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At least 19 recordsLinked to original sources
PubMed1997

Comparative central nervous system effects and pharmacokinetics of neu-metoclopramide and metoclopramide in healthy volunteers.

Metoclopramide, a drug used for the relief of nausea and emesis, is currently under development as a radio- and chemosensitizing agent. Its usefulness in high doses, however, is limited by its central nervous system side effects. Neu-metoclopramide (Neu-Sensamide), a novel, concentrated, phosphate-buffered, pH-adjusted (pH = 6.5-7.0) formulation of metoclopramide, has been shown to have an improved side-effect profile in animal studies. The present double-blind, four-way crossover study compared the central nervous system effects and pharmacokinetics of neu-metoclopramide (intravenously and intramuscularly at 1.8 mg/kg) with intravenous metoclopramide and intramuscular placebo in 19 healthy male volunteers. Eight participants withdrew from the study, one because of noncompliance and seven because of adverse events. A total of 28 central nervous system events were observed with intravenous metoclopramide administration, whereas 16, 15, and 6 such events were attributed to intravenous neu-metoclopramide, intramuscular neu-metoclopramide, and placebo, respectively. Extra-pyramidal effects occurred on 10 occasions: 7 after intravenous metoclopramide, 2 after intravenous neu-metoclopramide, and 1 after intramuscular neu-metoclopramide. No significant differences were observed in the pharmacokinetic profiles of the three formulations of metoclopramide. It may be speculated, therefore, that the molecular conformational changes inherent to neu-metoclopramide result in a reduced side-effect profile compared with conventional metoclopramide formulations.

Adult↗
PubMed1985

Improved control of cisplatin-induced emesis with high-dose metoclopramide and with combinations of metoclopramide, dexamethasone, and diphenhydramine. Results of consecutive trials in 255 patients.

A series of consecutive trials were undertaken to determine whether higher doses of intravenous metoclopramide and combinations of metoclopramide, dexamethasone, and diphenhydramine would improve antiemetic control or decrease treatment-related side effects in patients receiving cisplatin at 120 mg/m2. Metoclopramide and dexamethasone were studied because of their proven efficacy as single agents and their differing mechanisms of action and side effects. Diphenhydramine was used because of its possible antiemetic properties and its ability to control acute dystonic reactions. Two hundred fifty-five patients who had never received chemotherapy or antiemetics were observed in the hospital for the 24 hours following cisplatin administration. The addition of dexamethasone or dexamethasone plus diphenhydramine to intravenous metoclopramide 2 mg/kg produced both improved antiemetic control and a decrease in treatment-associated diarrhea (P = 0.002). The use of metoclopramide alone at a dose of 3 mg/kg for only two doses appeared as effective as 2 mg/kg for five doses. When dexamethasone and diphenhydramine were given with metoclopramide 3 mg/kg for two intravenous dosages, 81% of patients experienced no emesis and 93% had two or fewer vomiting episodes. The antiemetic results of this 2-hour "short-course" regimen were superior to metoclopramide 2 mg/kg, with (P = 0.002) or without (P = 0.0001) dexamethasone and diphenhydramine. It was concluded that combinations of metoclopramide plus dexamethasone plus diphenhydramine improve antiemetic control, facilitate the usage of higher doses of metoclopramide, and decrease the incidence of treatment-related side effects.

Adult↗
PubMed1989

Metoclopramide versus metoclopramide and lorazepam. Superiority of combined therapy in the control of cisplatin-induced emesis.

