
Nexgen Pharma, Inc.
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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 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.
•
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
others, including visitors to the
home.
•
Get emergency help right away if you take more than 4,000 mg of
acetaminophen i

Termékjellemzők

BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE-
BUTALBITAL,
ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE CAPSULE
NEXGEN PHARMA, INC.
----------
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._
•
•
•
•
•
•
•
•
•
RECENT MAJOR CHANGES
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, INCLUDING ALCOHOL