1
`CZ:L96 1
`PRESCRIBING INFORMATION 2
`COMPAZINE® 3
`brand of 4
`prochlorperazine 5
`antiemetic • antipsychotic • tranquilizer 6
`DESCRIPTION 7
`Compazine (prochlorperazine) is a phenothiazine derivative, present in Compazine tablets and 8
`Spansule sustained release capsules as the maleate. Its chemical name is 2-chloro-10-[3-(4-9
`methyl-1-piperazinyl)propyl]-10H-phenothiazine (Z)-2-butenedioate (1:2). 10
`11
`prochlorperazine maleate 12
`Compazine vials and syrup contain prochlorperazine as the ed
`isylate salt and Compazine 13
`suppositories contain prochlorperazine base. Empirical formulas (and molecular weights) are: 14
`prochlorperazine maleate—C 20H24CIN3S•2C4H4O4 (606.10); prochlorperazine edisylate --15
`C20H24CIN3S•C2H6O6S2 (564.14); and prochlorperazine base—C 20H24CIN3S (373.95). 16
`Tablets–Each round, yellow-green, coated tablet contains prochlorperazine maleate equivalent 17
`to prochlorperazine as follows: 5 mg imprinted SKF and C66; 10 mg imprinted SKF and C67. 18
`5 mg and 10 mg Tablets–Inactive ingredients consist of cellulose, lactose, magnesium 19
`stearate, polyethylene glycol, sodium croscarmellose, titanium dioxide, D&C Yellow No. 10, 20
`FD&C Blue No. 2, FD&C Yellow No. 6, FD&C Red No. 40, iron oxide, starch, stearic acid and 21
`trace amounts of other inactive ingredients, including aluminum lake dyes. 22
`Spansule® sustained release capsules–Each Compazine® Spansule capsule is so prepared 23
`that an initial dose is released promptly and the remaining medication is released gradually over 24
`a prolonged period. Food slows absorption of prochlorperazine and decreases Cmax by 23% and 25
`AUC by 13%. 26
`Each capsule, with black cap and natural body, contains prochlorperazine maleate equivalent to 27
`prochlorperazine. The 10 mg capsule is imprinted 10 mg and 3344 on the black cap and is 28
`imprinted 10 mg and SB on the natural body. The 15 mg capsule is imprinted 15 mg and 3346 on 29
`the black cap and is imprinted 15 mg and SB on the natural body. Inactive ingredients consist of 30
`ammonio methacrylate co-polymer, D&C Green No. 5, D&C Yellow No. 10, FD&C Blue No. 1, 31
`This label may not be the latest approved by FDA.
`For current labeling information, please visit https://www.fda.gov/drugsatfda
`HELSINN EXHIBIT 2093
`Azurity Pharmaceuticals, Inc. v. Helsinn Healthcare S.A.
