TREZIX- acetaminophen, caffeine, dihydrocodeine bitartrate capsule

Страна: Соединенные Штаты

Язык: английский

Источник: NLM (National Library of Medicine)

Активный ингредиент:

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

Доступна с:

Bryant Ranch Prepack

ИНН (Международная Имя):

ACETAMINOPHEN

состав:

ACETAMINOPHEN 320.5 mg

Администрация маршрут:

ORAL

Тип рецепта:

PRESCRIPTION DRUG

Терапевтические показания :

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

Обзор продуктов:

NDC: 63629-5637-1: 30 Capsules in a BOTTLE NDC: 63629-5637-2: 60 Capsules in a BOTTLE NDC: 63629-5637-3: 90 Capsules in a BOTTLE NDC: 63629-5637-4: 120 Capsules in a BOTTLE

Статус Авторизация:

Abbreviated New Drug Application

тонкая брошюра

TREZIX- acetaminophen, caffeine, dihydrocodeine bitartrate capsule
Bryant Ranch Prepack
----------
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 pro

Характеристики продукта

TREZIX- ACETAMINOPHEN, CAFFEINE, DIHYDROCODEINE BITARTRATE CAPSULE
BRYANT RANCH PREPACK
----------
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 FACTO