(proe klor PER a zeen)
Management of severe nausea and vomiting; psychotic disorders, including schizophrenia and anxiety (Note: Not a recommended therapy by schizophrenia treatment guidelines [Hasan 2012; Lehman 2004]); nonpsychotic anxiety
Hypersensitivity to prochlorperazine or any component of the formulation (cross-reactivity between phenothiazines may occur); coma or presence of large amounts of CNS depressants (eg, alcohol, opioids, barbiturates); postoperative management of nausea/vomiting following pediatric surgery; use in infants and children <2 years or <9 kg; pediatric conditions for which dosage has not been established
Documentation of allergenic cross-reactivity for phenothiazines is limited. However, because of similarities in chemical structure and/or pharmacologic actions, the possibility of cross-sensitivity cannot be ruled out with certainty.
Canadian labeling: Additional contraindications (not in US labeling): Presence of circulatory collapse; severe cardiovascular disorders; altered state of consciousness; concomitant use of high dose hypnotics; severe depression; presence of blood dyscrasias, hepatic or renal impairment, or pheochromocytoma; suspected or established subcortical brain damage with or without hypothalamic damage
Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analyses of 17 placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in drug-treated patients between 1.6 and 1.7 times the risk of death in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was approximately 4.5% compared with a rate of approximately 2.6% in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (eg, heart failure, sudden death) or infectious (eg, pneumonia) in nature. Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to some characteristic(s) of the patients is not clear. Prochlorperazine is not approved for the treatment of patients with dementia-related psychosis.
Note: Injection solution mesylate formulation has Canadian availability (not available in US).
Antiemetic:
Oral (tablet): 5 to 10 mg 3 to 4 times/day; usual maximum: 40 mg/day; larger doses may rarely be required
IM (as edisylate): 5 to 10 mg every 3 to 4 hours; usual maximum: 40 mg/day
IM (as mesylate): 5 to 10 mg 2 to 3 times/day; usual maximum: 40 mg/day
IV (as edisylate): 2.5 to 10 mg; maximum: 10 mg/dose or 40 mg/day; may repeat dose every 3 to 4 hours as needed
Rectal:
US labeling: 25 mg twice daily
Canadian labeling: 5 to 10 mg 3 to 4 times/day
Surgical nausea/vomiting:Note: Should not exceed 40 mg/day
IM (as edisylate): 5 to 10 mg 1 to 2 hours before anesthesia induction or to control symptoms during or after surgery; may repeat once if necessary
IM (as mesylate): 5 to 10 mg 1 to 2 hours before anesthesia induction; may repeat once if needed during surgery; postoperatively: 5 to 10 mg every 3 to 4 hours as needed up to maximum of 40 mg daily
IV (as edisylate): 5 to 10 mg 15 to 30 minutes before anesthesia induction or to control symptoms during or after surgery; may repeat once if necessary
IV (as mesylate): 20 mg/L of IV solution during surgery or postoperatively; usual maximum: 30 mg daily
Rectal (off-label use; Golembiewski 2005): 25 mg
Antipsychotic:
Oral: 5 to 10 mg 3 to 4 times/day; titrate dose slowly every 2 to 3 days; doses up to 150 mg/day may be required in some patients for treatment of severe disturbances
IM (as edisylate): Initial: 10 to 20 mg; if necessary repeat initial dose every 2 to 4 hours to gain control; more than 3 to 4 doses are rarely needed. If parenteral administration is still required; give 10 to 20 mg every 4 to 6 hours; convert to oral therapy as soon as possible.
IM (as mesylate): Initial: 10 to 20 mg; if necessary repeat initial dose every 2 to 4 hours to gain control; more than 3 to 4 doses are rarely needed; convert to oral therapy as soon as possible.
Nonpsychotic anxiety: Oral (tablet): Usual dose: 5 mg 3 to 4 times/day; do not exceed 20 mg/day or administer >12 weeks
Initiate at lower end of dosage range; titrate slowly and cautiously. Refer to adult dosing.
Note: Injection solution mesylate formulation has Canadian availability (not available in US).
Use is contraindicated in children <9 kg or <2 years.
