TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN tablet

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

TRAMADOL HYDROCHLORIDE (UNII: 9N7R477WCK) (TRAMADOL - UNII:39J1LGJ30J), ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)

Sẵn có từ:

Macleods Pharmaceuticals Limited

INN (Tên quốc tế):

TRAMADOL HYDROCHLORIDE

Thành phần:

TRAMADOL HYDROCHLORIDE 37.5 mg

Tuyến hành chính:

ORAL

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

Tramadol hydrochloride and acetaminophen tablets are indicated for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use Tramadol hydrochloride and acetaminophen tablets are indicated for short-term use of five days or less. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.1], reserve tramadol hydrochloride and acetaminophen 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 and acetaminophen is contraindicated for: • all children younger than 12 years of age [see Warnings and Precautions ( 5.4 ) ] • post-operative management in children younger than 18 years of age following tonsillectomy and

Tóm tắt sản phẩm:

Tramadol hydrochloride and acetaminophen tablets, USP 37.5 mg/325 mg are light yellow, capsule shaped, biconvex, beveled edge, film-coated tablets debossed with "L21" on one side and plain on other side and are supplied as follows: Bottles of 100                                     NDC 33342-202-11 Bottles of 500                                     NDC 33342-202-15 Bottles of 1000                                   NDC 33342-202-44 Unit dose blister pack 100 (10 x 10's) NDC 33342-202-12 Dispense in a tight container. Store at 20°C 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 and acetaminophen tablets securely and dispose of properly [see Patient Counseling Information(17) ].

Tình trạng ủy quyền:

Abbreviated New Drug Application

Tờ rơi thông tin

TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN - TRAMADOL HYDROCHLORIDE AND
ACETAMINOPHEN TABLET
Macleods Pharmaceuticals Limited
----------
SPL MEDGUIDE SECTION
Medication Guide
Tramadol hydrochloride (TRAM-a-dol HYE-droe-KLOR-ide) and
acetaminophen (a seet'' a min'oh fen)
Tablets, CIV
Tramadol hydrochloride and acetaminophen tablets are:
• A strong prescription pain medicine that contains an opioid
(narcotic) that is used for the short-term (five
days or less) management of acute pain, 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 and acetaminophen
tablets:
• Get emergency help right away if you take too much tramadol
hydrochloride and acetaminophen tablets
(overdose). When you first start taking tramadol hydrochloride and
acetaminophen 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.
• Tramadol hydrochloride and acetaminophen tablets can cause severe
drowsiness, breathing problems
(respiratory depression), coma and death when taken with
benzodiazepines or other medicines that depress
consciousness.
• Never give anyone else your tramadol hydrochloride and
acetaminophen tablets. They could die from
taking it. Selling or giving away tramadol hydrochloride and
acetaminophen tablets are against the law.
Store tramadol hydrochloride and acetaminophen tablets securely, out
of sight and reach of children, and in a
location not accessible by others, including visitors to the home.
• Get emergency help right away if you take more than 4,000 mg of
acetaminophen in 1 day. Taking
tramadol hydrochloride and acetaminophen tablets with other products
that contain acetaminophen can lead
to

Đặc tính sản phẩm

TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN - TRAMADOL HYDROCHLORIDE AND
ACETAMINOPHEN TABLET
MACLEODS PHARMACEUTICALS LIMITED
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
TRAMADOL HYDROCHLORIDE AND
ACETAMINOPHEN TABLETS, SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR TRAMADOL
HYDROCHLORIDE AND ACETAMINOPHEN TABLETS.
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLETS, FOR ORAL USE, C-IV
INITIAL U.S. APPROVAL – 2001
WARNING: ADDICTION, ABUSE, AND MISUSE; RISK EVALUATION AND MITIGATION
STRATEGY
(REMS); LIFETHREATENING 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; HEPATOTOXICITY; AND RISKS
FROM
CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
• TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLETS EXPOSES 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 AND ACETAMINOPHEN 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 AND ACETAMINOPHEN
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