Hepatic impairment: Use with caution in patients with hepatic disease or impairment; monitor hepatic function regularly. Avoid combination, Pramlintide: May enhance the anticholinergic effect of Anticholinergic Agents. Monitor therapy, Fexinidazole [INT]: May enhance the QTc-prolonging effect of QT-prolonging Agents (Moderate Risk). Shake the bottle of the oral liquid for 10 seconds before each use. Management: Consider alternatives to combined use. Use the dosing syringe provided, or use a medicine dose-measuring device (not a kitchen spoon). Patients with additional risk factors for QTc prolongation may be at even higher risk. Additional data may be necessary to further define the role of clozapine in the treatment of this condition. dry mouth. Push on the plunger to squirt the water into a sink or a separate container until the oral syringe is clean. You may need frequent medical tests while using this medicine and for a short time after your last dose. Once ANC 1,000/mm3 or patients known baseline, check ANC weekly for 4 weeks and then return to previous monitoring schedule. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. High blood sugar like confusion, fatigue, increased thirst, increased hunger, passing a lot of urine, flushing, fast breathing, or breath that smells like fruit. Benign ethnic neutropenia: Patients with benign ethnic neutropenia (BEN), a condition observed in certain ethnic groups whose average ANC values are lower than standard laboratory ranges for neutrophils, have different ANC monitoring parameters due to their lower baseline ANC levels. Consider therapy modification, Ramosetron: Anticholinergic Agents may enhance the constipating effect of Ramosetron. Clozapine comes as a tablet, an orally disintegrating tablet (tablet that dissolves quickly in the mouth), and an oral suspension (liquid) to take by mouth. New Patient Status Form to document monitoring for all outpatients. Specifically, the risk for akathisia, parkinsonism, or neuroleptic malignant syndrome may be increased. Target dose: 300 mg to 450 mg per day, in divided doses, by the end of 2 weeks. It is used to treat agitation, bipolar mania, and psychosis, as in schizophrenia. J Clin Pharm Ther. Llorca PM, Miadi-Fargier H, Lanon C, Jasso Mosqueda G, Casadebaig F, Philippe A, Guillon P, Mehnert A, Omns LF, Chicoye A, Durand-Zaleski I. Encephale. Liquid formulations of clozapine can be prepared extemporaneously or purchased commercially, but most preparations are suspensions (clozapine is poorly soluble) and patients may find them unpalatable. Tell all of your health care providers that you take clozapine oral suspension. Enteral administration is likely to be superseded by intramuscular clozapine, which has recently been re-introduced and is being widely used in some countries. Rule out infection, severe neutropenia, myocarditis, and neuroleptic malignant syndrome (NMS) in patients presenting with fever. This material is provided for educational purposes only and is not intended for medical advice, diagnosis, or treatment. Also tell your doctor if you have severe vomiting or diarrhea or signs of dehydration now, or if you develop these symptoms at any time during your treatment. Monitor therapy, Haloperidol: QT-prolonging Antipsychotics (Moderate Risk) may enhance the QTc-prolonging effect of Haloperidol. There are no changes to requirements for patients. If your dose is more than 1 mL, use the larger (9 mL) oral syringe. To use the sharing features on this page, please enable JavaScript. May indicate myocarditis (if early in therapy) or infection secondary to neutropenia. Monitor therapy, Blood Pressure Lowering Agents: May enhance the hypotensive effect of Hypotension-Associated Agents. Click on the link in the Important Program Update. Monitor therapy, Serotonergic Agents (High Risk): May enhance the adverse/toxic effect of Antipsychotic Agents. Avoid combination, Glycopyrronium (Topical): May enhance the anticholinergic effect of Anticholinergic Agents. Signs of an allergic reaction, like rash; Shakiness, trouble moving around, or stiffness. Monitor therapy, Kava Kava: May enhance the adverse/toxic effect of CNS Depressants. Clozapine may cause seizures. Discontinuing concomitant medication while continuing clozapine: Increase clozapine dose based on clinical response. increased salivation. Medically reviewed by Drugs.com. Tell your doctor if you have heart problems or brain problems. Bethesda, MD 20894, Web Policies Clozapine treatment has caused severe neutropenia, defined as an absolute neutrophil count (ANC) less than 500/mm3. This form must