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PubMed2006

Influence of electrolytes/non-electrolytes on the cloud point phenomenon of the aqueous promethazine hydrochloride drug solution.

We have studied the clouding phenomena in promethazine hydrochloride (PMT) aqueous solutions in presence of electrolytes and non-electrolytes. PMT, a tranquillizer, shows phase separation. The cloud point (CP) decreases with increase in pH due to deprotonation of drug molecules. At constant pH, increasing salt addition causes an increase in CP, which is explained on the basis of their position in Hofmeister series and their hydrated radii. With quaternary salts CP increases due to adsorption/mixed micelle formation. Ureas decrease the CP and the behavior is explained on the basis of removal of water from the headgroup region.

Electrolytes↗
PubMed2005

Promethazine protects against 1-methyl-4-phenyl-1,2,3,6-tetrahydropyridine neurotoxicity.

Promethazine (PMZ) is an FDA-approved antihistaminergic drug that was identified as a potentially neuroprotective compound in the NINDS screening program. PMZ accumulates in brain mitochondria in vivo and inhibits Ca2+-induced mitochondrial permeability transition pore (PTP) in rat liver mitochondria in vitro. We hypothesized that PMZ may have a protective effect in a mitochondrial toxin model of Parkinson's disease (PD). Mice treated with 1-methyl-4-phenyl-1,2,3,6-tetrahydropyridine (MPTP) sustained a significant loss of dopaminergic neurons within the SNpc that was strongly attenuated by PMZ treatment. However, neither striatal MPP+ concentrations nor MPTP-induced inhibition of mitochondrial complex I were affected by PMZ treatment. In isolated mouse brain mitochondria, PMZ partially prevented and reversed MPP+-induced depolarization of membrane potential and inhibited the Ca2+-induced PTP in brain mitochondria. The sum of data indicates that PMZ is a strong neuroprotective agent capable of protecting dopaminergic neurons against MPTP toxicity in vivo.

1-Methyl-4-phenylpyridinium↗
PubMed1980

Rapid, sensitive determination of unchanged promethazine in biological material using a nitrogen-selective flame ionization detector. Identification of metabolites by gas chromatography-mass spectrometry.

A rapid, sensitive method has been developed to study the kinetics of unchanged promethazine (PM) in biological material using a nitrogen-selective flame ionization detector (N-FID). Unchanged PM is distinguished from its desmethyl metabolite. Sample clean-up of several biological fluids (rat plasma, blood, urine, liver and kidney homogenates) was studied and gas chromatographic (GC) conditions optimized. Usually 50 microliters-1.0 ml samples are extracted into n-heptane by shaking with NaOH, re-extracted into H2SO4 and again extracted into n-heptane by addition of NaOH. Finally, the organic phase is separated, concentrated under N2 and PM determined by N-FID. However, a rapid, single-step method requiring only NaOH extraction into n-heptane may be used whenever GC background permits. Imipramine is used as an internal standard for calibration by peak height ratios in the overall range 5--1500 ng PM per sample. Recovery of both methods is high (97--99%) but precision of the single-step method is lower (relative S.D. 10% versus 3--4%). Use of sample volumes up to 1 ml allows accurate determination of concentrations as low as 10 ng/g. Examples of applications to commonly used animal models employing PM are given and simple adaptation for clinical samples suggested.

Animals↗
PubMed1987

Adhesion properties of E. coli cells in the presence of promethazine.

Some E. coli strains were tested for adsorption to HEp-2 cells and on aluminium hydroxide gel. The adhesiveness of E. coli to HEp-2 cells was inhibited by promethazine. MRHA (mannose-resistant haemagglutinating activity) positive plasmid-carrying E. coli strains were found to be adsorbed to tissue culture cells more effectively than the MRHA-negative strains. Fifty percent of the clinical isolates contained antibiotic resistance plasmids, but only 40% of these strains were able to transfer the antibiotic resistance properties to E. coli as recipient. It is presumed that the hydrophobic adsorption of bacteria depends on the fimbriae, while aluminium hydroxide gel adsorption correlates with surface properties other than the fimbriae.

