ULTRACET- tramadol hydrochloride and acetaminophen tablet, coated

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

TRAMADOL HYDROCHLORIDE (UNII: 9N7R477WCK) (TRAMADOL - UNII:39J1LGJ30J), ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)

Dostopno od:

Janssen Pharmaceuticals, Inc.

INN (mednarodno ime):

tramadol hydrochloride

Sestava:

tramadol hydrochloride 37.5 mg

Pot uporabe:

ORAL

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

ULTRACET tablets are indicated for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use ULTRACET tablets are indicated for short-term use of five days or less. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.1)] , reserve ULTRACET 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. ULTRACET is contraindicated for: - all children younger than 12 years of age [see Warnings and Precautions (5.4)] - post-operative management in children younger than 18 years of age fol

Povzetek izdelek:

ULTRACET ® (tramadol hydrochloride/acetaminophen) tablets containing 37.5 mg tramadol hydrochloride and 325 mg acetaminophen are light yellow, coated, capsule-shaped tablets debossed with "O-M" on one side and "650" on the other and are available as follows: Dispense in a tight container. Store at 20–25°C (68–77°F); excursions permitted to 15–30°C (59–86°F). [see USP Controlled Room Temperature]. Store ULTRACET securely and dispose of properly [see Patient Counseling Information (17)].

Status dovoljenje:

New Drug Application

Navodilo za uporabo

Janssen Pharmaceuticals, Inc.
----------
This Medication Guide has been approved by the
U.S. Food and Drug Administration.
Revised: 02/2023
MEDICATION GUIDE
ULTRACET ® [UHL-truh-set]
(tramadol hydrochloride/acetaminophen)
Tablets, C- IV
ULTRACET is:
•
A strong prescription pain medicine that contains an opioid (narcotic)
that is used for the short-
term (five days or less) management of acute pain, 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 ULTRACET:
•
Get emergency help or call 911 right away if you take too much
ULTRACET (overdose). When
you first start taking ULTRACET, 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. Talk
to your healthcare provider about naloxone, a medicine for the
emergency treatment of an opioid
overdose.
•
ULTRACET can cause severe drowsiness, breathing problems (respiratory
depression), coma and
death when taken with benzodiazepines or other medicines that depress
consciousness.
•
Never give anyone else your ULTRACET. They could die from taking it.
Selling or giving away
ULTRACET is against the law.
•
Store ULTRACET securely, out of sight and reach of children, and in a
location not accessible by
others, including visitors to the home.
•
Get emergency help right away if you take more than 4,000 mg of
acetaminophen in 1 day.
Taking ULTRACET with other products that contain acetaminophen can
lead to serious liver
problems and death.
Important Information Guiding Use in Pediatric Patients:
•
Do not give ULTRACET to a child younger than 12 years of age.
•
Do not give ULTRACET to a child younger than 18 years of age after
surgery to remove the
tonsils and/or adenoids.
�

Lastnosti izdelka

ULTRACET- TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET, COATED
JANSSEN PHARMACEUTICALS, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ULTRACET SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ULTRACET.
ULTRACET (TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN) TABLETS, FOR ORAL USE,
C-IV
INITIAL U.S. APPROVAL – 2001
®
WARNING: ADDICTION, ABUSE, AND MISUSE; RISK EVALUATION AND MITIGATION
STRATEGY (REMS); LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL
INGESTION; ULTRA-RAPID METABOLISM OF TRAMADOL AND OTHER RISK FACTORS
FOR
LIFE-THREATENING RESPIRATORY DEPRESSION IN CHILDREN; NEONATAL OPIOID
WITHDRAWAL SYNDROME; INTERACTIONS WITH DRUGS AFFECTING CYTOCHROME P450
ISOENZYMES; HEPATOTOXICITY; AND RISKS FROM CONCOMITANT USE WITH
BENZODIAZEPINES OR OTHER CNS DEPRESSANTS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
ULTRACET EXPOSES USERS TO THE RISKS OF ADDICTION, ABUSE AND MISUSE,
WHICH CAN
LEAD TO OVERDOSE AND DEATH. ASSESS EACH PATIENT'S RISK PRIOR TO
PRESCRIBING
ULTRACET, AND MONITOR REGULARLY FOR THESE BEHAVIORS OR 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 DURING INITIATION OR FOLLOWING A DOSE INCREASE. ( 5.3)
ACCIDENTAL INGESTION OF ULTRACET, ESPECIALLY BY CHILDREN, CAN RESULT
IN A FATAL
OVERDOSE OF TRAMADOL. ( 5.3)
LIFE-THREATENING RESPIRATORY DEPRESSION AND DEATH HAVE OCCURRED IN
CHILDREN WHO
RECEIVED TRAMADOL. SOME OF THE REPORTED CASES FOLLOWED TONSILLECTOMY
AND/OR
ADENOIDECTOMY; IN AT LEAST ONE CASE, THE CHILD HAD EVIDENCE OF BEING
AN ULTRA-RAPID
METABOLIZER OF TRAMADOL DUE TO A CYP2D6 POLYMORPHISM ( 5.4). ULTRACET
IS
CONTRAINDICATED IN CHILDREN YOUNGER THAN 12 YEARS OF AGE AND IN
CHILDREN YOUNGER
THAN 18 YE