TRAMADOL HYDROCHLORIDE EXTENDED-RELEASE- tramadol hydrochloride capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Trigen Laboratories, LLC

INN (International Name):

TRAMADOL HYDROCHLORIDE

Composition:

TRAMADOL HYDROCHLORIDE 100 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Tramadol Hydrochloride Extended-Release Capsules are indicated for the management of pain severe enough to require daily, around-the-clock, long term opioid treatment and for which alternative treatment options are inadequate. Limitation of Use - Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release/long-acting opioid formulations [see Warnings and Precautions (5.1) ], reserve Tramadol Hydrochloride Extended-Release Capsules for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. - Tramadol Hydrochloride Extended-Release Capsules are not indicated as an as-needed (prn) analgesic. Tramadol Hydrochloride Extended-Release Capsules are contraindicated for: - all children younger than 12 years of age [see Warnings and Precautions (5.

Product summary:

Tramadol Hydrochloride Extended-Release Capsules are supplied as opaque white hard gelatin capsules, imprinted as follows. 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 ]. Keep out of reach of children. Store Tramadol Hydrochloride Extended-Release Capsules securely and dispose of properly [see Patient Counseling Information (17) ].

Authorization status:

New Drug Application Authorized Generic

Patient Information leaflet

Trigen Laboratories, LLC
----------
This Medication Guide has been approved by the
U.S. Food and Drug Administration.
Issued: 1/2022
Medication Guide
Tramadol Hydrochloride Extended-Release Capsules , CIV
Tramadol Hydrochloride Extended-Release Capsules are:
•
A strong prescription pain medicine that contains an opioid (narcotic)
that is used to manage pain
severe enough to require daily around-the-clock, long-term treatment
with an opioid, when other pain
treatments such as non-opioid pain medicines or immediate-release
opioid medicines do not treat
your pain well enough or you cannot tolerate them.
•
A long-acting (extended-release) 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.
•
Not for use to treat pain that is not around-the-clock.
Important information about Tramadol Hydrochloride Extended-Release
Capsules:
•
Get emergency help right away or call 911 right away if you take too
much Tramadol Hydrochloride
Extended-Release Capsules (overdose). When you first start taking
Tramadol Hydrochloride
Extended-Release Capsules, 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 Tramadol Hydrochloride Extended-Release Capsules 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 Extended-Release
Capsules. They could die
from taking it. Selling or giving away Tramadol Hydrochloride
Extended-Release Capsules is against
the law.
•
Store Tramadol Hydrochloride Extended-Release Capsules securely, out
of sight and reach of
children, and in a

Summary of Product characteristics

TRAMADOL HYDROCHLORIDE EXTENDED-RELEASE- TRAMADOL
HYDROCHLORIDE CAPSULE
TRIGEN LABORATORIES, LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
TRAMADOL HYDROCHLORIDE
EXTENDED-RELEASE CAPSULES SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
TRAMADOL HYDROCHLORIDE EXTENDED-RELEASE CAPSULES.
TRAMADOL HYDROCHLORIDE EXTENDED-RELEASE CAPSULES 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 EXTENDED-RELEASE CAPSULES EXPOSE USERS TO RISKS
OF
ADDICTION, ABUSE, AND MISUSE, WHICH CAN LEAD TO OVERDOSE AND DEATH.
ASSESS
PATIENT'S RISK BEFORE PRESCRIBING AND MONITOR REGULARLY FOR THESE
BEHAVIORS AND
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 UPON INITIATION OR FOLLOWING A DOSE INCREASE. INSTRUCT
PATIENTS TO SWALLOW
TRAMADOL HYDROCHLORIDE EXTENDED-RELEASE CAPSULES INTACT, AND NOT TO
SPLIT, CHEW,
CRUSH, OR DISSOLVE CONTENT OF THE CAPSULES TO AVOID EXPOSURE TO A
POTENTIALLY FATAL
DOSE OF TRAMADOL. (5.3)
ACCIDENTAL INGESTION OF TRAMADOL HYDROCHLORIDE EXTENDED-RELEASE
CAPSULES,
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 TRA