If this SPL includes inactivated NDCs mentioned through the FDA initiated compliance action, they will be specified as such.

Use of cytochrome P450 3A4 inducers, 3A4 inhibitors, or 2D6 inhibitors with Promethazine with Codeine Oral Answer involves mindful consideration of the effects on the father or mother drug, codeine, plus the Energetic metabolite, morphine.

Promethazine hydrochloride and codeine phosphate syrup is indicated with the momentary relief of coughs and higher respiratory signs and symptoms linked with allergy or the prevalent chilly.

The potential risk of infant publicity to codeine and morphine through breast milk ought to be weighed against the many benefits of breastfeeding for both of those the mother and little one. Warning must be exercised when codeine is administered to a nursing girl. If a codeine-made up of products is selected, the bottom dose really should be prescribed for the shortest timeframe to accomplish the specified scientific effect. Moms making use of codeine must be informed about when to hunt quick healthcare treatment and the way to establish the signals and signs or symptoms of neonatal toxicity, for example drowsiness or sedation, trouble breastfeeding, respiration problems, and decreased tone, inside their toddler.

Youngsters could possibly be specifically sensitive on the additive respiratory depressant outcomes when promethazine is merged with other respiratory depressants, which include codeine.

Instruct nursing mothers to talk to the newborn's doctor instantly whenever they recognize these symptoms and, if they can't reach the health practitioner at once, to go ahead and take toddler to an crisis room or call 911 (or local emergency companies).

Assess Every single client's chance previous to prescribing Promethazine with Codeine Oral Resolution, prescribe Promethazine with Codeine Oral Resolution for that shortest duration that's consistent with unique affected individual cure aims, keep an eye on all clients regularly for the event of addition or abuse, and refill only right after reevaluation of the need for ongoing therapy. [see Warnings and Safety measures (5.one)]

Promethazine is surely an H1 receptor blocking agent. As well as its antihistaminic motion, it offers clinically valuable sedative and antiemetic effects.

The precise mechanism of motion of codeine read more and various opiates isn't identified; however, codeine is thought to act centrally to the cough Heart. In extreme doses, codeine will depress respiration.

In Yet another study just one a hundred-mg/kg dose of codeine administered to pregnant mice reportedly resulted in delayed ossification within the offspring.

Usually speak to your Health care service provider to be certain the data shown on this page applies to your own circumstances.

Drug interactions may perhaps improve how your prescription drugs operate or improve your risk for really serious Unwanted effects. This doc will not have all achievable drug interactions.

Codeine is contraindicated in small children young than twelve yrs of age and in children of any age who are undergoing tonsillectomy and/or adenoidectomy. Stay clear of use in adolescents twelve to eighteen many years of age who have other chance factors which will raise their sensitivity on the respiratory depressant result of codeine.

Notify your physician Should you be pregnant or Feel you might be pregnant. For the duration of pregnancy, this products is not suggested. It may hurt an unborn toddler. Check with your doctor concerning the risks and benefits of this medication. See also Warning section.