TRAMADOL HYDROCHLORIDE- tramadol hydrochloride tablet, extended release

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

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

Dostupné z:

Patriot Pharmaceuticals, LLC

INN (Medzinárodný Name):

TRAMADOL HYDROCHLORIDE

Zloženie:

TRAMADOL HYDROCHLORIDE 100 mg

Spôsob podávania:

ORAL

Typ predpisu:

PRESCRIPTION DRUG

Terapeutické indikácie:

Tramadol HCl Extended-Release Tablets is 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 HCl 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 HCl Extended-Release Tablets is not indicated as an as-needed (prn) analgesic. Tramadol HCl Extended-Release Tablets is contraindicated for: - all children younger than 12 years of age [see Warnings and Precautions (5.3)] - post-operative management in children younger than 1

Prehľad produktov:

Tramadol HCl Extended-Release Tablets (tramadol hydrochloride) Extended-release tablets are supplied in the following package and dose strength forms: 100 mg tablets (round, convex, white to off-white, non-scored) imprinted with "100" over "ER" on one side in black ink Bottle of 30 tablets – NDC 10147-0901-3 Bottle of 90 tablets – NDC 10147-0901-9 200 mg tablets (round, convex, white to off-white, non-scored) imprinted with "200" over "ER" on one side in black ink Bottle of 30 tablets – NDC 10147-0902-3 Bottle of 90 tablets – NDC 10147-0902-9 300 mg tablets (round, convex, white to off-white, non-scored) imprinted with "300" over "ER" on one side in black ink Bottle of 30 tablets – NDC 10147-0903-3 Bottle of 90 tablets – NDC 10147-0903-9 Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15–30°C (59 – 86°F) [see USP Controlled Room Temperature].

Stav Autorizácia:

New Drug Application Authorized Generic

Príbalový leták

Patriot Pharmaceuticals, LLC
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MEDICATION GUIDE
TRAMADOL HYDROCHLORIDE EXTENDED RELEASE TABLETS
(TRAMADOL HYDROCHLORIDE) [TABLETS]
This Medication Guide has been approved by the
U.S. Food and Drug Administration.
Issued/Revised: 10/2017
Tramadol HCl Extended-Release Tablets is:
•
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 HCl Extended-Release Tablets:
•
Get emergency help right away if you take too much Tramadol HCl
Extended-Release Tablets
(overdose). When you first start taking Tramadol HCl 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.
•
Taking Tramadol HCl 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 HCl Extended-Release Tablets.
They could die from
taking it. Store Tramadol HCl Extended-Release Tablets away from
children and in a safe place
to prevent stealing or abuse. Selling or giving away Tramadol HCl
Extended-Release Tablets is
against the law.
Important Information Guiding Use in Pediatric Patients:
•
Do not give Tramadol HCl Extended-Release Tablets to a child younger
than 12 years of age.
•
Do not give Tram

Súhrn charakteristických

TRAMADOL HYDROCHLORIDE- TRAMADOL HYDROCHLORIDE TABLET, EXTENDED
RELEASE
PATRIOT PHARMACEUTICALS, LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
TRAMADOL HCL EXTENDED-RELEASE TABLETS C
IV SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
TRAMADOL HCL EXTENDED-RELEASE TABLETS.
TRAMADOL HCL EXTENDED-RELEASE TABLETS C IV (TRAMADOL HYDROCHLORIDE)
EXTENDED-RELEASE TABLETS FOR ORAL USE,
C IV
INITIAL U.S. APPROVAL: 1995
WARNING: ADDICTION, ABUSE, AND MISUSE; 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 HCL EXTENDED-RELEASE TABLETS EXPOSES 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)
SERIOUS, LIFE-THREATENING, OR FATAL RESPIRATORY DEPRESSION MAY OCCUR.
MONITOR CLOSELY, ESPECIALLY UPON
INITIATION OR FOLLOWING A DOSE INCREASE. INSTRUCT PATIENTS TO SWALLOW
TRAMADOL HCL EXTENDED-RELEASE
TABLETS TRAMADOL HCL EXTENDED-RELEASE TABLETS INTACT, AND NOT TO CUT,
BREAK, CHEW, CRUSH, OR DISSOLVE
THE TABLETS TO AVOID EXPOSURE TO A POTENTIALLY FATAL DOSE OF TRAMADOL.
(5.2)
ACCIDENTAL INGESTION OF TRAMADOL HCL EXTENDED-RELEASE TABLETS,
ESPECIALLY BY CHILDREN, CAN RESULT IN A
FATAL OVERDOSE OF TRAMADOL. (5.2)
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
(5.3). ULTRAM ER IS CONTRAINDICATED IN CHILD