TRAMADOL HCL tablet, coated

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:

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]: - Have not been tolerated or are not expected to be tolerated. - Have not provided adequate analgesia or are not expected to provide adequate analgesia. Tramadol hydrochloride 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)]. Tramadol hydrochloride is also contraindicated in patients with: - Significant respiratory depression [see WARNINGS AND PRECAUTIONS

Product summary:

Tramadol Hydrochloride Tablets USP, 50 mg are supplied as unscored, white, round film-coated tablets debossed “AN” over “627” on one side and plain on the other side. They are supplied as follows: Bottles of 15 Tablets NDC: 80425-0057-04 Bottles of 30 Tablets NDC: 80425-0057-01 Bottles of 60 Tablets NDC: 80425-0057-02 Bottles of 90 Tablets NDC: 80425-0057-03 Bottles of 120 Tablets NDC: 80425-0057-05 Dispense in a tight container. Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Store tramadol hydrochloride tablets securely and dispose of properly [see PATIENT COUNSELING INFORMATION (17)].

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

TRAMADOL HCL- TRAMADOL HCL TABLET, COATED
Advanced Rx Pharmacy of Tennessee, LLC
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MEDICATION GUIDE SECTION
MEDICATION GUIDE
Tramadol Hydrochloride (tram’ a dol hye” droe klor’ ide)
Tablets, USP CIV
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 much
(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. 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 obs

Summary of Product characteristics

TRAMADOL HCL- TRAMADOL HCL TABLET, COATED
ADVANCED RX PHARMACY OF TENNESSEE, LLC
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TRAMADOL HCL 50MG 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 DEPRESSANTS
ADDICTION, ABUSE AND MISUSE
Tramadol hydrochloride 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, 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
tramadol hydrochloride. Monitor for respiratory depression, especially
during
initi