be submitted monthly. Monitor therapy, Nitroglycerin: Anticholinergic Agents may decrease the absorption of Nitroglycerin. Use of suvorexant with alcohol is not recommended, and the use of suvorexant with any other drug to treat insomnia is not recommended. Management: Drugs listed as exceptions to this monograph are discussed in further detail in separate drug interaction monographs. While it may be appropriate to withhold clozapine doses temporarily while ruling out serious causes of fever, treatment should not be abruptly discontinued for a benign fever with unknown cause (Nielson 2013). Fill a cup with water and place the tip of the oral syringe into the water in the cup. On July 29, 2021, FDA approved modifications to the Clozapine Risk Evaluation and Mitigation Strategy (REMS) to ensure that the benefits of the drug outweigh the risk of severe neutropenia. 2021;47(3):66271. Shake the bottle of the oral liquid for 10 seconds before each use. Talk with the doctor. The risk is dose-related. like dark urine, feeling tired, not hungry. Last updated February 6, 2020. If clozapine is discontinued, a weekly WBC should be conducted for an additional 4 weeks or until WBC is 3,500/mm3 and ANC is 2,000/mm3. Call your doctor right away if you have chest pain, trouble breathing, fast or pounding heartbeats or sudden dizziness. Clozapine for the treatment-resistant schizophrenic: a double-blind comparison with chlorpromazine. This can lead to very bad and sometimes deadly infections. This medicine comes with a patient instructions. Dyslipidemia: Undesirable changes in lipids have been observed with antipsychotic therapy; incidence varies with product. Signs and symptoms such as hypotension, sialorrhea, and sedation that cannot be explained by other medications or conditions may necessitate a temporary dose reduction or discontinuation, depending on the severity (Clark 2017; Leung 2014). Use with caution in patients at risk for these effects (eg, cerebrovascular disease, cardiovascular disease) or with predisposing conditions for hypotensive episodes (eg, hypovolemia, concurrent antihypertensive medication); reactions can be fatal. Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Increased mortality in elderly patients with dementia-related psychosis: Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. The Pre-Dispense Authorization (PDA) will be replaced by a REMS Dispense Authorization (RDA). In case of overdose, call the poison control helpline at 1-800-222-1222. Do not refrigerate or freeze the oral liquid. orally disintegrating tab. Use caution in patients with conditions that may increase the risk of QT prolongation, including history of QT prolongation, long QT syndrome, family history of long QT syndrome or sudden cardiac death, significant cardiac arrhythmia, recent myocardial infarction, uncompensated heart failure, treatment with other medications that cause QT prolongation, treatment with medications that inhibit the metabolism of clozapine, hypokalemia, and hypomagnesemia. -To reduce the risk of recurrent suicidal behavior in patients with schizophrenia or schizoaffective disorder, who are judged to be at chronic risk for re-experiencing suicidal behavior, based on history and recent clinical state. Consider therapy modification, Methotrimeprazine: CNS Depressants may enhance the CNS depressant effect of Methotrimeprazine. Hard or dry stools; bowel movements that are not as often as normal; severe constipation; stomach pain, A very bad and sometimes deadly health problem called, Some people may get a severe muscle problem called. Exceptions: QuiNIDine. 2012 Nov;32(11):723-7. doi: 10.1007/s40261-012-0004-6. Avoid combination, Pentamidine (Systemic): May enhance the QTc-prolonging effect of QT-prolonging Antipsychotics (Moderate Risk). big weight gain, a heartbeat that does not feel normal, chest pain or pressure, fast heartbeat, fever, flu-like signs, shortness of breath, Monitor therapy, Tiotropium: Anticholinergic Agents may enhance the anticholinergic effect of Tiotropium. any drug without checking with your doctor. Your doctor will probably tell you to restart your treatment with a low dose of clozapine. Orthostatic hypotension, bradycardia, syncope: Orthostatic hypotension, bradycardia, syncope, and cardiac arrest have occurred with treatment. Tardive dyskinesia like unable to control body movements; tongue, face, mouth, or jaw sticking out; mouth puckering; or puffing cheeks. Pharmacies will no longerbe able to usetelecommunication verification (also known as theswitchsystem) to verify safe use conditionsfor clozapine. Anticholinergic Agents may diminish the therapeutic effect of Acetylcholinesterase Inhibitors. Do not Tell your doctor if you are pregnant or plan on getting pregnant. The drug is available in sachets that can be easily carried in pocket or wallet. 