Anaphylaxis: Anaphylaxis is reported with codeine, on the list of substances in promethazine HCl and codeine phosphate oral Alternative.
The opioid antagonists, naloxone and nalmefene, are precise antidotes for respiratory depression ensuing from opioid overdose. For clinically considerable respiratory or circulatory melancholy secondary to codeine overdose, administer an opioid antagonist. An antagonist should not be administered while in the absence of clinically significant respiratory despair. As the period of opioid reversal is predicted for being below the duration of action of codeine in promethazine HCl and codeine phosphate oral Remedy, cautiously observe the affected person until finally spontaneous respiration is reliably reestablished.
Existence-threatening breathing problems (respiratory melancholy). Promethazine Hydrochloride and Codeine Phosphate Oral Answer could potentially cause breathing troubles (respiratory melancholy) which will happen Anytime during treatment and may lead to Loss of life. Your possibility of breathing challenges is greatest when you very first begin having Promethazine Hydrochloride and Codeine Phosphate Oral Answer, are taking other medicines that could cause breathing complications, have sure lung problems, are elderly or have sure other health problems.
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Evaluate Each individual client’s risk ahead of prescribing promethazine HCl and codeine phosphate oral Alternative, prescribe promethazine HCl and codeine phosphate oral Option to the shortest length that is certainly in keeping with person affected person remedy objectives, keep track of all individuals on a regular basis for the development of addition or abuse, and refill only soon after reevaluation of the need for ongoing therapy. [see Warnings and Precautions (5.1)]
Promethazine HCl and codeine phosphate oral Resolution should be made use of with caution in sufferers with impairment of hepatic functionality, and patients must be monitored carefully for respiratory depression, sedation, and hypotension.
Promethazine HCl and codeine phosphate oral Option exposes people and other customers on the threats of opioid addiction, abuse, and misuse, which can cause overdose and Dying. Reserve promethazine HCl and codeine phosphate oral Alternative for use in adult people for whom the many benefits of cough suppression are predicted to outweigh the challenges, and in whom an sufficient assessment with the etiology with the cough has actually been manufactured.
5.eight Actions Necessitating Psychological Alertness: Pitfalls of Driving or Running Equipment Codeine and promethazine, two of your active substances in promethazine HCl and codeine phosphate oral Answer, may well create marked drowsiness and impair the psychological and/or Bodily capabilities needed for the effectiveness of potentially dangerous tasks such as driving a car or truck or operating machinery.
five.two Life-Threatening Respiratory Melancholy Severe, lifetime-threatening, or lethal respiratory despair continues to be described with using opioids, including codeine, among the list of Lively ingredients in promethazine HCl and codeine phosphate oral Answer. Codeine produces dose-relevant respiratory depression by immediately acting to the Mind stem respiratory Middle that controls respiratory rhythm and will generate irregular and periodic breathing. Codeine is issue to variability in metabolism based mostly on CYP2D6 genotype, which may result in an increased exposure to your active metabolite morphine [see Warnings and Safety measures (5.
Propulsive peristaltic waves during the colon are decreased, while tone could possibly be amplified to the point of spasm resulting in constipation. Other opioid-induced results could include things like a discount in biliary and pancreatic secretions, spasm of sphincter of Oddi, and transient elevations in serum amylase.
Promethazine HCl and codeine phosphate oral solution is just not recommended for use in pregnant Females. Prolonged utilization of promethazine HCl and codeine phosphate oral Option throughout pregnancy may lead to neonatal opioid withdrawal syndrome, which can be everyday living-threatening Otherwise acknowledged and taken care of.
Labor or Shipping Opioids cross the placenta and could generate respiratory melancholy and psycho-physiologic consequences in neonates. An opioid antagonist, including naloxone, need to be available for reversal of opioid-induced respiratory depression while in the neonate. Opioids, together with promethazine HCl and codeine phosphate oral Answer, can extend labor through steps which briefly lessen the strength, duration, and frequency of uterine contractions.
Recommend individuals to not boost the dose or dosing frequency of promethazine HCl and codeine phosphate oral solution simply because major adverse events for instance respiratory despair may well come about with overdosage [see Warnings and Precautions (5.
Promethazine HCl and codeine phosphate oral Remedy is for oral use only. Abuse of promethazine HCl and codeine phosphate oral more info Option poses a hazard of overdose and Demise.