`IPR2025-00948
`Page 1 of 15
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`FD&C Blue No. 1 aluminum lake, FD&C Red No. 40, FD&C Yellow No. 6, gelatin, 32
`hydroxypropyl methylcellulose, propylene glycol, silicon dioxide, simethicone emulsion, sodium 33
`lauryl sulfate, sorbic acid, sugar spheres, talc, triethyl citrate, and trace amounts of other inactive 34
`ingredients. 35
`Vials, 2 mL (5 mg/mL) and 10 mL (5 mg/mL)–Each mL contains, in aqueous solution, 5 mg 36
`prochlorperazine as the edisylate, 5 mg sodium biphosphate, 12 mg sodium tartrate, 0.9 mg 37
`sodium saccharin and 0.75% benzyl alcohol as preservative. 38
`Suppositories–Each suppository contains 2½ mg, 5 mg or 25 mg of prochlorperazine; with 39
`glycerin, glyceryl monopalmitate, glyceryl monostearate, hydrogenated cocoanut oil fatty acids 40
`and hydrogenated palm kernel oil fatty acids. 41
`Syrup–Each 5 mL (1 teaspoonful) of clear, yellow-orange, fruit-flavored liquid contains 5 mg 42
`of prochlorperazine as the edisylate. Inactive ingredients consist of FD&C Yellow No. 6, flavors, 43
`polyoxyethylene polyoxypropylene glycol, sodium benzoate, sodium citrate, sucrose and water. 44
`INDICATIONS 45
`For control of severe nausea and vomiting. 46
`For the treatment of schizophrenia. 47
`Compazine (prochlorperazine) is effective for the short-term treatment of generalized 48
`non-psychotic anxiety. However, Compazine is not the first drug to be used in therapy for most 49
`patients with non-psychotic anxiety, because certain risks associated with its use are not shared 50
`by common alternative treatments (e.g., benzodiazepines). 51
`When used in the treatment of non-psychotic anxiety, Compazine should not be administered at 52
`doses of more than 20 mg per day or for longer than 12 weeks, because the use of Compazine at 53
`higher doses or for longer intervals may cause persistent tardive dyskinesia that may prove 54
`irreversible (see WARNINGS). 55
`The effectiveness of Compazine as treatment for non-psychotic anxiety was established in 56
`4-week clinical studies of outpatients with generalized anxiety disorder. This evidence does not 57
`predict that Compazine will be useful in patients with other non-psychotic conditions in which 58
`anxiety, or signs that mimic anxiety, are found (e.g., physical illness, organic mental conditions, 59
`agitated depression, character pathologies, etc.). 60
`Compazine has not been shown effective in the management of behavioral complications in 61
`patients with mental retardation. 62
`CONTRAINDICATIONS 63
`Do not use in patients with known hypersensitivity to phenothiazines. 64
`This label may not be the latest approved by FDA.
`For current labeling information, please visit https://www.fda.gov/drugsatfda
`Page 2 of 15
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`Do not use in comatose states or in the presence of large amounts of central nervous system 65
`depressants (alcohol, barbiturates, narcotics, etc.). 66
`Do not use in pediatric surgery. 67
`Do not use in pediatric patients under 2 years of age or under 20 lbs. Do not use in children for 68
`conditions for which dosage has not been established. 69
`WARNINGS 70
`The extrapyramidal symptoms which can occur secondary to Compazine 71
`(prochlorperazine) may be confused with the central nervous system signs of an 72
`undiagnosed primary disease responsible for the vomiting, e.g., Reye’s syndrome or other 73
`encephalopathy. The use of Compazine (prochlorperazine) and other potential 74
`hepatotoxins should be avoided in children and adolescents whose signs and symptoms 75
`suggest Reye’s syndrome. 76
`Tardive Dyskinesia: Tardive dyskinesia, a syndrome consisting of potentially irreversible, 77
`involuntary, dyskinetic movements, may develop in patients treated with antipsychotic drugs. 78
`Although the prevalence of the syndrome appears to be highest among the elderly, especially 79
`elderly women, it is impossible to rely upon prevalence estimates to predict, at the inception of 80
`antipsychotic treatment, which patients are likely to develop the syndrome. Whether 81
`antipsychotic drug products differ in their potential to cause tardive dyskinesia is unknown. 82
`Both the risk of developing the syndrome and the likelihood that it will become irreversible are 83
`believed to increase as the duration of treatment and the total cumulative dose of antipsychotic 84
`drugs administered to the patient increase. However, the syndrome can develop, although much 85
`less commonly, after relatively brief treatment periods at low doses. 86
`There is no known treatment for established cases of tardive dyskinesia, although the syndrome 87
`may remit, partially or completely, if antipsychotic treatment is withdrawn. Antipsychotic 88
`treatment itself, however, may suppress (or partially suppress) the signs and symptoms of the 89
`syndrome and thereby may possibly mask the underlying disease process. 90
`The effect that symptomatic suppression has upon the long-term course of the syndrome is 91
`unknown. 92
`Given these considerations, antipsychotics should be prescribed in a manner that is most likely to 93
`minimize the occurrence of tardive dyskinesia especially in the elderly. Chronic antipsychotic 94
`treatment should generally be reserved for patients who suffer from a chronic illness that, 1) is 95
`known to respond to antipsychotic drugs, and 2) for whom alternative, equally effective, but 96
`potentially less harmful treatments are not available or appropriate. In patients who do require 97
`chronic treatment, the smallest dose and the shortest duration of treatment producing a 98
`satisfactory clinical response should be sought. The need for continued treatment should be 99
`reassessed periodically. 100
`This label may not be the latest approved by FDA.
