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PubMed1989

Extrapyramidal reactions to metoclopramide and prochlorperazine.

We have investigated prospectively the incidence of extrapyramidal events amongst patients receiving 'first' prescriptions for metoclopramide (n = 2557) and prochlorperazine (n = 2811) from general practitioners in the Northern Region using community pharmacists to capture prescriptions. There were 12 reports of acute dystonic-dyskinetic events following metoclopramide and the incidence of this reaction was significantly greater in those under 30 years than in those 30 years and over. Following prochlorperazine there were eight reports of Parkinsonism in patients whose ages were known; seven were over 60 years. The incidence in those over 60 years was significantly higher than in those less than 60 years.

Adolescent↗

PubMed1987

[A randomized controlled trial of acute and delayed cisplatin-induced emesis with metoclopramide, dexamethasone and prochlorperazine].

Forty patients with advanced lung cancer who had received chemotherapy containing cisplatin (80 mg/m2) were accrued for a randomized controlled trial to evaluate the additional effect of prochlorperazine on the combination of high-dose metoclopramide and dexamethasone for the treatment of acute cisplatin-induced emesis. The effect of intravenous metoclopramide and dexamethasone in emesis occurring more than 24 hours after cisplatin administration was also evaluated. Excellent emetic control (no emesis during 24 hours after cisplatin administration) was achieved in 70% (14/20) and 76% (16/21) of the patients who received the combination of prochlorperazine, metoclopramide and dexamethasone and the combination of metoclopramide and dexamethasone, respectively. The overall toxicities associated with both regimens were not serious and were similar. Patients treated with metoclopramide and dexamethasone on days 2-7 experienced less delayed emesis, nausea and anorexia compared with those treated with a placebo (delayed emesis, 25% versus 50%, respectively, p = 0.105; more than 4 days of nausea, 10% versus 35%, respectively, p = 0.059; less than 3 days of anorexia, 80% versus 50%, respectively, p = 0.048). It was concluded that metoclopramide and dexamethasone showed an excellent antiemetic effect on acute drug-induced emesis, as well as on delayed emesis, induced by cisplatin.

Adult↗

PubMed1976

Controlled clinical trial comparing the effect of betahistine hydrochloride and prochlorperazine maleate on patients with Meniére's disease.

Therapeutic effects of prochlorperazine and betahistine on patients with confirmed Meniere's disease (range of duration 1-11 years) were compared in a double-blind cross-over trial. The two active treatment periods lasted 4 montsh each, separated by a single blind "wash-out" period of 1 month's duration. Out of 30 patients 23 completed the trial. The clinical status of the patients was followed by the investigator by regular control visits during the trial period. Upon completion of the study preference for the first or the second period was assessed. The therapeutic effect of betahistine was found to be superior to that of prochlorperazine (sign test a = 0.05). The number of vertigo attacks was calculated in 17 patients and on this basis the two drugs were of equal value (Pratt's test 2 a = 0.05). No side effects were observed.

Adult↗

PubMedDate not supplied

Improved control of high-dose-cisplatin-induced acute emesis with the addition of prochlorperazine to granisetron/dexamethasone.

PURPOSE: To evaluate the antiemetic efficacy and safety of adding the dopamine antagonist prochlorperazine to the combination of granisetron and dexamethasone in the prevention of acute nausea and vomiting following high-dose cisplatin. PATIENTS AND METHODS: Sixty patients receiving cisplatin (> or = 75 mg/m2) (median dose = 100 mg/m2) were enrolled at three sites. Patients received prochlorperazine spansule 15 mg orally, 60 minutes prior to and 12 hours after cisplatin; dexamethasone 20 mg intravenously, 45 minutes prior to cisplatin, and 10 mg intravenously or orally, 12 hours after cisplatin; and granisetron 10 micrograms/kg intravenously, 30 minutes prior to cisplatin. Efficacy was assessed during the 24-hour period after cisplatin using complete antiemetic response (no emetic episodes and no rescue antiemetics) and patient assessment of nausea and satisfaction using 100-mm visual analog scales (nausea: 0 = none, 100 = nausea as bad as it can be; satisfaction: 0 = not at all satisfied, 100 = satisfied as can be). RESULTS: Complete response (0 emetic episodes) was noted in 84% (49/58) of patients. Forty-two patients (72%) experienced no nausea. The mean change in posttreatment nausea visual analog scales from baseline was 8.9 mm. Forty-eight patients (83%) were completely satisfied with their antiemetic treatment. The mean posttreatment patient satisfaction score was 92 mm. Treatment was well tolerated, with infrequent and minor adverse events. CONCLUSIONS: This three-drug antiemetic regimen is well tolerated and highly effective in the prevention of acute nausea and vomiting arising from high-dose cisplatin. Further studies evaluating this regimen are warranted.

