TRAMADOL HYDROCHLORIDE tablet, coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Quality Care Products, LLC

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Tramadol hydrochloride tablets, USP 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, USP are 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

Product summary:

Tramadol Hydrochloride Tablets, USP 50 mg are white to off white, capsule-shaped film coated tablet debossed with “018” on one side and scored on other side. 55700-997-15 55700-997-30 55700-997-60 55700-997-90 55700-997-01 55700-997-18 55700-997-24 Tramadol Hydrochloride Tablets, USP 100 mg are white to off white, capsule-shaped film coated tablet debossed with “019” on one side and scored on other side. Dispense in a tight container. Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). [see USP Controlled Room Temperature]. Store tramadol hydrochloride tablets securely and dispose of properly [ see Patient Counselling Information (17) ]

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

TRAMADOL HYDROCHLORIDE- TRAMADOL HYDROCHLORIDE TABLET, COATED
Quality Care Products, LLC
----------
SPL MEDGUIDE
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 or call 911 right away if you take too much
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. Talk to your
healthcare provider
about naloxone, a medicine for the emergency treatment of an opioid
overdose.
•
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 are 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

Summary of Product characteristics

TRAMADOL HYDROCHLORIDE- TRAMADOL HYDROCHLORIDE TABLET, COATED
QUALITY CARE PRODUCTS, LLC
----------
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 TABLETS 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 TABLETS, 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 TABLETS, 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 TABLETS ARE