`For current labeling information, please visit https://www.fda.gov/drugsatfda
`Page 3 of 15
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`If signs and symptoms of tardive dyskinesia appear in a patient on antipsychotics, drug 101
`discontinuation should be considered. However, some patients may require treatment despite the 102
`presence of the syndrome. 103
`For further information about the description of tardive dyskinesia and its clinical detection, 104
`please refer to the sections on PRECAUTIONS and ADVERSE REACTIONS. 105
`Neuroleptic Malignant Syndrome (NMS): A potentially fatal symptom complex sometimes 106
`referred to as Neuroleptic Malignant Syndrome (NMS) has been reported in association with 107
`antipsychotic drugs. Clinical manifestations of NMS are hyperpyrexia, muscle rigidity, altered 108
`mental status and evidence of autonomic instability (irregular pulse or blood pressure, 109
`tachycardia, diaphoresis and cardiac dysrhythmias). 110
`The diagnostic evaluation of patients with this syndrome is complicated. In arriving at a 111
`diagnosis, it is important to identify cases where the clinical presentation includes both serious 112
`medical illness (e.g., pneumonia, systemic infection, etc.) and untreated or inadequately treated 113
`extrapyramidal signs and symptoms (EPS). Other important considerations in the differential 114
`diagnosis include central anticholinergic toxicity, heat stroke, drug fever and primary central 115
`nervous system (CNS) pathology. 116
`The management of NMS should include 1) immediate discontinuation of antipsychotic drugs 117
`and other drugs not essential to concurrent therapy, 2) intensive symptomatic treatment and 118
`medical monitoring, and 3) treatment of any concomitant serious medical problems for which 119
`specific treatments are available. There is no general agreement about specific pharmacological 120
`treatment regimens for uncomplicated NMS. 121
`If a patient requires antipsychotic drug treatment after recovery from NMS, the potential 122
`reintroduction of drug therapy should be carefully considered. The patient should be carefully 123
`monitored, since recurrences of NMS have been reported. 124
`An encephalopathic syndrome (characterized by weakness, lethargy, fever, tremulousness and 125
`confusion, extrapyramidal symptoms, leukocytosis, elevated serum enzymes, BUN and FBS) has 126
`occurred in a few patients treated with lithium plus an antipsychotic. In some instances, the 127
`syndrome was followed by irreversible brain damage. Because of a possible causal relationship 128
`between these events and the concomitant administration of lithium and antipsychotics, patients 129
`receiving such combined therapy should be monitored closely for early evidence of neurologic 130
`toxicity and treatment discontinued promptly if such signs appear. This encephalopathic 131
`syndrome may be similar to or the same as neuroleptic malignant syndrome (NMS). 132
`Patients with bone marrow depression or who have previously demonstrated a hypersensitivity 133
`reaction (e.g., blood dyscrasias, jaundice) with a phenothiazine should not receive any 134
`phenothiazine, including Compazine, unless in the judgment of the physician the potential 135
`benefits of treatment outweigh the possible hazards. 136
`This label may not be the latest approved by FDA.
