TRAMADOL HYDROCHLORIDE tablet, film coated

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Virtus Pharmaceuticals LLC

INN (International Name):

Tramadol hydrochloride

Sammensetning:

Tramadol hydrochloride 50 mg

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

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 tablets 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

Produkt oppsummering:

Bottles of 100 tablets with child-resistant closure: NDC 69543-136-10 Bottles of 500 tablets: NDC 69543-136-50 Bottles of 1000 tablets: NDC 69543-136-11 Dispense in a tight container. Keep out of reach of children. 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]. Store tramadol hydrochloride tablets securely and dispose of properly [see Patient Counseling Information (17)] .

Autorisasjon status:

Abbreviated New Drug Application

Informasjon til brukeren

Virtus Pharmaceuticals LLC
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Medication Guide
Tramadol Hydrochloride Tablets, USP
(tram' a dol hye'' droe klor' ide)
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 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.
•
Avoid giving tramadol hydrochloride tablets to children between 12 to
18 years of age who have risk
factors for breathing problems such as obstructive sleep apnea,
obesity, or underlying lu

Preparatomtale

TRAMADOL HYDROCHLORIDE- TRAMADOL HYDROCHLORIDE TABLET, FILM COATED
VIRTUS PHARMACEUTICALS LLC
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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, CIV
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 CONTRAINDIC