Prochlorperazine Edisylate

Class: Phenothiazines
Note: This monograph also contains information on Prochlorperazine, Prochlorperazine Maleate
VA Class: CN701
CAS Number: 58-38-8
Brands: Compazine, Compro

Special Alerts:

[Posted 02/22/2011] ISSUE: FDA notified healthcare professionals that the Pregnancy section of drug labels for the entire class of antipsychotic drugs has been updated. The new drug labels now contain more and consistent information about the potential risk for abnormal muscle movements (extrapyramidal signs or EPS) and withdrawal symptoms in newborns whose mothers were treated with these drugs during the third trimester of pregnancy.

The symptoms of EPS and withdrawal in newborns may include agitation, abnormally increased or decreased muscle tone, tremor, sleepiness, severe difficulty breathing, and difficulty in feeding. In some newborns, the symptoms subside within hours or days and do not require specific treatment; other newborns may require longer hospital stays.

BACKGROUND: Antipsychotic drugs are used to treat symptoms of psychiatric disorders such as schizophrenia and bipolar disorder.

RECOMMENDATION: Healthcare professionals should be aware of the effects of antipsychotic medications on newborns when the medications are used during pregnancy. Patients should not stop taking these medications if they become pregnant without talking to their healthcare professional, as abruptly stopping antipsychotic medications can cause significant complications for treatment. For more information visit the FDA website at: and .

[Posted 06/16/2008] FDA notified healthcare professionals that both conventional and atypical antipsychotics are associated with an increased risk of mortality in elderly patients treated for dementia-related psychosis. In April 2005, FDA notified healthcare professionals that patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk of death. Since issuing that notification, FDA has reviewed additional information that indicates the risk is also associated with conventional antipsychotics. Antipsychotics are not indicated for the treatment of dementia-related psychosis. The prescribing information for all antipsychotic drugs will now include the same information about this risk in a BOXED WARNING and the WARNINGS section. For more information visit the FDA website at: , and .

Introduction

Phenothiazine; antipsychotic and antiemetic agent.^{a d e f}

Uses for Prochlorperazine Edisylate

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Psychotic Disorders

Symptomatic management of psychotic disorders (i.e., schizophrenia).^{d e f}

Nonpsychotic Anxiety

Short-term management of nonpsychotic anxiety in patients with generalized anxiety disorder.^{d e f}

Not established whether prochlorperazine is useful for the management of other nonpsychotic conditions in which anxiety or manifestations that mimic anxiety are evident (e.g., physical illness, organic mental conditions, agitated depression, character pathologies).^{d e f}

Because of the risks of toxicity, use only as an alternative to other less toxic anxiolytic agents (e.g., benzodiazepines) in most patients.^{d e f}

Nausea and Vomiting

Management of severe nausea and vomiting of various etiologies (e.g., postoperative, acute migraine, toxins, radiation, or cytotoxic drugs).^{a b e f g}

Not effective in preventing vertigo or motion sickness, or for the management of emesis caused by the action of drugs on the nodose ganglion or locally on the GI tract.^{a b}

Use not recommended for the prevention and treatment of nausea and vomiting associated with pregnancy except in cases of severe nausea and vomiting so serious and intractable that pharmacologic intervention is required and the potential benefits justify the possible risks to the fetus.^{a b e f g} (See Fetal/Neonatal Morbidity under Cautions.)

Other Uses

Has not been shown to be effective for the management of behavioral complications in patients with mental retardation.^{d e f}

Prochlorperazine Edisylate Dosage and Administration

General

• 
  

  Adjust dosage carefully according to individual requirements and response; use the lowest possible effective dosage.^{d e f g}

  
  


• 
  

  Periodically evaluate patients receiving long-term therapy to determine whether maintenance dosage can be decreased or drug therapy discontinued.^{d e f g} (See Tardive Dyskinesia under Cautions.)

  
  

Psychotic Disorders

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

• 
  

  Symptomatic relief of psychotic disorders may be seen in many patients during the first 2 days of therapy; however, optimum antipsychotic effect usually requires prolonged administration of the drug.^d

  
  


• 
  

  For prompt control of severe psychotic symptoms, administer IM; after symptoms are controlled, oral therapy should replace parenteral therapy at the same dosage level or higher.^d

  
  

Administration

Prochlorperazine edisylate is administered orally, by deep IM injection, by direct IV injection, or by IV infusion.^{a d f}

Prochlorperazine maleate is administered orally.^{a d e}

Prochlorperazine is administered rectally.^{a g}

Sub-Q administration is not recommended because of local irritation.^d

IV Administration

For solution and drug compatibility information, see Compatibility under Stability.

