[see WARNINGS AND PRECAUTIONS (5.1)].
Monitor patients closely for respiratory depression, especially within the first 24 to 72 hours of initiating therapy and following dosage increases with tramadol hydrochloride and acetaminophen tablets and adjust the dosage accordingly [see WARNINGS AND PRECAUTIONS (5.2)].
2.2 Initial Dosage
The initial dose of tramadol hydrochloride and acetaminophen tablets is 2 tablets every 4 to 6 hours as needed for pain relief up to a maximum of 8 tablets per day.
2.3 Dosage Modification in Patients with Renal Impairment
In patients with creatinine clearances of less than 30 mL/min, do not exceed 2 tablets every 12 hours.
2.4 Discontinuation of Tramadol Hydrochloride and Acetaminophen Tablets
Tramadol hydrochloride and acetaminophen tablets are not approved for use greater than 5 days. In circumstances where physical dependence with tramadol hydrochloride and acetaminophen tablets is possible, use a gradual downward taper and do not stop use of tramadol hydrochloride and acetaminophen tablets abruptly [see WARNINGS AND PRECAUTIONS (5.18)].
3 DOSAGE FORMS AND STRENGTHS
Tramadol hydrochloride and acetaminophen tablets USP each contain 37.5 mg of tramadol hydrochloride USP and 325 mg of acetaminophen USP. The tablets are light yellow, capsule shaped, biconvex film-coated debossed with “I90” on one side and plain on the other side.
4 CONTRAINDICATIONS
Tramadol hydrochloride and acetaminophen tablets are contraindicated in patients with:
Significant respiratory depression [see WARNINGS AND PRECAUTIONS (5.2)].
Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see WARNINGS AND PRECAUTIONS (5.11)].
Patients with known or suspected gastrointestinal obstruction, including paralytic ileus [see WARNINGS AND PRECAUTIONS (5.15)].
Hypersensitivity to tramadol, acetaminophen, any other component of this product [see WARNINGS AND PRECAUTIONS (5.16)].
Concurrent use of monoamine oxidase inhibitors (MAOIs) or use within the last 14 days [see DRUG INTERACTIONS (7)].
5 WARNINGS AND PRECAUTIONS
5.1 Addiction, Abuse and Misuse
Tramadol hydrochloride and acetaminophen tablets contain tramadol, a Schedule IV controlled substance. As an opioid, tramadol hydrochloride and acetaminophen exposes users to the risks of addiction, abuse, and misuse [see DRUG ABUSE AND DEPENDENCE (9)].
Although the risk of addiction in any individual is unknown, it can occur in patients appropriately prescribed tramadol hydrochloride and acetaminophen. Addiction can occur at recommended dosages and if the drug is misused or abused.
Assess each patient’s risk for opioid addiction, abuse, or misuse prior to prescribing tramadol hydrochloride and acetaminophen, and monitor all patients receiving tramadol hydrochloride and acetaminophen for the development of these behaviors and conditions. Risks are increased in patients with a personal or family history of substance abuse (including drug or alcohol abuse or addiction) or mental illness (e.g., major depression). The potential for these risks should not, however, prevent the proper management of pain in any given patient. Patients at increased risk may be prescribed opioids such as tramadol hydrochloride and acetaminophen, but use in such patients necessitates intensive counseling about the risks and proper use of tramadol hydrochloride and acetaminophen along with |
