TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

tramadol hydrochloride (UNII: 9N7R477WCK) (tramadol - UNII:39J1LGJ30J), acetaminophen (UNII: 362O9ITL9D) (acetaminophen - UNII:362O9ITL9D)

Available from:

Apotex Corp.

INN (International Name):

tramadol hydrochloride

Composition:

tramadol hydrochloride 37.5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Tramadol hydrochloride and acetaminophen tablets are indicated for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.   Limitations of Use Tramadol hydrochloride and acetaminophen tablets are indicated for short-term use of five days or less.   Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.1)] , reserve tramadol hydrochloride and acetaminophen 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 and acetaminophen tablets 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 adeno

Product summary:

Tramadol hydrochloride and acetaminophen tablets, USP 37.5 mg/325 mg are yellow, capsule-shaped, film-coated tablets, engraved "37.5-325" on one side, "APO" on the other side. They are supplied as follows: Bottles of 30 (NDC 60505-2644-3) Bottles of 90 (NDC 60505-2644-9) Bottles of 100 (NDC 60505-2644-1) Bottles of 500 (NDC 60505-2644-5) Bottles of 1,000 (NDC 60505-2644-8) Store at 20°C to 25°C (68°F to 77°F); excursions permitted from 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container [see USP]. Store tramadol hydrochloride and acetaminophen tablets securely and dispose of properly [see Patient Counseling Information (17)].

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN- TRAMADOL HYDROCHLORIDE AND
ACETAMINOPHEN TABLET
Apotex Corp.
----------
MEDICATION GUIDE
Tramadol Hydrochloride/Acetaminophen
(tram' a dol hye'' droe klor' ide/ a seet'' a min' oh fen)
Tablets, CIV
Tramadol Hydrochloride and Acetaminophen Tablets are:
•
A strong prescription pain medicine that contains an opioid (narcotic)
that is used for the short-term
(five days or less) management of acute pain, 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 and acetaminophen
tablets:
•
Get emergency help right away if you take too much tramadol
hydrochloride and acetaminophen
tablets (overdose). When you first start taking tramadol hydrochloride
and acetaminophen 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.
•
Tramadol hydrochloride and acetaminophen tablets can cause severe
drowsiness, breathing problems
(respiratory depression), coma and death when taken with
benzodiazepines or other medicines that
depress consciousness.
•
Never give anyone else your tramadol hydrochloride and acetaminophen
tablets. They could die from
taking it. Selling or giving away tramadol hydrochloride and
acetaminophen tablets are against the
law.
•
Store tramadol hydrochloride and acetaminophen tablets securely, out
of sight and reach of children,
and in a location not accessible by others, including visitors to the
home.
•
Get emergency help right away if you take more than 4,000 mg of
acetaminophen in 1 day. Taking
tramadol hydrochloride and acetaminophen tablets with other products
that contain acetaminophen
can lead to serious liver problems and death.
Imp

Summary of Product characteristics

TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN- TRAMADOL HYDROCHLORIDE AND
ACETAMINOPHEN TABLET
APOTEX CORP.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
TRAMADOL HYDROCHLORIDE AND
ACETAMINOPHEN TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR TRAMADOL
HYDROCHLORIDE AND ACETAMINOPHEN TABLETS.
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLETS, FOR ORAL USE, C-IV
INITIAL U.S. APPROVAL – 2001
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 AND ACETAMINOPHEN 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 ACETAMINOPHEN, 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 AND ACETAMINOPHEN,
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-RA