May be administered undiluted or diluted in isotonic solution.^{f g}

To minimize hypotension following IV administration, patient should remain in supine position under observation for ≥30 minutes.^{e f g} (See Hypotension under Cautions.)

Rate of Administration

Administer by IV infusion or by direct IV injection at a rate not exceeding 5 mg/minute.^{a f}

Do not administer as a rapid (“bolus”) injection.^{a f}

IM Administration

Administer by deep IM injection into the upper outer quadrant of the gluteus maximus.^{a b c d f}

If possible, avoid IM administration in geriatric patients who are thin or debilitated with reduced muscle mass (injections may be painful and absorption may be erratic or unpredictable).^b

Dosage

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Available as prochlorperazine, prochlorperazine edisylate, or prochlorperazine maleate; dosage expressed in terms of prochlorperazine.^{a d}

Pediatric Patients

Children should receive the lowest possible effective dosage, and parents should be instructed not to exceed the prescribed dosage.^{d e f}

Use not recommended in children <2 years of age or those weighing <9 kg.^{d e}

Prescriptions for 2.5-mg pediatric suppositories should be written as “2 ½ mg” to avoid confusion with 25-mg adult suppositories.^c

Psychotic Disorders

Oral or Rectal

Children 2–12 years of age: Initially, 2.5 mg 2 or 3 times daily.^{d e} Dosage may be increased according to patient’s therapeutic response and tolerance, but usually should not exceed 20 and 25 mg daily for children 2–5 and 6–12 years of age, respectively.^{d e}

Dosage for children <2 years of age or those weighing <9 kg not established.^{d e}

IM

Children <12 years of age: 0.13 mg/kg for prompt control of severe psychotic symptoms.^{d e} Generally, most pediatric patients respond after 1 dose, and oral therapy should replace parenteral therapy at the same dosage level or higher.^{d e}

Nausea and Vomiting

Oral or Rectal

Dosage for Treatment of Severe Nausea and Vomiting in Children ≥2 Years of Agece

Weight (kg)	Daily Dosage
≤9	Use not recommended
9.1–13.2	2.5 mg once or twice daily
13.6–17.7	2.5 mg 2 or 3 times daily
18.2–38.6	2.5 mg 3 times daily or 5 mg twice daily

Alternatively, in children ≥2 years of age and weighing >9 kg: 0.4 mg/kg or 10 mg/m² daily given in 3 or 4 divided doses.^a

Generally, it is not necessary to continue therapy for >24 hours.^{a c e}

IM

Children ≥2 years of age and weighing >9 kg: 0.13 mg/kg.^{a f} Generally, a single dose is sufficient to control nausea and vomiting in most patients.^{a f}

Adults

Psychotic Disorders

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Oral

5 or 10 mg (as conventional tablets or oral solution) 3 or 4 times daily in office patients and outpatients with relatively mild symptomatology.^{d e}

Initially, 10 mg (as conventional tablets or oral solution) 3 or 4 times daily for hospitalized or well-supervised patients with moderate to severe symptomatology.^{d e} Gradually increase dosage every 2 or 3 days until symptoms are controlled or adverse effects become troublesome.^{d e} Although some patients exhibit optimum response with 50–75 mg daily, dosages up to 150 mg daily may be required in severely disturbed patients.^{d e}

IM

10–20 mg for prompt control in patients with severe symptomatology; may be necessary to repeat the initial dose every 1–4 hours to control symptoms in some patients.^{d f} Generally, not more than 3 or 4 doses are required.^{d f}

10–20 mg every 4–6 hours, if prolonged parenteral therapy is required.^{d f}

After the patient’s symptoms are controlled, oral therapy should replace parenteral therapy at the same dosage level or higher.^{d f}

Nonpsychotic Anxiety

Oral

5 mg (as conventional tablets or oral solution) 3 or 4 times daily for ≤12 weeks.^{d e}

Alternatively, a dosage of 15 mg (as extended-release capsules) once daily upon arising or 10 mg (as extended-release capsules) every 12 hours may be used.^{c d}

Nausea and Vomiting

Oral

Usually, 5 or 10 mg (as conventional tablets or oral solution) 3 or 4 times daily.^{a e}