`For current labeling information, please visit https://www.fda.gov/drugsatfda
`Page 4 of 15
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`Compazine (prochlorperazine) may impair mental and/or physical abilities, especially during the 137
`first few days of therapy. Therefore, caution patients about activities requiring alertness (e.g., 138
`operating vehicles or machinery). 139
`Phenothiazines may intensify or prolong the action of central nervous system depressants (e.g., 140
`alcohol, anesthetics, narcotics). 141
`Usage in Pregnancy: Safety for the use of Compazine during pregnancy has not been 142
`established. Therefore, Compazine is not recommended for use in pregnant patients except in 143
`cases of severe nausea and vomiting that are so serious and intractable that, in the judgment of 144
`the physician, drug intervention is required and potential benefits outweigh possible hazards. 145
`There have been reported instances of prolonged jaundice, extrapyramidal signs, hyperreflexia or 146
`hyporeflexia in newborn infants whose mothers received phenothiazines. 147
`Nursing Mothers: There is evidence that phenothiazines are excreted in the breast milk of 148
`nursing mothers. Caution should be exercised when Compazine is administered to a nursing 149
`woman. 150
`PRECAUTIONS 151
`The antiemetic action of Compazine (prochlorperazine) may mask the signs and symptoms of 152
`overdosage of other drugs and may obscure the diagnosis and treatment of other conditions such 153
`as intestinal obstruction, brain tumor and Reye’s syndrome (see WARNINGS). 154
`When Compazine is used with cancer chemotherapeutic drugs, vomiting as a sign of the toxicity 155
`of these agents may be obscured by the antiemetic effect of Compazine. 156
`Because hypotension may occur, large doses and parenteral administration should be used 157
`cautiously in patients with impaired cardiovascular systems. To minimize the occurrence of 158
`hypotension after injection, keep patient lying down and observe for at least ½ hour. If 159
`hypotension occurs after parenteral or oral dosing, place patient in head-low position with legs 160
`raised. If a vasoconstrictor is required, Levophed®* and Neo-Synephrine®† are suitable. Other 161
`pressor agents, including epinephrine, should not be used because they may cause a paradoxical 162
`further lowering of blood pressure. 163
`Aspiration of vomitus has occurred in a few post-surgical patients who have received Compazine 164
`(prochlorperazine) as an antiemetic. Although no causal relationship has been established, this 165
`possibility should be borne in mind during surgical aftercare. 166
`Deep sleep, from which patients can be aroused, and coma have been reported, usually with 167
`overdosage. 168
`Antipsychotic drugs elevate prolactin levels; the elevation persists during chronic administration. 169
`Tissue culture experiments indicate that approximately one third of human breast cancers are 170
`prolactin-dependent in vitro, a factor of potential importance if the prescribing of these drugs is 171
`contemplated in a patient with a previously detected breast cancer. Although disturbances such 172
`This label may not be the latest approved by FDA.
`For current labeling information, please visit https://www.fda.gov/drugsatfda
`Page 5 of 15
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`as galactorrhea, amenorrhea, gynecomastia and impotence have been reported, the clinical 173
`significance of elevated serum prolactin levels is unknown for most patients. An increase in 174
`mammary neoplasms has been found in rodents after chronic administration of antipsychotic 175
`drugs. Neither clinical nor epidemiologic studies conducted to date, however, have shown an 176
`association between chronic administration of these drugs and mammary tumorigenesis; the 177
`available evidence is considered too limited to be conclusive at this time. 178
`Chromosomal aberrations in spermatocytes and abnormal sperm have been demonstrated in 179
`rodents treated with certain antipsychotics. 180
`As with all drugs which exert an anticholinergic effect, and/or cause mydriasis, prochlorperazine 181
`should be used with caution in patients with glaucoma. 182
`Because phenothiazines may interfere with thermoregulatory mechanisms, use with caution in 183
`persons who will be exposed to extreme heat. 184
`Phenothiazines can diminish the effect of oral anticoagulants. 185
`Phenothiazines can produce alpha-adrenergic blockade. 186
`Thiazide diuretics may accentuate the orthostatic hypotension that may occur with 187
`phenothiazines. 188
`Antihypertensive effects of guanethidine and related compounds may be counteracted when 189
`phenothiazines are used concomitantly. 190
`Concomitant administration of propranolol with phenothiazines results in increased plasma 191
`levels of both drugs. 192
`Phenothiazines may lower the convulsive threshold; dosage adjustments of anticonvulsants may 193
`be necessary. Potentiation of anticonvulsant effects does not occur. However, it has been 194
`reported that phenothiazines may interfere with the metabolism of Dilantin®‡ and thus precipitate 195
`Dilantin toxicity. 196
`The presence of phenothiazines may produce false-positive phenylketonuria (PKU) test results. 197
`Long-Term Therapy: Given the likelihood that some patients exposed chronically to 198
`antipsychotics tardive dyskinesia, it is advised that all patients in whom chronic use is 199
`contemplated be given, if possible, full information about this risk. The decision to inform 200
`patients and/or their guardians must obviously take into account the clinical circumstances and 201
`the competency of the patient to understand the information provided. 202
`To lessen the likelihood of adverse reactions related to cumulative drug effect, patients with a 203
`history of long-term therapy with Compazine (prochlorperazine) and/or other antipsychotics 204
`should be evaluated periodically to decide whether the maintenance dosage could be lowered or 205
`drug therapy discontinued. 206
`This label may not be the latest approved by FDA.
