If this SPL contains inactivated NDCs mentioned by the FDA initiated compliance motion, they will be specified as a result.
Dosing problems have resulted from confusion involving mg and mL when prescribing, dispensing, and administering oral Alternative; ensure that dose is communicated Obviously and dispensed precisely
Educate sufferers and caregivers on how to acknowledge respiratory despair and emphasize the significance of contacting 911 or finding crisis medical assist right away within the event of a identified or suspected overdose (see PRECAUTIONS, Info for Individuals/Caregivers).
Blend acetaminophen and codeine phosphate tablets (will not crush) with an unpalatable substance including dirt, cat litter, or applied espresso grounds;
As the duration of opioid reversal is anticipated to become a lot less than the length of action of codeine in acetaminophen and codeine phosphate tablets, diligently keep an eye on the patient right up until spontaneous respiration is reliably reestablished. In the event the reaction to an opioid antagonist is suboptimal or only short in mother nature, administer supplemental antagonist as directed through the product’s prescribing data. In an individual physically depending on opioids, administration in the recommended normal dosage of your antagonist will precipitate an acute withdrawal syndrome.
Codeine crosses the blood-brain barrier which is found in fetal tissue and breast milk. The plasma focus isn't going to correlate with brain focus or reduction of soreness. Codeine is about 7 to 25% sure to plasma proteins and will not accumulate in overall body tissues.
Serotonin syndrome: Scenarios of serotonin syndrome, a probably life-threatening affliction, have already been claimed for the duration of concomitant utilization of opioids with serotonergic drugs.
Patient Use of Naloxone with the Crisis Therapy of Opioid Overdose Go over The supply of naloxone for that emergency therapy of opioid overdose with the patient and caregiver and assess the likely need to have for access to naloxone, both when initiating and renewing click here therapy with acetaminophen and codeine phosphate tablets. Notify people and caregivers about the assorted approaches to get naloxone as permitted by individual state naloxone dispensing and prescribing needs or pointers (e.
Codeine provides respiratory despair by immediate motion on brain stem get more info respiratory facilities. The respiratory melancholy requires a reduction in the responsiveness of the Mind stem respiratory facilities to both of websiteclick here those boosts in carbon dioxide pressure and electrical stimulation.
If concomitant read more utilization of CYP3A4 inhibitor is essential, think about dosage reduction of acetaminophen and codeine tablets right up until secure drug effects are attained. Appraise patients at Repeated intervals for respiratory despair and sedation.
Nevertheless it can help Lots of individuals, this medication may well from time to time result in habit. This danger could be greater When you have a substance use ailment (for instance overuse of or addiction to medication/Alcoholic beverages).
Acetaminophen and codeine phosphate tablets, like other opioids, may be diverted for nonmedical use into illicit channels of distribution.
Expecting or planning to come to be Expecting. Prolonged utilization of Acetaminophen and Codeine Phosphate Tablets, USP throughout pregnancy could potentially cause withdrawal symptoms inside your new child little one that may be life-threatening Otherwise recognized and dealt with.
Alert patients not to generate or function unsafe equipment Until They are really tolerant to the results of acetaminophen and codeine phosphate tablets and know the way they can react for the medication (see Safeguards, Information for Individuals/Caregivers).