BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE capsule

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

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)

זמין מ:

Mayne Pharma Inc.

INN (שם בינלאומי):

Butalbital

הרכב:

Butalbital 50 mg

מסלול נתינה (של תרופות):

ORAL

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

Butalbital, aspirin, 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, aspirin, 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, aspirin, caffeine, and codeine phosphate capsules are 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

leaflet_short:

Butalbital, aspirin, caffeine, and codeine phosphate capsules Each capsule has a yellow body and a purple cap. The yellow body is imprinted with "312" in black. NDC 68308-312-10 Bottles of 100 capsules Store and Dispense Store at 20°C to 25°C (68°F to 77°F). [See USP Controlled Room Temperature] Protect from moisture. Store butalbital, aspirin, caffeine, and codeine phosphate capsules securely and dispose of properly [see Patient Counseling Information (17)] . Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

מצב אישור:

Abbreviated New Drug Application

עלון מידע

CODEINE PHOSPHATE CAPSULE
Mayne Pharma Inc.
----------
MEDICATION GUIDE
BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE CAPSULES, CIII
(BUE-TAL-BE-TAL, AS-PRIN, KAF-EEN, KOE-DEEN FOS-FATE) CAPSULES, CIII
This Medication Guide has been approved by the
U.S. Food and Drug Administration.
Issued: 11/2019
Butalbital, aspirin, 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, aspirin, caffeine, and codeine
phosphate capsules:
•
Get emergency help right away if you take too much butalbital,
aspirin, caffeine, and codeine
phosphate capsules (overdose). When you first start taking butalbital,
aspirin, 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, aspirin, 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, aspirin, caffeine, and codeine
phosphate capsules. They
could die from taking it. Selling or giving away butalbital, aspirin,
caffeine, and codeine
phosphate capsules is against the law.
•
Store butalbital, aspirin, 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.
I

מאפייני מוצר

BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE- BUTALBITAL,
ASPIRIN,
CAFFEINE, AND CODEINE PHOSPHATE CAPSULE
MAYNE PHARMA INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE
PHOSPHATE CAPSULES SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR BUTALBITAL, ASPIRIN, CAFFEINE, AND
CODEINE PHOSPHATE CAPSULES.
BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE 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
INTERACTIONS
WITH DRUGS AFFECTING CYTOCHROME P450 ISOENZYMES
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
BUTALBITAL, ASPIRIN, 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, ASPIRIN, CAFFEINE, AND CODEINE
PHOSPHATE CAPSULES, 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. RESE