`For current labeling information, please visit https://www.fda.gov/drugsatfda
`Page 6 of 15
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`Children with acute illnesses (e.g., chickenpox, CNS infections, measles, gastroenteritis) or 207
`dehydration seem to be much more susceptible to neuromuscular reactions, particularly 208
`dystonias, than are adults. In such patients, the drug should be used only under close 209
`supervision. 210
`Drugs which lower the seizure threshold, including phenothiazine derivatives, should not be used 211
`with Amipaque®§. As with other phenothiazine derivatives, Compazine (prochlorperazine) 212
`should be discontinued at least 48 hours before myelography, should not be resumed for at least 213
`24 hours postprocedure, and should not be used for the control of nausea and vomiting occurring 214
`either prior to myelography with Amipaque, or postprocedure. 215
`Geriatric Use: Clinical studies of Compazine did not include sufficient numbers of subjects 216
`aged 65 and over to determine whether elderly subjects respond differently from younger 217
`subjects. Geriatric patients are more sensitive to the side effects of antipsychotics, including 218
`Compazine. These adverse events include hypotension, anticholinergic effects (such as urinary 219
`retention, constipation, and confusion), and neuromuscular reactions (such as parkinsonism and 220
`tardive dyskinesia) (see PRECAUTIONS and ADVERSE REACTIONS). Also, postmarketing 221
`safety experience suggests that the incidence of agranulocytosis may be higher in geriatric 222
`patients compared to younger individuals who received Compazine. In general, dose selection for 223
`an elderly patient should be cautious, usually starting at the low end of the dosing range, 224
`reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of 225
`concomitant disease or other drug therapy (see DOSAGE AND ADMINISTRATION). 226
`ADVERSE REACTIONS 227
`Drowsiness, dizziness, amenorrhea, blurred vision, skin reactions and hypotension may occur. 228
`Neuroleptic Malignant Syndrome (NMS) has been reported in association with antipsychotic 229
`drugs (see WARNINGS). 230
`Cholestatic jaundice has occurred. If fever with grippe-like symptoms occurs, appropriate liver 231
`studies should be conducted. If tests indicate an abnormality, stop treatment. There have been a 232
`few observations of fatty changes in the livers of patients who have died while receiving the 233
`drug. No causal relationship has been established. 234
`Leukopenia and agranulocytosis have occurred. Warn patients to report the sudden appearance of 235
`sore throat or other signs of infection. If white blood cell and differential counts indicate 236
`leukocyte depression, stop treatment and start antibiotic and other suitable therapy. 237
`Neuromuscular (Extrapyramidal) Reactions 238
`These symptoms are seen in a significant number of hospitalized mental patients. They may be 239
`characterized by motor restlessness, be of the dystonic type, or they may resemble parkinsonism. 240
`Depending on the severity of symptoms, dosage should be reduced or discontinued. If therapy is 241
`reinstituted, it should be at a lower dosage. Should these symptoms occur in children or pregnant 242
`This label may not be the latest approved by FDA.