Antiemetic:
Oral (therapy >1 day usually not required):
9 to 13 kg: 2.5 mg 1 to 2 times/day as needed (maximum: 7.5 mg/day)
>13 to 18 kg: 2.5 mg 2 to 3 times/day as needed (maximum: 10 mg/day)
>18 to 39 kg: 2.5 mg 3 times/day or 5 mg 2 times/day as needed (maximum: 15 mg/day)
IM (as edisylate): 0.13 mg/kg/dose; convert to oral therapy as soon as possible
IM (as mesylate): 0.14 mg/kg/dose; convert to oral therapy at equivalent or greater dose (if necessary) as soon as possible
Antipsychotic: Children 2 to 12 years:
Oral: 2.5 mg 2 to 3 times/day; do not give more than 10 mg the first day; increase dosage as needed to maximum daily dose of 20 mg for 2 to 5 years and 25 mg for 6 to 12 years
IM (as edisylate): 0.13 mg/kg/dose; convert to oral therapy as soon as possible
IM (as mesylate): 0.14 mg/kg/dose; convert to oral therapy at equivalent or greater dose (if necessary) as soon as possible
US labeling: There are no dosage adjustments provided in the manufacturer 's labeling.
Canadian labeling: Use is contraindicated.
US labeling: There are no dosage adjustments provided in the manufacturer 's labeling; systemic exposure may be increased as drug undergoes hepatic metabolism.
Canadian labeling: Use is contraindicated.
IM: Inject by deep IM into outer quadrant of buttocks.
IV: May be administered by slow IV push at a rate not exceeding 5 mg/minute or by IV infusion. Do not administer as a bolus injection. To reduce the risk of hypotension, patients receiving IV prochlorperazine must remain lying down and be observed for at least 30 minutes following administration. Avoid skin contact with injection solution, contact dermatitis has occurred. Do not dilute with any diluent containing parabens as a preservative.
Oral: Administer tablet without regard to meals.
Rectal: Do not remove from wrapper until ready to use.
Increase dietary intake of riboflavin; should be administered with food or water. Rectal suppositories may contain coconut and palm oil.
Injection:
Edisylate: Store at 20 � �C to 25 � �C (68 � �F to 77 � �F); do not freeze. Protect from light. Clear or slightly yellow solutions may be used.
Mesylate (Canadian availability; not available in US): Store at 15 � �C to 30 � �C (59 � �F to 86 � �F). Protect from light. Do not use if solution is discolored or hazy.
IV infusion: Injection may be diluted in 50 to 100 mL NS or D5W.
Suppository: Store at 20 � �C to 25 � �C (68 � �F to 77 � �F). Do not remove from wrapper until ready to use.
Tablet: Store at 20 � �C to 25 � �C (68 � �F to 77 � �F). Protect from light.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Solution, Injection, as edisylate [strength expressed as base]:
Generic: 5 mg/mL (2 mL, 10 mL)
Suppository, Rectal:
Compazine: 25 mg (12 ea [DSC])
Compro: 25 mg (12 ea)
Generic: 25 mg (12 ea, 1000 ea)
Tablet, Oral, as maleate [strength expressed as base]:
Compazine: 5 mg [DSC], 10 mg [DSC]
Generic: 5 mg, 10 mg
Stable in D5W, D10W, D5LR, D51/4NS, D51/2NS, D5NS, LR, 1/2NS, NS.
Y-site administration: Incompatible with aldesleukin, allopurinol, amifostine, amphotericin B cholesteryl sulfate complex, aztreonam, bivalirudin, cefepime, etoposide phosphate, fenoldopam, filgrastim, fludarabine, foscarnet, gemcitabine, pantoprazole, pemetrexed, piperacillin/tazobactam, vitamin B complex with C.
Compatibility in syringe: Incompatible with dimenhydrinate, ketorolac, midazolam, pantoprazole, pentobarbital, thiopental.
