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:

Cardinal Health

INN (שם בינלאומי):

TRAMADOL HYDROCHLORIDE

הרכב:

TRAMADOL HYDROCHLORIDE 50 mg

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 hydrochloride tablets are 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 is 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

leaflet_short:

Tramadol Hydrochloride Tablets, USP are available containing 50 mg of tramadol hydrochloride, USP. The 50 mg tablets are white, film-coated, round, unscored tablets debossed with M on one side of the tablet and T7 on the other side. They are available as follows: Overbagged with 10 tablets per bag, NDC 55154-5656-0 Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] PHARMACIST: Dispense a Medication Guide with each prescription. The brands listed are trademarks of their respective owners.

מצב אישור:

Abbreviated New Drug Application

עלון מידע

TRAMADOL HYDROCHLORIDE- TRAMADOL HYDROCHLORIDE TABLET, FILM COATED
Cardinal Health
----------
MEDICATION GUIDE
Tramadol Hydrochloride Tablets, USP CIV
(tram' a dol hye'' droe klor' ide)
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 it. 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 problem

מאפייני מוצר

TRAMADOL HYDROCHLORIDE- TRAMADOL HYDROCHLORIDE TABLET, FILM COATED
CARDINAL HEALTH
----------
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 HYDROCHLORIDE TABLETS EXPOSE
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
HYDROCHLORIDE TABLETS,
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 HYDROCHLORIDE
TABLETS. MONITOR FOR
RESPIRATORY DEPRESSION, ESPECIALLY DURING INITIATION OF TRAMADOL
HYDROCHLORIDE TABLETS OR
FOLLOWING A DOSE INCREASE (SEE WARNINGS).
ACCIDENTAL INGESTION: ACCIDENTAL INGESTION OF TRAMADOL HYDROCHLORIDE
TABLETS,
ESPECIALLY BY CHILDREN, CAN BE FATAL (SEE WARNINGS).
NEONATAL OPIOID WITHDRAWAL SYNDROME: PROLONGED USE OF TRAMADOL
HYDROCHLORIDE TABLETS 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
HYDROCHLORIDE TABLETS
REQUIRE CAREFUL CONSIDERATION OF THE EFFECTS ON THE PARENT