TRAMADOL HYDROCHLORIDE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Contract Pharmacy Services-PA

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Tramadol hydrochloride 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. Limitations of Use Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses ( see WARNINGS), 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 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

Product summary:

Tramadol hydrochloride tablets, USP 50 mg is available as white capsule shaped film coated tablets, debossed with “377” on one side and plain on the other side. 30's NDC 67046-729-30 Blisterpacks of 30 Dispense in tight container. Store at 25°C (77°F); excursions permitted to 15 - 30°C (59 -86°F). [see USP Controlled Room Temperature]. Distributed By: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 PGPI0173I Rev. 03/17 Repackaged by: Contract Pharmacy Services-PA 125 Titus Ave Suite 200 Warrington, PA 18976 USA

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Contract Pharmacy Services-PA
----------
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. Store
tramadol hydrochloride tablets away from children and in a safe place
to prevent stealing or
abuse. Selling or giving away tramadol hydrochloride tablets are
against the law.
Do not take tramadol hydrochloride tabletsif 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 hydrochloride tablets, tell your healthcare
provider if you have a history of:
•
head injury, seizures
•
liver, kidney, thyroid problems
•
problems urinating
•
pancreas or gallbladde

Summary of Product characteristics

TRAMADOL HYDROCHLORIDE- TRAMADOL HYDROCHLORIDE TABLET
CONTRACT PHARMACY SERVICES-PA
----------
TRAMADOL HYDROCHLORIDE TABLETS, USP, CIV 729
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 HYDROCHLORIDE TABLETS EXPOSE 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 HYDROCHLORIDE TABLETS, 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
HYDROCHLORIDE TABLETS. MONITOR FOR RESPIRATORY DEPRESSION, ESPECIALLY
DURING INITIATION OF
TRAMADOL HYDROCHLORIDE TABLETS OR FOLLOWING A DOSE INCREASE ( SEE
WARNINGS).
ACCIDENTAL INGESTION
ACCIDENTAL INGESTION OF TRAMADOL HYDROCHLORIDE TABLETS, ESPECIALLY BY
CHILDREN, CAN BE FATAL. (
SEE WARNINGS).
NEONATAL OPIOID WITHDRAWAL SYNDROME
PROLONGED USE OF TRAMADOL HYDROCHLORIDE TABLETS 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
HYDROCHLORIDE TABLETS REQUIRES
CAREF