Tell your health practitioner For anyone who is pregnant or think you might be pregnant. All through pregnancy, this merchandise will not be advised. It may harm an unborn toddler. Speak to your medical doctor concerning the hazards and great things about this medication. See also Warning area.
Opioids are sought by drug abusers and individuals with addiction disorders and are topic to prison diversion. Think about these risks when prescribing or dispensing Promethazine HCl and Codeine Phosphate Oral Alternative. Methods to cut back these pitfalls include prescribing the drug while in the smallest appropriate quantity and advising the affected person on the correct disposal of unused drug [see Client Counseling Information and facts (17)].
This product or service might have inactive components, which may trigger allergic reactions or other troubles. Discuss with your pharmacist for more details.
The consequences of concomitant use or discontinuation of cytochrome P450 3A4 inducers, 3A4 inhibitors, or 2D6 inhibitors with codeine are elaborate.
Promethazine should not be utilized by small children younger than two many years since it might bring about critical (maybe lethal) sluggish/shallow breathing. This problem has transpired Despite typical doses in this age group.
This product or service may have inactive components, which might result in allergic reactions or other difficulties. Speak to your pharmacist for more information.
Examine the Medication Information supplied by your pharmacist before you start getting promethazine/phenylephrine/codeine and each time you get a refill. When you've got any queries, question your medical professional or pharmacist.
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Certain reports to check the action of your drug on parturition, lactation, and development on the animal neonate weren't done, but a basic preliminary study in rats indicated no impact on these parameters.
If this SPL includes inactivated NDCs outlined because of the FDA initiated compliance motion, they will be specified therefore.
The consequences of concomitant use or discontinuation of cytochrome P450 3A4 inducers, 3A4 inhibitors, or 2D6 inhibitors with codeine are complicated, requiring thorough consideration of the effects within the mother or father drug, codeine, as well as Energetic metabolite, morphine.
Codeine is described to show no proof of carcinogenicity or mutagenicity in a variety of test programs, such as the micronucleus and sperm abnormality assays and also the Salmonella assay. Promethazine was nonmutagenic while in the Salmonella exam procedure of Ames.
When utilized for an extended time, this medication may not perform too and may need different dosing. Talk to your health care provider if this medication stops Doing work well.
To help prevent withdrawal, your medical professional may possibly reduce your dose bit by bit. Withdrawal is a lot more likely if you have utilised this medication for many years (quite a lot of weeks) or in significant doses. Notify your medical professional or pharmacist without delay if you have withdrawal.