Alternatively, 15 mg (as extended-release capsules) once daily upon arising or 10 mg (as extended-release capsules) every 12 hours may be used; some patients subsequently may require a dosage of 30 mg (using the appropriate number of 10- or 15-mg extended-release capsules) once daily in the morning.^{a c}

Dosages >40 mg daily should be used only in resistant cases.^{a c}

Rectal

25 mg twice daily.^g

IV

2.5–10 mg.^{a f}

For control of severe nausea and vomiting during surgery: 5–10 mg given 15–30 minutes before induction of anesthesia.^{a f} If necessary, repeat initial dose once before surgery.^{a f}

To control acute symptoms during or after surgery, usually 5–10 mg, repeated once, if necessary; single IV doses of the drug should not exceed 10 mg.^a

IM

Initially, 5–10 mg; if necessary, initial dose may be repeated every 3 or 4 hours, but total dosage should not exceed 40 mg daily.^{a f}

For control of severe nausea and vomiting during surgery: 5–10 mg given 1–2 hours before induction of anesthesia.^{a f} If necessary, dose may be repeated once, 30 minutes after the initial dose.^{a f}

To control acute symptoms during or after surgery: 5–10 mg, repeated once in 30 minutes, if necessary.^{a f}

Prescribing Limits

Pediatric Patients

Psychotic Disorders

Oral or Rectal

Maximum 10 mg daily for the first day.^d

Subsequently, maximum 20 and 25 mg daily for children 2–5 and 6–12 years of age, respectively.^{d e}

Nausea and Vomiting

Oral or Rectal

Maximum Dosage for Treatment of Severe Nausea and Vomiting in Children ≥2 Years of Agee

Weight (kg)	Maximum Daily Dosage
≤9	Use not recommended
9.1–13.2	Maximum 7.5 mg daily
13.6–17.7	Maximum 10 mg daily
18.2–38.6	Maximum 15 mg daily

Adults

Nonpsychotic Anxiety

Oral

Maximum 20 mg daily; do not administer for >12 weeks.^e

Nausea and Vomiting

Oral

Dosages >40 mg daily should be used only in resistant cases.^{a c}

IV

Maximum 10 mg as a single dose.^{a f} Maximum 40 mg daily (total daily dosage).^{a f}

IM

Maximum 40 mg daily (total daily dosage).^{a f}

Special Populations

Geriatric Patients

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Generally, select dose at lower end of recommended range; increase dosage gradually and monitor closely.^{d e f g} (See Geriatric Use under Cautions.)

Debilitated or Emaciated Patients

Increase dosage gradually.^{d e f g}

Cautions for Prochlorperazine Edisylate

Contraindications

• 
  

  Comatose states or in the presence of large amounts of CNS depressants (e.g., alcohol, barbituates, opiates).^{d e f g} (See Specific Drugs and Laboratory Tests under Interactions.)

  
  


• 
  

  Pediatric surgery.^{d e f g}

  
  


• 
  

  Children <2 years of age or <9 kg.^{d e f g}

  
  


• 
  

  Children with conditions for which dosage has not been established.^{d e f g}

  
  


• 
  

  Known hypersensitivity to prochlorperazine or other phenothiazines.^{d e f g}

  
  

Warnings/Precautions

Warnings

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Shares the toxic potentials of other phenothiazines; observe the usual precautions of phenothiazine therapy.^{a d}

Extrapyramidal Reactions

Possible extrapyramidal reactions, especially in hospitalized psychiatric patients and in children.^{d e f g} Consider dosage reduction or discontinuance, depending on severity of symptoms.^{c e f g} An anticholinergic antiparkinsonian agent or diphenhydramine may be given to control persistent or severe reactions.^{b c}

Signs and symptoms may be similar to those accompanying certain disorders (e.g., encephalitis, Reye’s syndrome, encephalopathy, meningitis, tetanus); diagnosis of these disorders may be obscured or the disease-associated signs and symptoms may be incorrectly diagnosed as drug induced.^b

Tardive Dyskinesia

Possible persistent and potentially irreversible tardive dyskinesia, especially in geriatric patients receiving high dosages (especially females).^{b e f g} Use of higher dosages or longer periods of treatment may increase risk of developing the syndrome.^{b e f g}

Reserve long-term therapy for patients with a chronic disorder known to be responsive to antipsychotic agents and for which alternative, equally effective, but potentially less toxic therapy is not available or appropriate.^b