`For current labeling information, please visit https://www.fda.gov/drugsatfda
`Page 7 of 15
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`patients, the drug should be stopped and not reinstituted. In most cases barbiturates by suitable 243
`route of administration will suffice. (Or, injectable Benadryl®|| may be useful.) In more severe 244
`cases, the administration of an anti-parkinsonism agent, except levodopa (see PDR), usually 245
`produces rapid reversal of symptoms. Suitable supportive measures such as maintaining a clear 246
`airway and adequate hydration should be employed. 247
`Motor Restlessness: Symptoms may include agitation or jitteriness and sometimes insomnia. 248
`These symptoms often disappear spontaneously. At times these symptoms may be similar to the 249
`original neurotic or psychotic symptoms. Dosage should not be increased until these side effects 250
`have subsided. 251
`If these symptoms become too troublesome, they can usually be controlled by a reduction of 252
`dosage or change of drug. Treatment with anti-parkinsonian agents, benzodiazepines or 253
`propranolol may be helpful. 254
`Dystonias: Symptoms may include: spasm of the neck muscles, sometimes progressing to 255
`torticollis; extensor rigidity of back muscles, sometimes progressing to opisthotonos; carpopedal 256
`spasm, trismus, swallowing difficulty, oculogyric crisis and protrusion of the tongue. 257
`These usually subside within a few hours, and almost always within 24 to 48 hours, after the 258
`drug has been discontinued. 259
`In mild cases, reassurance or a barbiturate is often sufficient. In moderate cases, barbiturates will 260
`usually bring rapid relief. In more severe adult cases, the administration of an anti-parkinsonism 261
`agent, except levodopa (see PDR), usually produces rapid reversal of symptoms. In children, 262
`reassurance and barbiturates will usually control symptoms. (Or, injectable Benadryl may be 263
`useful. Note: See Benadryl prescribing information for appropriate children’s dosage.) If 264
`appropriate treatment with anti-parkinsonism agents or Benadryl fails to reverse the signs and 265
`symptoms, the diagnosis should be reevaluated. 266
`Pseudo-parkinsonism: Symptoms may include: mask-like facies; drooling; tremors; 267
`pillrolling motion; cogwheel rigidity; and shuffling gait. Reassurance and sedation are important. 268
`In most cases these symptoms are readily controlled when an anti-parkinsonism agent is 269
`administered concomitantly. Anti-parkinsonism agents should be used only when required. 270
`Generally, therapy of a few weeks to 2 or 3 months will suffice. After this time patients should 271
`be evaluated to determine their need for continued treatment. (Note: Levodopa has not been 272
`found effective in pseudo-parkinsonism.) Occasionally it is necessary to lower the dosage of 273
`Compazine (prochlorperazine) or to discontinue the drug. 274
`Tardive Dyskinesia: As with all antipsychotic agents, tardive dyskinesia may appear in some 275
`patients on long-term therapy or may appear after drug therapy has been discontinued. The 276
`syndrome can also develop, although much less frequently, after relatively brief treatment 277
`periods at low doses. This syndrome appears in all age groups. Although its prevalence appears 278
`to be highest among elderly patients, especially elderly women, it is impossible to rely upon 279
`This label may not be the latest approved by FDA.
