TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN- tramadol hydrochloride and acetaminophen tablet

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

TRAMADOL HYDROCHLORIDE (UNII: 9N7R477WCK) (TRAMADOL - UNII:39J1LGJ30J)

Dostupné s:

Unit Dose Services

INN (Mezinárodní Name):

TRAMADOL HYDROCHLORIDE

Složení:

TRAMADOL HYDROCHLORIDE 37.5 mg

Podání:

ORAL

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

Tramadol HCl and acetaminophen 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 Tramadol HCl and acetaminophen 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 tramadol HCl and acetaminophen tablets 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. Tramadol HCl and acetaminophen tablets are contraindicated in patients with: - Significant respiratory depression [see Warnings and Precautions (5.2)] . - Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see Warnings and Precautions (5.11)] . - Pa

Přehled produktů:

Product: 50436-6291 NDC: 50436-6291-1 30 TABLET in a BOTTLE NDC: 50436-6291-4 10 TABLET in a BOTTLE

Stav Autorizace:

Abbreviated New Drug Application

Informace pro uživatele

ACETAMINOPHEN TABLET
Unit Dose Services
----------
MEDICATION GUIDE
Tramadol (TRAM-a-
dol) Hydrochloride and
Acetaminophen (a-
SEET-a-MIN-oh-fen)
Tablets, CIV
Tramadol HCl and
acetaminophen tablets
are:
•
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 tramadol HCl and
acetaminophen tablets:
•
Get emergency
help right away
if you take too
much tramadol
HCl and
acetaminophen
tablets
(overdose).
When you first
start taking
tramadol HCl
and
acetaminophen
tablets, 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.
•
Tramadol HCl
and
acetaminophen
tablets 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
tramadol HCl
and
acetaminophen
tablets. They
could die from
taking it. Store
tramadol HCl
and
acetaminophen
tablets away
from children
and in a safe
place to prevent
stealing or
abuse. Selling or
giving away
tramadol HCl
and
acetaminophen
tablets is against
the law.
•
Get emergency
help right away
if you take more
than 4,000 mg of
acetaminophen
in 1 day. Taking
tramadol HCl
and
acetaminophen
tablets with other
products that
contain
acetaminophen
can lead to
serious liver
problems and
death.
Do not take tramadol
HCl and acetaminophen
tablets if you have:
•
Severe asthma,
trouble
breathing, or
other lung
problems.
•
A bowel
blockage or have
narrowing of the
stomach or
intestines.
•
An allergy to
any of its
ingredi

Charakteristika produktu

TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN- TRAMADOL HYDROCHLORIDE AND
ACETAMINOPHEN TABLET
UNIT DOSE SERVICES
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
TRAMADOL HYDROCHLORIDE AND
ACETAMINOPHEN TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR TRAMADOL
HYDROCHLORIDE AND ACETAMINOPHEN TABLETS.
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLETS, FOR ORAL USE, C-IV INITIAL U.S. APPROVAL: 2001
WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY
DEPRESSION;
ACCIDENTAL INGESTION; 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._
TRAMADOL HYDROCHLORIDE (HCL) AND ACETAMINOPHEN 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 TRAMADOL
HCL AND ACETAMINOPHEN, AND MONITOR REGULARLY FOR THESE BEHAVIORS OR
CONDITIONS. (5.1)
SERIOUS, LIFE-THREATENING, OR FATAL RESPIRATORY DEPRESSION MAY OCCUR.
MONITOR CLOSELY, ESPECIALLY DURING
INITIATION OR FOLLOWING A DOSE INCREASE. (5.2)
ACCIDENTAL INGESTION OF TRAMADOL HCL AND ACETAMINOPHEN, ESPECIALLY BY
CHILDREN, CAN RESULT IN A FATAL
OVERDOSE OF TRAMADOL. (5.2)
PROLONGED USE OF TRAMADOL HCL AND ACETAMINOPHEN, DURING PREGNANCY CAN
RESULT IN NEONATAL OPIOID
WITHDRAWAL SYNDROME, WHICH MAY BE LIFE THREATENING IF NOT RECOGNIZED
AND TREATED. IF PROLONGED
OPIOID USE IS REQUIRED IN A PREGNANT WOMAN, ADVISE THE PATIENT OF THE
RISK OF NEONATAL OPIOID
WITHDRAWAL SYNDROME AND ENSURE THAT APPROPRIATE TREATMENT WILL BE
AVAILABLE. (5.3)
THE EFFECTS OF CONCOMITANT USE OR DISCONTINUATION OF CYTOCHROME P450
3A4 INDUCERS, 3A4 INHIBITORS,
OR 2D6 INHIBITORS WITH TRAMADOL ARE COMPLEX. USE OF CYTOCHROME P450
3A4 INDUCERS, 3A4 INHIBITORS, OR
2D6 INHIBITORS WITH TRAMADOL HCL AND ACETAMINOPHEN REQUIRES CAREFUL
CON