Periodically reassess the need for continued therapy in patients requiring chronic treatment.^{b e f g} Unless contraindicated, make periodic efforts to gradually reduce dosage and provide drug holidays and/or nondrug (e.g., behavioral) therapy in an attempt to discontinue antipsychotic drug therapy whenever clinically possible.^b

If signs and symptoms of tardive dyskinesia develop, consider discontinuance of the drug.^{e f g} Some patients may require treatment despite the presence of the syndrome.^{e f g}

Neuroleptic Malignant Syndrome

Potentially fatal neuroleptic malignant syndrome (NMS) characterized by hyperthermia, severe extrapyramidal dysfunction, varying levels of consciousness, altered mental status, and autonomic instability has been reported.^{b e f g}

Immediately discontinue therapy and initiate supportive and symptomatic therapy if NMS occurs.^{b e f g} Careful monitoring recommended if therapy is reinstituted following recovery; the risk that NMS can recur must be considered.^{b e f g}

Fetal/Neonatal Morbidity

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Safety of use during pregnancy not established.^{b e f g} Jaundice, prolonged extrapyramidal signs and symptoms, hyperreflexia, and hyporeflexia reported in some neonates born to women who received phenothiazines during pregnancy.^{b e f g} Generally, use during pregnancy only when the potential benefits justify the possible risks to the fetus.^{b e f g}

Sensitivity Reactions

Possible sensitivity reactions (e.g., cholestatic jaundice, blood dyscrasias, dermatoses, photosensitivity).^{e f g} Use generally not recommended in patients with bone marrow depression or those who have previously demonstrated a hypersensitivity reaction (e.g., blood dyscrasias, jaundice) to a phenothiazine, unless potential benefits outweigh the possible risks.^{b e f g}

Contact dermatitis occurs rarely following skin contact with prochlorperazine edisylate oral solution or injection; use care to avoid skin contact with oral solution or injection.^{a b d f}

General Precautions

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

CNS Depression

May impair mental and/or physical abilities, especially during the first few days of therapy; use caution with activities requiring alertness (e.g., operating vehicles or machinery).^{b e f g}

Because of CNS depressant effects, use with caution in patients with chronic respiratory disorders (e.g., severe asthma, emphysema, acute respiratory tract infections).^b

Hypotension

Possible hypotension; large dosages and parenteral administration should be used with caution in patients with severe cardiovascular disorders.^{b e f g}

To minimize hypotension following IV administration, patient should remain in supine position under observation for ≥30 minutes.^{e f g}

If hypotension occurs, place patient in Trendelenburg’s position and, if required, administer norepinephrine or phenylephrine; epinephrine or dopamine should not be used.^{e f g} (See Specific Drugs and Laboratory Tests under Interactions.)

Prolactin Secretion

Increased serum prolactin concentrations; may be associated with galactorrhea, menstrual cycle changes (e.g., oligomenorrhea, amenorrhea), and gynecomastia.^{b e f g}

Since approximately one-third of human breast cancers are prolactin dependent, use with caution in patients with previously detected breast cancer.^{b e f g}

Mutagenicity

Chromosomal aberrations in spermatocytes and abnormal sperm have been demonstrated in rodents.^{b e f g}

Anticholinergic Effects

Possible anticholinergic effects (e.g., dry mouth, blurred vision, mydriasis, constipation, nausea, adynamic ileus, atonic colon, urinary retention, decreased sweating, and impotence).^{b e f g}

Use with caution in patients with glaucoma or prostatic hypertrophy.^{b e f g}

Regulation of Body Temperature

Phenothiazines depress the hypothalamic mechanism for regulation of body temperature; possible hyperthermia and heat prostration or hypothermia when exposed to temperature extremes.^{b e f g}

Use with caution in patients exposed to extreme heat or cold.^{b e f g}

Surgery

Possible suppression of the cough reflex and aspiration of gastric contents.^{b e f g} Use caution in postoperative patients.^{b e f g}

Other Precautions

Antiemetic effects may mask signs of overdosage of other drugs (e.g., antineoplastic agents) or obscure the cause of vomiting in various disorders (e.g., intestinal obstruction, brain tumor, Reye’s syndrome).^{b e f g} (See Extrapyramidal Effects under Cautions.)