AbobotulinumtoxinA: Anticholinergic Agents may enhance the anticholinergic effect of AbobotulinumtoxinA. Monitor therapy
Acetylcholinesterase Inhibitors: May diminish the therapeutic effect of Anticholinergic Agents. Anticholinergic Agents may diminish the therapeutic effect of Acetylcholinesterase Inhibitors. Monitor therapy
Acetylcholinesterase Inhibitors (Central): May enhance the neurotoxic (central) effect of Antipsychotic Agents. Severe extrapyramidal symptoms have occurred in some patients. Monitor therapy
Aclidinium: May enhance the anticholinergic effect of Anticholinergic Agents. Avoid combination
Alcohol (Ethyl): CNS Depressants may enhance the CNS depressant effect of Alcohol (Ethyl). Monitor therapy
Aminolevulinic Acid: Photosensitizing Agents may enhance the photosensitizing effect of Aminolevulinic Acid. Monitor therapy
Amisulpride: Antipsychotic Agents may enhance the adverse/toxic effect of Amisulpride. Avoid combination
Amphetamines: Antipsychotic Agents may diminish the stimulatory effect of Amphetamines. Monitor therapy
Analgesics (Opioid): Antipsychotic Agents (Phenothiazines) may enhance the hypotensive effect of Analgesics (Opioid). Monitor therapy
Analgesics (Opioid): Anticholinergic Agents may enhance the adverse/toxic effect of Analgesics (Opioid). Specifically, the risk for constipation and urinary retention may be increased with this combination. Monitor therapy
Antacids: May decrease the absorption of Antipsychotic Agents (Phenothiazines). Monitor therapy
Anticholinergic Agents: May enhance the adverse/toxic effect of other Anticholinergic Agents. Monitor therapy
Antidepressants (Serotonin Reuptake Inhibitor/Antagonist): Antipsychotic Agents (Phenothiazines) may enhance the adverse/toxic effect of Antidepressants (Serotonin Reuptake Inhibitor/Antagonist). Specifically, this may be manifest as symptoms consistent with serotonin syndrome or neuroleptic malignant syndrome. Antidepressants (Serotonin Reuptake Inhibitor/Antagonist) may enhance the hypotensive effect of Antipsychotic Agents (Phenothiazines). Monitor therapy
Antimalarial Agents: May increase the serum concentration of Antipsychotic Agents (Phenothiazines). Monitor therapy
Anti-Parkinson Agents (Dopamine Agonist): May diminish the therapeutic effect of Antipsychotic Agents (First Generation [Typical]). Antipsychotic Agents (First Generation [Typical]) may diminish the therapeutic effect of Anti-Parkinson Agents (Dopamine Agonist). Management: Avoid concomitant therapy if possible and monitor for decreased effects of both agents when these combinations cannot be avoided. Atypical antipsychotics such as clozapine and quetiapine may be less likely to reduce the effects of anti-Parkinson agents. Consider therapy modification
Azelastine (Nasal): CNS Depressants may enhance the CNS depressant effect of Azelastine (Nasal). Avoid combination
Beta-Blockers: Antipsychotic Agents (Phenothiazines) may enhance the hypotensive effect of Beta-Blockers. Beta-Blockers may decrease the metabolism of Antipsychotic Agents (Phenothiazines). Antipsychotic Agents (Phenothiazines) may decrease the metabolism of Beta-Blockers. Exceptions: Atenolol; Levobunolol; Metipranolol; Nadolol. Monitor therapy
Blonanserin: CNS Depressants may enhance the CNS depressant effect of Blonanserin. Consider therapy modification
Brimonidine (Topical): May enhance the CNS depressant effect of CNS Depressants. Monitor therapy
Buprenorphine: CNS Depressants may enhance the CNS depressant effect of Buprenorphine. Management: Consider reduced doses of other CNS depressants, and avoiding such drugs in patients at high risk of buprenorphine overuse/self-injection. Initiate buprenorphine patches (Butrans brand) at 5 mcg/hr in adults when used with other CNS depressants. Consider therapy modification
Cannabis: May enhance the CNS depressant effect of CNS Depressants. Monitor therapy
Cimetropium: Anticholinergic Agents may enhance the anticholinergic effect of Cimetropium. Avoid combination
CNS Depressants: May enhance the adverse/toxic effect of other CNS Depressants. Monitor therapy
Deferoxamine: May enhance the adverse/toxic effect of Prochlorperazine. Specifically, prolonged loss of consciousness has been reported. Consider therapy modification
Dimethindene: May enhance the CNS depressant effect of CNS Depressants. Monitor therapy
Dofetilide: Prochlorperazine may increase the serum concentration of Dofetilide. Avoid combination
