roductive potential that tramadol hydrochloride and acetaminophen can cause fetal harm and to inform the healthcare provider of a known or suspected pregnancy [see USE IN SPECIFIC POPULATIONS (8.1)].
Lactation
Advise nursing mothers to monitor infants for increased sleepiness (more than usual), breathing difficulties, or limpness. Instruct nursing mothers to seek immediate medical care if they notice these signs [see USE IN SPECIFIC POPULATIONS (8.2)].
Infertility
Inform patients that chronic use of opioids may cause reduced fertility. It is not known whether these effects on fertility are reversible [see USE IN SPECIFIC POPULATIONS (8.3)].
Driving or Operating Heavy Machinery
Inform patients that tramadol hydrochloride and acetaminophen may impair the ability to perform potentially hazardous activities such as driving a car or operating heavy machinery. Advise patients not to perform such tasks until they know how they will react to the medication [see WARNINGS AND PRECAUTIONS (5.19)].
Constipation
Advise patients of the potential for severe constipation, including management instructions and when to seek medical attention [see ADVERSE REACTIONS (6)].
Disposal of Unused Tramadol Hydrochloride and Acetaminophen
Advise patients to throw the unused tramadol hydrochloride and acetaminophen in the household trash following these steps. 1) Remove the drugs from their original containers and mix with an undesirable substance, such as used coffee grounds or kitty litter (this makes the drug less appealing to children and pets, and unrecognizable to people who may intentionally go through the trash seeking drugs). 2) Place the mixture in a sealable bag, empty can, or other container to prevent the drug from leaking or breaking out of a garbage bag.
Maximum Daily Acetaminophen Use
Advise patients not to take more than 4,000 milligrams of acetaminophen per day and call their doctor if they have taken more than the recommended dose [see WARNINGS AND PRECAUTIONS (5.5, 5.17)].
Use with Other Acetaminophen-Containing Products
Advise patients not to take tramadol hydrochloride and acetaminophen tablets in combination with other tramadol or acetaminophen-containing products, including over-the-counter preparations [see WARNINGS AND PRECAUTIONS (5.5, 5.17)].
Dispense with Medication Guide available at: www.aurobindousa.com/product-medication-guides
MEDICATION GUIDE
Tramadol Hydrochloride and Acetaminophen Tablets USP CIV
(tram' a dol hye'' droe klor' ide and a seet'' a min' oh fen)
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 (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 breathin |