Sixty-four patients treated with cisplatin-containing regimens were entered into a randomized, double-blinded study examining the antiemetic efficacy of metoclopramide with and without lorazepam for control of cisplatin-induced emesis. Metoclopramide was administered to all patients at 2 mg/kg, intravenously, 30 minutes before chemotherapy and 1.5, 3.5, and 5.5 hours posttreatment. Patients randomized to receive combined antiemetic therapy were administered lorazepam at 2 mg/m2 (maximum, 4 mg dose) intravenously, 30 minutes before chemotherapy. Those patients not receiving lorazepam were given normal saline placebo. Degree of nausea and number of vomiting episodes were recorded on a data flow sheet with a visual analogue scale. Drug toxicities were evaluated before each administered dose. Patients receiving both metoclopramide and lorazepam experienced significantly less vomiting episodes (P less than 0.05) and nausea (P less than 0.01) when compared to patients given metoclopramide alone. Forty-four percent of those receiving the combined therapy reported no nausea or vomiting episodes compared to only 22% receiving metoclopramide alone. Sedation was significantly more common in patients receiving lorazepam (88%) as opposed to patients receiving only metoclopramide (43%), P less than 0.01. Amnesia was seen in 25% receiving lorazepam. No significant difference in diarrhea, dystonia, or disinhibition was observed between the two arms. The authors conclude that the combination of lorazepam and metoclopramide was superior to metoclopramide alone in the prevention of cisplatin-induced nausea and vomiting, with sedation and amnesia more commonly observed in the combined regimen.

Adult↗
PubMed1995

The effects of oral droperidol versus oral metoclopramide versus both oral droperidol and metoclopramide on postoperative vomiting when used as a premedicant for strabismus surgery.

STUDY OBJECTIVE: To compare the efficacy of oral droperidol versus oral metoclopramide, or both oral droperidol and metoclopramide, on postoperative vomiting when used as a premedicant for strabismus surgery. DESIGN: Double-blind, randomized, prospective study. SETTING: Academic children's hospital. PATIENTS: 154 ASA physical status I and II ambulatory patients, ages 1 to 15 years, scheduled for strabismus surgery. INTERVENTIONS: Patients were randomly assigned to receive colored sugar water containing either droperidol 300 mcg/kg orally, metoclopramide 0.15 mg/kg orally, both droperidol 300 mcg/kg and metoclopramide 0.15 mg/kg orally, or no active ingredient (placebo group) as a premedicant. The premedications were given orally 1 to 1.5 hours prior to the operation. MEASUREMENTS AND MAIN RESULTS: Patients were analyzed for the number of episodes of vomiting from the time of their emergence from anesthesia through the first 24 hours postoperatively, including the convalescent period at home. Patients were also analyzed for length of hospital stay. There were no statistically significant differences between groups regarding age, premedication time, surgery time, or discharge time. Droperidol and droperidol-metoclopramide were significantly more effective (p < 0.012) than either the metoclopramide group or the placebo group in preventing postoperative nausea and vomiting following strabismus surgery. CONCLUSIONS: Our data suggest that oral droperidol 300 mcg/kg and the combination of oral droperidol 300 mcg/kg and metoclopramide 0.15 mg/kg are effective in reducing the frequency of vomiting within the first 24 hours after strabismus surgery. The combination of oral droperidol and oral metoclopramide is highly effective in reducing the frequency of vomiting postoperatively in strabismus ambulatory surgery patients (p = 0.017). This combination seems to represent an inexpensive alternative to the more costly ondansetron.

Administration, Oral↗
PubMed1987

A randomised cross-over trial comparing low-dose metoclopramide and chlorpromazine with high-dose metoclopramide in Chinese patients with advanced cancer receiving cisplatinum and 5-fluorouracil.

Nineteen Chinese patients receiving chemotherapy for advanced cancer were studied for chemotherapy-induced acute nausea and vomiting. The chemotherapy consisted of cisplatinum 100 mg/m2 i.v. infusion over 4 h on day 1 and 5-fluorouracil (5-FU) 1000 mg/m2 120-h continuous infusion from day 2 to day 6, repeated every 3 weeks. At the first course of chemotherapy the patients were randomized to receive either low-dose metoclopramide and chlorpromazine or high-dose metoclopramide, and then crossed over for the second course. In the high-dose metoclopramide group there was a suggestion of an earlier onset of emesis, with slightly more frequent retching and vomiting and less food consumed. However, the duration of emesis was shorter in the high-dose group. These differences were not statistically significant. There were no major side effects. Mild salutary drowsiness was noticed in patients receiving low-dose metoclopramide and chlorpromazine. This trial suggests that, in the dosage, route and schedule described, high-dose metoclopramide is no more effective than low-dose metoclopramide together with chlorpromazine in preventing cisplatinum-induced nausea and vomiting. The low-dose scheme is more economic and suitable for patients with advanced cancer.