Doxylamine: May enhance the CNS depressant effect of CNS Depressants. Management: The manufacturer of Diclegis (doxylamine/pyridoxine), intended for use in pregnancy, specifically states that use with other CNS depressants is not recommended. Monitor therapy
Dronabinol: May enhance the CNS depressant effect of CNS Depressants. Monitor therapy
Dronedarone: Antipsychotic Agents (Phenothiazines) may enhance the arrhythmogenic effect of Dronedarone. Avoid combination
Droperidol: May enhance the CNS depressant effect of CNS Depressants. Management: Consider dose reductions of droperidol or of other CNS agents (e.g., opioids, barbiturates) with concomitant use. Consider therapy modification
Eluxadoline: Anticholinergic Agents may enhance the constipating effect of Eluxadoline. Avoid combination
Flunitrazepam: CNS Depressants may enhance the CNS depressant effect of Flunitrazepam. Consider therapy modification
Gastrointestinal Agents (Prokinetic): Anticholinergic Agents may diminish the therapeutic effect of Gastrointestinal Agents (Prokinetic). Monitor therapy
Glucagon: Anticholinergic Agents may enhance the adverse/toxic effect of Glucagon. Specifically, the risk of gastrointestinal adverse effects may be increased. Avoid combination
Glycopyrrolate (Oral Inhalation): Anticholinergic Agents may enhance the anticholinergic effect of Glycopyrrolate (Oral Inhalation). Avoid combination
HYDROcodone: CNS Depressants may enhance the CNS depressant effect of HYDROcodone. Management: Consider starting with a 20% to 30% lower hydrocodone dose when using together with any other CNS depressant. Dose reductions in the other CNS depressant may also be warranted. Consider therapy modification
HydrOXYzine: May enhance the CNS depressant effect of CNS Depressants. Monitor therapy
Ipratropium (Oral Inhalation): May enhance the anticholinergic effect of Anticholinergic Agents. Avoid combination
Itopride: Anticholinergic Agents may diminish the therapeutic effect of Itopride. Monitor therapy
Kava Kava: May enhance the adverse/toxic effect of CNS Depressants. Monitor therapy
Levosulpiride: Anticholinergic Agents may diminish the therapeutic effect of Levosulpiride. Avoid combination
Lithium: May enhance the neurotoxic effect of Antipsychotic Agents. Lithium may decrease the serum concentration of Antipsychotic Agents. Specifically noted with chlorpromazine. Monitor therapy
Magnesium Sulfate: May enhance the CNS depressant effect of CNS Depressants. Monitor therapy
Mequitazine: Antipsychotic Agents may enhance the arrhythmogenic effect of Mequitazine. Management: Consider alternatives to one of these agents when possible. While this combination is not specifically contraindicated, mequitazine labeling describes this combination as discouraged. Consider therapy modification
Methotrimeprazine: CNS Depressants may enhance the CNS depressant effect of Methotrimeprazine. Methotrimeprazine may enhance the CNS depressant effect of CNS Depressants. Management: Reduce adult dose of CNS depressant agents by 50% with initiation of concomitant methotrimeprazine therapy. Further CNS depressant dosage adjustments should be initiated only after clinically effective methotrimeprazine dose is established. Consider therapy modification
Methylphenidate: Antipsychotic Agents may enhance the adverse/toxic effect of Methylphenidate. Methylphenidate may enhance the adverse/toxic effect of Antipsychotic Agents. Monitor therapy
Metoclopramide: May enhance the adverse/toxic effect of Antipsychotic Agents. Avoid combination
MetyroSINE: CNS Depressants may enhance the sedative effect of MetyroSINE. Monitor therapy
MetyroSINE: May enhance the adverse/toxic effect of Antipsychotic Agents. Monitor therapy
Mianserin: May enhance the anticholinergic effect of Anticholinergic Agents. Monitor therapy
Minocycline: May enhance the CNS depressant effect of CNS Depressants. Monitor therapy
Mirabegron: Anticholinergic Agents may enhance the adverse/toxic effect of Mirabegron. Monitor therapy
Mirtazapine: CNS Depressants may enhance the CNS depressant effect of Mirtazapine. Monitor therapy
Nabilone: May enhance the CNS depressant effect of CNS Depressants. Monitor therapy
OnabotulinumtoxinA: Anticholinergic Agents may enhance the anticholinergic effect of OnabotulinumtoxinA. Monitor therapy
Orphenadrine: CNS Depressants may enhance the CNS depressant effect of Orphenadrine. Avoid combination
Oxatomide: May enhance the anticholinergic effect of Anticholinergic Agents. Avoid combination
