TREZIX- acetaminophen, caffeine, dihydrocodeine bitartrate capsule

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D), CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E), DIHYDROCODEINE BITARTRATE (UNII: 8LXS95BSA9) (DIHYDROCODEINE - UNII:N9I9HDB855)

Verfügbar ab:

Wraser Llc

INN (Internationale Bezeichnung):

ACETAMINOPHEN

Zusammensetzung:

ACETAMINOPHEN 320.5 mg

Verabreichungsweg:

ORAL

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

TREZIX™ (acetaminophen, caffeine, and dihydrocodeine bitartrate) capsules are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use Because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses [see WARNINGS], reserve TREZIX™ for use in patients for whom alternative treatment options [e.g., non-opioid 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 TREZIX™ is contraindicated for: - All children younger than 12 years of age [see WARNINGS and PRECAUTIONS] - Post-operative management in children younger than 18 years of age following tonsillectomy and/or adenoidectomy [see WARNINGS and PRECAUTIONS]. - TREZIX​TM ​ is also contraindicated in patients with: - Significant respiratory depression [see WARNINGS] - Acute or severe bronchial asthma in an unmonitored setting

Produktbesonderheiten:

TREZIX™ capsules, containing acetaminophen 320.5 mg, caffeine 30 mg and dihydrocodeine bitartrate 16 mg, are supplied in bottles of 100 capsules (NDC #66992-840-10). Capsules are imprinted “TREZIX” on the red cap in white ink. Store at 20°C to 25°C (68°F to 77°F). [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container with a child-resistant closure. Protect from moisture. Rx Only Manufactured for: WraSer Pharmaceuticals LLC Ridgeland, MS 39157 13001 Rev. 4/2017 Physician’s Desk Reference® is the registered trademark of Thomson Healthcare, Inc.

Berechtigungsstatus:

Abbreviated New Drug Application

Gebrauchsinformation

TREZIX- ACETAMINOPHEN, CAFFEINE, DIHYDROCODEINE BITARTRATE CAPSULE
Wraser Llc
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Medication Guide
Trezix (Tre~zix)
Capsules, CIII
Trezix is:
•
A strong prescription pain medicine that contains an opioid (narcotic)
that is used to manage
moderate to moderately severe pain, when otherpain 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 Trezix:
•
Get emergency help right away if you take too much Trezix (overdose).
When you first start
taking Trezix, 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 Trezix with other opioid medicines, benzodiazepines, alcohol,
or other central nervous
system depressants (including street drugs) can cause severe
drowsiness, decrease awareness,
breathing problems, coma and death.
•
Never give anyone else your Trezix. They could die from taking it.
Store Trezix away from
children and in a safe place to prevent stealing or abuse. Selling or
giving away Trezix is against
the law.
Important Information Guiding Use in Pediatric Patients:
•
Do not give Trezix to a child younger than 12 years of age.
•
Do not give Trezix to a child younger than 18 years of age after
surgery to remove the tonsils and/
or adenoids.
•
Avoid giving Trezix to children between 12 to 18 years of age who have
risk factors for breathing
problems such as obstructive sleep apnea, obesity, or underlying lung
problems
Do not take Trezix if you have:
•
severe asthma, trouble breathing, or other lung problems.
•
a bowel blockage or have narrowing of the stomach or intestines.
•
previously had an allergic reaction to dihydrocodeine or
acetaminophen.
Before taking Trezix, tell your healthcare provider if

Fachinformation

TREZIX- ACETAMINOPHEN, CAFFEINE, DIHYDROCODEINE BITARTRATE CAPSULE
WRASER LLC
----------
TREZIX™ CAPSULES
ACETAMINOPHEN, CAFFEINE AND DIHYDROCODEINE BITARTRATE
320.5 MG / 30 MG / 16 MG
RX ONLY CIII
WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING
RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; 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 ISOENYME; HEPTATOTOXICITY; AND RISKS FROM
CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS
ADDICTION, ABUSE AND MISUSE
TREZIX™ EXPOSE PATIENTS AND OTHER USERS TO THE RISKS OF OPIOID
ADDICTION, ABUSE AND
MISUSE, WHICH CAN LEAD TO OVERDOSE AND DEATH. ASSESS EACH PATIENT’S
RISK PRIOR TO
PRESCRIBING TREZIX™, AND MONITOR ALL PATIENTS REGULARLY FOR THE
DEVELOPMENT OF THESE
BEHAVIORS AND CONDITIONS [SEE WARNINGS].
LIFE-THREATENING RESPIRATORY DEPRESSION
SERIOUS, LIFE-THREATENING, OR FATAL RESPIRATORY DEPRESSION MAY OCCUR
WITH USE OF TREZIX™.
MONITOR FOR RESPIRATORY DEPRESSION, ESPECIALLY DURING INITIATION OF
TREZIX™ OR FOLLOWING A
DOSE INCREASE [SEE WARNINGS].
ACCIDENTAL INGESTION
ACCIDENTAL INGESTION OF TREZIX™, ESPECIALLY BY CHILDREN, CAN RESULT
IN A FATAL OVERDOSE OF
TREZIX™ [SEE WARNINGS].
ULTRA-RAPID METABOLISM OF CODEINE AND OTHER RISK FACTORS FOR
LIFE-THREATENING
RESPIRATORY DEPRESSION IN CHILDREN
LIFE-THREATENING RESPIRATORY DEPRESSION AND DEATH HAVE OCCURRED IN
CHILDREN WHO RECEIVED
CODEINE. MOST OF THE REPORTED CASES OCCURRED FOLLOWING TONSILLECTOMY
AND/OR
ADENOIDECTOMY, AND MANY OF THE CHILDREN HAD EVIDENCE OF BEING AN
ULTRA-RAPID METABOLIZER
OF CODEINE DUE TO CYP2D6 POLYMORPHISM [SEE WARNINGS AND PRECAUTIONS].
TREZIX IS CONTRAINDICATED IN CHILDREN YOUNGER THAN 12 YEARS OF AGE AND IN
CHILDREN
YOUNGER THAN 18 YEARS OF AGE FOLLOWING TONSILLECTOMY AND/OR
ADENOIDECTOMY [SEE
CONTRAINDICATIONS]. AVOID THE USE OF TREZIX™ IN ADOLESCENTS 12 TO 18
YEARS OF AGE
WHO HAVE OTHER RISK FACTORS THAT MAY