Aluminum Hydroxide↗
PubMed1991

A prospective analysis of intramuscular meperidine, promethazine, and chlorpromazine in pediatric emergency department patients.

STUDY OBJECTIVE: To examine physiologic responses and efficacy of 2, 1, and 1 mg/kg IM meperidine, promethazine, and chlorpromazine (MPC), respectively, in children. DESIGN: Prospective, unblinded trial. SETTING: A university and community emergency department. PATIENTS: Sixty-three hemodynamically and neurologically stable children. INTERVENTION: Single dose of IM MPC. MEASUREMENTS AND MAIN RESULTS: Serial respirations, heart rate, arterial systolic blood pressure, oxygen saturation, and Glasgow Coma Scale were measured at 30-minute intervals. Effectiveness was assessed by two independent observers using separate visual analog scales for cooperation and sedation. Times to sleep (27 +/- 24 minutes), sitting upright (103 +/- 87 minutes), ED discharge (4.7 +/- 2.4 hours), eating (11 +/- 7.9 hours), and normal behavior (19 +/- 15 hours) were acceptable. Minor, but statistically significant, changes in respiration rate (-1.9 +/- 0.4), heart rate (+4.5 +/- 1.8), oxygen saturation (-0.7 +/- 0.3%), and Glasgow Coma Scale (-2.5 +/- 0.6) occurred for 120 minutes after MPC. No serious complications or resuscitation were required. Mean visual analog scale scores were 5.0/10.4 or more in 71% of cases, with interobserver agreement very good (cooperation, r = .79; effectiveness, r = .80). Twenty-nine percent of children were judged insufficiently sedated. CONCLUSION: IM MPC is a safe and generally effective agent for ED procedures in selected children.

Anesthesia↗
PubMed1991

Rectal thiopental compared with intramuscular meperidine, promethazine, and chlorpromazine for pediatric sedation.

STUDY OBJECTIVES: We studied the hypothesis that rectal thiopental is an effective agent for emergency department pediatric sedation and may have advantages over a more traditional regimen. DESIGN: Rectal thiopental 25 mg/kg was compared with the combination of meperidine 2 mg/kg, promethazine 1 mg/kg, and chlorpromazine 1 mg/kg in a prospective, randomized, double-blinded study. TYPE OF PARTICIPANTS: Children between 18 months and 6 years of age presenting to our teaching hospital ED for laceration repair were entered after the clinical decision was made to sedate. Patients with altered sensorium, medical contraindications to sedation, or medication allergy were excluded. INTERVENTIONS: After informed consent, each patient received IM injection (drug combination or placebo) and rectal suspension (rectal thiopental or placebo) simultaneously. MEASUREMENTS AND MAIN RESULTS: Vital signs, pulse oximetry, and pediatric Glasgow Coma Scores were recorded before and every 15 minutes after sedation until discharge. Intradermal lidocaine and suturing began when the patient appeared adequately sedated, and response was numerically scored. Patients were discharged when able to stand. Twenty-nine patients 34 +/- 13 months old were studied. Fifteen patients received rectal thiopental, and 14 received the drug combination. Analysis using the Wilcoxon two-sample test revealed no differences in age, sex, weight, or wound location between groups. The time course of sedation was different for the two treatment regimens. At 15 and 30 minutes after administration, patients who received rectal thiopental were more deeply sedated than those who received the drug combination, as evidenced by significantly lower Glasgow Coma Scores (P less than .05). Accordingly, time from medication administration to suturing was 29 +/- 12 minutes in the thiopental group and 54 +/- 33 minutes (P less than .01) in the drug combination group. Patients in the thiopental group also recovered more quickly and were discharged approximately one-half hour earlier than those in the drug combination group (89 +/- 25 vs 120 +/- 44 minutes, P less than .05). No difference in response to lidocaine injection or suturing was demonstrated between the groups. Laceration repair time was comparable between the groups. There were eight sedation failures (three of 15 in thiopental group and five of 14 in drug combination group, P = NS). Vital signs remained stable, no adverse reactions occurred, and no patient had decreased oxygen saturation to less than 95%. CONCLUSION: Rectal thiopental is superior to this drug combination for pediatric sedation because it can be administered painlessly, has a more rapid onset and offset of action, and is of equal safety and efficacy at the dosage studied.