OxyCODONE: CNS Depressants may enhance the CNS depressant effect of OxyCODONE. Management: When oxycodone is combined with another CNS depressant, a dose reduction of one or both agents should be considered. The extended release oxycodone starting dose should be reduced 50% to 67% when initiated in patients already receiving CNS depressants. Consider therapy modification
Paraldehyde: CNS Depressants may enhance the CNS depressant effect of Paraldehyde. Avoid combination
Perampanel: May enhance the CNS depressant effect of CNS Depressants. Management: Patients taking perampanel with any other drug that has CNS depressant activities should avoid complex and high-risk activities, particularly those such as driving that require alertness and coordination, until they have experience using the combination. Consider therapy modification
Piribedil [INT]: Antipsychotic Agents may diminish the therapeutic effect of Piribedil [INT]. Piribedil [INT] may diminish the therapeutic effect of Antipsychotic Agents. Management: Use of piribedil with antiemetic neuroleptics is contraindicated, and use with antipsychotic neuroleptics, except for clozapine, is not recommended. Avoid combination
Porfimer: Photosensitizing Agents may enhance the photosensitizing effect of Porfimer. Monitor therapy
Potassium Chloride: Anticholinergic Agents may enhance the ulcerogenic effect of Potassium Chloride. Management: Patients on drugs with substantial anticholinergic effects should avoid using any solid oral dosage form of potassium chloride. Avoid combination
Pramlintide: May enhance the anticholinergic effect of Anticholinergic Agents. These effects are specific to the GI tract. Consider therapy modification
Quinagolide: Antipsychotic Agents may diminish the therapeutic effect of Quinagolide. Monitor therapy
Ramosetron: Anticholinergic Agents may enhance the constipating effect of Ramosetron. Monitor therapy
RimabotulinumtoxinB: Anticholinergic Agents may enhance the anticholinergic effect of RimabotulinumtoxinB. Monitor therapy
Rufinamide: May enhance the adverse/toxic effect of CNS Depressants. Specifically, sleepiness and dizziness may be enhanced. Monitor therapy
Secretin: Anticholinergic Agents may diminish the therapeutic effect of Secretin. Management: Avoid using drugs with substantial anticholinergic effects in patients receiving secretin whenever possible. If such agents must be used in combination, monitor closely for a diminished response to secretin. Consider therapy modification
Selective Serotonin Reuptake Inhibitors: CNS Depressants may enhance the adverse/toxic effect of Selective Serotonin Reuptake Inhibitors. Specifically, the risk of psychomotor impairment may be enhanced. Monitor therapy
Serotonin Modulators: May enhance the adverse/toxic effect of Antipsychotic Agents. Specifically, serotonin modulators may enhance dopamine blockade, possibly increasing the risk for neuroleptic malignant syndrome. Antipsychotic Agents may enhance the serotonergic effect of Serotonin Modulators. This could result in serotonin syndrome. Exceptions: Nicergoline. Monitor therapy
Sodium Oxybate: May enhance the CNS depressant effect of CNS Depressants. Management: Consider alternatives to combined use. When combined use is needed, consider minimizing doses of one or more drugs. Use of sodium oxybate with alcohol or sedative hypnotics is contraindicated. Consider therapy modification
Sulpiride: Antipsychotic Agents may enhance the adverse/toxic effect of Sulpiride. Avoid combination
Suvorexant: CNS Depressants may enhance the CNS depressant effect of Suvorexant. Management: Dose reduction of suvorexant and/or any other CNS depressant may be necessary. Use of suvorexant with alcohol is not recommended, and the use of suvorexant with any other drug to treat insomnia is not recommended. Consider therapy modification
Tapentadol: May enhance the CNS depressant effect of CNS Depressants. Management: Start tapentadol at a dose of one-third to one-half of the normal dose if being initiated in a patient who is taking another drug with CNS depressant effects. Monitor closely for evidence of excessive CNS depression. Consider therapy modification
Tetrabenazine: May enhance the adverse/toxic effect of Antipsychotic Agents. Monitor therapy
Tetrahydrocannabinol: May enhance the CNS depressant effect of CNS Depressants. Monitor therapy
Thalidomide: CNS Depressants may enhance the CNS depressant effect of Thalidomide. Avoid combination
