ABSTRACT
The objective of this study was to compare the efficacy and safety of cough mixture containing pholcodeine and promethazine - Tixylix (CS1) to a cough mixture which has noscapine, ammonium chloride, and sodium citrate (CS2) as its constituents in treatment of children suffering from dry cough. A total of 208 patients were enrolled at 4 sites. Of these, 179 (94 receiving CS1 and 99 receiving CS2) completed the study. Results of this study suggest that both the cough mixtures were comparable as per evaluation of their primary parameters. According to global assessment for efficacy and tolerability by parents on Day 7, Group CS1 performed better than CS2. It was also observed that no AE was reported in Group CS1 as compared to 2 AEs in Group CS2. To conclude, cough mixture combination of pholcodeine and promethazine - Tixylix exhibited efficacy and safety that was comparable with cough mixture which has noscapine, ammonium chloride, and sodium citrate. It was proven to be efficacious, safe and well tolerated in the select population.
Subject(s)
Ammonium Chloride/pharmacology , Ammonium Chloride/therapeutic use , Antitussive Agents/therapeutic use , Child , Child, Preschool , Citrates/analogs & derivatives , Citrates/pharmacology , Citrates/therapeutic use , Codeine/analogs & derivatives , Codeine/pharmacology , Codeine/therapeutic use , Cough/drug effects , Cough/drug therapy , Drug Combinations , Female , Humans , Male , Morpholines/analogs & derivatives , Morpholines/pharmacology , Morpholines/therapeutic use , Multicenter Studies as Topic , Noscapine/pharmacology , Noscapine/therapeutic use , Promethazine/analogs & derivatives , Promethazine/pharmacology , Promethazine/therapeutic use , Randomized Controlled Trials as Topic , Treatment OutcomeABSTRACT
The coordination chemistry of iron (III) is the environment of an antihistaminic drug, promethazine has been explained to include a low spin, six-coordinate complex [Fe(Prometha)2(H2O) Cl] Cl2. Metaldrug interaction in vitro in aqueous KCl phase was studied polarographically at physiological pH and temperature. On the basis of elemental, magnetic, conductometric, IR, UV-visible, NMR spectroscopic analysis it is concluded that in solid phase two promethazine molecules with their N,N donor sites encompass the metal. Mass spectral study on the complex confirms that one of the three chlorides is involved in the coordination. The respective changes in the antihistaminic activity of the drug as a result of complexation has been determined and a possible mechanism is suggested.