Promethazine HCl and codeine phosphate oral Remedy isn't proposed for use in Expecting Females [see Use in Precise Populations (8.one)]. Extended usage of promethazine HCl and codeine phosphate oral Remedy during pregnancy may lead to neonatal opioid withdrawal syndrome, which can be daily life-threatening Otherwise regarded and taken care of, and requires management In keeping with protocols formulated by neonatology specialists.
you happen to be breathing incredibly rapid or struggling to breathe (you may grow to be pretty wheezy or really feel like you're choking or gasping for air)
Neuroleptic malignant syndrome (NMS) which may result in death. Convey to your Health care supplier instantly Should you have any of the subsequent signs of NMS:
If this SPL is made up of inactivated NDCs shown with the FDA initiated compliance action, They are going to be specified therefore.
Codeine has minimal plasma protein binding with about 7 to twenty five% of codeine certain to plasma proteins. Codeine passes the blood Mind barrier plus the placental barrier. Small quantities of codeine and its metabolite, morphine, are transferred to human breast milk.
Withdrawal symptoms can manifest in breastfed infants when maternal administration of an opioid is stopped, or when breastfeeding is stopped.
Usually do not get any benzodiazepines or medicines that can result in drowsiness or sleepiness through cure with Promethazine Hydrochloride and Codeine Phosphate Oral Resolution. Ask your healthcare service provider for a listing of these medicines if You aren't guaranteed.
Released reports with codeine have documented inconsistent findings and also have significant methodological limits (see Facts). You will find reviews of respiratory despair when codeine is applied through labor and supply (see Scientific Criteria).
Get hold of community condition Expert licensing board or state managed substances authority for info on how to avoid and detect abuse or diversion of this product.
The phosphate salt of codeine takes place as white, needle-shaped crystals or white crystalline powder. Codeine phosphate is freely soluble in water and slightly soluble in Alcoholic beverages. The molecular fat is 406.37. Its molecular formulation is C18H21NO3•H3PO4 • ½ H2O, and it has the next chemical construction.
Postmarketing instances of respiratory melancholy, which includes fatalities happen to be noted with usage of promethazine in pediatric sufferers.
Promethazine HCl and codeine phosphate oral Remedy, like other opioids, can be diverted for non-clinical use into illicit channels of distribution.
Labor or Supply Opioids cross the placenta and should create respiratory despair and psycho-physiologic results in neonates. An opioid antagonist, such as naloxone, need to be check here readily available for reversal of opioid-induced respiratory despair while in the neonate. Opioids, which include promethazine HCl and codeine phosphate oral Remedy, can lengthen labor by means of steps which temporarily decrease the toughness, duration, and frequency of uterine contractions.
1)]. Instruct patients not to share promethazine HCl and codeine phosphate oral solution with others and to choose steps to protect promethazine HCl and codeine phosphate oral Answer from theft or misuse.