Adult↗
PubMed1987

A randomized trial of high dose bolus metoclopramide versus low-dose continuous infusion metoclopramide in the prevention of cisplatin-induced emesis.

We compared the antiemetic efficacy of metoclopramide in a bolus low-dose infusion schedule to that of metoclopramide given in a conventional high-dose bolus schedule in a randomized crossover trial. Thirty-two treatment courses in 16 patients receiving cisplatin chemotherapy were evaluable. The metoclopramide regimen was either 2 mg/kg i.v. bolus, then 20 mg/h by infusion for 4 h, or 2 mg/kg i.v. bolus every 2 h for three doses. Dexamethasone 20 mg i.v. and diphenhydramine 50 mg i.v. were also given. Antiemetic efficacy was assessed by a questionnaire. There were no differences in antiemetic efficacy between the metoclopramide regimens. With either program, 75% of patients were emesis-free, 13% had mild symptoms, and 13% had moderate symptoms (greater than two emetic episodes). The infusion metoclopramide regimen was 30% less expensive than the bolus schedule in our pharmacy. Thus, we recommend low-dose metoclopramide infusion as a less expensive, equally effective alternative to high-dose bolus regimens for antiemetic treatment.

Adolescent↗
PubMed1986

Comparison of metoclopramide and metoclopramide plus dexamethasone for complete protection from cisplatinum-induced emesis.

Metoclopramide was compared to a metoclopramide plus dexamethasone combination in patients receiving high-dose cisplatinum. Metoclopramide 2 mg/kg intravenously was given every 2 hours for 4 doses during two consecutive chemotherapy cycles. A randomized double-blind crossover was used with placebo or dexamethasone 20 mg given intravenously before the first metoclopramide dose. Thirty-six patients completed both study arms. There was no difference in mean vomiting episodes (1.92 for metoclopramide versus 1.33 for the combination, p = 0.20). However complete protection (no vomiting episodes) was achieved in 56% receiving the combination but only 36% receiving metoclopramide alone (p less than 0.08). No significant difference in toxicity or patient preference was noted. Late nausea or vomiting lasting 2 to 7 days appeared in 26% of cycles and was associated with but not completely explained by a greater number of acute vomiting episodes. Combination antiemetic therapy can achieve a higher incidence of complete protection from cisplatinum-induced vomiting. However, late nausea and vomiting may require modification of present regimens.

Adult↗
PubMed1985

Antiemetic efficacy of moderately high-dose metoclopramide in patients receiving varying doses of cisplatin. Controlled comparison with a combination of methylprednisolone and metoclopramide.

In 29 patients (48 courses of chemotherapy), a randomized double-blind crossover study was undertaken to establish the antiemetic effectiveness of a combination of metoclopramide at a moderately high dose (5 mg/kg body weight) with 1 g methylprednisolone (treatment A) as compared with metoclopramide monotherapy (5 mg/kg body weight; treatment B). With cisplatin doses of 60 mg/m2, a good antiemetic effect (0-1 vomiting episodes in 24 h) was observed in 9 out of 10 patients under treatment A as well as under treatment B. With a cisplatin dose of 120 mg/m2, treatment A produced a good antiemetic effect in 9 out of 11 patients (82%), while treatment B produced such an effect in only 3 out of 11 patients (27%; p less than 0.5). The results obtained permit the following conclusions to be made: At doses of cisplatin of up to 60 mg/m2, the antiemetic effect produced by metoclopramide (5 mg/kg body weight) given alone is adequate. At doses of cisplatin of 120 mg/m2 and more, high-dose methylprednisolone has a good additive antiemetic effect vis-à-vis metoclopramide (5 mg/kg body weight). The antiemetic effect of this combination corresponds approximately to the antiemetic effect produced with high-dose metoclopramide (10 mg/kg body weight) administered alone.

