TRAMADOL HYDROCHLORIDE - tramadol hydrochloride tablet, extended release TRAMADOL HYDROCHLORIDE - tramadol hydrochloride tabl

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Unit Dose Services

INN (International Name):

TRAMADOL HYDROCHLORIDE

Composition:

TRAMADOL HYDROCHLORIDE 200 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Tramadol hydrochloride extended-release tablets are indicated for the management of pain severe enough to require daily, around-the-clock, long term opioid treatment and for which alternative treatment options are inadequate. Limitations of Use - Because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations [see WARNINGS ], reserve tramadol hydrochloride extended-release tablets or use in patients for whom alternative treatment options [e.g., non-opioid analgesics or immediate-release opioids], are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. - Tramadol hydrochloride extended-release tablets are not indicated as an as-needed (prn) analgesic. Tramadol hydrochloride extended-release tablets are contraindicated for: - all children younger than 12 years of age [see WARNINGS ] - postoperative management in children younger than

Product summary:

Product: 50436-0824 NDC: 50436-0824-1 30 TABLET, EXTENDED RELEASE in a BOTTLE Product: 50436-8788 NDC: 50436-8788-1 30 TABLET, EXTENDED RELEASE in a BOTTLE

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Tramadol Hydrochloride Extended-Release Tablets, C-IV Rx
Only

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TRAMADOL HYDROCHLORIDE -
tramadol hydrochloride tablet, extended
release  TRAMADOL HYDROCHLORIDE
 - tramadol hydrochloride tablet, extended
release  Unit Dose Services
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Medication Guide
Tramadol Hydrochloride
(tram a dol hye droe klor ide)

Extended-Release Tablets, CIV
Tramadol hydrochloride extended-
release tablets are:

A strong prescription pain medicine that contains an
opioid (narcotic) that is used to manage pain severe enough to
require daily around-the-clock, long-term treatment with an
opioid, when other pain treatments such as non-opioid pain
medicines or immediate-release opioid medicines do not treat your
pain well enough or you cannot tolerate them.
A long-acting (extended-release) opioid pain medicine
that can put you at risk for overdose a

Read the complete document

Summary of Product characteristics

TRAMADOL HYDROCHLORIDE - TRAMADOL HYDROCHLORIDE TABLET, EXTENDED
RELEASE
TRAMADOL HYDROCHLORIDE - TRAMADOL HYDROCHLORIDE TABLET, EXTENDED
RELEASE
UNIT DOSE SERVICES
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TRAMADOL HYDROCHLORIDE EXTENDED-RELEASE TABLETS, C-IV
RX ONLY
WARNING: ADDICTION, ABUSE, AND MISUSE; 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
ADDICTION, ABUSE, AND MISUSE
TRAMADOL HYDROCHLORIDE EXTENDED-RELEASE TABLETS EXPOSE PATIENTS AND
OTHER USERS TO THE
RISKS OF OPIOID ADDICTION, ABUSE, AND MISUSE, WHICH CAN LEAD TO
OVERDOSE AND DEATH. ASSESS
EACH PATIENT’S RISK PRIOR TO PRESCRIBING TRAMADOL HYDROCHLORIDE
EXTENDED-RELEASE TABLETS,
AND MONITOR ALL PATIENTS REGULARLY FOR THE DEVELOPMENT OF THESE
BEHAVIORS AND CONDITIONS
[SEE WARNINGS].
LIFE-THREATENING RESPIRATORY DEPRESSION
SERIOUS, LIFE-THREATENING, OR FATAL RESPIRATORY DEPRESSION MAY OCCUR
WITH USE OF TRAMADOL
HYDROCHLORIDE EXTENDED-RELEASE TABLETS. MONITOR FOR RESPIRATORY
DEPRESSION, ESPECIALLY
DURING INITIATION OF TRAMADOL HYDROCHLORIDE EXTENDED-RELEASE TABLETS
OR FOLLOWING A DOSE
INCREASE [SEE WARNINGS].
ACCIDENTAL INGESTION
ACCIDENTAL INGESTION OF TRAMADOL HYDROCHLORIDE EXTENDED-RELEASE
TABLETS, ESPECIALLY BY
CHILDREN, CAN RESULT IN A FATAL OVERDOSE OF TRAMADOL HYDROCHLORIDE
EXTENDED-RELEASE TABLETS
[SEE WARNINGS].
ULTRA-RAPID METABOLISM OF TRAMADOL AND OTHER RISK FACTORS FOR
LIFE-THREATENING RESPIRATORY DEPRESSION IN CHILDREN
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 [SEE WARNINGS]. TRAMADOL HYDROCHLORIDE
EXTENDED-RELEASE
TA