TRAMADOL HYDROCHLORIDE tablet, coated

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

Unit Dose Services

INN (Διεθνής Όνομα):

TRAMADOL HYDROCHLORIDE

Σύνθεση:

TRAMADOL HYDROCHLORIDE 50 mg

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

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 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 following tonsillectomy and/or adenoidectomy [see Warnings and Precautions (5.4)] . Tramadol hydrochloride is also contraindicated in patients with: Tramadol hydrochloride is also contraindicated in patients wit

Περίληψη προϊόντος:

Product: 50436-8787 NDC: 50436-8787-2 90 TABLET, COATED in a BOTTLE NDC: 50436-8787-3 60 TABLET, COATED in a BOTTLE NDC: 50436-8787-5 120 TABLET, COATED in a BOTTLE NDC: 50436-8787-1 30 TABLET, COATED in a BOTTLE NDC: 50436-8787-6 180 TABLET, COATED in a BOTTLE NDC: 50436-8787-8 240 TABLET, COATED in a BOTTLE

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Φύλλο οδηγιών χρήσης

TRAMADOL HYDROCHLORIDE- TRAMADOL HYDROCHLORIDE TABLET, COATED
Unit Dose Services
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MEDICATION GUIDE
Tramadol Hydrochloride (tram’ a dol hye” droe klor’ ide)
Tablets, USP CIV
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 many tramadol
hydrochloride tablets (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. Store
tramadol hydrochloride tablets away from children and in a safe place
to prevent stealing or abuse.
Selling or giving away tramadol hydrochloride tablets is against the
law.
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 problems such as obstructive sleep apnea,
obesity, or underlying l

Αρχείο Π.Χ.Π.

TRAMADOL HYDROCHLORIDE- TRAMADOL HYDROCHLORIDE TABLET, COATED
UNIT DOSE SERVICES
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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; HEPATOTOXICITY; 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