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PubMed2004

Rapid tranquillisation of violent or agitated patients in a psychiatric emergency setting. Pragmatic randomised trial of intramuscular lorazepam v. haloperidol plus promethazine.

BACKGROUND: The pharmacological management of violence in people with psychiatric disorders is under-researched. AIMS: To compare interventions commonly used for controlling agitation or violence in people with serious psychiatric disorders. METHOD: We randomised 200 people to receive intramuscular lorazepam (4 mg) or intramuscular haloperidol (10 mg) plus promethazine (25-50 mg mix). RESULTS: At blinded assessments 4 h later (99.5% follow-up), equal numbers in both groups (96%) were tranquil or asleep. However, 76% given the haloperidol-promethazine mix were asleep compared with 45% of those allocated lorazepam (RR=2.29,95% CI 1.59-3.39; NNT=3.2,95% CI 2.3-5.4). The haloperidol-promethazine mix produced a faster onset of tranquillisation/sedation and more clinical improvement over the first 2 h. Neither intervention differed significantly in the need for additional intervention or physical restraints, numbers absconding, or adverse effects. CONCLUSIONS: Both interventions are effective for controlling violent/agitated behaviour. If speed of sedation is required, the haloperidol-promethazine combination has advantages over lorazepam.

Antipsychotic Agents↗
PubMedDate not supplied

Morphine and promethazine as intravenous premedicants.

Two hundred seventy patients received morphine 5 mg or 10 mg alone or with promethazine 6.25 mg, 12.5 mg, or 25 mg. Promethazine 25 mg alone also was studied. All drugs were given intravenously. Anxiety relief, sedation, patient acceptance, lack of recall, and side effects were the variables examined. Promethazine improved relief of anxiety, sedation, and patient acceptance when added to morphine. Doses of promethazine larger than 12.5 mg intravenously failed to improve these effects. Memory remained unaffected by any of the drugs.

Adolescent↗
PubMed1985

Effect of promethazine and isosafrole on rat-hepatic microsomal mono-oxygenase activity: comparison with classic inducers phenobarbitone and beta-naphthoflavone.

The characteristics of induction of rat-hepatic microsomal mono-oxygenase activity by promethazine and isosafrole have been investigated and compared with the classic inducers phenobarbitone and beta-naphthoflavone. Both promethazine and isosafrole pretreatments result in increased cytochromes P-450, and enhanced NADPH-cytochrome c reductase, aminopyrine N-demethylase, dichloronitroanisole O-demethylase, ethoxycoumarin O-deethylase and ethoxyresorufin O-deethylase activity. Isosafrole but not promethazine increased the liver to body weight ratio. It is concluded that promethazine and isosafrole pretreatment produces an induction of the rat-hepatic microsomal mono-oxygenase system which shows both phenobarbitone- and polycyclic aromatic hydrocarbon-type characteristics.

Animals↗
PubMed2004

The effect of dexamethasone and promethazine in combination with buparvaquone in the management of East Coast fever.

The effects of dexamethasone and promethazine on the amelioration of pulmonary oedema in East Coast fever were investigated. The clinical effects of these drugs were further investigated when used in conjunction with the antitheilerial drug, buparvaquone. In the first experiment, 15 crossbred (Friesian x Zebu) steers were divided into four groups. With the exception of the animals in group IV, that served as a control group all the others were infected with Theileria parva sporozoites. On the second day of the febrile reaction, the steers in groups I and II were treated with dexamethasone (0.1 mg/kg) and promethazine (1 mg/kg), respectively. Group III steers served as the infected untreated controls. On the fifth day of the febrile reaction the animals in groups I, II and III were infused intravenously with tattoo ink suspension and 1 h later sacrificed for post-mortem examination and tissue sampling. The clinical picture indicated that both drugs significantly mitigated dyspnoea and the post mortem examination revealed a significant reduction in morphological changes. Tattoo ink particle count reflected a significant (P< 0.01) reduction in vascular leakage in the treated animals, with promethazine being significantly (P < 0.05) more effective than dexamethasone in this respect. In the second experiment, 18 steers were infected with T. parva sporozoites, and then were randomly allotted into three groups each of which contained six animals. After the onset of ECF clinical signs, the animals in the first two groups were treated with buparvaquone in combination with either dexamethasone (group I) or promethazine (group II), and the third group was treated with buparvaquone alone. The results indicated that all the animals in groups I, II and III recovered well and no significant differences were observed in clinical disposition between the groups. Two months later, serum samples were collected from the refractory animals and demonstrated the presence of antibodies against T. parva. When the animals were subsequently artificially challenged with T. parva, none of them succumbed to clinical disease. The same T. parva stabilate stock was used in both experiments and it proved to be infective in a separate batch of steers.

