TRAMADOL HYDROCHLORIDE- tramadol hydrochloride tablet, coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

REMEDYREPACK INC.

INN (International Name):

TRAMADOL HYDROCHLORIDE

Composition:

TRAMADOL HYDROCHLORIDE 50 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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. Limitations of Use 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 are contraindicated for: - all children younger than 12 years of age (see WARNINGS ) all children younger than 12 years of age (see WARNINGS ) - post-operative management in children younger than 18 years of age following tonsillectomy and/or adenoidectomy (see WARNINGS ). post-operative management in children younger than 18 years of age following tonsillectomy and/or adenoidectomy (see WARNINGS ). Tramadol HCl t

Product summary:

Tramadol HCl tablets, USP, 50 mg, are supplied as unscored, white, round film-coated tablets debossed “AN” over “627” on one side and plain on the other side. They are supplied as follows: Bottles of 10 count:                NDC 65162-627-01 Bottles of 100 count:              NDC 65162-627-10 Bottles of 500 count:              NDC 65162-627-50 Bottles of 1000 count:            NDC 65162-627-11 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. Manufactured by: Amneal Pharmaceuticals of NY LLC Brookhaven, NY 11719 Distributed by: Amneal Pharmaceuticals LLC Glasgow, KY 42141 Rev. 10-2018-07

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

REMEDYREPACK INC.
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MEDICATION GUIDE
Tramadol (TRAM-a-dol) Hydrochloride Tablets USP, CIV
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 many 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.
Important Information Guiding Use in Pediatric Patients:
• Do not give tramadol HCl tablets to a child younger than 12 years
of age.
• Do not give tramadol HCl tablets to a child younger than 18 years
of age after surgery to remove the
tonsils and/or adenoids.
• Avoid giving tramadol HCl 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 problems.
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 al

Summary of Product characteristics

TRAMADOL HYDROCHLORIDE- TRAMADOL HYDROCHLORIDE TABLET, COATED
REMEDYREPACK INC.
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TRAMADOL HYDROCHLORIDE TABLETS, USP CIV
(50 MG)
RX ONLY
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
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).
OPIOID ANALGESIC RISK EVALUATION AND MITIGATION STRATEGY (REMS)
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 REMS FOR
THESE PRODUCTS
(SEE WARNINGS). UNDER THE REQUIREMENTS OF THE REMS, DRUG COMPANIES
WITH APPROVED
OPIOID ANALGESIC PRODUCTS MUST MAKE REMS COMPLIANT EDUCATION PROGRAMS
AVAILABLE TO
HEALTHCARE PROVIDERS. HEALTHCARE PROVIDERS ARE STRONGLY ENCOURAGED TO
COMPLETE A REMS-COMPLIANT EDUCATION PROGRAM.
COUNSEL PATIENTS AND/OR THEIR CAREGIVERS, WITH EVERY PRESCRIPTION, ON
SAFE USE, SERIOUS
RISKS, STORAGE, AND DISPOSAL OF THESE PRODUCTS.
EMPHASIZE TO PATIENTS AND THEIR CAREGIVERS THE IMPORTANCE OF READING
THE MEDICATION
GUIDE EVERY TIME IT IS PROVIDED BY THEIR PHARMACIST.
CONSIDER OTHER TOOLS TO IMPROVE PATIENT, HOUSEHOLD, AND COMMUNITY
SAFETY.
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