TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN tablet, film coated

Negara: Amerika Serikat

Bahasa: Inggris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Tersedia dari:

Zydus Pharmaceuticals USA Inc.

INN (Nama Internasional):

ACETAMINOPHEN

Komposisi:

ACETAMINOPHEN 325 mg

Rute administrasi :

ORAL

Jenis Resep:

PRESCRIPTION DRUG

Indikasi Terapi:

Tramadol hydrochloride 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 hydrochloride 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, which can occur at any dosage or duration [see Warnings and Precautions (5.1)] , reserve tramadol hydrochloride 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 hydrochloride and acetaminophen tablets should not be used for an extended period of time. Tramadol hydrochloride and acetaminophen tablets are contraindicated for: - all children younger than 12 years of age [see Warnings and Precautions

Ringkasan produk:

Tramadol Hydrochloride and Acetaminophen Tablets USP, 37.5 mg/325 mg are white, capsule-shaped, beveled-edge, biconvex, film-coated tablets, debossed "334" on one side and plain on other side and are supplied as follows: NDC 68382-334-01 in bottle of 100 tablets NDC 68382-334-05 in bottle of 500 tablets NDC 68382-334-10 in bottle of 1000 tablets Storage Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight container. Store tramadol hydrochloride and acetaminophen tablets securely and dispose of properly [see Patient Counseling Information (17)] .

Status otorisasi:

Abbreviated New Drug Application

Selebaran informasi

TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN- TRAMADOL HYDROCHLORIDE AND
ACETAMINOPHEN TABLET, FILM COATED
Zydus Pharmaceuticals USA Inc.
----------
SPL MEDGUIDE
MEDICATION GUIDE
Tramadol Hydrochloride
(tram′ a dol hye″ droe klor′ ide) and
Acetaminophen (a seet″ a min′ oh fen) Tablets, USP C-IV
Tramadol Hydrochloride 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 Hydrochloride and Acetaminophen
Tablets:
•
Get emergency help or call 911 right away if you take too much
tramadol hydrochloride
and acetaminophen tablets (overdose) . When you first start taking
tramadol hydrochloride
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. Talk to
your healthcare provider about naloxone, a medicine for the emergency
treatment of an
opioid overdose.
•
Tramadol hydrochloride 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 hydrochloride and acetaminophen
tablets. They
could die from taking it. Selling or giving away tramadol
hydrochloride and acetaminophen
tablets is against the law.
•
Store tramadol hydrochloride and acetaminophen tablets 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 4,0

Karakteristik produk

TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN- TRAMADOL HYDROCHLORIDE
AND ACETAMINOPHEN TABLET, FILM COATED
ZYDUS PHARMACEUTICALS USA INC.
----------
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: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF TRAMADOL AND
ACETAMINOPHEN TABLETS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET 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 HYDROCHLORIDE AND
ACETAMINOPHEN
TABLETS, 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 HYDROCHLORIDE AND ACETAMINOPHEN
TABLETS,
ESPECIALLY BY CHILDREN, CAN RESULT IN A FATAL OVERDOSE OF TRAMADOL.
(5.2)
CONCOMITANT USE OF OPIOIDS 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)
PROLONGED USE OF TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLETS,
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 A