Clozapine

Clozapine Brand Names

Clozaril | Fazaclo | VERSACLOZ

What is Clozapine

Clozapine is an oral dibenzodiazepine-derived atypical antipsychotic.

Clozapine is structurally related to the antipsychotic loxapine but differs in efficacy and adverse effects.

Approximately 35 mg of clozapine is equivalent to 100 mg of chlorpromazine (CPZ EQ), the prototype typical antipsychotic. Compared to traditional antipsychotics, clozapine has greater limbic system specificity and a low incidence of extrapyramidal side effects.

Clozapine had the distinction of being the first atypical antipsychotic that was proven effective in treating patients with schizophrenia refractory to other medications.

The prescribing information contains a boxed warning regarding the potential for life-threatening severe neutropenia (agranulocytosis); clozapine should be reserved for patients who have failed treatment with two or more trials of other schizophrenia drugs or who are at risk for recurrent suicidal behavior.

Clozapine therapy requires special monitoring and surveillance due to its potential for causing fatal agranulocytosis in about 1% of exposed patients per year; surveillance programs have been effective at reducing the incidence of clozapine-induced agranulocytosis to roughly 0.4% during postmarket use.

The Clozapine REMS Program includes the requirements for monitoring, prescribing, dispensing, and receiving clozapine, and the required management of therapy and monitoring for neutropenia.

Prescribers or their designated agents must enroll each patient into the Clozapine REMS Program prior to patient eligibility to receive the drug. All prescribers and dispensing pharmacies of clozapine are required to be certified by the program.

Indications

  1. behavioral or psychological symptoms of dementia
  2. bipolar disorder
  3. schizoaffective disorder
  4. schizophrenia

For the treatment of refractory schizophrenia that has failed to respond adequately to appropriate courses of standard antipsychotic agents; also to reduce the risk of recurrent suicidal behavior in patients with schizophrenia or schizoaffective disorder

Side Effects

  1. agitation
  2. agranulocytosis
  3. akathisia
  4. akinesia
  5. amnesia
  6. anemia
  7. angina
  8. angioedema
  9. anorexia
  10. anxiety
  11. apnea
  12. appetite stimulation
  13. arrhythmia exacerbation
  14. asthenia
  15. ataxia
  16. atopic dermatitis
  17. atrial fibrillation
  18. back pain
  19. bradycardia
  20. cardiac arrest
  21. cardiomyopathy
  22. chest pain (unspecified)
  23. chills
  24. cholestasis
  25. cirrhosis
  26. colitis
  27. confusion
  28. conjunctival hyperemia
  29. constipation
  30. cough
  31. cyanosis
  32. delirium
  33. depression
  34. diabetes mellitus
  35. diabetic ketoacidosis
  36. diarrhea
  37. dizziness
  38. drowsiness
  39. dysarthria
  40. dysgeusia
  41. dysmenorrhea
  42. dyspepsia
  43. dysphagia
  44. dyspnea
  45. dystonic reaction
  46. edema
  47. EEG changes
  48. ejaculation dysfunction
  49. elevated hepatic enzymes
  50. eosinophilia
  51. epistaxis
  52. eructation
  53. erythema
  54. erythema multiforme
  55. fatigue
  56. fever
  57. GI obstruction
  58. hallucinations
  59. headache
  60. heart failure
  61. hematemesis
  62. hematoma
  63. hepatic encephalopathy
  64. hepatic failure
  65. hepatic necrosis
  66. hepatitis
  67. hepatotoxicity
  68. hot flashes
  69. hyperbilirubinemia
  70. hypercholesterolemia
  71. hyperglycemia
  72. hyperhidrosis
  73. hyperkinesis
  74. hypersalivation
  75. hypertension
  76. hyperthermia
  77. hypertriglyceridemia
  78. hyperuricemia
  79. hyperventilation
  80. hyponatremia
  81. hypotension
  82. hypothermia
  83. ileus
  84. impotence (erectile dysfunction)
  85. increased urinary frequency
  86. infection
  87. insomnia
  88. interstitial nephritis
  89. irritability
  90. jaundice
  91. laryngitis
  92. lethargy
  93. leukocytosis
  94. leukopenia
  95. libido decrease
  96. libido increase
  97. lupus-like symptoms
  98. malaise
  99. mastalgia
  100. muscle cramps
  101. myalgia
  102. myasthenia
  103. mydriasis
  104. myocardial infarction
  105. myocarditis
  106. myoclonia
  107. nasal congestion
  108. nausea
  109. neuroleptic malignant syndrome
  110. neutropenia
  111. neutropenia
  112. nightmares
  113. nocturia
  114. nystagmus
  115. ocular hypertension
  116. orthostatic hypotension
  117. pallor
  118. palpitations
  119. pancreatitis
  120. paranoia
  121. paresthesias
  122. peptic ulcer
  123. pericardial effusion
  124. pericarditis
  125. petechiae
  126. phlebitis
  127. photosensitivity
  128. pleural effusion
  129. polydipsia
  130. polyuria
  131. premature ventricular contractions (PVCs)
  132. priapism
  133. pruritus
  134. pseudoparkinsonism
  135. pseudopheochromocytoma
  136. psychosis
  137. pulmonary embolism
  138. pyrosis (heartburn)
  139. QT prolongation
  140. rash
  141. renal failure (unspecified)
  142. restlessness
  143. rhabdomyolysis
  144. rhinorrhea
  145. seizures
  146. SIADH
  147. sinus tachycardia
  148. skin hyperpigmentation
  149. sneezing
  150. ST-T wave changes
  151. steatosis
  152. Stevens-Johnson syndrome
  153. stroke
  154. syncope
  155. tachypnea
  156. tardive dyskinesia
  157. throat irritation
  158. thrombocytopenia
  159. thrombocytosis
  160. thrombosis
  161. torsade de pointes
  162. tremor
  163. urinary incontinence
  164. urinary retention
  165. urinary urgency
  166. urticaria
  167. vasculitis
  168. ventricular fibrillation
  169. ventricular tachycardia
  170. vertigo
  171. visual impairment
  172. vomiting
  173. water intoxication
  174. weight gain
  175. weight loss
  176. wheezing
  177. withdrawal
  178. xerostomia