Adult↗
PubMed1990

Metoclopramide (Primperan) in the treatment of ureterolithiasis. A prospective double-blind study of metoclopramide compared with morphatropin on ureteral colic.

A prospective double-blind study was performed to compare metoclopramide (Primperan) with morphatropin in the treatment of ureteral colic. Twenty-one patients (10 in the morphatropin group and 11 in the metoclopramide group) entered the study and diagnosis was confirmed radiologically. Using the Mann-Whitney rank sum test, no significant difference was found in the pain-relieving effect 10, 20, or 30 min after treatment with either 1 ml morphatropin s.c. or 20 mg metoclopramide i.v. Two patients in the morphatropin group developed nausea and giddiness, respectively, and 1 patient from this group was omitted due to the development of urticaria. No side effects occurred in the metoclopramide group. Thus metoclopramide seems to be an alternative to the traditional treatment of ureteral colic with morphia.

Acute Disease↗
PubMed1993

Pharmacokinetics and bioavailability of metoclopramide nasal spray versus metoclopramide intravenous in healthy volunteers and cancer patients.

The kinetics and bioavailability of a new formulation of metoclopramide (CAS 364-62-5) nasal spray (MTC NS) were assessed in two separate studies versus the same drug administered intravenously (MTC IV) according to a balanced-block design where each study subject served as his own control. The first study involved 10 healthy subjects, each receiving metoclopramide NS 20 mg (one 10-mg puff per nostril) and metoclopramide IV 20 mg on two trial days separated by a 7-day washout period. On both occasions, blood samples were obtained at time 0 and at 20, 40, 60, 120, 150, 210, 280 and 360 min of dosing. Metoclopramide concentrations were assayed in plasma by HPLC. The second study involved 10 patients of oncologic domain, scheduled to receive mildly emetic chemotherapy regimes. The experimental design was similar to the one above except that blood was sampled at 0, 20, 40 and 60 min and again at 2, 3, 4, 6, and 8 h of dosing. All healthy subjects completed the trial without experiencing any adverse or untoward events; in the group of cancer patients, one subject dropped out after the nose spray treatment when he was removed to another department. This patient was replaced by another, and included in final data analysis only for the segment of treatment actually received. Metoclopramide kinetics after intravenous dosing were in good agreement with known data for the active substance, with no meaningful differences between healthy subjects and cancer patients. With MTC NS administration there was only a slight but significant difference of Cmax, being lower in the cancer patient group (p < 005).(ABSTRACT TRUNCATED AT 250 WORDS)

Administration, Intranasal↗
PubMed2002

Cardiac arrest after intravenous metoclopramide - a case of five repeated injections of metoclopramide causing five episodes of cardiac arrest.

We describe a patient where intravenous injection of metoclopramide was immediately followed by asystole repeatedly. The patient received metoclopramide 10 mg i.v. five times during 48 h. After interviewing the attending nurses and reviewing the written documentation, it is clear that every administration of metoclopramide was immediately (within s) followed by asystole. The asystole lasted 15-30 s on four occasions, on one occasion it lasted 2 min. The patient received atropine 0.5-1 mg and chest compressions, before sinus rhythm again took over. We interpret this as episodes of cardiac arrest caused by metoclopramide. The rapid injection via the central venous route and the concomitant tapering of dopamine infusion might have contributed in precipitating the adverse drug reaction.

Adult↗
PubMed2001

Prevention of postoperative nausea and vomiting after laparoscopic gynaecological surgery. Combined antiemetic treatment with tropisetron and metoclopramide vs. metoclopramide alone.

