TRAMADOL HYDROCHLORIDE- tramadol hydrochloride tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Preferred Pharmaceuticals Inc.

INN (International Name):

TRAMADOL HYDROCHLORIDE

Composition:

TRAMADOL HYDROCHLORIDE 50 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Tramadol Hydrochloride Tablets, USP are indicated for the management of pain in adults that is 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 ), reserve tramadol for use in patients for whom alternative treatment options [e.g., non-opioid analgesics]: Tramadol hydrochloride tablets are contraindicated for: Tramadol Hydrochloride Tablets are also contraindicated in patients with: Tramadol hydrochloride Tablets contain tramadol, a Schedule IV controlled substance. Tramadol contains tramadol, a substance with a high potential for abuse similar to other opioids. Tramadol can be abused and is subject to misuse, addiction, and criminal diversion (see WARNINGS ). All patients treated with opioids require careful monitoring for signs of abuse and addiction, because use of opioid analgesic products carries the risk of addiction even under appro

Product summary:

Tramadol Hydrochloride Tablets, USP 50 mg are white to off-white, round, film-coated tablets debossed with '319' on one side and plain on the other side and are supplied as follows: NDC 68788-6929-5 in bottle of 15 tablets NDC 68788-6929-2 in bottle of 20 tablets NDC 68788-6929-3in bottle of 30 tablets NDC 68788-6929-4 in bottle of 40 tablets NDC 68788-6929-7 in bottle of 50 tablets NDC 68788-6929-6 in bottle of 60 tablets NDC 68788-6929-9 in bottle of 90 tablets NDC 68788-6929-1 in bottle of 100 tablets NDC 68788-6929-8 in bottle of 12 tablets Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight container. *Tylenol is a registered trademark of McNeil Cons. $Tylox is a registered trademark of Ortho McNeil Pharm. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

TRAMADOL HYDROCHLORIDE- TRAMADOL HYDROCHLORIDE TABLET, FILM COATED
PREFERRED PHARMACEUTICALS INC.
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TRAMADOL HYDROCHLORIDE TABLETS, USP C-IV
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
ADDICTION, ABUSE AND MISUSE
TRAMADOL EXPOSES 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, AND MONITOR ALL PATIENTS REGULARLY FOR THE
DEVELOPMENT OF THESE
BEHAVIORS AND CONDITIONS (SEE WARNINGS).
OPIOID ANALGESIC RISK EVALUATION AND MITIGATION STRATEGY (REMS):
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 REMS FOR
THESE PRODUCTS
(SEE WARNINGS). UNDER THE REQUIREMENTS OF THE REMS, DRUG COMPANIES
WITH APPROVED
OPIOID ANALGESIC PRODUCTS MUST MAKE REMS COMPLIANT EDUCATION PROGRAMS
AVAILABLE TO
HEALTHCARE PROVIDERS.
HEALTHCARE PROVIDERS ARE STRONGLY ENCOURAGED TO
•
•
•
•
LIFE-THREATENING RESPIRATORY DEPRESSION
SERIOUS, LIFE-THREATENING, OR FATAL RESPIRATORY DEPRESSION MAY OCCUR
WITH USE OF TRAMADOL.
MONITOR FOR RESPIRATORY DEPRESSION, ESPECIALLY DURING INITIATION OF
TRAMADOL OR FOLLOWING A
DOSE INCREASE (SEE WARNINGS).
ACCIDENTAL INGESTION
ACCIDENTAL INGESTION OF TRAMADOL, ESPECIALLY BY CHILDREN, CAN BE
FATAL. (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