Monitoring Parameters

  • AIMS assessment
  • blood glucose
  • blood pressure
  • CBC with differential
  • heart rate
  • LFTs
  • neurologic function
  • pregnancy testing
  • serum creatinine
  • serum electrolytes
  • serum lipid profile
  • serum prolactin
  • thyroid function tests (TFTs)
  • weight

Contraindications

  • abrupt discontinuation
  • agranulocytosis
  • ambient temperature increase
  • anticholinergic medications
  • apheresis
  • AV block
  • bone marrow suppression
  • bradycardia
  • breast-feeding
  • cardiomyopathy
  • celiac disease
  • cerebrovascular disease
  • chemotherapy
  • children
  • closed-angle glaucoma
  • CNS depression
  • coadministration with other CNS depressants
  • constipation
  • dehydration
  • dementia
  • diabetes mellitus
  • diabetic ketoacidosis
  • driving or operating machinery
  • dysphagia
  • ethanol ingestion
  • fecal impaction
  • females
  • fever
  • geriatric
  • GI obstruction
  • heart failure
  • hepatic disease
  • hepatitis
  • hepatotoxicity
  • human immunodeficiency virus (HIV) infection
  • hypercholesterolemia
  • hyperglycemia
  • hyperlipidemia
  • hyperosmolar hyperglycemic state (HHS)
  • hyperparathyroidism
  • hyperthermia
  • hypertriglyceridemia
  • hypocalcemia
  • hypokalemia
  • hypomagnesemia
  • hypotension
  • hypothermia
  • hypothyroidism
  • hypovolemia
  • ileus
  • infants
  • infection
  • jaundice
  • leukemia
  • leukopenia
  • long QT syndrome
  • myocardial infarction
  • myocarditis
  • neonates
  • neurological disease
  • neutropenia
  • obesity
  • orthostatic hypotension
  • Parkinson’s disease
  • phenylketonuria
  • pheochromocytoma
  • poor metabolizers
  • pregnancy
  • pregnancy testing
  • prostatic hypertrophy
  • QT prolongation
  • renal failure
  • renal impairment
  • rheumatoid arthritis
  • seizure disorder
  • seizures
  • sickle cell disease
  • sleep deprivation
  • strenuous exercise
  • stroke
  • syncope
  • systemic lupus erythematosus (SLE)
  • tachycardia
  • tardive dyskinesia
  • thromboembolic disease
  • thromboembolism
  • tobacco smoking
  • torsade de pointes
  • urinary retention
  • ventricular arrhythmias