BACKGROUND AND OBJECTIVE: Female patients undergoing gynaecological procedures, especially laparoscopically, are at high risk of postoperative nausea and vomiting. No available antiemetic is entirely effective. This double-blinded randomized trial examines the efficacy and safety of tropisetron and metoclopramide in combination and compares the results with metoclopramide alone in laparoscopic gynaecological surgery. METHODS: One hundred and twenty female patients scheduled for minor gynaecological laparoscopy, aged 27-43 years, were randomly allocated to receive pretreatment with metoclopramide 10 mg intravenously (n=57) or tropisetron 5 mg with metoclopramide 5 mg (n=63). RESULTS: Fewer patients in the combined treatment group experienced postoperative nausea and vomiting (14% vs. 37%, P=0.008) or needed rescue antiemetic treatment (3% vs. 16%, P=0.038). No significant adverse events were observed. CONCLUSIONS: The combination of the antiemetics was superior, which is probably explained by the fact that the two drugs have different sites of action, thus preventing emesis by blocking different pathways.

Adult↗
PubMed1991

High-dose metoclopramide + lorazepam versus low-dose metoclopramide + lorazepam + dehydrobenzperidol in the treatment of cisplatin-induced nausea and vomiting.

In a randomized double-blind, cross-over trial of 34 patients receiving cisplatin-based chemotherapy (20-100 mg/m2), the antiemetic effect of high-dose metoclopramide (HDM) (10 mg/kg iv. loading dose + 7 hours continuous infusion) + lorazepam (L) (2.5 mg x 4 po) was compared with low-dose metoclopramide (LDM) (70 mg) + L (2.5 mg x 2 po) + dehydrobenzperidol (5 mg x 2 im). Among the 29 patients who completed the cross-over, HDM significantly reduced the number of vomiting episodes (p = 0.002) and the degree of nausea (p = 0.004). Seventeen patients preferred the HDM and 4 the LDM regimen (p = 0.01). Sedation was seen in all but 1 patient, and was graded as severe in 6 patients receiving the HDM and in 2 patients receiving the LDM regimen. No extrapyramidal adverse reactions were seen. We conclude that high-dose metoclopramide + lorazepam is a safe antiemetic regimen and significantly superior to low-dose metoclopramide + lorazepam + dehydrobenzperidol. Owing to the severe sedation which occurs in some patients, the dose of lorazepam should be individually adjusted.

Adult↗
PubMed1992

A study to compare oral sumatriptan with oral aspirin plus oral metoclopramide in the acute treatment of migraine. The Oral Sumatriptan and Aspirin plus Metoclopramide Comparative Study Group.

In a double-blind, placebo-controlled study, the efficacy, safety and tolerability of 100 mg oral sumatriptan, given as a dispersible tablet, was compared with that of 900 mg oral aspirin plus 10 mg oral metoclopramide in the acute treatment of migraine. A total of 358 patients treated up to three migraine attacks within 3 months, recording clinical information on a diary card. In attack 1, headache relief after 2 h, defined as a reduction in severity from severe or moderate pain to mild or no pain, was recorded in 56% (74/133) of patients who took sumatriptan and 45% (62/138) of patients who took aspirin plus metoclopramide (p = 0.078). This analysis of the primary efficacy end point was not statistically significant. However, for attacks 2 and 3 (secondary end points), headache relief was achieved in 58 versus 36% of patients (p = 0.001) and 65 versus 34% of patients (p less than 0.001), respectively. Relief from nausea, vomiting, photophobia and phonophobia was similar in both treatment groups. Rescue medication was required by fewer patients treated with sumatriptan than by those who received aspirin plus metoclopramide (attack 1, 34 versus 56%, p less than 0.001; attack 2, 32 versus 51%, p = 0.001, and attack 3, 35 versus 54%, p = 0.001). Sumatriptan also produced a faster improvement and resolution of migraine attacks. Comparing the sumatriptan and aspirin plus metoclopramide treatment groups, complete resolution of the attack occurred within 6 h in 32 versus 19% (attack 1), 35 versus 23% (attack 2) and 32 versus 20% of patients (attack 3).(ABSTRACT TRUNCATED AT 250 WORDS)

Administration, Oral↗
PubMed1985

Absent aldosterone response to metoclopramide in patients with high spinal cord transection: evidence that metoclopramide stimulates aldosterone secretion through central pathways.

