TRAMADOL HYDROCHLORIDE tablet, extended release

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Mylan Pharmaceuticals Inc.

INN (International Name):

TRAMADOL HYDROCHLORIDE

Sammensetning:

TRAMADOL HYDROCHLORIDE 100 mg

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

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: Tramadol hydrochloride extended-release tablets are contraindicated for: All children younger than 12 years of age [see Warnings and Precautions (5.4) ] Post-operative management in children younger than 18 years of age following tonsillectomy and/or adenoidectomy [see Warnings and Precautions (5.4) ] . Tramadol hydrochloride extended-release tablets are also contraindicated in patients with: Significant respiratory depression [see Warnings and Precautions (5.3) ] Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see Warnings and Precautions (5.12) ] Known or suspected gastrointestinal obstruction, including paralytic ileus [see Warnings and Precautions (5.15) ] Hypersensitivity to tramadol (e.g., anaphylaxis

Produkt oppsummering:

Tramadol Hydrochloride Extended-Release Tablets, USP are available containing 100 mg, 200 mg or 300 mg of tramadol hydrochloride, USP. The 100 mg tablets are white to off-white, coated, round, unscored tablets imprinted with M over T1 in black ink on one side of the tablet and plain on the other side. They are available as follows: NDC 0378-4152-93 bottles of 30 tablets The 200 mg tablets are white to off-white, coated, oval, unscored tablets imprinted with MT2 in black ink on one side of the tablet and plain on the other side. They are available as follows: NDC 0378-4153-93 bottles of 30 tablets The 300 mg tablets are white to off-white, coated, capsule shaped, unscored tablets imprinted with MT3 in black ink on one side of the tablet and plain on the other side. They are available as follows: NDC 0378-4154-93 bottles of 30 tablets Store at 20º to 25ºC (68º to 77ºF). [See USP Controlled Room Temperature.] Store tramadol hydrochloride extended-release tablets securely and dispose of properly [see Patient Counseling Information (17)] . Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. PHARMACIST: Dispense a Medication Guide with each prescription.

Autorisasjon status:

Abbreviated New Drug Application

Informasjon til brukeren

Mylan Pharmaceuticals Inc.
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Medication Guide
Tramadol Hydrochloride Extended-Release Tablets, USP CIV
(tramʹ a dol hyeʹʹ droe klorʹ 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 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.
Im

Preparatomtale

TRAMADOL HYDROCHLORIDE- TRAMADOL HYDROCHLORIDE TABLET, EXTENDED
RELEASE
MYLAN PHARMACEUTICALS INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
TRAMADOL
HYDROCHLORIDE EXTENDED-RELEASE TABLETS SAFELY AND EFFECTIVELY. SEE
FULL PRESCRIBING
INFORMATION FOR TRAMADOL HYDROCHLORIDE EXTENDED-RELEASE TABLETS.
TRAMADOL HYDROCHLORIDE EXTENDED-RELEASE TABLETS, FOR ORAL USE CIV
INITIAL U.S. APPROVAL: 1995
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
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
•
•
•
•
•
•
•
•
RECENT MAJOR CHANGES
Dosage and Administration, Patient Access to Naloxone for the
Emergency Treatment of Opioid Overdose
(2.2) 7/2020
Warnings and Precautions, Addiction, Abuse, and Misuse (5.1) 7/2020
Warnings and Precautions, Life-Threatening Respiratory Depression
(5.3) 7/2020
Warnings and Precautions, Risks from Concomitant Use with
Benzodiazepines or Other CNS Depressants
(5.7) 7/2020
Warnings and Precautions, Hyponatremia (5.19) 6/2021
Warnings and Precautions, Hypoglycemia (5.20) 6/2021
INDICATIONS AND USAGE
Tramadol hydrochloride extended-release tablets are an opioid agonist
indicated for the management of
pain severe enough to require daily around-the-clock, long-term opioid
treatment and for which alternative
TRAMADOL HYDROCHLORIDE EXTENDED-RELEASE TABLETS EXPOSE 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)
TO ENSURE THAT THE BENEFITS OF OPIOID ANALGESICS OUTWEIGH THE RISKS