TRAMADOL HYDROCHLORIDE tablet, extended release

Country: মার্কিন যুক্তরাষ্ট্র

ভাষা: ইংরেজি

সূত্র: NLM (National Library of Medicine)

সক্রিয় উপাদান:

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

থেকে পাওয়া:

Sun Pharmaceutical Industries, Inc.

প্রশাসন রুট:

ORAL

প্রেসক্রিপশন টাইপ:

PRESCRIPTION DRUG

থেরাপিউটিক ইঙ্গিত:

Tramadol hydrochloride extended-release tablets are indicated for the management of severe and persistent pain  that requires an extended treatment period with a daily opioid analgesic and for which alternative treatment options are inadequate. Limitations of Use - Because of the risks of addiction, abuse, and misuse, with opioids, which can occur at any dosages or duration, and because of the greater risks of overdose and death with extended-release/long-acting opioid formulations [see Warnings] , 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 ]. - postoperative management in children younger than 18 years of age following tonsillectomy and/or adenoidectomy [see WARNINGS ]. Tramadol hydrochloride extended-release tablets are also contraindicated in patients with: - Significant respiratory depression [see WARNINGS ] - Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see WARNINGS ] - Known or suspected gastrointestinal obstruction, including paralytic ileus [see WARNINGS ] - Hypersensitivity to tramadol (e.g., anaphylaxis) [see ADVERSE REACTIONS ] - Concurrent use of monoamine oxidase inhibitors (MAOIs) or use within the last 14 days [see PRECAUTIONS; Drug Interactions ]

পণ্য সারাংশ:

Tramadol hydrochloride extended-release tablets, USP are available as follows: 100 mg: White, round shape, biconvex, beveled edge, coated tablet with release portal on the center of the tablet on any one side, imprinted “531” with black ink on one side and plain on other side. Bottles of 30’s with Child Resistant Cap…………..….NDC 47335-531-83 Bottles of 100’s with Child Resistant Cap………….....NDC 47335-531-88 Bottles of 100’s with Non Child Resistant Cap…….....NDC 47335-531-08 Bottles of 1000’s with Non Child Resistant Cap……...NDC 47335-531-18 200 mg: White, round shape, biconvex, beveled edge, coated tablet with release portal on the center of the tablet on any one side, imprinted “533” with black ink on one side and plain on other side. Bottles of 30’s with Child Resistant Cap………………NDC 47335-533-83 Bottles of 100’s with Child Resistant Cap……………..NDC 47335-533-88 Bottles of 100’s with Non Child Resistant Cap………..NDC 47335-533-08 Bottles of 1000’s with Non Child Resistant Cap……....NDC 47335-533-18 300 mg: White, round shape, biconvex, beveled edge, coated tablet with release portal on the center of the tablet on any one side, imprinted “537” with black ink on one side and plain on other side. Bottles of 30’s with Child Resistant Cap…...................NDC 47335-537-83 Bottles of 100’s with Child Resistant Cap….................NDC 47335-537-88 Bottles of 100’s with Non Child Resistant Cap….........NDC 47335-537-08 Bottles of 1000’s with Non Child Resistant Cap….......NDC 47335-537-18 Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F) [see USP Controlled Room Temperature]. Dispense in a tight, light resistant container. Warning: keep out of reach of children. Store tramadol hydrochloride extended-release tablets securely and dispose of properly [see PRECAUTIONS/ Information for Patients ]. Dispense with Medication Guide available at: https://www.sunpharma.com/usa/products

অনুমোদন অবস্থা:

Abbreviated New Drug Application

তথ্য লিফলেট

TRAMADOL HYDROCHLORIDE- TRAMADOL HYDROCHLORIDE TABLET, EXTENDED
RELEASE
Sun Pharmaceutical Industries, Inc.
----------
MEDICATION GUIDE
Tramadol Hydrochloride (tram a dol hye droe klor ide)
Extended-Release Tablets, USP, C-IV
Tramadol hydrochloride extended-release tablets are:
•
A strong prescription pain medicine that contains an opioid (narcotic)
that is used to manage
severe and persistent pain that requires an extended treatment period
with a daily opioid pain
medicine when other pain 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 to be taken on an “as needed” basis.
Important information about tramadol hydrochloride extended-release
tablets:
•
Get emergency help or call 911 right away if you take too many
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 many
(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 them. 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 location not accessible by others, including visitors to the
home

পণ্য বৈশিষ্ট্য

TRAMADOL HYDROCHLORIDE- TRAMADOL HYDROCHLORIDE TABLET, EXTENDED
RELEASE
SUN PHARMACEUTICAL INDUSTRIES, INC.
----------
TRAMADOL HYDROCHLORIDE EXTENDED-RELEASE TABLETS, USP C-IV
RX ONLY
WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF
TRAMADOL HYDROCHLORIDE EXTENDED-RELEASE TABLETS
ADDICTION, ABUSE, AND MISUSE
BECAUSE THE USE OF TRAMADOL HYDROCHLORIDE EXTENDED-RELEASE TABLETS
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 AND REASSESS ALL PATIENTS
REGULARLY FOR
THE DEVELOPMENT OF THESE BEHAVIORS AND CONDITIONS _[SEE WARNINGS]_.
LIFE-THREATENING RESPIRATORY DEPRESSION
SERIOUS, LIFE-THREATENING, OR FATAL RESPIRATORY DEPRESSION MAY OCCUR
WITH
USE OF TRAMADOL HYDROCHLORIDE EXTENDED-RELEASE TABLETS, ESPECIALLY
DURING INITIATION OR FOLLOWING A DOSE INCREASE. TO REDUCE THE RISK OF
RESPIRATORY DEPRESSION, PROPER DOSING AND TITRATION OF TRAMADOL
HYDROCHLORIDE EXTENDED-RELEASE TABLETS ARE ESSENTIAL_ [SEE_
_WARNINGS]_. INSTRUCT PATIENTS TO SWALLOW TRAMADOL HYDROCHLORIDE
EXTENDED-RELEASE TABLETS WHOLE TO AVOID EXPOSURE TO A POTENTIALLY
FATAL
DOSE OF TRAMADOL.
ACCIDENTAL INGESTION
ACCIDENTAL INGESTION OF EVEN ONE DOSE OF TRAMADOL HYDROCHLORIDE
EXTENDED-RELEASE TABLETS, ESPECIALLY BY CHILDREN, CAN RESULT IN A
FATAL
OVERDOSE OF TRAMADOL _[SEE WARNINGS]_.
RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS
DEPRESSANTS
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 OF TRAMADOL HYDROCHLORIDE EXTENDED-RELEASE
TABLETS AND BENZODIAZEPINES OR OTHER CNS DEPRESSANTS FOR USE IN
PATIENTS FOR WHOM ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE_ [_SEE
WARNINGS, PRECAUTIONS; DRUG INTERACTIONS_]_.
NEONATAL OPIOID WITHDRAWAL SYNDROME (NOWS)
IF OPIOID USE IS REQUIRED FOR AN EXTENDED PERIOD OF TIME IN A PREGNANT
WOMAN, ADVISE THE PATI