Animals↗
PubMed2002

The effect of meperidine and promethazine on fetal heart rate indices during the active phase of labor.

BACKGROUND: Visual interpretation of fetal heart rare monitoring is subject to intra- and inter-observer variability. OBJECTIVE: To examine the effect of intrapartum administration of meperidine and promethazine on fetal heart activity measured objectively by a computerized system. METHODS: Fourteen healthy women with normal pregnancies at term were studied during the active phase of labor. Fetal heart rate was recorded with the Oxford Sonicaid system 8000. Recordings were performed for 40 minutes prior to and after maternal intravenous administration of meperidine 50 mg with promethazine 25 mg. RESULTS: The combination of meperidine and promethazine caused a significant decrease in the number of accelerations of 10 beats per minute (9.7 versus 2.6, P = 0.002) and 15 beats per minute (5.2 vs. 1.4, P = 0.003), time spent in episodes of high variation (14.8 vs. 2.0, P = 0.005) and short-term variation (7.8 vs. 5.0, P = 0.003). On the other hand there was an increase in the time spent in episodes of low variation (5.3 vs. 19.7, P = 0.009). CONCLUSIONS: Maternal administration of meperidine with promethazine has a significant effect on FHR indices during the active phase of normal labor.

Adjuvants, Anesthesia↗
PubMed1992

Influence of promethazine on symptom-therapy scores for nausea during patient-controlled analgesia with morphine.

We assessed whether adding promethazine to the syringe containing morphine for patient-controlled analgesia (PCA) decreases nausea after gynecologic surgery. Patients were assigned randomly to receive PCA (morphine 1.5 mg, 6-min lockout interval) with or without promethazine (0.625 mg/PCA dose, providing an average of 17.6 mg/24 h). Assessments included a visual analogue scale (VAS) for nausea (0 = none, 10 = worst possible) at scheduled times, rescue therapy requirements, and a maximum symptom-therapy score that provided an aggregate assessment of nausea intensity, duration, and response to rescue therapy (0 = no nausea; 1 = mild; 2 = moderate, requiring droperidol; 3 = severe or persistent, requiring droperidol; 4 = requiring droperidol+transdermal scopolamine; 5 = unrelieved). Nausea scores on the visual analogue scale at 2, 6, 8, and 24 h and use of rescue droperidol identified no significant differences between the groups. However, symptom-therapy scores differed significantly, with median values of 0 and 2, respectively, for the promethazine-treated and control groups. We conclude that simultaneous titration of morphine and promethazine decreases nausea associated with PCA therapy; the difference may best be appreciated with use of the combined symptom-therapy score.

Adult↗
PubMed1991

[Potentiation by promethazine of hypotensive effects of adrenergic drugs on intraocular pressure].

Experiments including previous installations of promethazine (pipolphen) into the conjunctival sac followed by the topical administration of beta-adrenergic blocker timolol or a sympathomimetic drug isoptoepinal (adrenaline) have been performed on 24 rabbits (48 eyes). The substantial changes in the action mode of the mentioned drugs as the enhancement of their hypotensive effect on the intraocular pressure (IOP) have been demonstrated under the performance of the above mentioned procedure. When applied after promethazine instillations, timolol induced significantly increased outflow facility of the aqueous humor that was not usually noted in the cases of timolol topical instillations without a pretreatment of the eye with promethazine. The similar increased hypotensive effect on the IOP was noted for adrenaline when it has been used after promethazine treatment. The possible mechanisms underlying the changes in pharmacological activities of the investigated adrenergic drugs are discussed.