Thiazide and Thiazide-Like Diuretics: Anticholinergic Agents may increase the serum concentration of Thiazide and Thiazide-Like Diuretics. Monitor therapy
Thiopental: Antipsychotic Agents (Phenothiazines) may enhance the adverse/toxic effect of Thiopental. Monitor therapy
Tiotropium: Anticholinergic Agents may enhance the anticholinergic effect of Tiotropium. Avoid combination
Topiramate: Anticholinergic Agents may enhance the adverse/toxic effect of Topiramate. Monitor therapy
Trimeprazine: May enhance the CNS depressant effect of CNS Depressants. Monitor therapy
Umeclidinium: May enhance the anticholinergic effect of Anticholinergic Agents. Avoid combination
Verteporfin: Photosensitizing Agents may enhance the photosensitizing effect of Verteporfin. Monitor therapy
Zolpidem: CNS Depressants may enhance the CNS depressant effect of Zolpidem. Management: Reduce the Intermezzo brand sublingual zolpidem adult dose to 1.75 mg for men who are also receiving other CNS depressants. No such dose change is recommended for women. Avoid use with other CNS depressants at bedtime; avoid use with alcohol. Consider therapy modification
Mental status; vital signs (as clinically indicated); weight, height, BMI, waist circumference (baseline; at every visit for the first 6 months; quarterly with stable antipsychotic dose); CBC (as clinically indicated; monitor frequently during the first few months of therapy in patients with preexisting low WBC or history of drug-induced leukopenia/neutropenia); electrolytes and liver function (annually and as clinically indicated); fasting plasma glucose level/HbA1c (baseline, then yearly; in patients with diabetes risk factors or if gaining weight repeat 4 months after starting antipsychotic, then yearly); lipid panel (baseline; repeat every 2 years if LDL level is normal; repeat every 6 months if LDL level is >130 mg/dL); changes in menstruation, libido, development of galactorrhea, erectile and ejaculatory function (at each visit for the first 12 weeks after the antipsychotic is initiated or until the dose is stable, then yearly); abnormal involuntary movements or parkinsonian signs (baseline; repeat weekly until dose stabilized for at least 2 weeks after introduction and for 2 weeks after any significant dose increase); tardive dyskinesia (every 6 months; high-risk patients every 3 months); visual changes (inquire yearly); ocular examination (yearly in patients >40 years; every 2 years in younger patients) (ADA 2004; Lehman 2004; Marder 2004).
False-positives for phenylketonuria, pregnancy
Reported with prochlorperazine or other phenothiazines. Frequency not defined.
Cardiovascular: Cardiac arrest, cerebral edema, hypotension, peripheral edema, Q-wave distortions, sudden death, T-wave distortions
Central nervous system: Agitation, altered cerebrospinal fluid proteins, catatonia, coma, cough reflex suppressed, dizziness, drowsiness, fever (mild [IM]), headache, hyperpyrexia, impairment of temperature regulation, insomnia, neuroleptic malignant syndrome (NMS), oculogyric crisis, opisthotonos, restlessness, seizure, somnolence, tremulousness
Dermatologic: Angioedema, contact dermatitis, epithelial keratopathy, erythema, eczema, exfoliative dermatitis, itching, photosensitivity, skin pigmentation, urticaria
Endocrine & metabolic: Amenorrhea, galactorrhea, gynecomastia, glucosuria, hyper-/hypoglycemia, lactation, libido (changes in), menstrual irregularity
Gastrointestinal: Appetite increased, atonic colon, constipation, ileus, nausea, obstipation, vomiting, weight gain, xerostomia
Genitourinary: Ejaculating dysfunction, ejaculatory disturbances, impotence, priapism, urinary retention
Hematologic: Agranulocytosis, aplastic anemia, eosinophilia, hemolytic anemia, leukopenia, pancytopenia, thrombocytopenic purpura
Hepatic: Biliary stasis, cholestatic jaundice, hepatotoxicity
Neuromuscular & skeletal: Dystonias (torticollis, carpopedal spasm, trismus, protrusion of tongue); extrapyramidal symptoms (pseudoparkinsonism, akathisia, dystonias, tardive dyskinesia, hyperreflexia); SLE-like syndrome, tremor
Ocular: Blurred vision, lenticular/corneal deposits, miosis, mydriasis, pigmentary retinopathy
Respiratory: Asthma, laryngeal edema, nasal congestion
Miscellaneous: Allergic reactions, asphyxia, diaphoresis
Concerns related to adverse effects:
- Altered cardiac conduction: May alter cardiac conduction (life-threatening arrhythmias have occurred with therapeutic doses of phenothiazines).
