TRAMADOL HYDROCHLORIDE tablet

Valsts: Amerikas Savienotās Valstis

Valoda: angļu

Klimata pārmaiņas: NLM (National Library of Medicine)

Aktīvā sastāvdaļa:

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

Pieejams no:

Northstar Rx LLC

SNN (starptautisko nepatentēto nosaukumu):

TRAMADOL HYDROCHLORIDE

Kompozīcija:

TRAMADOL HYDROCHLORIDE 50 mg

Ievadīšanas:

ORAL

Receptes veids:

PRESCRIPTION DRUG

Ārstēšanas norādes:

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]: Tramadol hydrochloride tablets are contraindicated for: Tramadol hydrochloride tablets are also contraindicated in patients with: Risk Summary Prolonged use of opioid analgesics during pregnancy may cause neonatal opioid withdrawal syndrome. Available data with tramadol hydrochloride tablets in pregnant women are insufficient to inform a drug- associated risk for major birth defects and miscarriage. In animal reproduction studies, tramadol administration during organogenesis decreased fetal weights and reduced ossification in mice, rats, and rabbits at 1.4,

Produktu pārskats:

Tramadol hydrochloride tablets, USP, 50 mg are available as white capsule shaped film coated tablets, debossed with "377" on one side and plain on the other side. Bottles of 100 tablets: NDC 57664-377-08 Bottles of 500 tablets: NDC 57664-377-13 Bottles of 1000 tablets: NDC 57664-377-18 Dispense in a tight container. Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). [see USP Controlled Room Temperature]. Store tramadol hydrochloride tablets securely and dispose of properly [see Patient Counseling Information (17)] .

Autorizācija statuss:

Abbreviated New Drug Application

Lietošanas instrukcija

Northstar Rx LLC
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MEDICATION GUIDE
Tramadol Hydrochloride Tablets, USP
(TRAM a dol hye” droe cklo' ride"), 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.
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.
•
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 tonsils and/or adenoids.
•
Avoid giving tramadol hydrochloride tablets to children between 12 to
18 years of age who have risk
factors for breathing problems such as obstructive sleep apnea,
obesity, or underlying lung prob

Produkta apraksts

TRAMADOL HYDROCHLORIDE- TRAMADOL HYDROCHLORIDE TABLET
NORTHSTAR RX LLC
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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._
•
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•
•
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RECENT MAJOR CHANGES
INDICATIONS AND USAGE
Tramadol hydrochloride tablets are an opioid agonist indicated in
adults for the management of pain severe enough to
require an opioid analgesic and for which alternative treatments are
inadequate (1).
Limitations of Use (1)
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
CH