Interactions

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  • Acetaminophen; Codeine
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  • Chlorpheniramine; Dihydrocodeine; Phenylephrine
  • Chlorpheniramine; Dihydrocodeine; Pseudoephedrine
  • Chlorpheniramine; Guaifenesin; Hydrocodone; Pseudoephedrine
  • Chlorpheniramine; Hydrocodone
  • Chlorpheniramine; Hydrocodone; Phenylephrine
  • Chlorpheniramine; Hydrocodone; Pseudoephedrine
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  • Chlorpheniramine; Pseudoephedrine
  • Chlorpromazine
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  • food
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  • Nebivolol; Valsartan
  • Nefazodone
  • Nelarabine
  • Nelfinavir
  • Nevirapine
  • Nicardipine
  • Nifedipine
  • Nilotinib
  • Nisoldipine
  • Nitroprusside
  • Non-Ionic Contrast Media
  • Norfloxacin
  • Obeticholic Acid
  • Obinutuzumab
  • Octreotide
  • Ofatumumab
  • Ofloxacin
  • Olanzapine
  • Olodaterol
  • Omacetaxine
  • Ombitasvir; Paritaprevir; Ritonavir
  • Omeprazole
  • Omeprazole; Amoxicillin; Rifabutin
  • Omeprazole; Sodium Bicarbonate
  • Ondansetron
  • Oritavancin
  • Orphenadrine
  • Osilodrostat
  • Osimertinib
  • Oxaliplatin
  • Oxazepam
  • Oxcarbazepine
  • Oxycodone
  • Oxymorphone
  • Ozanimod
  • Palbociclib
  • Paliperidone
  • Panobinostat
  • Paroxetine
  • Pasireotide
  • Pazopanib
  • Peginterferon Alfa-2b
  • Peginterferon beta-1a
  • Penbutolol
  • Pentamidine
  • Pentazocine
  • Pentazocine; Naloxone
  • Pentobarbital
  • Perampanel
  • Pergolide
  • Perindopril; Amlodipine
  • Perphenazine
  • Perphenazine; Amitriptyline
  • Pertuzumab
  • Phenelzine
  • Phenobarbital
  • Phenoxybenzamine
  • Phenylephrine; Promethazine
  • Phenytoin
  • Pimavanserin
  • Pimozide
  • Pindolol
  • Pioglitazone
  • Pirbuterol
  • Pitolisant
  • Pomalidomide
  • Ponatinib
  • Posaconazole
  • Potassium-sparing diuretics
  • Pralatrexate
  • Pramipexole
  • Pramlintide
  • Prazosin
  • Pregabalin
  • Prilocaine; Epinephrine
  • Primaquine
  • Primidone
  • Procainamide
  • Prochlorperazine
  • Promethazine
  • Propafenone
  • Propofol
  • Propoxyphene
  • Propranolol
  • Purine analogs
  • Quazepam
  • Quetiapine
  • Quinidine
  • Quinine
  • Radium-223 Dichloride
  • Ramucirumab
  • Ranolazine
  • Rasagiline
  • Remifentanil
  • Repaglinide
  • Reserpine
  • Ribociclib
  • Ribociclib; Letrozole
  • Rifabutin
  • Rifampin
  • Rilpivirine
  • Risperidone
  • Ritonavir
  • Rivastigmine
  • Rolapitant
  • Romidepsin
  • Ropinirole
  • Rosiglitazone
  • Rotigotine
  • Rucaparib
  • Ruxolitinib
  • Safinamide
  • Salmeterol
  • Saquinavir
  • Saxagliptin
  • Secobarbital
  • Selegiline
  • Selpercatinib
  • Semaglutide
  • Sertraline
  • Sevoflurane
  • SGLT2 Inhibitors
  • Short-acting beta-agonists
  • Sibutramine
  • Siltuximab
  • Simeprevir
  • Simvastatin; Sitagliptin
  • Siponimod
  • Sipuleucel-T
  • Sitagliptin
  • Sodium picosulfate; Magnesium oxide; Anhydrous citric acid
  • Solifenacin
  • Sorafenib
  • Sotalol
  • Sparfloxacin
  • St. John’s Wort, Hypericum perforatum
  • Streptogramins
  • Sufentanil
  • Sulfonylureas
  • Sunitinib
  • Suvorexant
  • Tacrine
  • Tacrolimus
  • Tamoxifen
  • Tapentadol
  • Telaprevir
  • Telavancin
  • Telithromycin
  • Telotristat Ethyl
  • Temazepam
  • Terbinafine
  • Terbutaline
  • Teriflunomide
  • Tetrabenazine
  • Tezacaftor; Ivacaftor
  • Thalidomide
  • Thiabendazole
  • Thiazide diuretics
  • Thiopental
  • Thioridazine
  • Thiothixene
  • Timolol
  • Tiotropium; Olodaterol
  • Tipranavir
  • tobacco
  • Tolcapone
  • Tolterodine
  • Toremifene
  • Tositumomab
  • Tramadol
  • Trandolapril; Verapamil
  • Tranylcypromine
  • Trazodone
  • Treprostinil
  • Tretinoin, ATRA
  • Triazolam
  • Tricyclic antidepressants
  • Trifluoperazine
  • Triprolidine
  • Triptorelin
  • Trospium
  • Tucatinib
  • Umeclidinium; Vilanterol
  • Valproic Acid, Divalproex Sodium
  • Vandetanib
  • Vardenafil
  • Vasopressin, ADH
  • Vemurafenib
  • Venlafaxine
  • Verapamil
  • Vismodegib
  • Voriconazole
  • Vorinostat
  • Warfarin
  • Zafirlukast
  • Zaleplon
  • Ziconotide
  • Zileuton
  • Ziprasidone
  • Ziv-Aflibercept
  • Zolpidem
  • Zonisamide

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