This study evaluates dopaminergic regulation of aldosterone secretion in 6 patients with high spinal cord transections. Administration of the dopamine antagonist metoclopramide resulted in a marked rise in plasma aldosterone and 18-hydroxycorticosterone levels in 12 normal individuals, but no change in plasma levels of these zona glomerulosa corticosteroid products in spinal cord patients. Spinal cord transected patients also did not have the rise in plasma renin activity that was observed in normals following metoclopramide administration. Basal levels of aldosterone, 18 hydroxycorticosterone, corticosterone and renin activity as well as the aldosterone responses to graded dose infusion of adrenocorticotropin were similar in the spinal cord patients and the normals. These data suggest that dopaminergic regulation of adrenal zona glomerulosa corticosteroid and renal renin secretion is absent in patients with high spinal cord transections, suggesting that intact neural pathways from the central nervous system are necessary for metoclopramide stimulation of aldosterone and renin secretion in men. Since basal plasma aldosterone levels were normal in spinal cord transected patients, it appears that the absence of dopaminergic control does not result in elevated secretion.

18-Hydroxycorticosterone↗
PubMed1979

[Action of metoclopramide bromide and metoclopramide chloride on the lower esophagogastric junction and the peristalsis of the lower 3d of the esophagus].

In 10 patients with esophageal hiatus hernia the effect of metoclopramide bromide and metoclopramide chloride compared with placebo, was studied by the double blind method. Both drugs produced an increase of the lower esophageal sphincter pressure and of the peristalsis of the lower third of the esophagus, only being statistically significative the action of metoclopramide chloride on the perstalsis. No significative side-effects were noted.

Adult↗
PubMed1989

Antiemetic activity of high-dose metoclopramide combined with methylprednisolone versus metoclopramide alone in dacarbazine-treated cancer patients. A randomized double-blind study of the Italian Oncology Group for Clinical Research.

In a double-blind randomized trial, we compared the efficacy and tolerability of high-dose (2 mg/kg X 4) intravenous metoclopramide (MTC) versus metoclopramide plus high-dose (250 mg X 2) intravenous methylprednisolone (MP) administered for the first 2 days in untreated patients submitted to dacarbazine chemotherapy for 5 days. Thirty-four patients entered the study. Complete protection from nausea and vomiting was achieved in the majority of patients all through the study period with both antiemetic treatments, with slightly greater efficacy at day 2 for the combination. However, after suspension of the antiemetic therapy, there was a relapse of vomiting in patients. Side effects were not different between the two treatments, but extrapyramidal reactions were significantly increased on the second day of antiemetic therapy. In conclusion, high-dose MTC with or without MP can give good antiemetic protection and the combination seems to be slightly more efficacious. However, the relapse of vomiting after discontinuing antiemetic treatment and the high incidence of extrapyramidal reactions justify further studies to find a better antiemetic treatment.

Dacarbazine↗
PubMed1985

Polymorphism in metoclopramide hydrochloride and metoclopramide.

Metoclopramide hydrochloride (MCPHCl.H2O) and metoclopramide base (MCP) have been studied by DSC, thermomicroscopy, X-ray diffraction and infrared spectroscopy. MCPHCl.H2O does not readily lose water of crystallization either from the solid state or from the melt, but depending on the conditions, dehydration can give rise to two anhydrous polymorphs, MCPHCl/Form I (mp 187 degrees C) and MCPHCL/Form II (mp 155 degrees C). Form I crystallizes from the melt of Form II and not by a reversible solid-solid transition. The anhydrous hydrochloride therefore shows monotropic polymorphism where Form I is the stable polymorph and Form II, a metastable polymorph. Thermal analysis of MCP shows that the base exists as two enantiotropic polymorphs. The transition of the form stable at room temperature (MCP/Form I) to the form stable at high temperatures (MCP/Form II mp 147 degrees C) occurs extremely rapidly at 125 degrees C but the reverse process requires one month at room temperature (approximately equal to 22 degrees C). It is therefore possible to compare the X-ray diffraction powder patterns and infrared spectra of MCP Forms I and II.

Calorimetry, Differential Scanning↗