Acute Disease↗

PubMed1982

Cannabis and cancer chemotherapy: a comparison of oral delta-9-THC and prochlorperazine.

Delta-9-tetrahydrocannabinol (THC) and prochlorperazine (Compazine) were found to be equally efficacious in reducing nausea and vomiting associated with cancer chemotherapy across a wide range of chemotherapeutic regimens and tumor types. Both drugs were administered orally one hour before chemotherapy, then every four hours for a total of four doses. Compazine was administered in a fixed dose of 10 mg; THC was administered by body surface area (BSA): BSA less than 1.4 m2 = 7.5 mg; BSA 1.4-1.8 m2 = 10- mg; and BSA greater than 1.8 m2 = 12.5 mg. Two hundred and fourteen subjects (75% of whom had previously received Compazine with varying results) were evaluated employing a double-blind, crossover design. Additional parameters evaluated were study drug effects on appetite, food intake, mood, activity, relaxation, interaction, and concentration. There were significant drug effects with THC: less ability to concentrate (P less than 0.01), less social interaction (P less than 0.05), and less activity (P less than 0.05). There were no significant differences between the two drugs in the level of food intake or appetite. Patients of all ages did equally well on both drugs. Neither past marijuana use nor past Compazine use were related to study the drug efficacy. Those patients who correctly identified their THC cycle did better on THC versus those who could not correctly identify which antiemetic they had received (P less than 0.05). There were more drug-related effects associated with THC, but these did not reduce the patients' preference for the drug, and were associated with nausea reduction (P less than 0.05).

Adolescent↗

PubMed1983

Synthesis of deuterium-labeled prochlorperazine.

The propylpiperazine side chain of prochlorperazine was labeled with two, four, or six deuterium atoms by lithium aluminum deuteride reduction of the appropriate amide. The isotopic purity of the products after correcting for chlorine isotopes was greater than 95.7%.

Deuterium↗

PubMed1985

High-dose intravenous metoclopramide and intermittent intramuscular prochlorperazine and diazepam in the management of emesis induced by cis-dichlorodiammineplatinum.

Intravenous metoclopramide and IM prochlorperazine and diazepam were compared in the management of vomiting occurring during treatment with cis-dichlorodiammineplatinum (cis-platinum). A total of 104 cycles in 30 patients were evaluated. Twenty-two patients took part in a cross-over study in which emetic profiles for each patient managed with each anti-emetic schedule were compared. In all, 44 cycles of treatment in 22 patients were evaluated as part of a cross-over study. No significant difference in emetic control was observed between the two anti-emetic regimens. The side-effects observed using IV metoclopramide included extrapyramidal phenomena (19%) and flushing attacks (16%).

Antiemetics↗

PubMed1993

Prochlorperazine as a doxorubicin-efflux blocker: phase I clinical and pharmacokinetics studies.

Doxorubicin (DOX) efflux in drug-resistant cells is blocked by phenothiazines such as trifluoperazine (TFP) and prochlorperazine (PCZ) in vitro. The present phase I study was conducted in 13 patients with advanced, incurable, nonhematologic tumors to determine whether PCZ plasma levels high enough to block DOX efflux could be achieved in vivo. The treatment schedule consisted of prehydration and i.v. administration of 15, 30, 50, and 75 mg/m2 PCZ followed by a standard dose of 60 mg/m2 DOX. The hematologic toxicities attributable to DOX were as expected and independent of the PCZ dose used. Toxicities attributable to PCZ were sedation, dryness of the mouth, cramps, chills, and restlessness. The maximal tolerated dose (MTD) of PCZ in this schedule was 75 mg/m2. Pharmacokinetic analysis indicated a large interpatient variation in peak plasma PCZ levels that ranged from 95 to 1100 ng/ml. The three plasma half-lives of PCZ were: t1/2 alpha (+/- SE), 20.9 +/- 5.3 min; t1/2 beta, 1.8 +/- 0.3 h; and t1/2 gamma, 21.9 +/- 5.3 h. The volume of distribution (Vd), total clearance (ClT), and area under the curve (AUC) for PCZ were 2254 +/- 886 l/m2, 60.2 +/- 13.5 l m-2 h-1, and 1624 +/- 686 ng ml-1 h, respectively. DOX retention in tumor cells retrieved from patients during the course of therapy indicated the appearance of cells with enhanced DOX retention. The combination of DOX and high-dose i.v. PCZ appeared to be safe, well tolerated, and active in non-small-cell lung carcinoma.

Aged↗

PubMed1994

Phase I and pharmacokinetics studies of prochlorperazine 2-h i.v. infusion as a doxorubicin-efflux blocker.

In an earlier phase I study, we reported that the maximal tolerated dose (MTD) of prochlorperazine (PCZ) given as a 15-min i.v. infusion was 75 mg/m2. The highest peak plasma PCZ concentration achieved was 1100 ng/ml. The present study was conducted to determine if PCZ levels high enough to block doxorubicin (DOX) efflux in vitro could be achieved and sustained in vivo by increasing the duration of i.v. infusion from 15 min to 2 h. The treatment schedule consisted of i.v. prehydration with at least 500 ml normal saline (NS) and administration of a fixed standard dose of 60 mg/m2 DOX as an i.v. bolus over 15 min followed by i.v. doses of 75, 105, 135, or 180 mg/m2 PCZ in 250 ml NS over 2 h. The hematologic toxicities attributable to DOX were as expected and independent of the PCZ dose. Toxicities attributable to PCZ were sedation, dryness of mouth, anxiety, akathisia, hypotension, cramps, and confusion. The MTD of PCZ was 180 mg/m2. Large interpatient variation in peak PCZ plasma levels (91-3215 ng/ml) was seen, with the plasma half-life (t1/2 alpha) being approximately 57 min in patients given 135-180 mg/m2 PCZ. The volume of distribution (Vd), total clearance (ClT), and area under the curve (AUC) were 350.1 +/- 183.8 1/m2, 260.7 +/- 142.7 l m2 h-1 and 1539 +/- 922 ng ml h-1, respectively, in patients given 180 mg/m2 PCZ and the respective values for patients receiving 135 mg/m2 were 48.9 +/- 23.76 l/m2, 33.2 +/- 2.62 l m2 h-1, and 4117 +/- 302 ng ml h-1. High PCZ plasma levels (> 600 ng/ml) were sustained in all patients treated with 135 mg/m2 PCZ for up to 24 h. DOX plasma elimination was biphasic at 135 and 180 mg/m2 PCZ, and a > 10-ng/ml DOX plasma level was maintained for 24 h. Partial responses were seen in three of six patients with malignant mesothelioma, in two of ten patients with non-small-cell lung carcinoma, and in the single patient with hepatoma. Our data show that PCZ can be safely given as a 2-h infusion at 135 mg/m2 with clinically manageable toxicities. The antitumor activity of the combination of DOX and PCZ needs to be confirmed in phase II trials.

Adult↗

PubMed1989

Protection against cisplatin nephrotoxicity by prochlorperazine.

Prochlorperazine (Compazine; PCPZ) is often used to limit cisplatin (CDDP)-induced emesis. However, recent studies in mice have shown that PCPZ protects against renal injury produced by treatment with various nephrotoxicants (e.g., MethylCCNU, mercuric chloride). Because renal toxicity remains a serious limitation to the effective use of CDDP, we conducted the present study to determine whether PCPZ could also protect against CDDP-induced renal injury. PCPZ treatment was shown to ameliorate CDDP-induced renal lesions in both rats and mice at doses and treatment schedules that were comparable with those used for alleviating chemotherapy-induced emesis. A PCPZ dose of 10 mg/kg x 2 offered complete protection against CDDP-induced increases in blood urea nitrogen (BUN) levels in mice, with significant protection occurring at a PCPZ dose as low as 5 mg/kg. Similarly, PCPZ ameliorated CDDP-induced increases in BUN, glucosouria, and enzymuria in F344 rats. PCPZ treatment did not affect the urinary excretion or renal tissue levels of total platinum or the plasma pharmacokinetics of free platinum. However, it did cause a marked reduction in the concentration of total plasma platinum (free platinum + protein-bound platinum). PCPZ was not found to affect the in vivo antitumor activity of CDDP against P388 leukemia. The present study suggests that PCPZ may be of therapeutic benefit when used with CDDP and provides a rational basis for the selection of antiemetic therapy.

Animals↗

PubMed1989

Intraoperative prochlorperazine for prevention of post-operative nausea and vomiting.

The effectiveness of 10 mg IV prochlorperazine in preventing postoperative nausea and vomiting was compared with placebo when given perioperatively to 100 patients in a prospective double-blind randomized trial. The occurrence of nausea and vomiting was assessed in the recovery room prior to and after narcotic administration for pain relief. No statistically significant difference in the frequency of postoperative nausea and vomiting was found between the treatment and control groups.

Adult↗

PubMed2000

A phase I study of carboplatin and etoposide administered in conjunction with dipyridamole, prochlorperazine and cyclosporine A.

PURPOSE: In recognition of the variety of available chemotherapeutic modulating agents and their potential to enhance the efficacy of platinum-based therapy, we embarked upon a phase I study to investigate the feasibility of combining fixed doses of carboplatinum (CBDCA) and etoposide (VP-16) with 24-h concurrent infusions of dipyridamole (DP), prochlorperazine (PCZ) and cyclosporine A (CSA) administered in escalating doses. METHODS: Patients received intravenous VP-16 (200 mg/m2) and CBDCA (300 mg/m2), each over 30 min, starting at hour 6 of the modulator infusions. Resistance modulators were escalated sequentially to determine their respective maximally tolerated doses (MTDs). The pharmacokinetics (PK) of VP-16, CBDCA, and the three drug resistance (DR) modifiers were studied in eight patients. RESULTS: A total of 59 patients were entered on study. The MTD was established at DP 5 mg/kg per day, PCZ 24 mg/h, and CSA 9.5 mg/kg per day. Dose-limiting toxicities included hypotension and severe sedation, presumably related to PCZ. No objective responses were seen. PK studies were performed when PCZ and DP doses were 24 mg/h and 3.3 mg/kg, and the CSA dose was either 8.5 mg/kg (five patients) or 9.5 mg/kg (three patients). The median clearance of VP-16 was 0.96 l/h per m2 (range 0.8-1.5 l/h per m2), which is lower than for VP-16 alone and similar to previously reported effects of CSA on VP-16 elimination. The median measured CBDCA AUC was 3.0 mg/ml x min (range 2.4-4.8 mg/ml x min). CBDCA AUC predicted by the Calvert formula using measured creatinine clearance underestimated the actual AUC in seven of the eight patients, in one case by as much as twofold. The median end of infusion PCZ and total DP plasma concentrations were 1.2 microM (range 0.5-2.2 microM) and 4.4 microM (range 1.3-5.9 microM), respectively, consistent with in vitro resistance modulatory levels. However, free DP was only 0.02 microM (range 0.004-0.04 microM). The median CSA level at 24 h of 1450 microg/l (range 1075-1640 microg/l) is in agreement with concentrations required for partial DR reversal in vitro, although it is much lower than levels achieved in our previous phase I study of CBDCA + CSA alone using similar doses of CSA. The CSA dose on the current trial was escalated beyond the MTD for the previous phase I study, suggesting that there may be an interaction between CSA and one of the other modulators. CONCLUSION: These results demonstrate that in vitro DR-reversing levels of two of the three agents used in this study can be achieved in vivo, and that this combination of DR modulators has significant effects on the pharmacokinetics of VP-16.

Adult↗

PubMed1994

Displacement of [3H] gamma-hydroxybutyrate binding by benzamide neuroleptics and prochlorperazine but not by other antipsychotics.

Since gamma-hydroxybutyrate receptor agonists exhibit dopaminergic regulatory properties and neuroleptic-like effects in neuropharmacological tests, the common neuroleptics were tested for [3H] gamma-hydroxybutyrate binding activity on rat brain membranes. (-)-Sulpiride, sultopride, amisulpride and prochlorperazine possess affinity for the gamma-hydroxybutyrate site(s), consistent with their therapeutic dosage. This study has revealed that gamma-hydroxybutyrate receptors represent an additional target for antipsychotics.

Animals↗

PubMed2006

Development of a simplified instrument for the diagnosis and grading of akathisia in a cohort of patients receiving prochlorperazine.

Akathisia is a common side-effect of dopamine receptor D2 antagonists that often remains undiagnosed. Conventional diagnostic and grading instruments are cumbersome and can be difficult to remember and to use. To facilitate the Emergency Department (ED) assessment of acute drug-induced akathisia, I sought to derive and evaluate a simplified instrument using the database compiled from three prior studies of acute drug-induced akathisia. These studies had used a conventional Long instrument in the prospective assessment of 360 adult ED patients aged 17-65 years who received intravenous prochlorperazine (10 mg) in the treatment of headache or nausea and vomiting. The Short instrument was derived from the Long instrument using the Wilcoxon z-test to identify the individual findings most strongly associated with the diagnosis of akathisia. I then retrospectively applied the Short instrument to the cohort and used pairwise analyses to compare results obtained from both instruments. Sensitivity, specificity and receiver operating characteristic curves were used to analyze the impact of instrument form on diagnostic accuracy. The Long criteria diagnosed akathisia in 118 (32.8%; 95% confidence interval [CI] 28.0%-37.9%) patients and the Short diagnosed akathisia in 120 (33.3%; 95% CI 28.5%-38.5%). When akathisia was characterized categorically as either absent or present, the Short criteria agreed with the Long in 358 cases (99.4%; 95% CI 98.0%-99.9%). Treating the diagnoses established by the Long criteria as the gold standard, the Short instrument had a sensitivity of 100.0% (95% CI 96.9%-100%) and a specificity of 99.2% (95% CI 97.0%-99.9%). Regarding the accuracy of categorizing akathisia into four severity grades, the Short scale agreed in 325 of 360 cases (90.3%; 95% CI 86.7%-93.1%) and misgraded 35 cases (9.7%; 95% CI 6.9%-13.3%), 34 of which fell within one grade of the Long scale. The Short instrument is highly accurate in diagnosing acute drug-induced akathisia, in comparison with the Long criteria, in the ED setting. The Short instrument also provides fairly accurate grading of akathisia severity. This simplified instrument should facilitate the detection and treatment of akathisia in the ED.

Adolescent↗

PubMed1988

Prochlorperazine-induced chronic cholestasis.

A patient with prochlorperazine-induced cholestasis that persisted for more than 2 years is reported. The timing of the onset of jaundice, the clinical, biochemical and histological findings and the subsequent course of this patient were typical of chlorpromazine-induced chronic cholestasis. Despite subsequent resolution of jaundice, liver biopsy performed 2 years after the onset of clinical disease showed fibrous expansion of the portal tracts with focal porto-portal and centro-portal bridging fibrosis, and paucity of inter-lobular bile ducts, a picture simulating that of primary biliary cirrhosis. Long-term follow-up is required to determine whether this patient will progress to frank cirrhosis.

Aged↗

PubMed1999

Prochlorperazine induces akathisia in emergency patients.

STUDY OBJECTIVE: Prochlorperazine (PCZ), a commonly used antiemetic and analgesic agent, is known to cause akathisia. The incidence of akathisia after a single 10-mg dose of intravenous PCZ has not been prospectively evaluated. We determined the incidence and severity of PCZ-induced akathisia at 1 hour and the incidence of delayed akathisic symptoms at 48 hours. METHODS: This prospective controlled study evaluated a convenience sample of 140 adult patients at a 400-bed, academic, tertiary-care medical center with an annual emergency department census of 95,000 patient visits. One hundred patients who received intravenous PCZ for the treatment of severe headache or vomiting constituted the PCZ group. Forty patients receiving nonakathisic intravenous therapy (eg, saline solution or antibiotics) served as control subjects. Patients were excluded if they had preexisting motor disorders (eg, restless-leg syndrome or Parkinson's disease) or if they recently had received any medication with extrapyramidal, anticholinergic, sedative, or antiakathisic properties. All patients underwent an akathisia assessment before and 1 hour after receiving their respective intravenous medications. An established scale was used to detect the presence of akathisia and grade its severity as mild, moderate, or severe. The delayed development of akathisic symptoms within 48 hours also was measured in the PCZ group. RESULTS: Akathisia developed in 44 (44%) of the patients receiving PCZ within 1 hour (95% confidence interval, 34% to 54%). The akathisia was graded as mild, moderate, and severe in 14, 22, and 8 subjects, respectively. Delayed symptoms suggestive of akathisia developed in 3 other patients within 48 hours. None of the 40 control subjects developed akathisia. CONCLUSION: Single-dose intravenous PCZ frequently induced akathisia within 1 hour of administration. Acute akathisia was not observed in patients receiving intravenous saline solution or antibiotics. The delayed development of akathisia symptoms 48 hours after a single dose of intravenous PCZ was uncommon.

Adolescent↗

PubMed1977

Prochlorperazine in childhood: side-effects.

The side-effects of prochlorperazine (CompazineR StemetilR) were traced in thirty-six children up to the age of sixteen years and compared with those collected from literature. These side-effects appeared to be predominantly neurological and were independent of the dosage. Impaired consciousness, dyskinesia, pyramidal signs and hypertonus were the main neurological manifestations. Dyskinesia was the most frequent sign. These side-effects disappear spontaneously after discontinuation of the drug. Instant cure can be acquired by intra-muscular administration of orphenadrine (DisipalR).

Adolescent↗

PubMedDate not supplied

Prochlorperazine-induced neuroleptic malignant syndrome.

Neuroleptic malignant syndrome can present in a variety of ways. In a review of the medical literature we could find few well-documented reports of prochlorperazine-induced neuroleptic malignant syndrome. We report such a case with its workup, recognition, and management.

Acidosis↗