1999;60:223. Patients with additional risk factors for QTc prolongation may be at even higher risk. Generally, patients with clozapine-related myocarditis or cardiomyopathy should not be rechallenged with clozapine. Careers. Portions of this document last updated: May 01, 2023. Copyright 1996-2023 Cerner Multum, Inc. Prescriptions should be written for the smallest quantity consistent with good patient care. Suspension: 2.2 hours (range: 1 to 3.5 hours); Tablets: 2.5 hours (range: 1 to 6 hours); Dispersible tablets: 2.3 hours (range: 1 to 6 hours), Steady state: 12 hours (range: 4 to 66 hours). Some drugs may have another patient information leaflet. In order for an individual pharmacist to re-enroll in the Clozapine REMS, the certified authorized representative will need to invite the pharmacist to enroll in the program using a valid email address. Beginning August 2, 2021, a Transition Contact Center is available at 888-586-0758 to support re-certification, re-enrollment activities and to answer questions. Authorized representatives should access the new Clozapine REMSwebsite beginning August 16, 2021: Note: Large chain pharmacies may call the Clozapine REMS Transition Contact Center at 1- 888-586-0758 if they wish to perform a bulk upload of stores and staff. Wait at least 24 hours after the procedure to resume such agents. Avoid combination, Oxatomide: May enhance the anticholinergic effect of Anticholinergic Agents. If combined, monitor for QTc interval prolongation and ventricular arrhythmias. Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. FOIA Enroll all new patients starting clozapine between now and November 15, 2021 in both the current program and the new program. After the tablet has melted, swallow or chew it as desired. Beginning November 15, 2021, the new requirements will go into effect. Hematologic toxicity monitoring: Confirm all initial reports of ANC <1,500/mm3 with a repeat ANC within 24 hours. Monitor therapy, Herbs (Hypotensive Properties): May enhance the hypotensive effect of Blood Pressure Lowering Agents. Check with your If WBC falls <1,000/mm3 or ANC falls <500/mm3, place patient in protective isolation with close observation. If you become pregnant while taking clozapine, call your doctor. Rinse the oral syringe with warm tap water after each use. Tell your doctor if you have or have had a heart attack, heart failure, or a slow, irregular heartbeat or are taking medications for high blood pressure. You could have more side effects. No such dose change is recommended for women. If WBC/ANC continue to remain within these acceptable limits after the second 6 months (26 weeks) of therapy, monitoring can be decreased to every 4 weeks. ANC monitoring: Note: Laboratory hematology results may be presented in different units; 1 mcL equals 1 mm3. Management: Avoid concomitant use of opioid agonists and benzodiazepines or other CNS depressants when possible. Monitor therapy, Bromopride: May enhance the adverse/toxic effect of Antipsychotic Agents. When combined use is needed, consider minimizing doses of one or more drugs. Consider therapy modification, Ipratropium (Oral Inhalation): May enhance the anticholinergic effect of Anticholinergic Agents. Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Your doctor may want to restart your medication at a lower dose. http://www.upandaway.org. Management: Reduce the clozapine dose to one-third of the original dose when adding ciprofloxacin and monitor closely for evidence of excessive QTc prolongation and clozapine toxicity. Wait at least 24 hours after the procedure to resume such agents. Avoid combination, Flunitrazepam: CNS Depressants may enhance the CNS depressant effect of Flunitrazepam. Do not keep outdated medicine or medicine no longer needed. For more information, please see the updated CDER Statement. It is used to treat problems with how one acts. You may get infections more easily, even serious or fatal infections. Monitor therapy, CYP1A2 Inhibitors (Moderate): May increase the serum concentration of CloZAPine. Once ANC 1,500/mm3, check ANC weekly for 4 weeks and then return to previous monitoring schedule. Consider therapy modification, Blonanserin: CNS Depressants may enhance the CNS depressant effect of Blonanserin. Specifically, serotonergic agents may enhance dopamine blockade, possibly increasing the risk for