Animal copy scientific studies have not been executed Along with the drug blend-promethazine and codeine. It is not recognised whether this drug blend could cause fetal hurt when administered into a Expecting lady or can influence copy potential.
Hyperexcitability and irregular movements are actually described in patients next an individual administration of promethazine HCl. Consideration really should be offered into the discontinuation of promethazine HCl and also to the usage of other drugs if these reactions occur.
Opioids are sought by drug abusers and those with habit Problems and so are matter to prison diversion. Consider these threats when prescribing or dispensing Promethazine HCl and Codeine Phosphate Oral Option. Approaches to cut back these threats include things like prescribing the drug while in the smallest appropriate quantity and advising the patient on the right disposal of unused drug [see Affected person Counseling Information and facts (17)].
Warning should be exercised when promethazine hydrochloride and codeine phosphate syrup is administered to the nursing female.
Promethazine and codeine may possibly result in marked drowsiness or may perhaps impair the mental and/or Actual physical capabilities required for that functionality of probably dangerous responsibilities, including driving a vehicle or functioning machinery.
Absorption Codeine is absorbed through the gastrointestinal tract with most plasma focus happening 60 minutes post administration. The existence of the substantial-Excess fat, superior-calorie meal didn't drastically influence the PK of codeine.
The exact mechanism of motion of codeine and other opiates is not really regarded; even so, codeine is believed to act centrally about the cough center. In abnormal doses, codeine will depress respiration.
Significant hypotension normally responds on the administration of norepinephrine or phenylephrine. EPINEPHRINE Shouldn't be Employed, considering that its use within a individual with partial adrenergic blockade could additional lower the hypertension.
Warning ought to be exercised when administering Promethazine HCl Oral Option to pediatric patients 2 yrs of age and older due to the probable for fatal respiratory depression. Respiratory melancholy and apnea, in some cases affiliated with Demise, are strongly associated with Promethazine goods and they are not directly associated with individualized fat-primarily based dosing, which might in any other case allow Risk-free administration.
Effects within the Cardiovascular Method Codeine provides peripheral vasodilation which may result in orthostatic hypotension or syncope. Manifestations of histamine release and/or peripheral vasodilation may perhaps involve pruritus, flushing, crimson eyes and more info perspiring and/or orthostatic hypotension.
Consideration needs to be specified into the discontinuation of Promethazine HCl also to the usage of other medicine if these reactions arise. Respiratory melancholy, nightmares, delirium, and agitated habits have also been documented in Many of these sufferers.
The opioid antagonists, naloxone and nalmefene, are distinct antidotes for respiratory despair resulting from opioid overdose. For clinically sizeable respiratory or circulatory melancholy secondary to codeine overdose, administer an opioid antagonist. An antagonist should not be administered in the absence of clinically sizeable respiratory melancholy. Because the period of opioid reversal is expected to be fewer than the duration of motion of codeine in Promethazine HCl and Codeine Phosphate Oral Remedy, cautiously monitor the client right up until spontaneous respiration is reliably reestablished.
In animal reproduction scientific studies, codeine administered because of the oral path to Expecting rats over the duration of organogenesis greater resorptions and lessened fetal weights in a dose somewhere around twenty five periods the most encouraged human dose (MRHD) from the existence of maternal toxicity (see Information).
Bodily dependence, the problem during which ongoing administration on the drug is required to circumvent the appearance of the withdrawal syndrome, assumes clinically important proportions only right after several months of ongoing oral opioid use, Despite the fact that some mild diploma of physical dependence may possibly create just after a few days of opioid therapy.