BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE capsule

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

Actavis Pharma, Inc.

INN (Διεθνής Όνομα):

CODEINE PHOSPHATE

Σύνθεση:

CODEINE PHOSPHATE 30 mg

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

Butalbital, Aspirin, Caffeine, and Codeine Phosphate Capsules, USP  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, USP 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, USP 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 adeno

Περίληψη προϊόντος:

Blue cap with a yellow body. Cap is imprinted with “WATSON” in red. Body is imprinted with “3546” in red. High density polyethylene bottles of 100 capsules (NDC 0591-3546-01) and 500 capsules (NDC 0591-3546-05) are supplied with child-resistant closures.  Store and Dispense Store at 20 - 25°C (68 - 77°F); excursions permitted to 15 - 30°C (59 - 86°F) [see USP Controlled Room Temperature]. Protect from moisture and light. Store Butalbital, Aspirin, Caffeine, and Codeine Phosphate Capsules, USP securely and dispose of properly [see Patient Counseling Information ( 17 )] .

Καθεστώς αδειοδότησης:

New Drug Application Authorized Generic

Φύλλο οδηγιών χρήσης

TAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE- BUTALBITAL, ASPIRIN,
CAFFEINE AND CODEINE
PHOSPHATE CAPSULE
Actavis Pharma, Inc.
----------
Medication Guide
Butalbital, Aspirin, Caffeine, and Codeine Phosphate Capsules, USP
CIII
Butalbital, Aspirin, Caffeine, and Codeine Phosphate Capsules, USP
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, USP:
•
Get emergency help or call 911 right away if you take too many
Butalbital, Aspirin, Caffeine, and
Codeine Phosphate Capsules, USP (overdose). When you first start
taking Butalbital, Aspirin,
Caffeine, and Codeine Phosphate Capsules, USP, when your dose is
changed, or if you take too many
(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
for the emergency treatment
of an opioid overdose.
•
Taking Butalbital, Aspirin, Caffeine, and Codeine Phosphate Capsules,
USP 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, USP.
They could die from taking them. Selling or giving away Butalbital,
Aspirin, Caffeine, and Codeine
Phosphate Capsules, USP is against the law.
•
Store Butalbital, Aspirin, Caffeine, and Codeine Phosphate Capsules,
USP securely, out of sig

Αρχείο Π.Χ.Π.

BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE- BUTALBITAL,
ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE
ACTAVIS 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, USP
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 BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE
PHOSPHATE
CAPSULES, USP, 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