Use phenothiazines with caution in patients with hypocalcemia, since susceptibility to dystonic reactions may be increased.^b

Specific Populations

Pregnancy

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Category C.^f

Lactation

Distributed into milk.^{e f g} Caution if used in nursing women.^{e f g}

Pediatric Use

Safety and efficacy not established in children <2 years of age or those weighing <9 kg.^{a d e f}

Avoid use in children and adolescents with suspected Reye’s syndrome, since the antiemetic and potential extrapyramidal effects produced by the drug may obscure the diagnosis of or be confused with CNS manifestations of this condition.^{a d e f} (See Extrapyramidal Reactions under Cautions.)

Not recommended for use in children during surgery or in conditions for which pediatric dosage has not been established.^{a d e f}

Incidence of extrapyramidal reactions appears to be relatively high in children.^{d e f g} Children with acute illnesses (e.g., varicella-zoster [chickenpox] infections, CNS infections, measles, gastroenteritis) or dehydration appear to be at increased risk of such reactions (particularly dystonic reactions and akathisia); use only under close supervision in these patients.^{b c e f g}

Geriatric Use

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Possible increased incidence of adverse nervous system (e.g., tardive dyskinesia), anticholinergic, and cardiovascular (e.g., hypotension) effects compared with younger adults. (See Tardive Dyskinesia and also Anticholinergic Effects and also Hypotension, under Cautions.)^{b d e f g}

Generally, select dose at lower end of recommended range; increase dosage gradually and monitor closely.^{d e f g}

Hepatic Impairment

Use with caution.^b

Renal Impairment

Use with caution.^b

Common Adverse Effects

Drowsiness, dizziness, amenorrhea, blurred vision, skin reactions, hypotension.^{e f g}

Interactions for Prochlorperazine Edisylate

Specific Drugs and Laboratory Tests

Drug or Test	Interaction	Comments
Anticoagulants, oral	Potential decreased effect of oral anticoagulantse f g
Anticonvulsants (phenytoin)	Prochlorperazine may lower seizure thresholde f g Prochlorperazine may interfere with phenytoin metabolism and precipitate phenytoin toxicitye f g	Dosage adjustments of anticonvulsants may be necessarye f g
CNS depressants (e.g., alcohol, anesthetics, opiates)	May potentiate CNS depressione f g	Use with caution to avoid excessive sedation or CNS depressionb
Epinephrine or dopamine	Phenothiazines decrease these drugs’ vasopressor effectse f g	Do not use epinephrine or dopamine to treat phenothiazine-induced hypotension; concomitant use may cause further lowering of BPb e f g (see Hypotension under Cautions)
Guanethidine and related compounds	Potential for decreased effectiveness of guanethidine and related compoundse f g
Lithium	Possible acute encephalopathic syndrome, especially with high serum lithium concentrationsb c	Observe patients receiving combined therapy for evidence of adverse neurologic effects; discontinue treatment promptly if such signs or symptoms appearb c
Propranolol	Increased plasma concentrations of prochlorperazine and propranolole f g
Test for phenylketonuria (PKU)	Potential false positive test resultse f g
Thiazide diuretics	Potential for increased orthostatic hypotensione f g

Prochlorperazine Edisylate Pharmacokinetics

Absorption

Bioavailability

Phenothiazines are generally well absorbed from the GI tract and from parenteral sites.^b

Onset

Psychotic disorders: Symptomatic relief may be seen during the first 2 days of oral therapy; however, optimum antipsychotic effect usually requires prolonged administration.^d

Antiemetic effects: onset in 30–40 minutes (conventional tablet or extended-release capsule), 60 minutes (rectal suppository), or 10–20 minutes (IM administration).^a

Duration

Antiemetic effects: duration of 3–4 hours (conventional tablet, rectal suppository, or IM administration) or 10–12 hours (extended-release capsule).^a

Food

Extended-release capsule (Compazine Spansule): Food decreases rate of absorption and decreases peak plasma concentration by 23% and AUC by 13%.^c

Distribution

Extent

Phenothiazines are distributed into most body tissues and fluids, with high concentrations being distributed into the brain, lungs, liver, kidneys, and spleen.^b

Phenothiazines cross the placenta.^b Prochlorperazine is distributed into milk.^{e f g}

Plasma Protein Binding

Phenothiazines are highly bound to plasma proteins.^b

Elimination

Metabolism

Extensively metabolized, principally in the liver.^b

Elimination Route

Phenothiazines and their metabolites are excreted in urine and feces.^b

Stability

Storage

Rectal

Suppositories

15–30°C.^g Do not remove from wrapper until ready to use.^g

Oral

Tablets, Extended-release Capsules, and Oral Solution

15–30°C.^{c e} Protect from light.^{c e}

Parenteral

Injection

20–25°C; do not freeze.^f Protect from light.^f

Compatibility

For information on systemic interactions resulting from concomitant use, see Interactions.