Adrenergic beta-Antagonists↗
PubMed1990

[Effects of promethazine on acupuncture analgesia].

Promethazine, one of histaminergic H1-receptor antagonist, was often used as an adjuvant drug prior to and during acupuncture anesthesia in clinics, However, its effects was not known clearly. By using potassium iontophoretic dolorimetry and stimulating unilateral "Hegu" and "Waiguan" points with electroacupuncture (EA) in 42 rabbits, we found that Promethazine could drop the pain threshold in small dosages (0.5 mg/kg, 1 mg/kg) and raise the pain threshold in relatively large dosages (2 mg/kg, 4 mg/kg). In different dosages (1 mg/kg, 2 mg/kg), promethazine could attenuate the analgesic effect of EA. It was suggested that promethazine should be used carefully in acupuncture anaesthesia.

Acupuncture Analgesia↗
PubMed1979

Prolonged kidney allograft survival with promethazine.

The effects of promethazine hydrochloride have been investigated in a rabbit kidney allograft model. The drug was ineffective on its own, but if added to a protocol that induced partial suppression of rejection in 50% of recipients, its effect was dramatic. Allograft survival was prolonged from a control mean of 10.3 days to a mean of 26.3 days. One animal survived 2 1/2 months, and no other drug than promethazine was given after day 6. Promethazine and 6-methylprednisolone alone also prolonged allograft survival, but the results were significantly better if the recipient had been exposed to donor blood before grafting. The results suggest that promethazine is a useful adjuvant immunosuppressive drug. It could be beneficial in man.

Adjuvants, Immunologic↗
PubMed1981

Liver microsomal drug-metabolizing enzyme activity: enhancement by blockade of degradative processes in promethazine-treated rats.

Daily injection of promethazine over 4 days significantly increased the liver cytochrome P-450 content and ethyl morphine N-demethylase activity. These increases were evident after the first dose and were prevented by puromycin or actinomycin D administration. Repeated administration of promethazine does not increase the liver's ability to incorporate [14]C DL-leucine in microsomes but slows down the decay of radioactivity in microsomes previously labelled with ([14C]-guanidino) arginine. Repeated treatment with promethazine leads to a marked proliferation of the rough endoplasmic reticulum (RER) and a slight increase in the smooth endoplasmic reticulum (SER). Our findings suggest that the enhancement of P-450 and EM-ase activity result from the decelerating effect of promethazine on protein degradation.

Animals↗
PubMed1980

Promethazine administration to rats and CCl4 induced lipid peroxidation of liver microsomal lipids.

Promethazine inhibited CCl4 stimulated microsomal lipid peroxidation in vitro at concentrations ranging from 10(-3) to 10(-8)M. CCl4 administered to rats at a dose of 1 ml/kg decreased the arachidonic acid content of microsomal lipids after 6 hours of intoxication. Prior promethazine treatment, at dosage regimes that preclude CCl4 induced liver necrosis at 24 hours, did not significantly prevent the CCl4 induced decrease in arachidonic acid content. Moreover, promethazine itself produced a similar decrease but in complete absence of liver damage. Results suggest that either lipid peroxidation is not relevant to liver injury or that the arachidonic acid decrease in microsomal lipids is not evidence for lipid peroxidation occurrence or that promethazine effects are not related to inhibition of lipid peroxidation.

Animals↗
PubMed1981

Determination of promethazine in serum by liquid chromatography.

We describe a procedure for the liquid-chromatographic determination of promethazine in low-nanogram concentrations in serum. Triflupromazine is used as the internal standard. The method is based on a single extraction of promethazine from serum with hexane and subsequent derivatization with trichloroethyl chloroformate. Analytical recovery of promethazine is about 90%. The lower limit of detection is 1 microgram/L when a 2.0-mL aliquot of serum is assayed. Our data illustrate the practicability of the method for bioavailability studies after oral or rectal administration of promethazine hydrochloride.

Administration, Oral↗
PubMed1994

[Absolute bioavailability of chlorpromazine, promazine and promethazine].

