Promethazine HCl and Codeine Phosphate Oral Solution is indicated to the short term aid of coughs and upper respiratory signs affiliated with allergy or even the popular cold in sufferers 18 several years of age and older.
See comprehensive prescribing information and facts for full boxed warning. Promethazine with Codeine Oral Solution exposes people to hazards of dependancy, abuse, and misuse, which can result in overdose and death. Assess affected individual’s danger before prescribing and keep an eye on closely for these behaviors and disorders. ( 5.1) Significant, lifetime-threatening, or fatal respiratory depression may well occur. Observe carefully, Specifically upon initiation or when used in people at bigger threat. ( 5.two) Accidental ingestion of Promethazine with Codeine Oral Solution, Particularly by kids, may end up in a lethal overdose of codeine. ( five.two) Daily life-threatening respiratory despair and death have transpired in children who received codeine; most scenarios adopted tonsillectomy and/or adenoidectomy, and lots of of the youngsters had evidence of remaining an extremely-rapid metabolizer of codeine as a consequence of a CYP2D6 polymorphism. ( five.three) Promethazine with Codeine Oral Solution is contraindicated in children younger than twelve yrs of age As well as in little ones youthful than eighteen several years of age following tonsillectomy and/or adenoidectomy. ( 4) Stay away from the usage of Promethazine with Codeine Oral Solution in adolescents 12 to 18 yrs of age who have other danger factors that may increase their sensitivity into the respiratory depressant outcomes of codeine. Postmarketing scenarios of respiratory melancholy, like fatalities are claimed with usage of promethazine in pediatric clients. Little ones may very well be especially sensitive towards the additive respiratory depressant consequences when promethazine is blended with other respiratory depressants, including codeine.
Physical dependence, the situation wherein continued administration on the drug is needed to forestall the appearance of the withdrawal syndrome, assumes clinically important proportions only right after numerous months of continued oral opioid use, Though some moderate degree of Actual physical dependence might acquire after a couple of days of opioid therapy.
If a nursing mom is surely an ultra-immediate metabolizer of codeine, it may lead to morphine overdose while in the nursing newborn and lead to quite severe Negative effects. For nursing mothers getting this drugs:
Impaired secretion from sweat glands following toxic doses of medication with anticholinergic Unintended effects could predispose to hyperthermia.
If both medicines are prescribed alongside one another, your doctor might change the dose or how often you use one particular or both in the medicines.
Due to the fact these reactions could be documented voluntarily from a population of uncertain sizing, It is far from generally doable to reliably estimate their frequency or create a causal partnership to drug publicity.
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Codeine wasn't mutagenic within the in vitro bacterial reverse mutation assay or clastogenic within the in vitro Chinese hamster ovary (CHO) cell chromosomal aberration assay.
The consequences of concomitant use or discontinuation of cytochrome P450 3A4 inducers, 3A4 inhibitors, or 2D6 inhibitors with codeine are elaborate.
Postmarketing circumstances of respiratory despair, which includes fatalities are actually claimed with utilization of promethazine in pediatric people.
Keep in mind that this medication continues to be prescribed simply because your medical doctor has judged that the advantage for you is larger than the risk of Unwanted effects. A lot of people utilizing this medication would not have major Unintended effects.
Before you get Promethazine with Codeine Oral Solution, inform your healthcare provider about all of your healthcare situations, such as in the event you: Possess a drug dependence
These Unintended effects could go away for the duration of remedy as your body adjusts click here into the drugs. Also, your health and fitness care Specialist might be able to tell you about strategies to avoid or decrease Many of these Unwanted side effects. Verify with your wellness care Qualified if any of the following Negative effects carry on or are bothersome or Should you have any questions about them: