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PubMed2002

Efficacy and tolerability of prochlorperazine buccal tablets in treatment of acute migraine.

OBJECTIVES: To study the efficacy and tolerability of prochlorperazine (PCZ) management of acute migraine. DESIGN AND METHODS: A double blind comparative study was conducted to assess the efficacy of buccal PCZ 3 mg compared with oral ergotamine tartarate 1 mg plus caffeine 100 mg (ERG) or placebo (buccal or oral) for treatment of acute migraine. In all, 114 episodes of acute migraine were evaluated. Patients graded symptoms on a four-point scale before and up to 4 hours after treatment. The primary efficacy parameters included headache resolution within 2 hours (grade 3 or 2 to grade 0) and alleviation of other accompanying symptoms of migraine. The supplementary endpoints included improvement in quality of life (QOL). RESULTS: The percentage of patients reporting resolution of headache (to grade 0) was 51.4% for buccal PCZ and 21.7% for buccal placebo, 23.1% for oral ERG and 28.6% for oral placebo, headache tended to recur in both the placebo and ERG groups after initial improvement. Buccal PCZ was well tolerated; no signs of local irritation were evident, and patients found the formulation easy to use. Mild but transient sedation and drowsiness were observed in 41%. CONCLUSIONS: In the present study, PCZ 3 mg via the buccal route produced faster improvement and greater efficacy than placebo (oral as well as buccal) or oral ERG. The global QOL score 2 hours after treatment scores was higher in the PCZ group. Buccal PCZ may represent a particularly effective alternative for acute migraine treatment.

Acute Disease↗
PubMed2000

Frequency of adverse reactions to prochlorperazine in the ED.

Prochlorperazine (Compazine, PCZ) is a frequently used medication in the emergency department (ED). Akathisia and dystonia are known adverse reactions to the use of this medication, but their incidence in the ED has not been well studied. We conducted a prospective, descriptive study to evaluate the frequency of akathisia and dystonia in the ED from the use of IV or IM PCZ in patients with nausea/vomiting or headache. Two hundred-twenty nine patients (> or =18 years old) were enrolled and contacted within 2 weeks of ED discharge to access the incidence of these adverse reactions. After the use of PCZ in the ED, 16% of patients developed akathisia and 4% developed dystonia. Emergency physicians and our patients need to be aware of these potential adverse reactions to the use of PCZ in the ED.

Adolescent↗
PubMed1999

Granisetron (Kytril) suppresses methotrexate-induced nausea and vomiting among patients with inflammatory arthritis and is superior to prochlorperazine (Stemetil).

OBJECTIVE: Methotrexate (MTX) is an increasingly popular anti-rheumatic drug with its usefulness limited by toxicity, most commonly gastrointestinal (GI). The aim of the study was to study the effectiveness of the 5-HT3 receptor antagonist granisetron (GR) in the therapy of MTX-induced nausea. METHODS: A single-blind 8 week pilot study with random allocation to either GR 1 mg or prochlorperazine (Stemetil; PCh) 10 mg was undertaken in 13 patients who were taking or had taken MTX for either rheumatoid arthritis (10) or psoriatic arthritis (3). RESULTS: One in six patients treated with PCh completed the 8 week study compared to 7/7 treated with GR. After switching of symptomatic patients, 11 completed the study on GR and median improvement was by two grades (P < 0.001) with a significantly better visual analogue scale score for patient satisfaction compared to PCh. CONCLUSION: Treatment with GR may be useful in establishing and maintaining some patients on MTX where GI toxicity would have precluded such therapy.

Antiemetics↗
PubMed1983

Radioimmunoassay for prochlorperazine in human plasma.

A new sensitive, specific, and rapid radioimmunoassay procedure for the determination of plasma concentrations of the antiemetic drug prochlorperazine is described. The assay enables the quantitation of 31 pg of the drug in 200 microliters of plasma with a coefficient of variation of approximately 2%. Except for N-desmethylprochlorperazine, the antiserum did not cross-react with the available metabolites tested. Also there was no cross-reactivity with the tricyclic antidepressants and antianxiety agents commonly co-administered with the drug. The method is suitable for single-dose pharmacokinetic and bioavailability studies. It should be adequate for the therapeutic monitoring of the drug in patients.

Animals↗
PubMed2005

Efficacy of a fixed combination of indomethacin, prochlorperazine, and caffeine in the treatment of episodic tension-type headache: a double-blind, randomized, nimesulide-controlled, parallel group, multicentre trial.

In this double-blind, randomized, parallel group, multicentre study the efficacy of a fixed combination of indomethacin, prochlorperazine, and caffeine (IndoProCaf) and nimesulide were compared over an 8-h period in the treatment of two consecutive episodes of tension-type headache (TTH). Both drugs were administered orally. Of 54 randomized patients, 40 were compliant to the protocol. More patients on IndoProCaf than on nimesulide were pain-free at 2 h post-dose (45% vs. 10%; P<0.05), reached a pain reduction of at least 50% at 2 (75% vs. 30%; P<0.05) and 4 h post-dose (90% vs. 58%; P<0.05), and had a statistically significant lower mean time to a 50 and 100% pain reduction in the second TTH episode. A higher percentage of patients reached a 50 or 100% pain reduction at 2 h post-dose with IndoProCaf compared with nimesulide, in two of two treated TTH episodes. A clinically and statistically significant change within each treatment group over time was found for the severity of pain, the headache intensity difference (HID), the sum of headache intensity difference (SHID), the maximum headache intensity difference (MAXHID), the headache relief (HER), the sum of total headache relief (TOTHER) and the maximum headache relief (MAXHER). In conclusion, IndoProCaf showed to be superior, but globally not statistically different from nimesulide in the treatment of episodic TTH. Both drugs were very effective and well tolerated.

Administration, Oral↗
PubMed1992

In vitro activities of chloroquine in combination with chlorpromazine or prochlorperazine against isolates of Plasmodium falciparum.

The combinations of chloroquine plus chlorpromazine and chloroquine plus prochlorperazine were evaluated in vitro for potentiation against isolates of Plasmodium falciparum. Potentiation was observed against all chloroquine-resistant isolates. There was no potentiation against 8 of 10 chloroquine-susceptible isolates. The results indicated that the phenothiazines can potentiate chloroquine action against resistant parasites found in natural conditions.

Animals↗
PubMed1989

Double-blind randomized cross-over trial of dexamethasone and prochlorperazine as anti-emetics for cancer chemotherapy.

A double-blind randomized cross-over trial of dexamethasone and prochlorperazine as adjunctive anti-emetics with cancer chemotherapy was undertaken. The drugs were compared for cisplatin, doxorubicin and several other chemotherapy regimens. A total of 44 eligible patients were analysed. Assessment was made by questionnaire answered by the patient 24 h after the chemotherapy. The parameters compared were period of time for nausea and vomiting, number of vomiting episodes, degree of somnolence and insomnia and overall preference. In all cases there was no significant difference for either drug in its ability to suppress emetic effects. Neither drug gave adequate protection against cisplatin-containing regimens. We conclude that dexamethasone alone is equivalent to the more standard dopamine antagonists.

Adult↗
PubMed1991

A double-blind randomized cross-over comparison of high-dose prochlorperazine with high-dose metoclopramide for cisplatin-induced emesis.

This double-blind randomized cross-over study was conducted to compare the safety and efficacy of high-dose prochlorperazine infusion and dexamethasone (HDPD) with an effective and safe combination of high-dose metoclopramide and dexamethasone (HDMD) in controlling cisplatin-induced emesis. None of the patients entering the study had received any prior chemotherapy. High-dose cisplatin was administered on an inpatient basis. Twenty eligible patients were analyzed based on the assessment made 24 h after the chemotherapy. The parameters compared were severity and duration of nausea and vomiting, severity of retching and side effects. Significantly less vomiting and retching episodes were recorded with HDPD combination. The severity of nausea was also less with this combination. There was no significant difference in the incidence of side effects.

Adult↗
PubMed1988

A randomized comparison of haloperidol plus dexamethasone versus prochlorperazine plus dexamethasone in preventing nausea and vomiting in patients receiving chemotherapy for breast cancer.

The antiemetic effectiveness of haloperidol plus dexamethasone was compared with that of prochlorperazine plus dexamethasone in a prospective study of patients receiving chemotherapy for breast cancer. Chemotherapy consisted of cyclophosphamide, doxorubicin or methotrexate, and fluorouracil in all patients. Patients who received the doxorubicin-containing combination experience significantly more nausea and vomiting than those who received the chemotherapy combination containing methotrexate. There was no significant difference between the two antiemetic regimens in the overall incidence of post-chemotherapy nausea and vomiting, but patients who received haloperidol and dexamethasone did have a lower incidence of severe vomiting. Neither regimen is highly effective, especially for the combination containing doxorubicin, and cannot be recommended as standard antiemetic therapy for this population of patients.

Antineoplastic Combined Chemotherapy Protocols↗
PubMed1996

Effect of 30 mg of morphine alone or with promethazine or prochlorperazine on the exercise capacity of patients with COPD.

OBJECTIVE: We have shown that the administration of 0.8 mg/kg of morphine (M) to patients with COPD resulted in a 20% increase in the maximum oxygen consumption (Vo2max), but was associated with significant drowsiness and euphoria. The objective of the present study was to ascertain whether lower doses of M alone or in combination with prochlorperazine (PC) or promethazine (P) could elicit significant increases in exercise tolerance. DESIGN: The exercise capacity, psychological status, and reaction times were assessed before and 60 min after the patients received placebo (PLAC), 30 mg M orally, 30 mg M plus 10 mg PC (M-PC), or 30 mg M plus 25 mg P (M-P) in a randomized double-blind crossover study. In a secondary study, nine patients were tested on three separate days before and after receiving PLAC, 25 mg P, or 30 mg M plus 25 mg P. PATIENTS: Seven COPD patients (FEV1=0.99 +/- 0.30 L, Vo2max=990 +/- 315 mL/min) who were ventilatory-limited. SETTING: Veterans Affairs medical center. RESULTS: After the patients ingested M-P, the increase in the Vo2max (129.0 +/- 104 mL/min), the workload (10.0 +/- 6.5 W) and the maximum minute ventilation (4.0 +/- 3.9 L/min) were significantly greater (p<0.05) than after PLAC ingestion (-4.8 +/- 79 mL/min, 1.4 +/- 6.9 W, and -1.6 +/- 2.4 L/min, respectively). Changes after the ingestion of M, P, o r M-PC were intermediate. The M-PC combination adversely affected the patient's reported mental status (Bond visual analog scale) more than the M-P or M regimens. No regimen significantly affected the reaction time. CONCLUSIONS: We conclude that the administration of 30 mg of M plus 25 mg of P significantly improves the exercise tolerance of patients with COPD, without significantly impairing the mental capabilities of the subjects. The utility of this regimen over longer time periods needs to be evaluated.

Administration, Oral↗
PubMed2001

Photosensitivity associated with fluorouracil, prochlorperazine, and topical tretinoin.

A woman newly diagnosed with colon cancer began chemotherapy with fluorouracil and leucovorin. Chemotherapy was given daily for 5 days with prochlorperazine premedication and was well tolerated. The patient continued her previous drug regimen during and after chemotherapy, which consisted of hormone replacement therapy, chloroquine, insulin, multivitamin, and tretinoin topical cream. Several days after the end of the first cycle of chemotherapy she experienced a dramatic photosensitivity reaction. Tretinoin application was discontinued, and she recovered. All other drugs remained unchanged. The patient was treated with five additional cycles of chemotherapy. She did not experience the reaction with any potentially photosensitizing agents again; only when the specific sequence and drug combination was administered in the first cycle.

Antimetabolites, Antineoplastic↗
PubMed2000

[Diagnostic image (17). Acute dystonia induced by prochlorperazine].

An 11-year-old girl had a one-day history of nausea and vomiting for which her family physician prescribed 4 suppositories of prochlorperazine 25 mg. Five hours after the last dose she developed dystonic posturing; she recovered rapidly after intramuscular injection of 40 mg orphenadrine.

Acute Disease↗
PubMedDate not supplied

The rat brain as a "deep compartment" in the kinetics of a common metabolite of prochlorperazine and perphenazine.

N-[gamma-(2-Chlorophenothiazin-10-yl)propyl]ethylenediamine (Cl-PPED), a common metabolite of prochlorperazine and perphenazine, was orally administered to male rats at a dose of 50 mg/kg, and its concentrations in plasma, liver, lung, kidney, and brain were followed from 6 hr to 40 days after dosage. Small quantities were measured by two-dimensional thin-layer chromatography of a fluorescent derivative and in situ fluorometry of the chromatograms. The kinetic behavior of Cl-PPED in brain differed from that in other tissues in that the concentration maximum was achieved later and the elimination half-life was distinctly longer (8 days vs. 1.2-3 days). Cl-PPED was evenly among the three major brain regions. Subcellular fractionation of liver and brain revealed preferential localization in mitochondria.

Animals↗
PubMedDate not supplied

Tissue metabolites of trifluorperazine, fluphenazine, prochlorperazine, and perphenazine. Kinetics in chronic treatment.

Repeated oral treatment of male rats with piperazine-substituted phenothiazine drugs in doses of 25 mg/kg or more daily led to an accumulation of metabolites containing an ethylenediamine group instead of the piperazine ring. These products of ring degradation with and without removal of the N-alkyl group were found, together with the parent drugs and their N-dealkylated metabolites, in liver, lung, kidney, and spleen, as well as in brain when high doses were administered. After termination of treatment, the ethylenediamine derivatives were eliminated more slowly than were their congeners containing the intact piperazine ring. Parallel observations were made in dogs given fluphenazine in daily doses of up to 40 mg/kg. Quantitative differences were observed in the relative amounts of mono- and disubstituted ethylenediamine metabolites accumulated in rat tissues during treatment with the various drugs; the proportion of the monosubstituted product formed by N-dealkylation and ring cleavage declined in the following order: perazine, prochlorperazine, trifluoperazine, fluphenazine, perphenazine. Condensation products of the ethylenediamine derivatives with formaldehyde were split in the extraction procedure used.

Animals↗
PubMed1991

Clinical pharmacology of prochlorperazine in healthy young males.

1. The pharmacokinetics and pharmacodynamics of prochlorperazine (PCZ) have been studied in healthy young males following single 12.5 mg i.v. and 50 mg oral doses, and during repeated doses (25 mg twice daily) for 14 days. 2. Oral bioavailability was low and an N-desmethyl metabolite was detected. Plasma clearance was high (0.98 1 kg-1 h) and the volume of distribution was large (12.9 1 kg-1) after i.v. dosing. 3. The terminal elimination half-life of PCZ was 9 +/- 1 h and 8 +/- 2 h after i.v. and single oral dosing, respectively. The urinary recoveries of drug and metabolite were low. 4. Accumulation of PCZ and its metabolite occurred following repeated dosing. The half-life at the end of 14 days therapy was 18 +/- 4 h. 5. Postural tachycardia, decreased salivary flow, impaired psychomotor function and a diminished level of arousal were observed after intravenous PCZ. Similar effects, but of lower magnitude were observed after single oral doses. During chronic dosing postural tachycardia and antihistaminic effects were observed, the latter not being observed after single doses. 6. After single intravenous dosing the maximal drug effects occurred 2-4 h after peak plasma drug concentrations for all measures except for plasma prolactin and self-scored restlessness 7. An antagonist action at dopamine (D2), muscarinic-cholinergic and alpha-adrenoceptors is postulated after single doses, with antihistaminic effects during chronic dosing, possibly indicating the presence of an active metabolite.

Administration, Oral↗
PubMed1991

Persistent extrapyramidal syndrome with dystonia and rigidity caused by combined metoclopramide and prochlorperazine therapy.

We have reported the case of a 58-year-old woman with cerebral palsy who experienced a persistent, generalized syndrome of dystonia and rigidity (tardive dystonia-parkinsonism) while being treated for vomiting with metoclopramide in combination with prochlorperazine. This syndrome was more severe than is typically seen in drug-induced extrapyramidal syndromes and may have contributed to her death. The extreme severity of this disorder was probably related to the use of a combination of dopamine antagonists in a patient who had premorbid cerebral dysfunction. Although dopamine antagonists should always be used with caution in individuals with cerebral dysfunction, this particular combination of antiemetics should probably be avoided in such patients.

Basal Ganglia Diseases↗
PubMed1991

Complications in the use of prochlorperazine.

This case presentation is of a patient who had the clinical appearance of epiglottitis, but actually had an oro-pharyngeal dystonic reaction to prochlorperazine. The intent of the discussion is to alert physicians that the appearance of epiglottis can occur from causes other than infection and that a surgical airway should not be the first thought when such a case arises.

Adult↗
PubMed1987

Randomized, double-blind, cross-over study comparing prochlorperazine and lorazepam with high-dose metoclopramide and lorazepam for the control of emesis in patients receiving cytotoxic chemotherapy.

To further define optimal combinations of antiemetics, high-dose metoclopramide and lorazepam (M+L) were compared with prochlorperazine and lorazepam (P+L) in a randomized, double-blind, cross-over study. Both patient and observer assessments were documented in 66 patients receiving cisplatin and noncisplatin chemotherapy. M+L significantly reduced the severity of vomiting (P = 0.01), duration of vomiting (P = 0.05), and number of vomiting episodes (P = 0.003). Comparing the severity or duration of nausea, M+L and P+L were not significantly different. M+L significantly reduced severity of vomiting (P = 0.005) and number of vomiting episodes (P = 0.03) in the cisplatin subset. The number of vomiting episodes was also reduced in the noncisplatin subset (P = 0.03). When asked to nominate a preferred regimen, 41% of patients preferred P+L, 35% preferred M+L, and 24% rated them equally. M+L was associated with significantly more anxiety and less sedation than P+L. Patient assessments produced similar results to observer assessments but gave a broader understanding of our patients' tolerance to chemotherapy. M+L is a superior regimen in controlling vomiting induced by chemotherapy.

Adult↗