Animal copy studies haven't been carried out With all the drug mix-promethazine and codeine. It is far from acknowledged no matter whether this drug combination could potentially cause fetal harm when administered to the pregnant female or can have an effect on replica ability.
It is important that Promethazine HCl Oral Option is measured using an correct measuring gadget (see Safety measures-Information and facts for People). A family teaspoon will not be an accurate measuring machine and could lead on to overdosage, especially when half a teaspoon would be to be measured.
Respiratory difficulties (respiratory despair)that can result in Demise and opioid withdrawal can take place if you start using or quit using other medicines while having Promethazine Hydrochloride and Codeine Phosphate Oral Resolution, such as:
DailyMed will provide notification of updates and additions to Drug Label data at this time demonstrated on This page via its RSS feed.
The mixture of promethazine hydrochloride and codeine phosphate is contraindicated in pediatric patients a lot less than 6 yrs of age. Concomitant administration of promethazine items with other respiratory depressants has an Affiliation with respiratory melancholy, and occasionally Demise, in pediatric patients.
Narcotic analgesics could lead to nausea and vomiting by stimulating the chemoreceptor result in zone (CTZ); however, In addition they depress the vomiting Centre, so that subsequent doses are not likely to produce vomiting. Nausea is minimal after usual oral doses of codeine.
If this SPL consists of inactivated NDCs outlined via the FDA initiated compliance action, they will be specified as a result.
For example, lots of claimed situations of Loss of life happened from the put up-operative time period following tonsillectomy and/or adenoidectomy, and several of the kids experienced evidence of being extremely-fast metabolizers of codeine. Furthermore, small children with obstructive rest apnea who are dealt with with codeine for submit-tonsillectomy and/or adenoidectomy pain can be specifically delicate to its respiratory depressant result. Due to chance of life-threatening respiratory melancholy and Dying:
Cure of Overdose Therapy of overdosage is driven by the overall medical presentation, and is made of discontinuation of Promethazine HCl and Codeine Phosphate Oral Alternative along with establishment of appropriate therapy. Give Major awareness to the reestablishment of satisfactory respiratory exchange by way of provision of the patent and guarded airway as well as establishment of assisted or managed air flow.
If your reaction to an opioid antagonist is suboptimal or only transient in character, administer more antagonist as directed because of the products’s prescribing information and facts. The respiratory depressant consequences of promethazine are not reversed by opioid antagonists, such as naloxone.
It's important that Promethazine HCl Oral Solution is measured having an correct measuring device (see PRECAUTIONS-Information and facts for Clients). A home teaspoon is not an precise measuring gadget and could lead on to overdosage, especially when 50 % a teaspoon is always to be measured.
Hemodialysis is not really routinely made use of to reinforce the elimination of codeine or promethazine from the body.
The causal purpose of opioids in the clinical syndrome of hypogonadism is unfamiliar since the many healthcare, physical, Life-style, and psychological stressors that will impact gonadal hormone concentrations haven't been sufficiently managed for in studies performed up to now [see Adverse Reactions (6)].
The diagnostic analysis of sufferers with this particular syndrome is complicated. In arriving in a diagnosis, it get more info is important to determine cases where the medical presentation consists of equally major health care health issues (e.