No evidence of tumorigenicity was observed in male and woman mice at codeine dietary doses as many as four hundred mg/kg/working day (around equivalent to 45 situations the MRHD over a mg/m2 basis).

Antihistamines and codeine are both equally contraindicated to be used from the cure of decreased respiratory tract indicators, including bronchial asthma.

A likely deadly symptom intricate occasionally often called Neuroleptic Malignant Syndrome (NMS) is reported in association with promethazine HCl by itself or in combination with antipsychotic medications.

The narcotic antagonist, naloxone hydrochloride, could possibly be administered when important respiratory melancholy happens with promethazine and codeine; any depressant consequences of promethazine are not reversed with naloxone. Diazepam can be utilized to manage convulsions. Prevent analeptics, which may trigger convulsions. Acidosis and electrolyte losses ought to be corrected. An increase in temperature or pulmonary troubles may well signal the necessity for institution of antibiotic therapy.

There's no standard arrangement about specific pharmacological procedure regimens for uncomplicated NMS.

Clearance might be diminished as well as the metabolites may possibly accumulate to Significantly larger plasma levels in people with renal failure when compared with people with ordinary renal functionality.

Elevated pressure in the head (improved intracranial force). Prevent the use of Promethazine Hydrochloride and Codeine Phosphate Oral Solution In case you have a head injury or happen to be explained to you have variations within the tissue of the brain (Mind lesions) or improved force as part of your head.

A healthcare Skilled must be consulted before getting any drug, modifying any diet regime or commencing or discontinuing any study course of treatment.

Warning sufferers that some individuals have a variation in a liver enzyme and change codeine into morphine a lot more rapidly and completely than other people. These persons are ultra-quick metabolizers and usually tend to have better-than-standard amounts of morphine of their blood soon after taking codeine which can result in overdose indications for example Severe sleepiness, confusion, or shallow respiration. In most cases, it really is not known if someone is definitely an extremely-speedy codeine metabolizer.

The believed qualifications threat of key birth defects and miscarriage for that indicated inhabitants is unfamiliar. All pregnancies have a history threat of birth defect, decline, or other adverse outcomes.

Severe, daily life-threatening, or deadly respiratory depression has been documented with the use of opioids, which includes codeine, one of many active elements in Promethazine HCl and Codeine Phosphate Oral Solution. Codeine generates dose-associated respiratory despair by straight acting about the Mind stem respiratory Centre that controls respiratory rhythm and should make irregular and periodic respiratory. Codeine is issue to variability in metabolism centered on CYP2D6 genotype, which can lead to a heightened exposure to the Lively metabolite morphine [see Warnings and Safety measures (5.three)]. Promethazine exerts a depressant impact on the respiratory Centre that is unbiased of and additive to that of other respiratory depressants, including codeine [see Warnings and Safeguards (five.

Postmarketing situations of Promethazine codeine syrup respiratory melancholy, such as fatalities have been noted with use of promethazine in pediatric clients.

Promethazine and codeine might bring about marked drowsiness or may impair the psychological and/or physical capabilities necessary with the performance of doubtless harmful tasks, like driving a car or truck or functioning machinery.

Drug interactions may possibly alter how your prescription drugs function or improve your threat for significant Unwanted effects. This document isn't going to incorporate all achievable drug interactions.