TRAMADOL HYDROCHLORIDE tablet, film coated

Riik: Ameerika Ühendriigid

keel: inglise

Allikas: NLM (National Library of Medicine)

Toimeaine:

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

Saadav alates:

Aurobindo Pharma Limited

INN (Rahvusvaheline Nimetus):

TRAMADOL HYDROCHLORIDE

Koostis:

TRAMADOL HYDROCHLORIDE 50 mg

Manustamisviis:

ORAL

Retsepti tüüp:

PRESCRIPTION DRUG

Näidustused:

Tramadol hydrochloride tablets are indicated in adults 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 and Precautions (5.1)] , reserve tramadol hydrochloride 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 tablets are contraindicated for: - all children younger than 12 years of age [see Warnings and Precautions (5.4)] . - postoperative management in children younger than 18 years of age following tonsillectomy and/or adenoidectomy [see Warnings and Precautions (5.4)] . Tramadol hydrochloride tablets are also contraindicated in patients with: - Significant respiratory depression [see Warn

Toote kokkuvõte:

Tramadol Hydrochloride Tablets USP, 50 mg are white to off-white, capsule shaped, coated tablet, debossed ‘T’ on one side and ‘03’ on the other side. Bottles of 100                    NDC 65862-667-01 Bottles of 500                    NDC 65862-667-05 Bottles of 1,000                 NDC 65862-667-99 Dispense in a tight container. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Store tramadol hydrochloride tablets securely and dispose of properly [see Patient Counseling Information (17)] .

Volitamisolek:

Abbreviated New Drug Application

Infovoldik

TRAMADOL HYDROCHLORIDE - TRAMADOL HYDROCHLORIDE TABLET, FILM COATED
Aurobindo Pharma Limited
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MEDICATION GUIDE
Tramadol Hydrochloride Tablets, USP CIV
(tram’ a dol hye’’ droe klor’ ide)
Tramadol hydrochloride tablets are:
•
A strong prescription pain medicine that contains an opioid (narcotic)
that is used for the
management pain in adults, 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 tablets:
•
Get emergency help right away if you take too much tramadol
hydrochloride (overdose). When
you first start taking tramadol hydrochloride 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.
•
Taking tramadol hydrochloride tablets with other opioid medicines,
benzodiazepines, alcohol, or
other central nervous system depressants (including street drugs) can
cause severe drowsiness,
decreased awareness, breathing problems, coma, and death.
•
Never give anyone else your tramadol hydrochloride tablets. They could
die from taking it. Selling
or giving away tramadol hydrochloride tablets is against the law.
•
Store tramadol hydrochloride tablets securely, out of sight and reach
of children, and in a location
not accessible by others, including visitors to the home.
Important Information Guiding Use in Pediatric Patients:
•
Do not give tramadol hydrochloride tablets to a child younger than 12
years of age.
•
Do not give tramadol hydrochloride tablets to a child younger than 18
years of age after surgery to
remove the tonsils and/or adenoids.
•
Avoid giving tramadol hydrochloride tablets to children between 12 to
18 years of age who have
risk factors for breathing pr

Toote omadused

TRAMADOL HYDROCHLORIDE - TRAMADOL HYDROCHLORIDE TABLET, FILM COATED
AUROBINDO PHARMA LIMITED
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
TRAMADOL HYDROCHLORIDE TABLETS
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR TRAMADOL
HYDROCHLORIDE TABLETS.
TRAMADOL HYDROCHLORIDE TABLETS, FOR ORAL USE, C-IV
INITIAL U.S. APPROVAL – 1995
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; AND
RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS
DEPRESSANTS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
TRAMADOL HYDROCHLORIDE 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
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 TRAMADOL HYDROCHLORIDE, 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 ).
TRAMADOL HYDROCHLORIDE IS CONTRAINDICATED IN CHILDREN YOUNGER THAN 12