`For current labeling information, please visit https://www.fda.gov/drugsatfda
`Page 8 of 15
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`prevalence estimates to predict at the inception of antipsychotic treatment which patients are 280
`likely to develop the syndrome. The symptoms are persistent and in some patients appear to be 281
`irreversible. The syndrome is characterized by rhythmical involuntary movements of the tongue, 282
`face, mouth or jaw (e.g., protrusion of tongue, puffing of cheeks, puckering of mouth, chewing 283
`movements). Sometimes these may be accompanied by involuntary movements of extremities. In 284
`rare instances, these involuntary movements of the extremities are the only manifestations of 285
`tardive dyskinesia. A variant of tardive dyskinesia, tardive dystonia, has also been described. 286
`There is no known effective treatment for tardive dyskinesia; anti-parkinsonism agents do not 287
`alleviate the symptoms of this syndrome. It is suggested that all antipsychotic agents be 288
`discontinued if these symptoms appear. 289
`Should it be necessary to reinstitute treatment, or increase the dosage of the agent, or switch to a 290
`different antipsychotic agent, the syndrome may be masked. 291
`It has been reported that fine vermicular movements of the tongue may be an early sign of the 292
`syndrome and if the medication is stopped at that time the syndrome may not develop. 293
`Contact Dermatitis: Avoid getting the Injection solution on hands or clothing because of the 294
`possibility of contact dermatitis. 295
`Adverse Reactions Reported with Compazine (prochlorperazine) or Other 296
`Phenothiazine Derivatives: Adverse reactions with different phenothiazines vary in type, 297
`frequency and mechanism of occurrence, i.e., some are dose-related, while others involve 298
`individual patient sensitivity. Some adverse reactions may be more likely to occur, or occur with 299
`greater intensity, in patients with special medical problems, e.g., patients with mitral 300
`insufficiency or pheochromocytoma have experienced severe hypotension following 301
`recommended doses of certain phenothiazines. 302
`Not all of the following adverse reactions have been observed with every phenothiazine 303
`derivative, but they have been reported with 1 or more and should be borne in mind when drugs 304
`of this class are administered: extrapyramidal symptoms (opisthotonos, oculogyric crisis, 305
`hyperreflexia, dystonia, akathisia, dyskinesia, parkinsonism) some of which have lasted months 306
`and even years–particularly in elderly patients with previous brain damage; grand mal and petit 307
`mal convulsions, particularly in patients with EEG abnormalities or history of such disorders; 308
`altered cerebrospinal fluid proteins; cerebral edema; intensification and prolongation of the 309
`action of central nervous system depressants (opiates, analgesics, antihistamines, barbiturates, 310
`alcohol), atropine, heat, organophosphorus insecticides; autonomic reactions (dryness of mouth, 311
`nasal congestion, headache, nausea, constipation, obstipation, adynamic ileus, ejaculatory 312
`disorders/impotence, priapism, atonic colon, urinary retention, miosis and mydriasis); 313
`reactivation of psychotic processes, catatonic-like states; hypotension (sometimes fatal); cardiac 314
`arrest; blood dyscrasias (pancytopenia, thrombocytopenic purpura, leukopenia, agranulocytosis, 315
`eosinophilia, hemolytic anemia, aplastic anemia); liver damage (jaundice, biliary stasis); 316
`endocrine disturbances (hyperglycemia, hypoglycemia, glycosuria, lactation, galactorrhea, 317
`This label may not be the latest approved by FDA.