Parenteral

Solution Compatibility^HID

Compatible
Dextran 6% in dextrose 5%
Dextran 6% in sodium chloride 0.9%
Dextrose–Ringer’s injection combinations
Dextrose–Ringer’s injection, lactated, combinations
Dextrose–saline combinations
Dextrose 2½, 5, or 10% in water
Fructose 10% in sodium chloride 0.9%
Fructose 10% in water
Invert sugar 5 and 10% in sodium chloride 0.9%
Invert sugar 5 and 10% in water
Ionosol products
Ringer’s injection
Ringer’s injection, lactated
Sodium chloride 0.45 or 0.9%
Sodium lactate (1/6) M

Drug Compatibility

Admixture CompatibilityHID

Compatible
Amikacin sulfate
Ascorbic acid injection
Dexamethasone sodium phosphate
Dimenhydrinate
Erythromycin lactobionate
Ethacrynate sodium
Lidocaine HCl
Nafcillin sodium
Penicillin G posassium
Sodium bicarbonate
Vitamin B complex with C
Incompatible
Aminophylline
Chloramphenicol sodium succinate
Chlorothiazide sodium
Furosemide
Hydrocortisone sodium succinate
Thiopental sodium
Variable
Calcium gluconate

Y-Site CompatibilityHID

Compatible
Amsacrine
Calcium gluconate
Cisplatin
Cladribine
Cyclophosphamide
Cytarabine
Dexmedetomidine HCl
Docetaxel
Doxorubicin HCl
Doxorubicin HCl liposome injection
Fluconazole
Granisetron HCl
Heparin sodium
Hetastarch in lactated electrolyte injection (Hextend)
Hydrocortisone sodium succinate
Linezolid
Melphalan HCl
Methotrexate sodium
Ondansetron HCl
Oxaliplatin
Paclitaxel
Potassium chloride
Propofol
Remifentanil HCl
Sargramostim
Sufentanil citrate
Teniposide
Thiotepa
Topotecan HCl
Vinorelbine tartrate
Vitamin B complex with C
Incompatible
Aldesleukin
Allopurinol sodium
Amifostine
Amphotericin B cholesteryl sulfate complex
Aztreonam
Bivalirudin
Cefepime HCl
Etoposide phosphate
Fenoldopam mesylate
Filgrastim
Fludarabine phosphate
Foscarnet sodium
Gallium nitrate
Gemcitabine HCl
Lansoprazole
Pemetrexed disodium
Piperacillin sodium–tazobactam sodium

ActionsActions

• 
  

  Exhibits weak anticholinergic effects, moderate sedative effects, strong extrapyramidal effects, and strong antiemetic effects.^a

  
  


• 
  

  May antagonize dopamine-mediated neurotransmission at the synapses and may block postsynaptic dopamine receptor sites; however, precise mechanism(s) of action have not been determined.^b

  
  


• 
  

  Exerts an antiemetic effect by directly affecting the medullary chemoreceptor trigger zone (CTZ), apparently by blocking dopamine receptors in the CTZ.^{a e g} Inhibits apomorphine-induced vomiting.^a

  
  


• 
  

  Also has peripheral and/or central antagonistic activity against α-adrenergic, serotonergic, histaminic H₁, and muscarinic receptors.^b

  
  

Advice to Patients

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

• 
  

  Potential for drug to impair mental alertness or physical coordination; use caution when driving or operating machinery until effects on individual are known.^{e f g}

  
  


• 
  

  Importance of clinicians informing patients in whom chronic use is contemplated of risk of tardive dyskinesia, taking into account clinical circumstances and competency of patient to understand information provided.^b

  
  


• 
  

  Importance of reporting signs or symptoms of hypersensitivity reactions (e.g., sore throat, other signs of infection).^{b c}

  
  


• 
  

  Importance of informing clinician of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses (e.g., cardiovascular disease).^{e f g}

  
  


• 
  

  Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.^{e f g}

  
  


• 
  

  Importance of advising patients of other important precautionary information.^{e f g} (See Cautions.)

  
  

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Prochlorperazine

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Rectal	Suppositories	2.5 mg	Compazine	GlaxoSmithKline
		5 mg	Compazine	GlaxoSmithKline
		25 mg*	Compazine