FIORINAL WITH CODEINE- butalbital, aspirin, caffeine, and codeine phosphate capsule

Nchi: Marekani

Lugha: Kiingereza

Chanzo: NLM (National Library of Medicine)

Viambatanisho vya kazi:

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)

Inapatikana kutoka:

Actavis Pharma, Inc.

INN (Jina la Kimataifa):

CODEINE PHOSPHATE

Tungo:

CODEINE PHOSPHATE 30 mg

Njia ya uendeshaji:

ORAL

Dawa ya aina:

PRESCRIPTION DRUG

Matibabu dalili:

FIORINAL 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 FIORINAL 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 FIORINAL with CODEINE is contraindicated for : • All children younger than 12 years of age [see Warnings and Precautions (5.4)] • Postoperative management in children younger than 18 years of age following tonsillectomy and/or adenoidectomy [see Warnings and Precautions (5.4)] . FIORINAL with CODEINE is also contraindicated in patients with: • Significant r

Bidhaa muhtasari:

FIORINAL with CODEINE (Butalbital, Aspirin, Caffeine, and Codeine Phosphate Capsules, USP) Blue cap with a yellow body. Cap is imprinted twice with “FIORINAL” and “CODEINE” in red. Body is imprinted twice with “WATSON 956” in red. High density polyethylene bottles of 100 capsules are supplied with child-resistant closures. (NDC 52544-956-01) Store and Dispense Below 25°C (77°F);  tight container. Protect from moisture. Rx only

Idhini hali ya:

New Drug Application

Taarifa za kipeperushi

FIORINAL WITH CODEINE- BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE
PHOSPHATE CAPSULE
Actavis Pharma, Inc.
----------
Medication Guide
FIORINAL with CODEINE (FYORE-in-ALL)
(Butalbital, Aspirin, Caffeine, and Codeine Phosphate) capsules, CIII
FIORINAL 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 FIORINAL with CODEINE:
•
Get emergency help right away if you take too much FIORINAL with
CODEINE (overdose).
When you first start taking FIORINAL 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 FIORINAL 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 FIORINAL with CODEINE. They could die from
taking it. Store
FIORINAL with CODEINE away from children and in a safe place to
prevent stealing or abuse.
Selling or giving away FIORINAL with CODEINE is against the law.
Important Information Guiding Use in Pediatric Patients:
•
Do not give FIORINAL with CODEINE to a child younger than 12 years of
age.
•
Do not give FIORINAL with CODEINE to a child younger than 18 years of
age after surgery
to remove the tonsils and/or adenoids.
•
Avoid giving FIORINAL with CODEINE to children between 12 to 18 years
of age who have
risk factors for breathing problems such as obstructive sleep apnea,
obesity, or underlyi

Tabia za bidhaa

FIORINAL WITH CODEINE- 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
FIORINAL WITH CODEINE SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR FIORINAL WITH
CODEINE.
FIORINAL
WITH CODEINE (BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE,
USP) CAPSULES, FOR ORAL USE,
CIII
INITIAL U.S. APPROVAL: 1990
WARNING: ADDICTION, ABUSE, AND MISUSE; 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._
FIORINAL 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)
SERIOUS, LIFE-THREATENING, OR FATAL RESPIRATORY DEPRESSION MAY OCCUR.
MONITOR CLOSELY, ESPECIALLY UPON
INITIATION OR FOLLOWING A DOSE INCREASE. (5.2)
ACCIDENTAL INGESTION OF FIORINAL WITH CODEINE, ESPECIALLY BY CHILDREN,
CAN RESULT IN FATAL OVERDOSE.
(5.2)
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 MINIMUM
REQUIRED; AND FOLLOW PATIENTS FOR
SIGNS AND SYMPTOMS OF RESPIRATORY DEPRESSION AND SEDATION. (5.3, 7)
LIFE-THREATENING RESPIRATORY DEPRESSION AND DEATH HAVE OCCURRED IN
CHILDREN WHO RECEIVED CODEINE;
MOST CASES FOLLOWED TONSILLECTOMY AND/OR ADENOIDECTOMY, AND MANY OF
THE CHILDREN HAD