Anaphylaxis: Anaphylaxis is noted with codeine, one of the ingredients in promethazine HCl and codeine phosphate oral Answer.
Absorption Codeine is absorbed through the gastrointestinal tract with most plasma focus developing 60 minutes article administration. The presence of the higher-fat, high-calorie food did not noticeably effect the PK of codeine.
Promethazine hydrochloride wasn't mutagenic within the in vitro bacterial reverse mutation assay or clastogenic in the in vitro Chinese hamster ovary (CHO) cell chromosomal aberration assay.
are Expecting. Usage of Promethazine Hydrochloride and Codeine Phosphate Oral Remedy through pregnancy could cause withdrawal signs and symptoms inside your newborn little one that might be daily life-threatening if not acknowledged and addressed. Notify your healthcare provider immediately If you're pregnant or think you could be pregnant. •
Stay away from using promethazine HCl and codeine phosphate oral Answer in patients who're having a CYP3A4 inhibitor, CYP3A4 inducer, or 2D6 inhibitor [see Warnings and
Promethazine HCl and codeine phosphate oral solution really should be utilized with caution in patients with impairment of hepatic purpose, and patients must be monitored intently for respiratory depression, sedation, and hypotension.
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Appropriate assessment of the client, appropriate prescribing practices, periodic re-evaluation of therapy, and correct dispensing and storage are correct measures that aid to Restrict abuse of opioid medicine.
Promethazine HCl and codeine phosphate oral Option will not be proposed for use in pregnant Ladies [see Use in Distinct Populations (eight.1)]. Extended use of promethazine HCl and codeine phosphate oral Option all through pregnancy may result in neonatal opioid withdrawal syndrome, which may be lifetime-threatening Otherwise recognized and treated, and requires administration In keeping with protocols made by neonatology professionals.
Lifetime-threatening respiratory melancholy and Dying have transpired in kids who acquired codeine. Almost all of the described cases occurred subsequent tonsillectomy and/or adenoidectomy, and a lot of of the children had evidence of getting an ultra-immediate metabolizer of codeine as a consequence of a CYP2D6 polymorphism [see Warnings and Safeguards (five.3)]. Promethazine HCl and codeine phosphate oral Remedy is contraindicated in little ones younger than 12 several years of age and in young children youthful than eighteen yrs of age following tonsillectomy and/or adenoidectomy [see Contraindications (four)].
Promethazine HCl and codeine phosphate oral Answer will not be encouraged for use in pregnant Gals. Extended usage of promethazine HCl and codeine phosphate oral solution through pregnancy can result in neonatal opioid withdrawal syndrome, which can be lifetime-threatening Otherwise acknowledged and dealt with.
If any of the medicines are recalled, authorities advocate calling your pharmacist to check out if you can find option merchandise or suppliers. If there is not any click here comparable generic alternative, you need to Make contact with your Health care service provider to debate other medication selections.
Serotonin Syndrome Tell sufferers that promethazine HCl and codeine phosphate oral Remedy could induce a rare but potentially everyday living-threatening situation resulting from concomitant administration of serotonergic drugs.
Make certain that patients have an oral dosing dispenser that steps the appropriate quantity in milliliters. Counsel sufferers regarding how to utilize an oral dosing dispenser and correctly measure the oral suspension as prescribed.