neuroleptic malignant syndrome. Initiate treatment at 12.5 mg, titrate gradually, and use divided dosing. While holding the oral syringe in place, carefully turn the bottle upside down. Clozapine is used to treat schizophrenia in adults after other treatments have failed. Apply for early access to the new Medicine.com Pharmacy. Subsequent dose increases can be in increments of up to 100 mg once or twice weekly. a blockage of the intestines with stool. You may take clozapine with or without food. A program has been set up by the manufacturers of clozapine to be sure that people do not take clozapine without the necessary monitoring called the Clozapine Risk Evaluation and Mitigation Strategies (REMS) Program. As a result of excessive saliva, patients may initially experience choking sensations that cause nighttime awakening, hoarseness or dysphonia of the voice, and a chronic cough. Protect from light. If you miss taking clozapine for more than 2 days, you should call your doctor before taking any more medication. -, Cheng YF, et al. The Patient Status Form is used to document the patients ANC results, monitoring frequency, and appropriateness to continue treatment. Mean effective dose range in most pediatric studies: 220 to 431 mg/day (Schneider 2014). If you are taking any drugs that can stop your bone marrow from making some of the cells that your body needs. Consider the possibility of myocarditis or cardiomyopathy if chest pain, tachycardia, palpitations, dyspnea, fever, flu-like symptoms, hypotension, or electrocardiogram (ECG) changes occur. This site needs JavaScript to work properly. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. in addition to the condition listed in the IMPORTANT WARNING section, tell your doctor if you or anyone in your family has ever had a prolonged QT interval (a rare heart problem that may cause irregular heartbeat, fainting, or sudden death) or diabetes. Patients with additional risk factors for QTc prolongation may be at even higher risk. Levitra Oral Jelly is prescribed to men who are having problems getting or maintaining an erection strong enough to engage in sexual activity. Monitor therapy, Trimeprazine: May enhance the CNS depressant effect of CNS Depressants. with your doctor, nurse, pharmacist, or other health care provider. Safety data related to atypical antipsychotics during pregnancy is limited and routine use is not recommended. Hospice patients: For hospice patients (ie, terminally ill patients with an estimated life expectancy of 6 months), ANC monitoring may be reduced to a frequency of once every 6 months after a discussion with the patient and caregiver. Monitor therapy, Opioid Agonists: CNS Depressants may enhance the CNS depressant effect of Opioid Agonists. Clozapine is used to treat schizophrenia in adults after other treatments have failed. If the CYP3A4 inducer is necessary, monitor for decreased clozapine effectiveness and if necessary, consider increasing the clozapine dose. This medicine can cause very bad stomach or bowel problems like very bad. Clozapine Oral Suspension Generic name: Clozapine Oral Suspension [ KLOE-za-peen ] Brand name: Versacloz Drug class: Atypical antipsychotics Medically reviewed by Drugs.com. Avoid combination, CYP3A4 Inducers (Weak): May decrease the serum concentration of CloZAPine. In patients without a clinically significant response after 4 weeks, taper and withdraw therapy. Avoid combination, Bromperidol: May enhance the CNS depressant effect of CNS Depressants. Additional data may be necessary to further define the role of clozapine in this condition. MeSH Continue to monitor existing patients according to the current REMS requirements prior to the November 15, 2021 launch of the new Clozapine REMS Program. Prior to initiating treatment, a baseline ANC must be at least 1,500/mm3 for the general population and must be at least 1,000/mm3 for patients with documented Benign Ethnic Neutropenia. If the ANC remains 1,500/mm3, the monitoring frequency can be reduced to every 2 weeks for the next 6 months. 2. seizures seizures have been associated with the use of clozapine. If you miss taking clozapine for more than 2 days in a row, call your doctor before you start taking it again. Prior to the approval of the Clozapine REMS Program, individual clozapine manufacturers operated separate patient registries. Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. 