- Anticholinergic effects: May cause anticholinergic effects (constipation, xerostomia, blurred vision, urinary retention); use with caution in patients with decreased gastrointestinal motility, paralytic ileus, urinary retention, BPH, xerostomia, or visual problems.
- Blood dyscrasias: Leukopenia, neutropenia, and agranulocytosis (sometimes fatal) have been reported in clinical trials and postmarketing reports with antipsychotic use; presence of risk factors (eg, preexisting low WBC or history of drug-induced leuko-/neutropenia) should prompt periodic blood count assessment. Discontinue therapy at first signs of blood dyscrasias or if absolute neutrophil count <1000/mm3.
- Esophageal dysmotility/aspiration: Antipsychotic use has been associated with esophageal dysmotility and aspiration; use with caution in patients at risk of pneumonia (ie, Alzheimers disease).
- Extrapyramidal symptoms (EPS): May cause extrapyramidal symptoms, including pseudoparkinsonism, acute dystonic reactions, akathisia, and tardive dyskinesia. Risk of dystonia (and possibly other EPS) may be greater with increased doses, use of conventional antipsychotics, males, and younger patients. Risk of tardive dyskinesia and potential for irreversibility often associated with total cumulative dose and therapy duration and may also be increased in elderly patients (particularly elderly women); antipsychotics may also mask signs/symptoms of tardive dyskinesia. Consider therapy discontinuation with signs/symptoms of tardive dyskinesia.
- Hyperprolactinemia: Use associated with increased prolactin levels; clinical significance of hyperprolactinemia in patients with breast cancer or other prolactin-dependent tumors is unknown.
- Hypotension: May occur following administration, particularly when parenteral form is used or in high dosages. May cause orthostatic hypotension; use with caution in patients at risk of this effect or in those who would not tolerate transient hypotensive episodes (cerebrovascular disease, cardiovascular disease, hypovolemia, or concurrent medication use which may predispose to hypotension/bradycardia).
- Neuroleptic malignant syndrome (NMS): May be associated with NMS; monitor for mental status changes, fever, muscle rigidity, and/or autonomic instability.
- Ocular effects: May cause pigmentary retinopathy, and lenticular and corneal deposits, particularly with prolonged therapy.
- Sedation: May cause sedation, which may impair physical or mental abilities; patients must be cautioned about performing tasks which require mental alertness (eg, operating machinery or driving).
- Temperature regulation: Impaired core body temperature regulation may occur; caution with strenuous exercise, heat exposure, dehydration, and concomitant medication possessing anticholinergic effects.
Disease-related concerns:
- Cardiovascular disease: Use with caution in patients with severe cardiovascular disease.
- Dementia: [US Boxed Warning]: Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death (compared to placebo). This was based on analyses of 17 placebo-controlled trials (duration ~10 weeks), predominantly in patients taking atypical antipsychotics which revealed a risk of death in drug-treated patients between 1.6 and 1.7 times the risk of death in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was ~4.5% compared with ~2.6% in the placebo group. Although the causes of death varied, most deaths appeared to be either cardiovascular (eg, heart failure, sudden death) or infectious (eg, pneumonia) in nature. Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality, although the extent to which increased mortality may be attributed to the antipsychotic drug as opposed to some characteristic(s) of the patients is not clear. Prochlorperazine is not approved for the treatment of dementia-related psychosis.
- Glaucoma: Use with caution in patients with narrow-angle glaucoma; condition may be exacerbated by cholinergic blockade.
- Hepatic impairment: Use with caution in patients with hepatic impairment. Canadian labeling contraindicates use in hepatic impairment.
- Parkinson's disease: Use with caution in patients with Parkinson's disease; they may be more sensitive to adverse effects.
- Renal impairment: Use with caution in patients with renal impairment. Canadian labeling contraindicates use in renal impairment.
- Reye 's syndrome: Avoid use in patients with signs/symptoms suggestive of Reye 's syndrome.
