TRAMADOL HYDROCHLORIDE 37.5 MG/ACETAMINOPHEN 325 MG, TABLETS

/TRAMADOL HYDROCHLORIDE 37.5 MG/ACETAMINOPHEN 325 MG, TABLETS
TRAMADOL HYDROCHLORIDE 37.5 MG/ACETAMINOPHEN 325 MG, TABLETS2018-09-06T09:12:40+00:00

Prescription Drug Name:

TRAMADOL HYDROCHLORIDE 37.5 MG/ACETAMINOPHEN 325 MG, TABLETS

ID:

7b4909e3-249e-4081-a6fb-d129e27c486a

Code:

34391-3

HEPATOTOXICITY


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displayName: BOXED WARNING SECTION
FDA Article Code: 34066-1

Tramadol Hydrochloride 37.5 mg/Acetaminophen 325 mg tablets contains tramadol HCl and acetaminophen. Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed 4,000 milligrams per day, and often involve more than one acetaminophen-containing product (see WARNINGS).

DESCRIPTION


id: ef7cef4f-33ad-4b70-b640-61c41b877112
displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3

Tramadol Hydrochloride 37.5 mg/Acetaminophen 325 mg tablets combine two analgesics, tramadol 37.5 mg and acetaminophen 325 mg. The chemical name for tramadol hydrochloride is (±)cis-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl) cyclohexanol hydrochloride. Its structural formula is: The molecular weight of tramadol hydrochloride is 299.84. Tramadol hydrochloride is a white, bitter, crystalline, and odorless powder. The chemical name for acetaminophen is N-acetyl-p-aminophenol. Its structural formula is: The molecular weight of acetaminophen is 151.17. Acetaminophen is an analgesic and antipyretic agent which occurs as a white, odorless, crystalline powder, possessing a slightly bitter taste. Tramadol Hydrochloride 37.5 mg/Acetaminophen 325 mg tablets contain 37.5 mg tramadol hydrochloride and 325 mg acetaminophen and are light yellow in color. Inactive ingredients in the tablet are powdered cellulose, pregelatinized corn starch, sodium starch glycolate, corn starch, magnesium stearate, hypromellose, polyethylene glycol, polysorbate 80, titanium dioxide, iron oxide, and carnauba wax.

CLINICAL PHARMACOLOGY


id: 5c5a8f40-8dbb-45a4-9db5-8a4ac2ce35ec
displayName: CLINICAL PHARMACOLOGY SECTION
FDA Article Code: 34090-1

The following information is based on studies of tramadol alone or acetaminophen alone, except where otherwise noted:

INDICATIONS AND USAGE


id: 8e77670e-2bd1-4d67-8cd6-b8fd2f354202
displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9

Tramadol HCl 37.5 mg/Acetaminophen 325 mg is indicated for the short-term (five days or less) management of acute pain.

CONTRAINDICATIONS


id: 798e5679-89b4-4903-8203-3213f217fd16
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3

Tramadol HCl 37.5 mg/Acetaminophen 325 mg should not be administered to patients who have previously demonstrated hypersensitivity to tramadol, acetaminophen, any other component of this product, or opioids. Tramadol HCl 37.5 mg/Acetaminophen 325 mg is contraindicated in any situation where opioids are contraindicated, including acute intoxication with any of the following: alcohol, hypnotics, narcotics, centrally acting analgesics, opioids, or psychotropic drugs. Tramadol HCl 37.5 mg/Acetaminophen 325 mg may worsen central nervous system and respiratory depression in these patients.

ADVERSE REACTIONS


id: d3b21e42-8528-4c2c-9c53-6189a86fd16f
displayName: ADVERSE REACTIONS SECTION
FDA Article Code: 34084-4

Table 2 reports the incidence rate of treatment-emergent adverse events over five days of Tramadol HCl 37.5 mg/Acetaminophen 325 mg use in clinical trials (subjects took an average of at least 6 tablets per day).

Table 2: Incidence of Treatment-Emergent Adverse Events (≥2.0%)
Body System
  Preferred Term Tramadol Hydrochloride 37.5 mg
/Acetaminophen 325 mg (N=142)
(%)
Gastrointestinal System Disorders
  Constipation 6
  Diarrhea 3
  Nausea 3
  Dry Mouth 2
Psychiatric Disorders
  Somnolence 6
  Anorexia 3
  Insomnia 2
Central & Peripheral Nervous System
  Dizziness 3
Skin and Appendages
  Sweating Increased 4
  Pruritus 2
Reproductive Disorders, Male
Number of males = 62
  Prostatic Disorder 2

OVERDOSAGE


id: e7580a05-64b0-47ec-9e1e-18dc7bfca7b1
displayName: OVERDOSAGE SECTION
FDA Article Code: 34088-5

Tramadol HCl 37.5 mg/Acetaminophen 325 mg is a combination product. The clinical presentation of overdose may include the signs and symptoms of tramadol toxicity, acetaminophen toxicity or both. The initial symptoms of tramadol overdosage may include respiratory depression and/or seizures. The initial symptoms seen within the first 24 hours following an acetaminophen overdose are: anorexia, nausea, vomiting, malaise, pallor and diaphoresis. An overdosage of Tramadol HCl 37.5 mg/Acetaminophen 325 mg tablets may be a potentially lethal polydrug overdose, and consultation with a regional poison control center is recommended.

DOSAGE AND ADMINISTRATION


id: eb366bd6-adfd-46ca-afc2-f6e86789ff43
displayName: DOSAGE & ADMINISTRATION SECTION
FDA Article Code: 34068-7

For the short-term (five days or less) management of acute pain, the recommended dose of Tramadol HCl 37.5 mg/Acetaminophen 325 mg is 2 tablets every 4 to 6 hours as needed for pain relief, up to a maximum of 8 tablets per day.

HOW SUPPLIED


id: 978701cd-10c0-4b7f-bd47-0b6a62fea7a1
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5

Tramadol Hydrochloride 37.5 mg/Acetaminophen 325 mg tablets are light yellow, coated, capsule-shaped tablets imprinted “O-M” on one side and “650” on the other and are available as follows:Bottles of 28   –  NDC 16590-230-28
Bottles of 30   –  NDC 16590-230-30
Bottles of 40   –  NDC 16590-230-40
Bottles of 50   –  NDC 16590-230-50
Bottles of 60   –  NDC 16590-230-60
Bottles of 84   –  NDC 16590-230-62
Bottles of 90   –  NDC 16590-230-90
Bottles of 100 –  NDC 16590-230-71
Bottles of 112 –  NDC 16590-230-73
Bottles of 120 –  NDC 16590-230-72
Bottles of 180 –  NDC 16590-230-82

PACKAGE LABEL – TRAMADOL / ACETAMIN 37.5 / 325 MG TABLETS


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displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4