Administration, Rectal↗
PubMed1989

Intramuscular meperidine, promethazine, and chlorpromazine: analysis of use and complications in 487 pediatric emergency department patients.

Despite widespread use of a parenterally administered mixture of meperidine, promethazine, and chlorpromazine (Demerol, Phenergan, and Thorazine, DPT), there has been no systematic evaluation of its efficacy and complications in emergency department patients. We reviewed the medical records of all patients less than 16 years old who received DPT in our ED during the 24-month period ending December 31, 1987. Of 487 patients who received DPT, the maximum dose was 50/25/25 mg, respectively. Wound repair (69%) and fracture reduction (12%) were the two most common indications. Lacerations most commonly involved the face (65%) or digits (20%). Efficacy was not directly reported, but only eight patients received repeat sedation. Head injuries and a lower mean initial meperidine dosage were more prevalent in patients requiring repeat sedation (P less than .05). Three patients (0.6%) experienced significant complications. All had respiratory depression and received IV naloxone. An abnormal initial mental status examination or an underlying neurologic abnormality was significantly associated with complications (P less than .05). DPT appears to be a safe and relatively effective sedative for selected pediatric ED patients when administered as a ratio of 2:1:1 mg/kg, respectively. Complications are increased in patients with acute or underlying neurologic abnormalities.

Analgesia↗
PubMed1994

A comparison of intranasal sufentanil and midazolam to intramuscular meperidine, promethazine, and chlorpromazine for conscious sedation in children.

STUDY OBJECTIVE: To compare intranasal sufentanil and midazolam (IN-SM) with intramuscular meperidine, promethazine, and chlorpromazine (IM-MPC) for sedation in children. DESIGN: Single-blind, randomized, controlled study. SETTING: Urban children's emergency department. PARTICIPANTS: A convenience sample of children aged 1 to 4 years requiring suturing. INTERVENTIONS: IN-SM or IM-MPC. RESULTS: Vital signs, O2 saturation, and anxiety and pain scores were recorded. A 6-point scale was used to assess response to medication, and a 12-point recovery score was used to determine readiness for discharge. Both groups were similar in age and sex distribution. There were no significant adverse effects in either group. Patients tolerated the IN regimen better than the IM regimen. Behavioral scores were lower during repair than at baseline within each group; however, they were not different between groups. Time to discharge was longer and recovery scores were lower (worse) among the IM-MPC group. CONCLUSION: IN-SM is as effective as IM-MPC for sedation in children.

Administration, Intranasal↗
PubMedDate not supplied

The effect of diazepam and promethazine treatment during pregnancy on the somatic development of human offspring.

The postnatal longitudinal somatic, neurological, mental, and behavioral developments were studied in children at birth, 8, 15, and 24 months of life, whose mothers were treated during pregnancy with clinical doses of diazepam (n = 126) and promethazine (n = 127) and whose mothers were unexposed. The latter group was differentiated in negative (n = 256) and positive (n = 102) control children. The positive control group involved mothers who had pregnancy complications similar to those of mothers in the drug groups but who were not treated with CNS-active drugs during pregnancy. It is very difficult to recruit persons for the study and control groups who are appropriate for comparative evaluation. Only firstborns and the so-called "normal" newborn infants were studied; children with low birth weight, major abnormalities, severe neonatal diseases, etc., were excluded. In this article the study design, study materials, and somatic (weight, length, head circumference) development are described. At birth, children had a lower weight in the diazepam group, but it was not noted at the eighth month of postnatal life.

Adult↗
PubMed2001

Antimicrobial activity of trifluoromethyl ketones and their synergism with promethazine.