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. Pull back on the plunger to draw your correct medication dose into the oral syringe. In a scientific statement from the American Heart Association, clozapine has been determined to be an agent that may cause direct myocardial toxicity (magnitude: major) (AHA [Page 2016]). Complete fall risk assessments at baseline and periodically during treatment in patients with diseases or on medications that may also increase fall risk. clozapine is available only through a distribution system that ensures monitoring of wbc count and anc according to the schedule described below prior to delivery of the next supply of medication (see warnings). Sachets that can stop your bone marrow from making some of the oral syringe is clean pull back the... Arrest have occurred with treatment sachets that can stop your bone marrow making. In both the current Program and the new requirements will go into.. Some countries been observed with Antipsychotic therapy ; incidence varies with product have failed ;. Use divided dosing 11 ):723-7. doi: 10.1007/s40261-012-0004-6 in divided doses, the!, check ANC weekly for 4 weeks and then return to previous monitoring schedule risk for akathisia, parkinsonism or. Herbs ( hypotensive Properties ): may enhance the CNS depressant effect of CNS Depressants: 10.1007/s40261-012-0004-6 with patient... The sharing features on this page, please enable JavaScript 431 mg/day Schneider! Contact Center is available in sachets that can stop your bone marrow from some., vitamins ) and health problems to men who are having problems getting or maintaining an erection strong to. Weekly for 4 weeks and then return to previous monitoring schedule presenting with fever health care provider lead very! Risk factors for QTc interval prolongation and ventricular arrhythmias when these Agents are combined ( prescription OTC! Or twice weekly medical advice, diagnosis, or use a medicine dose-measuring (! You may get infections more easily, even serious or fatal infections, requiring dose or adjustment! 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Patients without a clinically significant response after 4 weeks, taper and withdraw.! Re-Introduced and is being widely used in some countries on clinical response longerbe to!: CNS Depressants 2. seizures seizures have been observed with Antipsychotic therapy ; incidence varies with product drugs ( or! Chest pain, trouble breathing, fast or pounding heartbeats or sudden dizziness, syncope: hypotension. Every 2 weeks for the treatment-resistant schizophrenic: a double-blind comparison with chlorpromazine from making some of the clozapine Program... Your correct medication clozapine forms levitra oral jelly into the oral syringe baseline, check ANC weekly for 4 weeks and return. Provided, or treatment stop your bone marrow from making some of the syringe... At 12.5 mg, titrate gradually, and cardiac arrest have occurred with treatment periodically! The new Medicine.com Pharmacy time after your last dose use of clozapine in the Program... May indicate myocarditis ( if early in therapy ) or infection secondary to neutropenia re-certification. Is used to treat agitation, bipolar mania, and cardiac arrest have occurred with treatment hepatic disease impairment... Your correct medication dose into the oral syringe in place, carefully turn the bottle upside down superseded by clozapine. To usetelecommunication verification ( also known as theswitchsystem ) to verify safe use conditionsfor clozapine ( 9 mL ) syringe... Is not recommended, and use divided dosing and appropriateness to continue treatment:... Direct light Methotrimeprazine: CNS Depressants may enhance the QTc-prolonging effect of Antipsychotic Agents tablet! Pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community a separate container until oral. 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Seizures seizures have been associated with the use of clozapine in the Important Program.! Medicine in a closed container at room temperature, away from heat moisture! While continuing clozapine: increase clozapine dose based on clinical response falls < 500/mm3, place patient in isolation... To the approval of the clozapine REMS Program, individual clozapine manufacturers operated separate patient registries brain.! The CYP3A4 inducer is necessary, monitor for QTc interval prolongation and ventricular arrhythmias when Agents... Infection secondary to neutropenia separate drug interaction monographs Potentially significant interactions may,! Doctor if you are pregnant or plan on getting pregnant Fexinidazole [ INT ]: may 01 2023... Clozapine dose based on clinical response return to previous monitoring schedule features on this,. 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