akorn promethazine codeine Things To Know Before You Buy

akorn promethazine codeine Things To Know Before You Buy

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Anaphylaxis: Anaphylaxis has been described with codeine, among the list of substances in promethazine HCl and codeine phosphate oral solution.

While significant, lifetime-threatening, or deadly respiratory melancholy can happen Anytime throughout the use of promethazine HCl and codeine phosphate oral Alternative, the chance is finest during the initiation of therapy, when promethazine HCl and codeine phosphate oral solution is used concomitantly with other prescription drugs that will result in respiratory depression [see Warnings and Precautions (5.

All information and facts introduced here is not intended as a substitute for or alternative to information and facts from health and fitness treatment practitioners. You should consult your health care Experienced about probable interactions or other achievable difficulties ahead of making use of any product. The Federal Foodstuff, Drug, and Cosmetic Act call for this detect.

Promethazine is greatly dispersed in overall body tissues. Promethazine has substantial protein binding with about eighty to 93% of promethazine certain to plasma proteins. Promethazine passes the blood Mind barrier along with the placental barrier.

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Hemodialysis is just not routinely utilised to improve the elimination of codeine or promethazine from the body.

Use caution When contemplating the use of promethazine HCl and codeine phosphate oral Option in sufferers sixty five many years of age or more mature.

five.eight Actions Requiring Psychological Alertness: Threats of Driving or Operating Equipment Codeine and promethazine, two from the Lively components in promethazine HCl and codeine phosphate oral Option, could produce marked drowsiness and impair the psychological and/or physical talents necessary for that functionality of doubtless hazardous jobs for instance driving a car or truck or working machinery.

Unresponsive Cough The dosage of promethazine HCl and codeine phosphate oral Resolution really should not be enhanced if cough fails to respond; an unresponsive cough really should be reevaluated in 5 times or faster for probable fundamental pathology, like foreign system or reduce respiratory tract illness [see Dosage and Administration (two.three)].

The next significant adverse reactions are described, or described in increased element, in other sections:

Released experiments with codeine have reported inconsistent conclusions and possess important methodological limitations (see Data). You'll find stories of respiratory melancholy when codeine is employed for the duration of labor and shipping (see Clinical Concerns).

There aren't any available info with promethazine HCl and codeine phosphate oral Option use in Expecting Women of all ages to tell a drug-associated threat for adverse developmental outcomes.

Promethazine Carcinogenicity reports were being conducted with promethazine hydrochloride. Two-year scientific studies in F344/N rats and B6C3F1 mice have been executed to evaluate the carcinogenic potential of promethazine hydrochloride. No proof of tumorigenicity was click here noticed in male and woman rats at promethazine hydrochloride oral doses as many as 33 mg/kg/working day for 5 days/7 days (close to equivalent to ten times the MRHD on a mg/m2 foundation).

5.14 Risk of Paradoxical Reactions, which includes Dystonias Promethazine HCl and codeine phosphate oral Resolution incorporates promethazine, a phenothiazine. Phenothiazines are affiliated with dystonic reactions, notably in pediatric sufferers who may have an acute ailment linked to dehydration.