`For current labeling information, please visit https://www.fda.gov/drugsatfda
`Page 9 of 15
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`gynecomastia, menstrual irregularities, false-positive pregnancy tests); skin disorders 318
`(photosensitivity, itching, erythema, urticaria, eczema up to exfoliative dermatitis); other allergic 319
`reactions (asthma, laryngeal edema, angioneurotic edema, anaphylactoid reactions); peripheral 320
`edema; reversed epinephrine effect; hyperpyrexia; mild fever after large I.M. doses; increased 321
`appetite; increased weight; a systemic lupus erythematosus-like syndrome; pigmentary 322
`retinopathy; with prolonged administration of substantial doses, skin pigmentation, epithelial 323
`keratopathy, and lenticular and corneal deposits. 324
`EKG changes–particularly nonspecific, usually reversible Q and T wave distortions–have been 325
`observed in some patients receiving phenothiazines. 326
`Although phenothiazines cause neither psychic nor physical dependence, sudden discontinuance 327
`in long-term psychiatric patients may cause temporary symptoms, e.g., nausea and vomiting, 328
`dizziness, tremulousness. 329
`Note: There have been occasional reports of sudden death in patients receiving phenothiazines. 330
`In some cases, the cause appeared to be cardiac arrest or asphyxia due to failure of the cough 331
`reflex. 332
`DOSAGE AND ADMINISTRATION 333
`Notes on Injection: Stability–This solution should be protected from light. This is a clear, 334
`colorless to pale yellow solution; a slight yellowish discoloration will not alter potency. If 335
`markedly discolored, solution should be discarded. 336
`Compatibility–It is recommended that Compazine (prochlorperazine) Injection not be mixed 337
`with other agents in the syringe. 338
`DOSAGE AND ADMINISTRATION–ADULTS 339
`(For children’s dosage and administration, see below.) Dosage should be increased more 340
`gradually in debilitated or emaciated patients. 341
`Elderly Patients: In general, dosages in the lower range are sufficient for most elderly 342
`patients. Since they appear to be more susceptible to hypotension and neuromuscular reactions, 343
`such patients should be observed closely. Dosage should be tailored to the individual, response 344
`carefully monitored and dosage adjusted accordingly. Dosage should be increased more 345
`gradually in elderly patients. 346
`1. To Control Severe Nausea and Vomiting: Adjust dosage to the response of the 347
`individual. Begin with the lowest recommended dosage. 348
`Oral Dosage–Tablets: Usually one 5 mg or 10 mg tablet 3 or 4 times daily. Daily dosages above 349
`40 mg should be used only in resistant cases. 350
`Spansule capsules: Initially, usually one 15 mg capsule on arising or one 10 mg capsule q12h. 351
`Daily doses above 40 mg should be used only in resistant cases. 352
`This label may not be the latest approved by FDA.
`For current labeling information, please visit https://www.fda.gov/drugsatfda
`Page 10 of 15
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`Rectal Dosage: 25 mg twice daily. 353
`I.M. Dosage: Initially 5 to 10 mg (1 to 2 mL) injected deeply into the upper outer quadrant of the 354
`buttock. If necessary, repeat every 3 or 4 hours. Total I.M. dosage should not exceed 40 mg per 355
`day. 356
`I.V. Dosage: 2½ to 10 mg (½ to 2 mL) by slow I.V. injection or infusion at a rate not to exceed 357
`5 mg per minute. Compazine Injection may be administered either undiluted or diluted in 358
`isotonic solution. A single dose of the drug should not exceed 10 mg; total I.V. dosage should 359
`not exceed 40 mg per day. When administered I.V., do not use bolus injection. Hypotension is a 360
`possibility if the drug is given by I.V. injection or infusion. 361
`Subcutaneous administration is not advisable because of local irritation. 362
`2. Adult Surgery (for severe nausea and vomiting): Total parenteral dosage should not 363
`exceed 40 mg per day. Hypotension is a possibility if the drug is given by I.V. injection or 364
`infusion. 365
`I.M. Dosage: 5 to 10 mg (1 to 2 mL) 1 to 2 hours before induction of anesthesia (repeat once in 366
`30 minutes, if necessary), or to control acute symptoms during and after surgery (repeat once if 367
`necessary). 368
`I.V. Dosage: 5 to 10 mg (1 to 2 mL) as a slow I.V. injection or infusion 15 to 30 minutes before 369
`induction of anesthesia, or to control acute symptoms during or after surgery. Repeat once if 370
`necessary. Compazine (prochlorperazine) may be administered either undiluted or diluted in 371
`isotonic solution, but a single dose of the drug should not exceed 10 mg. The rate of 372
`administration should not exceed 5 mg per minute. When administered I.V., do not use bolus 373
`injection. 374
`3. In Adult Psychiatric Disorders: Adjust dosage to the response of the individual and 375
`according to the severity of the condition. Begin with the lowest recommended dose. Although 376
`response ordinarily is seen within a day or 2, long