Tramadol Hydrochloride And Acetaminophen

INDICATIONS AND USAGE Tramadol hydrochloride and acetaminophen tablets, USP are indicated for the short-term (five days or less) management of acute pain.

ADVERSE REACTIONS Table 2 reports the incidence rate of treatment-emergent adverse events over five days of tramadol hydrochloride and acetaminophen tablets use in clinical trials (subjects took an average of at least 6 tablets per day). Table 2: Incidence of Treatment-Emergent Adverse Events (≥2%) Body System Preferred Term Tramadol Hydrochloride and Acetaminophen Tablets (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 * Prostatic Disorder 2 * Number of males = 62 Incidence at least 1%, causal relationship at least possible or greater: the following lists adverse...

WARNINGS Hepatotoxicity Tramadol hydrochloride and acetaminophen tablets contain tramadol hydrochloride 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. The excessive intake of acetaminophen may be intentional to cause self-harm or unintentional as patients attempt to obtain more pain relief or unknowingly take other acetaminophen-containing products (see Boxed Warning). CONTRAINDICATIONS Tramadol hydrochloride and acetaminophen tablets, USP should not be administered to patients who have previously demonstrated hypersensitivity to tramadol, USP, acetaminophen, USP, any other component of this product, or opioids.