The antimicrobial effects of 30 trifluoromethyl ketones [1-30] were studied on various representative bacteria. Of the ketones, 4,4,4-trifluoro-1-phenyl-1,3-butanedione [10], 1,1,1-trifluoro-3-(4,5-dimethyloxazol-2-yl)-2-propanone [11] and 1-(2-benzoxazolyl)-3,3,3-trifluoro-2-propanone [18] were found to exhibit potent antibacterial activity against the Gram-positive Bacillus megaterium and Corynebacterium michiganese, but not against Gram-negative bacteria such as Pseudomonas aeruginosa and Serratia marcescens. Compounds 11 and 18 inhibited the Escherichia coli. Compound 18 was also effective against yeasts. The combination of promethazine with 18 was significantly synergistic against E. coli strains, especially the proton pump deficient mutant. The results suggest that membrane transporters are the target of trifluoromethyl ketones. The inhibition was more marked in the proton pump deficient E. coli mutant than in the wild type, which suggested that the antibacterial effect of trifluoromethyl ketones is partly prevented by the proton pump system.

Anti-Bacterial Agents↗
PubMed1999

The pharmacokinetics of promethazine after intravenous administration in camels.

The pharmacokinetics of promethazine were determined in seven camels (Camelus dromedarius) after an intravenous dose of 0.5 mg kg body weight.-1 The data obtained (median and range) were as follows: the elimination half-life (t1/2 beta) was 5.62 (2.84-6.51) h; the steady state volume of distribution (Vdss) was 8.90 (7.10-12.00) L kg-1, total body clearance (CT) was 24.5 (17.22-33.65) ml kg-1 min-1 and renal clearance (Clr) was 4.81 (1.97-5.48) ml kg-1 min-1.

Animals↗
PubMedDate not supplied

Systematic delivery of chloroquine and promethazine using pH-sensitive polymers.

Two pH sensitive polymers (Eudragit L30 D55 and L100) were used as coating materials, respectively, for promethazine hydrochloride and chloroquine phosphate granules formulated with sodium carboxylmethylcellulose and Carbopol 940, respectively, in the ratios 1:1, 1:2, 1:3, and 1:4 (drug:polymer). The granules were characterized. Release studies for the uncoated and coated particles were studied in simulated gastric fluid and simulated intestinal fluid. Result obtained showed that 1:1 and 1:2 ratios of both coated and uncoated granules of the two drugs had short release times and could be recommended for rapid action, whereas 1:4 ratio with low release time could be used for sustained effect. The two granules could be used at varying ratios to obtain desired release characteristics, such that therapeutic concentrations of the two drugs could be achieved.

Chloroquine↗
PubMed1999

In vitro release and diffusion studies of promethazine hydrochloride from polymeric dermatological bases using cellulose membrane and hairless mouse skin.

The study was designed to investigate the feasibility of developing a transdermal drug dosage form of promethazine hydrochloride (PMH). The in vitro release and diffusion characteristics of PMH from various dermatological polymeric bases were studied using cellulose membrane and hairless mouse skin as the diffusion barriers. These included polyethylene glycol (PEG), hydroxypropyl methylcellulose (HPMC), cross-linked microcrystalline cellulose, and carboxyl methyl cellulose sodium (Avicel CL-611), and a modified hydrophilic ointment USP. In addition, the effects of several additive ingredients known to enhance the drug release from topical formulations were evaluated. The general rank order for the drug release from these formulations using cellulose membrane was observed to be PEG > HMPC > Avicel CL-611 > hydrophilic ointment base. The inclusion of the additives had little or no effect on the drug diffusion from these bases, except for the hydrophilic ointment formulation containing 15% ethanol, which provided a significant increase in the drug release. However, when these formulations were studied for drug diffusion through the hairless mouse skin, the Avicel CL-611 base containing 15% ethanol exhibited the optimum drug release. The data also revealed that this formulation gave the highest steady-state flux, diffusion, and permeability coefficient values and correlated well with the amount of drug release.

Administration, Cutaneous↗
PubMed2001

A liquid chromatographic method for the simultaneous determination of promethazine and three of its metabolites in plasma using electrochemical and UV detectors.

