TRAMADOL HCL ER- tramadol hcl tablet, extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Advanced Rx Pharmacy of Tennessee, LLC

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

1 INDICATIONS AND USAGE Tramadol hydrochloride extended-release tablets 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. Limitations 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 opioid formulations [see Warnings and Precautions (5.1)] , reserve tramadol hydrochloride extended-release tablets 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 tablets are not indicated as an as-needed (prn) analgesic. Tramadol hydrochloride extended-release tablets are contraindicated for: all children younger than 12 years of age [see Warnings and Precaut

Product summary:

Tramadol hydrochloride extended-release tablets USP are supplied in the following package and dose strength forms: 100 mg tablets (white to off-white circular, biconvex, beveled edge, coated) imprinted with 'L010' on one side and plain on the other side. Bottles of 30 Tablets NDC: 80425-0108-01 Bottles of 60 Tablets NDC: 80425-0108-02 Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Store tramadol hydrochloride extended release tablets securely and dispose of properly [see Patient Counseling Information (17)].

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

TRAMADOL HCL ER- TRAMADOL HCL TABLET, EXTENDED RELEASE
Advanced Rx Pharmacy of Tennessee, LLC
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MEDICATION GUIDE
MEDICATION GUIDE
Medication Guide
Tramadol Hydrochloride Extended-Release Tablets , CIV
(tram' a dol hye'' droe klor' ide)
Tramadol hydrochloride extended-release tablets 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
tablets:
Get emergency help or call 911 right away if you take too much
tramadol hydrochloride extended-release
tablets (overdose). When you first start taking tramadol hydrochloride
extended-release tablets, 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 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 extended-release
tablets. They could die from taking it.
Selling or giving away tramadol hydrochloride extended-release tablets
is against the law.
Store tramadol hydrochloride extended-release tablets securely, out of
sight and reach of children, and in a
locatio

Summary of Product characteristics

TRAMADOL HCL ER- TRAMADOL HCL TABLET, EXTENDED RELEASE
ADVANCED RX PHARMACY OF TENNESSEE, LLC
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TRAMADOL HCL ER 100MG TABLETS
BOXED WARNING
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 DEPRESSENTS
Addiction, Abuse, and Misuse
Tramadol hydrochloride extended-release tablet 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
hydrochloride
extended-release tablets, and monitor all patients regularly for the
development of
these behaviors and conditions [see Warnings and Precautions (5.1)].
Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS)
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 REMS
for these products [see Warnings and Precautions (5.2)]. Under the
requirements
of the REMS, drug companies with approved opioid analgesic products
must make
REMS-compliant education programs available to healthcare providers.
Healthcare
providers are strongly encouraged to
• complete a REMS-compliant education program,
• counsel patients and/or their caregivers, with every prescription,
on safe use,
serious risks, storage, and disposal of these products,
• emphasize to patients and their caregivers the importance of
reading the
Medication Guide every time it is provided by their pharmacist, and
• consider other tools to improve patient, household, and community
safety.
Life-Threatening Respiratory Depression
Serious, life-threatening, or fatal respiratory depression may occur
with use of
tra