TRAMADOL HYDROCHLORIDE tablet, film coated

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

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

זמין מ:

Aphena Pharma Solutions - Tennessee, LLC

מסלול נתינה (של תרופות):

ORAL

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

Tramadol hydrochloride tablets 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. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses (see WARNINGS ), reserve tramadol hydrochloride tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics]: Tramadol contraindicated in patients with: Tramadol hydrochloride tablets contain tramadol, a Schedule IV controlled substance. Tramadol hydrochloride tablets contain tramadol, a substance with a high potential for abuse similar to other opioids. Tramadol hydrochloride tablets can be abused and are 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 appropriate medical use. Prescription drug abuse i

leaflet_short:

Tramadol Hydrochloride Tablets USP, 50 mg, are available as white, film-coated, unscored, oval-shaped tablets, debossed “TV” on one side and debossed “58” on the other side. They are available in bottles of 100 (NDC 60429-588-01) and 500 (NDC 60429-588-05). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. All brand names listed are the registered trademarks of their respective owners and are not trademarks of Teva Pharmaceuticals USA. Manufactured In Czech Republic By: Teva Czech Industries, s.r.o. Opava-Komarov, Czech Republic Manufactured For: Teva Pharmaceuticals USA, Inc. North Wales, PA 19454 Marketed/ Packaged by: GSMS, Inc. Camarillo, CA 93012 USA Rev. AC 12/2016

מצב אישור:

Abbreviated New Drug Application

עלון מידע

Aphena Pharma Solutions - Tennessee, LLC
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MEDICATION GUIDE
Medication Guide
Tramadol Hydrochloride (TRAM a dol Hye” droe klor’ ide) Tablets,
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 many tramadol
hydrochloride tablets (overdose).
When you first start taking tramadol hydrochloride tablets, when your
dose is changed, or if you
take too many (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 them.
Store tramadol hydrochloride tablets away from children and in a safe
place to prevent stealing or
abuse. Selling or giving away tramadol hydrochloride tablets is
against the law.
Do not take tramadol hydrochloride tablets if you have:
•
Severe asthma, trouble breathing, or other lung problems.
•
A bowel blockage or have narrowing of the stomach or intestines.
•
An allergy to tramadol.
•
Taken a Monoamine Oxidase Inhibitor, MAOI, (medicine used for
depression) within the last 14
days.
Before taking tramadol hydrochloride tablets, tell your healthcare
provider if you have a history of:
•
head injury, seizures
•
liver, kidney, thyroid problems
•
problems urinating

מאפייני מוצר

TRAMADOL HYDROCHLORIDE- TRAMADOL HYDROCHLORIDE TABLET, FILM COATED
APHENA PHARMA SOLUTIONS - TENNESSEE, LLC
----------
TRAMADOL HYDROCHLORIDE TABLETS USP, 50 MG
WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING
RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; 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).
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).
NEONATAL OPIOID WITHDRAWAL SYNDROME
PROLONGED USE OF TRAMADOL DURING PREGNANCY CAN RESULT IN NEONATAL
OPIOID WITHDRAWAL
SYNDROME, WHICH MAY BE LIFE-THREATENING IF NOT RECOGNIZED AND TREATED,
AND REQUIRES
MANAGEMENT ACCORDING TO PROTOCOLS DEVELOPED BY NEONATOLOGY EXPERTS. IF
OPIOID USE IS
REQUIRED FOR A PROLONGED PERIOD IN A PREGNANT WOMAN, ADVISE THE
PATIENT OF THE RISK OF
NEONATAL OPIOID WITHDRAWAL SYNDROME AND ENSURE THAT APPROPRIATE
TREATMENT WILL BE
AVAILABLE (SEE WARNINGS).
INTERACTIONS WITH DRUGS AFFECTING CYTOCHROME P450 ISOENZYMES
THE EFFECTS OF CONCOMITANT USE OR DISCONTINUATION OF CYTOCHROME P450
3A4 INDUCERS, 3A4
INHIBITORS, OR 2D6 INHIBITORS WITH TRAMADOL ARE COMPLEX. USE OF
CYTOCHROME P450 3A4
INDUCERS, 3A4 INHIBITORS, OR 2D6 INHIBITORS WITH TRAMADOL REQUIRES
CAREFUL CONSIDERATION OF
THE EFFECTS ON THE PARENT DRUG, TRAMADOL, AND THE ACTIVE METABOLITE,
M1 (SEE WARNINGS,
PRECAUTIONS; DRUG INTERACTIO