ther of the individual components given at the same dose. The onset of pain relief after tramadol hydrochloride and acetaminophen was faster than tramadol alone. Onset of analgesia occurred in less than one hour. The duration of pain relief after tramadol hydrochloride and acetaminophen was longer than acetaminophen alone. Analgesia was generally comparable to that of the comparator, ibuprofen.
16 HOW SUPPLIED/STORAGE AND HANDLING
Tramadol Hydrochloride and Acetaminophen Tablets USP containing 37.5 mg of tramadol hydrochloride USP and 325 mg of acetaminophen USP are light yellow, capsule shaped, biconvex film-coated tablets debossed with “I90” on one side and plain on the other side and are available as follows.
Bottles of 30 NDC 65862-922-30
Bottles of 100 NDC 65862-922-01
Bottles of 500 NDC 65862-922-05
Bottles of 1,000 NDC 65862-922-99
10 x 10 Unit-dose Tablets NDC 65862-922-78
Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Dispense in a tight container.
17 PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Medication Guide).
Addiction, Abuse, and Misuse
Inform patients that the use of tramadol hydrochloride and acetaminophen, even when taken as recommended, can result in addiction, abuse, and misuse, which can lead to overdose and death [see WARNINGS AND PRECAUTIONS (5.1)]. Instruct patients not to share tramadol hydrochloride and acetaminophen with others and to take steps to protect tramadol hydrochloride and acetaminophen from theft or misuse.
Life-Threatening Respiratory Depression
Inform patients of the risk of life-threatening respiratory depression, including information that the risk is greatest when starting tramadol hydrochloride and acetaminophen or when the dosage is increased, and that it can occur even at recommended dosages [see WARNINGS AND PRECAUTIONS (5.2)]. Advise patients how to recognize respiratory depression and to seek medical attention if breathing difficulties develop.
Accidental Ingestion
Inform patients that accidental ingestion, especially by children, may result in respiratory depression or death [see WARNINGS AND PRECAUTIONS (5.2)]. Instruct patients to take steps to store tramadol hydrochloride and acetaminophen securely and to dispose of unused tramadol hydrochloride and acetaminophen in accordance with the local state guidelines and/or regulations.
Interactions with Benzodiazepines and Other CNS Depr