The absolute bioavailability of the three phenothiazine neuroleptics, promazine (Sinophenin, CAS 58-40-2), chlorpromazine (Propaphenin, CAS 50-53-3) and promethazine (Prothazin, CAS 60-87-7) was tested in three single-dose cross-over studies. In each trial 12 to 14 healthy volunteers were enrolled. The single doses for promazine, promethazine and chlorpromazine were 100, 75 and 150 mg (orally) and 20, 50 and 50 mg (intravenously), resp. The serum concentrations of the three neuroleptics were measured by means of a selective HPLC-method. the distribution-free confidence intervals for the absolute bioavailability of the three phenothiazines were within 10.5 to 24.7% for chlorpromazine, 7.8 to 24.9% for promazine and 12.3 to 40% for promethazine. Promazine and chlorpromazine are pharmacokinetically very similar and differ substantially from promethazine.

Administration, Oral↗
PubMedDate not supplied

Efficacy and safety of promethazine hydrochloride as a local anaesthetic agent for inguinal hernia repair: a pilot study.

Promethazine hydrochloride is known to possess properties as a local anaesthetic which scientists have not researched well. Therefore, a prospective, randomised, double-blind clinical study was conducted to evaluate the efficacy of promethazine hydrochloride compared to lignocaine hydrochloride, when used as a local anaesthetic agent. Twenty adult male patients undergoing inguinal hernia repair were included in the study. Regional nerve block technique was employed in all the patients. Efficacy of the agents was assessed on a four-point scale and by recording the pulse and the blood pressure. Promethazine hydrochloride was found to be as effective as lignocaine hydrochloride in terms of the intensity and the duration of regional anaesthesia produced. None of the patients from either group required additional anaesthesia in any form, and no complications were witnessed. To conclude, promethazine hydrochloride appears to be a safe alternative to lignocaine hydrochloride for performing surgery under regional anaesthesia.

Adult↗
PubMed1998

Promethazine overdose: is it a "Goodnight" after all?

AIMS: To evaluate and describe the perceived increase in number of promethazine overdoses presenting to Auckland Hospital Emergency Department since Goodnight became available in New Zealand. METHOD: Emergency Department records were reviewed for 19.5 months from 19 December 1994 (when Goodnight became available on the New Zealand market) until 31 July 1996. The Emergency Department database for the preceding years dating back to 1 January 1984 was reviewed. RESULTS: There were a total of 25 patients (18 female; 7 male) with 17 patients being between the ages of 15-25. The first cases presented in April 1995 and 15 cases (60%) presented during the 1996 period of the study. Fifteen patients (60%) ingested one or more full boxes of Goodnight. Twelve patients (48%) were admitted to intensive care, eight of whom were intubated. Fifteen patients were discharged from hospital in under 24 hours, but five (20%) stayed 2-3 days. Records dating back to 1 January 1984 revealed a total of 31 cases of promethazine overdose in just under 11 years, nine being accidental ingestion in children less than 5 years of age. CONCLUSIONS: This review highlights the high morbidity and cost of having promethazine available as an unrestricted, pharmacy--only medication. It suggests that marketing laws should be reviewed and the availability of promethazine be curtailed.

Adolescent↗
PubMed1998

[The influence of cumulative dexamethasone, promethazine and dextran 70 used as protection against intraperitoneal adhesions on selected parameters of humoral immunity in women operated on for infertility].