- Seizure disorder: Use with caution in patients at risk of seizures, including those with a history of seizures, head trauma, brain damage, alcoholism, or concurrent therapy with medications which may lower seizure threshold.
Concurrent drug therapy issues:
- Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.
Special populations:
- Elderly: Use with caution in the elderly; increased risk for developing tardive dyskinesia, particularly elderly women.
- Pediatric: Children with acute illness or dehydration are more susceptible to neuromuscular reactions (eg, dystonias); use cautiously.
Dosage form specific issues:
- Benzyl alcohol and derivatives: Some dosage forms may contain benzyl alcohol; large amounts of benzyl alcohol ( ≥99 mg/kg/day) have been associated with a potentially fatal toxicity ( "gasping syndrome " �) in neonates; the "gasping syndrome " � consists of metabolic acidosis, respiratory distress, gasping respirations, CNS dysfunction (including convulsions, intracranial hemorrhage), hypotension, and cardiovascular collapse (AAP [Inactive" 1997]; CDC 1982); some data suggests that benzoate displaces bilirubin from protein binding sites (Ahlfors 2001); avoid or use dosage forms containing benzyl alcohol with caution in neonates. See manufacturer 's labeling.
- Sodium sulfite: Some dosage forms may contain sodium sulfite.
Other warnings/precautions:
- Antiemetic effects: May mask toxicity of other drugs or conditions (eg, intestinal obstruction, Reye's syndrome, brain tumor) due to antiemetic effects.
Jaundice or hyper- or hyporeflexia have been reported in newborn infants following maternal use of phenothiazines. Antipsychotic use during the third trimester of pregnancy has a risk for abnormal muscle movements (extrapyramidal symptoms [EPS]) and withdrawal symptoms in newborns following delivery. Symptoms in the newborn may include agitation, feeding disorder, hypertonia, hypotonia, respiratory distress, somnolence, and tremor; these effects may be self-limiting or require hospitalization. Use may interfere with pregnancy tests, causing false positive results. Prochlorperazine has been used for the treatment of nausea and vomiting associated with pregnancy (Levicheck 2002; Mahadevan 2006); however, other agents may be preferred (ACOG 2004).
Prochlorperazine is a piperazine phenothiazine antipsychotic which blocks postsynaptic mesolimbic dopaminergic D1 and D2 receptors in the brain, including the chemoreceptor trigger zone; exhibits a strong alpha-adrenergic and anticholinergic blocking effect and depresses the release of hypothalamic and hypophyseal hormones; believed to depress the reticular activating system, thus affecting basal metabolism, body temperature, wakefulness, vasomotor tone and emesis
Vd: 1400 to 1548 L (Taylor 1987)
Primarily hepatic; N-desmethyl prochlorperazine (major active metabolite)
Mainly in feces
Oral: 30 to 40 minutes; IM: 10 to 20 minutes; Rectal: ~60 minutes; Peak antiemetic effect: IV: 30 to 60 minutes
Rectal: 3 to 12 hours; IM, Oral: 3 to 4 hours
Oral: 6 to 10 hours (single dose), 14 to 22 hours (repeated dosing) (Isah 1991); IV: 6 to 10 hours (Isah 1991; Taylor 1987)
- Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)
- Patient may experience constipation, dry mouth, or fatigue. Have patient report immediately to prescriber signs of infection, signs of liver problems (dark urine, feeling tired, lack of appetite, nausea, abdominal pain, light-colored stools, vomiting, or yellow skin or eyes), abnormal movements, twitching, change in balance, difficulty speaking, dysphagia, severe dizziness, passing out, angina, illogical thinking, mood changes, seizures, tremors, difficulty moving, rigidity, drooling, swelling of arms or legs, vision changes, bruising, bleeding, severe anxiety, urinary retention, loss of strength and energy, enlarged breasts, nipple discharge, sexual dysfunction, amenorrhea, signs of neuroleptic malignant syndrome (fever, muscle cramps or stiffness, dizziness, very bad headache, confusion, change in thinking, fast heartbeat, abnormal heartbeat, or sweating a lot), or signs of tardive dyskinesia (unable to control body movements; tongue, face, mouth, or jaw sticking out; mouth puckering; and puffing cheeks) (HCAHPS).
- Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.
Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.