HIGHLIGHTS OF PRESCRIBING INFORMATION

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Janssen Pharmaceuticals, Inc.

INN (International Name):

tramadol hydrochloride

Composition:

tramadol hydrochloride 50 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

ULTRAM is 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 ULTRAM for use in patients for whom alternative treatment options [e.g., non-opioid analgesics]: - Have not been tolerated or are not expected to be tolerated. - Have not provided adequate analgesia or are not expected to provide adequate analgesia. ULTRAM is contraindicated for: - all children younger than 12 years of age [see Warnings and Precautions (5.4)] . - postoperative management in children younger than 18 years of age following tonsillectomy and/or adenoidectomy [see Warnings and Precautions (5.4)] . ULTRAM is also contraindicated in patients with: - Significant respiratory depression [see Warnings and Precautions (5.3)] . - Acute or severe bronchial asthma in an unmonitored setting or in th

Product summary:

ULTRAM® (tramadol hydrochloride) 50 mg tablets are white, capsule-shaped, coated, with a functional score. The tablets are imprinted "ULTRAM" on one side and "06 59" on the scored side. Bottle of 100 tablets: NDC 50458-659-60 Dispense in a tight container. Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). [see USP Controlled Room Temperature]. Store ULTRAM securely and dispose of properly [see Patient Counseling Information (17)] .

Authorization status:

New Drug Application

Patient Information leaflet

Janssen Pharmaceuticals, Inc.
----------
This Medication Guide has been approved by the U.S. Food and Drug
Administration. Revised:
09/2021
MEDICATION GUIDE
ULTRAM® [UHL-tram]
(tramadol hydrochloride)
Tablets, C-IV
ULTRAM is:
•
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 ULTRAM:
•
Get emergency help or call 911 right away if you take too much ULTRAM
(overdose). When you
first start taking ULTRAM, 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. Talk to your healthcare
provider about naloxone, a medicine for the emergency treatment of an
opioid overdose.
•
Taking ULTRAM 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 ULTRAM. They could die from taking it.
Selling or giving away
ULTRAM is against the law.
•
Store ULTRAM 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 ULTRAM to a child younger than 12 years of age.
•
Do not give ULTRAM to a child younger than 18 years of age after
surgery to remove the tonsils
and/or adenoids.
•
Avoid giving ULTRAM to children between 12 to 18 years of age who have
risk factors for
breathing problems such as obstructive sleep apnea, obesity, or
underlying lung problems.
Do not take ULTRAM if you have:
•
Severe a

Summary of Product characteristics

ULTRAM- TRAMADOL HYDROCHLORIDE TABLET, COATED
JANSSEN PHARMACEUTICALS, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ULTRAM SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR ULTRAM.
ULTRAM (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._
ULTRAM 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 ULTRAM, 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 ULTRAM, 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)
ULTRAM IS CONTRAINDICATED IN CHILDREN YOUNGER THAN 12 YEARS OF AGE AND
IN CHILDREN YOUNGER THAN 18 YEARS OF
AGE FOLLOWING TONSILLECTOMY AND/OR ADENOIDECTOMY (4). AVOID THE USE