In case the reaction to an opioid antagonist is suboptimal or only quick in nature, administer extra antagonist as directed by the item’s prescribing information and facts. The respiratory depressant results of promethazine aren't reversed by opioid antagonists, including naloxone.
five.three Extremely-Rapid Metabolism of Codeine together with other Chance Things for Life-Threatening Respiratory Despair in Little ones Lifetime-threatening respiratory depression and Loss of life have happened in kids who acquired codeine. Codeine is issue to variability in metabolism centered on CYP2D6 genotype (described down below), which can result in an increased exposure to your active metabolite morphine. Primarily based upon post-marketing reviews, young children younger than twelve yrs aged appear to be much more vulnerable to the respiratory depressant effects of codeine, specifically if you will discover risk factors for respiratory despair.
Existence-threatening respiration challenges (respiratory depression). Promethazine Hydrochloride and Codeine Phosphate Oral Solution can result in breathing challenges (respiratory depression) that will take place Anytime through therapy and can cause Loss of life. Your threat of respiration challenges is greatest if you to start with start taking Promethazine Hydrochloride and Codeine Phosphate Oral Resolution, are using other medicines that can result in respiration challenges, have certain lung problems, are aged or have specified other health conditions.
are Expecting. Use of Promethazine Hydrochloride and Codeine Phosphate Oral Option in the course of pregnancy can cause withdrawal indicators in your new child infant that would be life-threatening Otherwise regarded and dealt with. Inform your healthcare provider right away In case you are pregnant or Believe you may be Expecting. •
Overdose of codeine in Grown ups continues to be connected to deadly respiratory depression, and the use of codeine in kids younger than 12 years of age has been associated with fatal respiratory depression when utilised as recommended [see Warnings and Precautions (five.
Steer clear of using promethazine HCl and codeine phosphate oral Option in adolescents 12 to 18 many years of age who produce other risk things that will boost their sensitivity to your respiratory depressant consequences of codeine.
Although the hazard of habit in any unique is not known, it could possibly happen in sufferers appropriately prescribed promethazine HCl and codeine phosphate oral Answer. Dependancy can occur at recommended dosages and if the drug is misused or abused. Challenges read more are enhanced in individuals with a private or relatives heritage of substance abuse (which includes drug or Alcoholic beverages abuse or habit) or psychological ailment (e.g., big despair).
Endocrine/Metabolic: Circumstances of serotonin syndrome, a probably daily life-threatening ailment, have been claimed in the course of concomitant use of opioids with serotonergic medications.
In some Women of all ages, this transpires very quickly. Codeine and morphine move into your breast milk. A great deal of morphine might cause your little one to die.
Clinical Factors Infants subjected to promethazine HCl and codeine phosphate oral Resolution by means of breast milk should be monitored for extra sedation and respiratory despair.
Codeine was not mutagenic while in the in vitro bacterial reverse mutation assay or clastogenic from the in vitro Chinese hamster ovary (CHO) mobile chromosomal aberration assay.
Monitor people using a background of seizure Conditions for worsened seizure Handle throughout promethazine HCl and codeine phosphate oral Resolution therapy.
Keep away from the usage of promethazine HCl and codeine phosphate oral Resolution in adolescents 12 to 18 a long time of age who have other danger elements that could raise their sensitivity to the respiratory depressant effects of codeine unless the advantages outweigh the threats.
Physical dependence, the situation in which continued administration in the drug is required to prevent the appearance of a withdrawal syndrome, assumes clinically important proportions only immediately after various weeks of ongoing oral opioid use, Though some mild degree of physical dependence might create immediately after a couple of days of opioid therapy.