TRAMADOL HYDROCHLORIDE tablet, film coated

দেশ: মার্কিন যুক্তরাষ্ট্র

ভাষা: ইংরেজি

সূত্র: NLM (National Library of Medicine)

সক্রিয় উপাদান:

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

থেকে পাওয়া:

Zydus Pharmaceuticals USA Inc.

INN (আন্তর্জাতিক নাম):

TRAMADOL HYDROCHLORIDE

রচনা:

TRAMADOL HYDROCHLORIDE 50 mg

প্রশাসন রুট:

ORAL

প্রেসক্রিপশন টাইপ:

PRESCRIPTION DRUG

থেরাপিউটিক ইঙ্গিত:

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. L imitations of Use Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosages or duration [see Warnings and Precautions (5.1)] , reserve tramadol hydrochloride for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]: - 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 should not be used for an extended period of time unless the pain remains severe enough to require an opioid analgesic and for which alternative treatment options continue to be inadequate. Tramadol hydrochloride tablets are contraindicated for: - all children younger than 12 years of age [see Warnings and Precautions (5.6)]. - post-operative ma

পণ্য সারাংশ:

Tramadol Hydrochloride Tablets, USP 50 mg are white to off-white, round, film-coated tablets debossed with '319' on one side and plain on the other side and are supplied as follows: NDC 68382-319-01 in bottle of 100 tablets NDC 68382-319-05 in bottle of 500 tablets NDC 68382-319-10 in bottle of 1000 tablets NDC 68382-319-77 in cartons of 100 tablets (10 x 10 unit-dose) Storage Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight container. Store tramadol hydrochloride tablets securely and dispose of properly [see Patient Counseling Information (17)] .

অনুমোদন অবস্থা:

Abbreviated New Drug Application

তথ্য লিফলেট

Zydus Pharmaceuticals USA Inc.
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SPL MEDGUIDE
ME DICATION 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.
I mportant information about tramadol hydrochloride tablets:
G et emergency help right away if you take too much 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. Talk to your healthcare provider about
naloxone, a medicine for the
emergency treatment of an opioid overdose.
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
ha

পণ্য বৈশিষ্ট্য

TRAMADOL HYDROCHLORIDE- TRAMADOL HYDROCHLORIDE TABLET, FILM COATED
ZYDUS PHARMACEUTICALS USA 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, C-IV
INITIAL U.S. APPROVAL: 1995
WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF TRAMDOL
HYDROCHLORIDE
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
Tramadol hydrochloride 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
tramadol hydrochloride, and
monitor regularly for these behaviors or conditions. (5.1)
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 (5.6).
Accidental ingestion of tramadol hydrochloride, especially by
children, can result in a fatal
overdose of tramadol. (5.2)
Concomitant use of opioids with benzodiazepines or other central
nervous system (CNS)
depressants, including alcohol, may result in profound sedation,
respiratory depression, coma,
and death. Reserve concomitant prescribing for use in patients for
whom alternative treatment
options are inadequate; limit dosages and durations to the minimum
required; and follow patients
for signs and symptoms of respiratory depression and sedation. (5.3,
7)
Prolonged use of tramadol hydrochloride, during pregnancy can result
in neonatal opioid
withdrawal syndrome, which may be life threatening if not recognized
and treated If prolonged
opioid use is required in a pregnant woman, advise the patient of the
risk of neonatal opioid
withdrawal syndrome and ensure that appropriate treatment will be
available. (5.4)
To ensure t