TRAMADOL HYDROCHLORIDE tablet, film coated

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

Mylan Pharmaceuticals Inc.

INN (Διεθνής Όνομα):

TRAMADOL HYDROCHLORIDE

Σύνθεση:

TRAMADOL HYDROCHLORIDE 50 mg

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

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: Prolonged use of opioid analgesics during pregnancy may cause neonatal opioid withdrawal syndrome. Available data with tramadol hydrochloride tablets 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.

Περίληψη προϊόντος:

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: NDC 0378-4151-01 bottles of 100 tablets NDC 0378-4151-05 bottles of 500 tablets 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 using a child-resistant closure. Store tramadol hydrochloride tablets securely and dispose of properly [see Patient Counseling Information (17)] . PHARMACIST: Dispense a Medication Guide with each prescription.

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Φύλλο οδηγιών χρήσης

Mylan Pharmaceuticals Inc.
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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
of 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. 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 problems such as obstructive sleep apnea,
obesity, or underlyin

Αρχείο Π.Χ.Π.

TRAMADOL HYDROCHLORIDE- TRAMADOL HYDROCHLORIDE TABLET, FILM COATED
MYLAN PHARMACEUTICALS INC.
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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
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._
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RECENT MAJOR CHANGES
Dosage and Administration (2.4) 10/2019
TRAMADOL HYDROCHLORIDE TABLETS EXPOSE 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 TABLETS, 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 TABLETS, 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 TRA