TRAMADOL HYDROCHLORIDE tablet, film coated

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

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

Dostopno od:

Major Pharmaceuticals

INN (mednarodno ime):

TRAMADOL HYDROCHLORIDE

Sestava:

TRAMADOL HYDROCHLORIDE 50 mg

Pot uporabe:

ORAL

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

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 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: Risk Summary Prolonged use of opioid analgesics during pregnancy may cause neonatal opioid withdrawal syndrome. Available data with tramadol hydrochloride in pregnant women are insufficient to inform a drug- associated risk for major birth defects and miscarriage. In animal reproduction studies, tramadol administration during organogenesis decreased fetal weights and reduced ossification in mice, rats, and rabbits at 1.4, 0.6, and 3.6 tim

Povzetek izdelek:

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: Carton of 100 tablets (10 tablets each blister pack x 10) NDC 0904-6365-61 Storage Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight container. Store tramadol hydrochloride tablets securely and dispose of properly [see Patient Counseling Information (17)] .

Status dovoljenje:

Abbreviated New Drug Application

Navodilo za uporabo

TRAMADOL HYDROCHLORIDE- TRAMADOL HYDROCHLORIDE TABLET, FILM COATED
Major Pharmaceuticals
----------
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 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.
•
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 is 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.
•
Avoid giving tramadol hydrochloride tablets to children between 12 to
18 years of age who have
risk factors for breathing probl

Lastnosti izdelka

TRAMADOL HYDROCHLORIDE- TRAMADOL HYDROCHLORIDE TABLET, FILM COATED
MAJOR PHARMACEUTICALS
----------
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; 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
YEARS OF A