One of the most frequent reasons of the intraperitoneal adhesions formation in young women is pelvic inflammatory disease and surgical operations of pelvic organs. The element of more complex activities against adhesion creation is to limit an inflammatory reaction in the area of operation by intraperitoneal and systemic pharmacotherapy. The system of activities put into practice in the Clinic of Gynaecology includes in the field of pharmacological prophylaxis a systemic and intraperitoneal use of dexamethasone and promethazine before, during and after the operation, in total doses respectively: 250 mg and 300 mg, as well as intraperitoneal dosing of 500 ml of dextran 70, just before closing the peritoneal cavity. Verification of the results of these activities during laparoscopy or laparotomy shows its high effectiveness. For many years we did not observe any complications of any wound healing after the operations. Due to existing reports about possible complications in the postoperation period, which are probably caused by the use of the above-mentioned pharmaceutics, I decided to investigate how dexamethasone, promethazine and dextran 70 influence the selected parameters of humoral resistance in women who were operated on due to mechanical infertility. The investigated group consisted of 30 women, while the control group comprised 10 women who had gynaecological operations of similar extent. The venal blood samples were collected before the operation and on the third, fifth and twenty first day after the operation. The levels of selected acute phase proteins were checked and the character as well as the dynamics of value changes were monitored in both groups. Because of great variability between the proteins the fractions were picked out focusing on the differences in dynamics of metabolism, half-life time and biological functions. Following proteins were investigated: C-reactive protein, alfa1-acid glycoprotein, haptoglobin, alfa1-antitripsin, ceruloplazmin, alpha2-macroglobin, hemopexin, immunoglobulins A, G, M, albumins, transferrin, alpha2-HS-glycoprotein. The analysis of the study results has indicated that the application of dexamethasone, promethazine and dextran 70 only exerts modulating influence on the course of acute phase reaction induced by the operations. In the group having been studied earlier (in 3rd postoperative 24-hours) significant changes were revealed concerning the level of particular proteins in accordance with their physiological character (increase or decrease of level) in the control group such changes appeared later (about 5th 24-hours) and were characterized by markedly smaller amplitude and dynamics (Tab. 1-2, Fig. 1-15). The levels of proteins defined prior to operation were reached faster by patients of the study group (up to 21st 24-hours after operation). It has been disclosed that the use of composed antiadhesion therapy with dexamethasone, promethazine and dextran 70 accelerates, intensifies and simultaneously restricts the duration of transformations defined as acute phase reaction, which result in reducing the number of intraperitoneal adhesions. This therapy does not impair the mechanisms of humoral immunity in patients operated on.

Acute-Phase Reaction↗
PubMed1976

Effects of intravenous meperidine and meperidine with promethazine on uterine activity and fetal heart rate during labor.

A prospective study of the effects of the i.v. injection of 75 mg meperidine, alone or combined with 25 mg promethazine, was conducted by continuous and direct monitoring of the fetus and of intrauterine pressure. The study was carried out in 16 primiparas and 24 multiparas in active spontaneous labor with cervical dilatation of 3 to 4 cm. Administration of meperidine and of meperidine with promethazine was associated with an increase in uterine activity of 31 to 45% (Montevideo units), respectively. The most marked effects were on the amplitude of the uterine contractions. There was no significant change in uterine tone. A tetanic response was recorded in two patients who vomited after the administration of meperidine with promethazine and was followed by slowing of the fetal heart rate. In no other cases were there significant changes in fetal heart rate. Except for the latter two patients, no adverse effect of meperidine or of meperidine with promethazine on the fetal heart rate was noted. The condition of the newborns at birth was excellent in all but three cases, in two of which maternal amniotic infection and high fever were present.

Female↗
PubMedDate not supplied

Comparison of the bioavailability of oral, rectal and intramuscular promethazine.

The bioavailabilities of generic and reference promethazine 50 mg rectal suppositories were compared with that of 50 mg reference oral solution (24 subjects), and all three treatments were compared with a 50 mg reference i.m. injection (six subjects). Plasma samples were assayed by an HPLC method with triflupromazine as the internal standard. Both suppositories produced lower peak plasma concentrations (Cmax) and longer times to peak concentration (Tmax) than did the oral solution. There were no significant differences in the mean area under the plasma concentration-time curves (AUC) from 0 to 24 h among the three treatments. The Cmax of the i.m. injection was significantly higher than the other three treatments, while the Tmax of the injection was significantly shorter than the reference suppository only. The mean AUC of the injection was significantly greater than the AUCs of the other three treatments. Rectal suppositories of promethazine are more slowly absorbed than oral solutions or i.m. injections; rectal suppositories and oral solutions are less bioavailable than i.m. injections. Diminished systemic bioavailability may result from extensive first-pass hepatic metabolism that occurs after both oral and rectal dosing. There is a high degree of intersubject variation in the bioavailability of promethazine rectal suppositories and oral solutions.

Administration, Oral↗