A new assay method has been developed for the quantitation of promethazine (PMZ) with a sensitivity and reproducibility as good as any previously reported method. This method is also capable of quantitatively determining three metabolites of PMZ (monodemethylated, sulphoxidated, and monodemethylated sulphoxidated PMZ), which has not been previously described. The method uses high-performance liquid chromatography with amperometric and UV detection simultaneously and requires only one extraction step from serum with chloroform. The method uses trifluoperazine as the internal standard. The limit of detection level for PMZ is 1.0 ng/ml when a 0.2-mL specimen of plasma is assayed. A validation study is also conducted for evaluating the recovery, precision, linearity of response, sensitivity, and selectivity of the method.

Chromatography, High Pressure Liquid↗
PubMed2000

Oral ketamine/midazolam is superior to intramuscular meperidine, promethazine, and chlorpromazine for pediatric cardiac catheterization.

UNLABELLED: An IM combination of meperidine, promethazine, and chlorpromazine (DPT) has been given as sedation for pediatric procedures for more than 40 years. We compared this IM combination to oral (PO) ketamine/midazolam in children having cardiac catheterization. A total of 51 children, ages 9 mo to 10 yr, were enrolled and randomized in this double-blinded study. All children received an IM injection at time zero and PO fluid 15 minutes later. We observed acceptance of medication, onset of sedation and sleep, and sedative efficacy. The cardiorespiratory changes were evaluated. Sedation was supplemented with IV propofol as required. Recovery time, parental satisfaction, and patient amnesia were assessed. Ketamine/midazolam given PO was better tolerated (P < 0.0005), had more rapid onset (P < 0.001), and provided superior sedation (P < 0.005). Respiratory rate decreased after IM DPT only. Heart rate and shortening fraction were stable. Oxygen saturation and mean blood pressure decreased minimally in both groups. Supplemental propofol was more frequently required (P < or = 0.02) and in larger doses (P < 0.05) after IM DPT. Parental satisfaction ratings were higher (P < 0.005) and amnesia was more reliably obtained (P = 0.007) with PO ketamine/midazolam. Two patients needed airway support after the PO medication, as did two other patients when PO ketamine/midazolam was supplemented with IV propofol. Although PO ketamine/midazolam provided superior sedation and amnesia compared to IM DPT, this regimen may require the supervision of an anesthesiologist for safe use. IMPLICATIONS: Oral medication can be superior to IM injections for sedating children with congenital heart disease; however, the safety of all medications remains an issue.

Adjuvants, Anesthesia↗
PubMed1987

Promethazine-induced dystonic reaction.

The case of a 15-year-old girl who experienced an acute dystonic reaction to promethazine therapy administered during an uncomplicated episode of acute gastroenteritis is reported. The pertinent literature is reviewed.

Acute Disease↗
PubMed2001

Iatrogenic cardiopulmonary arrest during pediatric sedation with meperidine, promethazine, and chlorpromazine.

The pediatric sedative combination of meperidine, promethazine, and chlorpromazine (MPC) has been widely used for more than 40 years. Despite its relatively poor efficacy and questionable safety profile, many emergency departments (EDs) continue to stock specially formulated mixtures of these three agents. We report a case of iatrogenic cardiac arrest in a 2-month-old infant in whom a consulting resident administered too much MPC (10 times the expected dose) by the wrong route (intravenous instead of intramuscular). The child was successfully resuscitated with no apparent neurologic deficit. Subsequently, we have removed MPC entirely from our ED and instituted a policy restricting ED procedural sedation privileges to emergency physicians. We urge other EDs to do likewise.

Chlorpromazine↗
PubMed1981

A double-blind trial of the H2 receptor antagonist cimetidine, and the H1 receptor antagonist promethazine hydrochloride in the treatment of atopic dermatitis.

Twenty young adults with atopic dermatitis were allocated randomly in a clinical trial to compare the action of the H2 receptor antagonist cimetidine (Tagamet) and the H1 receptor antagonist promethazine hydrochloride (Phenergan), singly and in combination. No significant differences were found, clinically or in the laboratory investigations, between the patients on either drug alone or the combination of the two.

Adolescent↗