TRAMADOL HYDROCHLORIDE tablet, film coated

Country: Amerika Syarikat

Bahasa: Inggeris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Boleh didapati daripada:

Macleods Pharmaceuticals Limited

INN (Nama Antarabangsa):

TRAMADOL HYDROCHLORIDE

Komposisi:

TRAMADOL HYDROCHLORIDE 50 mg

Laluan pentadbiran:

ORAL

Jenis preskripsi:

PRESCRIPTION DRUG

Tanda-tanda terapeutik:

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 tablets are 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 tablets is also contraindicated in patients with: • Significant respiratory depression

Ringkasan produk:

Tramadol hydrochloride tablets USP, 50 mg are white to off-white, capsule shaped, biconvex, film-coated tablets debossed with “ML 4” on one side and plain on other side. Bottle of 100 tablets: NDC 33342-201-11 Bottle of 500 tablets: NDC 33342-201-15 Bottle of 1000 tablets: NDC 33342-201-44    Dispense in a tight container. Store at 20° to 25°C (68° to 77°F); excursions permitted to 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)].

Status kebenaran:

Abbreviated New Drug Application

Risalah maklumat

TRAMADOL HYDROCHLORIDE - TRAMADOL HYDROCHLORIDE TABLET, FILM COATED
Macleods Pharmaceuticals Limited
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SPL MEDGUIDE SECTION
Medication Guide
Tramadol Hydrochloride Tablets, USP C-IV
(tram’ a dol hye” droe klor’ ide)
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 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 are 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 tonsil

Ciri produk

TRAMADOL HYDROCHLORIDE - TRAMADOL HYDROCHLORIDE TABLET, FILM COATED
MACLEODS PHARMACEUTICALS LIMITED
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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: 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._•
TRAMADOL HYDROCHLORIDE
TABLETS EXPOSE 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 TABLETS, AND MONITOR REGULARLY FOR THESE BEHAVIORS OR
CONDITIONS. (5.1)
• 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 RISK
EVALUATION AND MITIGATION STRATEGY (REMS) FOR THESE PRODUCTS. (5.2)
• SERIOUS, LIFE-THREATENING, OR FATAL RESPIRATORY DEPRESSION MAY
OCCUR. MONITOR CLOSELY,
ESPECIALLY DURING INITIATION OR FOLLOWING A DOSE INCREASE. (5.3)
• ACCIDENTAL INGESTION OF TRAMADOL HYDROCHLORIDE TABLETS, ESPECIALLY
BY CHILDREN, CAN
RESULT IN A FATAL OVERDOSE OF TRAMADOL. (5.3)
• 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 (5.4).
• TRAMADOL HYDROCHL