TRAMADOL HYDROCHLORIDE- tramadol hydrochloride tablet, coated

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Aktív összetevők:

Tramadol Hydrochloride (UNII: 9N7R477WCK) (Tramadol - UNII:39J1LGJ30J)

Beszerezhető a:

Precision Dose, Inc.

Az alkalmazás módja:

ORAL

Recept típusa:

PRESCRIPTION DRUG

Terápiás javallatok:

Tramadol HCl tablets are indicated for the management of pain in adults that is severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses (see WARNINGS ), reserve tramadol HCl 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 HCl tablets 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, any other component of this product or opioids (see WARNINGS ). - Concurrent use of monoamine oxidase in

Termék összefoglaló:

Tramadol HCl tablets, USP, 50 mg , are supplied as unscored, white, round film-coated tablets debossed "AN" over "627". They are supplied as follows: NDC 68094-017-61 Unit Dose Packages of 100 Tablets (10 × 10) per carton Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Dispense in a tight container as defined in the USP.

Engedélyezési státusz:

Abbreviated New Drug Application

Betegtájékoztató

Precision Dose, Inc.
----------
MEDICATION GUIDE
TRAMADOL (TRAM-A-DOL) HYDROCHLORIDE TABLETS, USP, CIV
This Medication Guide has been approved by the U.S. Food and Drug
Administration.
Tramadol HCl 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 HCl tablets:
•
Get emergency help right away if you take too much tramadol HCl
tablets (overdose). When you first
start taking tramadol HCl 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 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 tablets. They could die from
taking it. Store tramadol HCl
tablets away from children and in a safe place to prevent stealing or
abuse. Selling or giving away
tramadol HCl tablets is against the law.
Do not take tramadol HCl tablets if you have:
•
Severe asthma, trouble breathing, or other lung problems.
•
A bowel blockage or have narrowing of the stomach or intestines.
•
An allergy to tramadol.
•
Taken a Monoamine Oxidase Inhibitor, MAOI, (medicine used for
depression) within the last 14
days.
Before taking tramadol HCl tablets, tell your healthcare provider if
you have a history of:
•
head injury, seizures
•
problems urinating
•
abuse of street or prescription drugs, alcohol addiction, or mental
health problems.
•
liver, kidney, thyr

Termékjellemzők

TRAMADOL HYDROCHLORIDE- TRAMADOL HYDROCHLORIDE TABLET, COATED
PRECISION DOSE, INC.
----------
TRAMADOL HYDROCHLORIDE
TABLETS, USP
CIV
RX ONLY
WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING
RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID
WITHDRAWAL SYNDROME; INTERACTIONS WITH DRUGS AFFECTING
CYTOCHROME P450 ISOENZYMES; AND RISKS FROM CONCOMITANT USE WITH
BENZODIAZEPINES OR OTHER CNS DEPRESSANTS
ADDICTION, ABUSE AND MISUSE
TRAMADOL HCL 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 TRAMADOL HCL, AND MONITOR 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
HCL. MONITOR FOR RESPIRATORY DEPRESSION, ESPECIALLY DURING INITIATION
OF TRAMADOL HCL OR
FOLLOWING A DOSE INCREASE (SEE WARNINGS).
ACCIDENTAL INGESTION
ACCIDENTAL INGESTION OF TRAMADOL HCL, ESPECIALLY BY CHILDREN, CAN BE
FATAL (SEE
WARNINGS).
NEONATAL OPIOID WITHDRAWAL SYNDROME
PROLONGED USE OF TRAMADOL HCL DURING PREGNANCY CAN RESULT IN NEONATAL
OPIOID WITHDRAWAL
SYNDROME, WHICH MAY BE LIFE-THREATENING IF NOT RECOGNIZED AND TREATED,
AND REQUIRES
MANAGEMENT ACCORDING TO PROTOCOLS DEVELOPED BY NEONATOLOGY EXPERTS. IF
OPIOID USE IS
REQUIRED FOR A PROLONGED PERIOD IN A PREGNANT WOMAN, ADVISE THE
PATIENT OF THE RISK OF
NEONATAL OPIOID WITHDRAWAL SYNDROME AND ENSURE THAT APPROPRIATE
TREATMENT WILL BE
AVAILABLE (SEE WARNINGS).
INTERACTIONS WITH DRUGS AFFECTING CYTOCHROME P450 ISOENZYMES
THE EFFECTS OF CONCOMITANT USE OR DISCONTINUATION OF CYTOCHROME P450
3A4 INDUCERS, 3A4
INHIBITORS, OR 2D6 INHIBITORS WITH TRAMADOL ARE COMPLEX. USE OF
CYTOCHROME P450 3A4
INDUCERS, 3A4 INHIBITORS, OR 2D6 INHIBITORS WITH TRAMADOL HCL REQUIRES
CAREFUL
CONSIDERATION OF THE EFFECTS ON THE PARENT DRUG, TRAMADOL, AND THE
ACTIVE METABOLITE, M1 (SEE
WARNINGS, PRECAUTIONS; DRUG INT