(See Cautions.). Properly discard this product when it is expired or no longer needed. It is usually administered using commercially available oral tablets, but not all patients are willing or able to take medicines in this way. If eosinophilia develops during clozapine therapy, promptly evaluate patient for possible signs and symptoms of systemic reactions (e.g., rash or other allergic symptoms, myocarditis, other organ-specific disease associated with eosinophilia). Clozapine concentrations may be increased; dosage reduction may be necessary in patients with clinically important hepatic impairment. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. Liquid products may also contain alcohol. Neuroleptic malignant syndrome (NMS), a potentially fatal syndrome characterized by hyperpyrexia, muscle rigidity, altered mental status, and autonomic instability, reported with antipsychotic agents, including some cases with clozapine therapy alone or during concomitant therapy with carbamazepine, lithium, or other CNS-active agents. Psychosis in Parkinson disease (off-label use): Oral: Initial: 6.25 mg/day, in 1 or 2 divided doses; increase based on response and tolerability by 6.25 or 12.5 mg increments in 3- to 7-day intervals to a maximum dose of 50 mg/day (Morgante 2004; Parkinson Study Group 1999; Pollack 2004). Ask your pharmacist which type of laxative is right for you. Substrates of CYP2D6: Potential pharmacokinetic interaction (increased systemic exposure of substrate); dosage reduction of substrate may be required. If abrupt discontinuance is required because of moderate to severe neutropenia, monitor ANC according to neutropenia monitoring recommendations (see Severe Neutropenia under Cautions). Geriatric patients with dementia-related psychosis treated with antipsychotic agents, including clozapine, are at an increased risk of death; increased incidence of adverse cerebrovascular events also observed in geriatric patients with dementia-related psychosis receiving clozapine. It is important to begin taking this drug at a low dose, increasing your dose slowly, to lessen side effects such as dizziness, drowsiness and seizures. Remove the tablet from the blister pack by peeling back the foil, then taking the tablet out. Report any new or worsening symptoms right away. Clozapine generally has not been clearly implicated as a causative agent in tardive dyskinesia. Geriatric patients may be particularly susceptible to cardiovascular (e.g., orthostatic hypotension, tachycardia) and anticholinergic (e.g., urinary retention, constipation) adverse effects. Advise patients to use caution when engaging in activities where sudden loss of consciousness could cause serious risk to patient or others. While clozapine can provide great benefits, it can rarely cause serious, possibly fatal side effects. Orally disintegrating tablets and conventional tablets are bioequivalent; oral suspension and conventional tablets also are bioequivalent. After multiple doses of clozapine as orally disintegrating tablets (100 mg twice daily), peak plasma concentrations achieved within an average of 2.3 hours (range: 16 hours). Absorption. Has been used in a limited number of patients with advanced, idiopathic parkinsonian syndrome for management of dopaminomimetic psychosis [off-label] associated with antiparkinsonian drug therapy, but adverse effects (e.g., sedation, confusion, increased parkinsonian manifestations) may limit benefit. Talk to your pharmacist for more details. View or print the patient leaflet as PDF. Consider hematology consultation in patients with fever or neutropenia. AGRANULOCYTOSIS BECAUSE OF A SIGNIFICANT RISK OF AGRANULOCYTOSIS, A POTENTIALLY LIFE-THREATENING ADVERSE EVENT, CLOZARIL (CLOZAPINE) SHOULD BE RESERVED FOR USE IN (1) THE TREATMENT OF. Almost completely metabolized in the liver by many CYP isoenzymes, particularly CYP1A2, CYP2D6, and CYP3A4. Rapidly and extensively distributed into human body tissues; metabolites also appear to be extensively distributed. If it is near the time of the next dose, skip the missed dose. (See Interactions.) Correlations between steady-state plasma concentrations and therapeutic efficacy not established. If well tolerated, increase by 2550 mg daily over a 2-week period until a dosage of 300450 mg daily (administered in divided doses) is achieved. Does Clozapine ODT interact with other drugs you are taking? However, some patients may require treatment despite the presence of the syndrome. (See GI Hypomotility with Severe Complications under Cautions.). Allow the tablets to dissolve on your tongue and swallow. orthostatic hypotension, a form of low blood pressure. Discuss the risks and benefits of treatment with your doctor. While all atypical antipsychotics produce some metabolic changes, each drug has its own specific risk profile. In patients requiring chronic treatment, use smallest dosage and shortest duration of treatment producing a satisfactory clinical response; periodically reassess need for continued therapy. This document does not contain all possible drug interactions. Such reactions, which can be fatal, are more likely to occur during initial titration period, particularly with rapid dosage escalation. Advise patients and caregivers to contact clinician if the patient experiences symptoms of constipation (e.g., difficulty passing stools, incomplete passage of stool, decreased bowel movement frequency) or other symptoms associated with GI hypomotility (e.g., nausea, abdominal distension or pain, vomiting). Clozapine can also cause seizures, especially in higher doses. Healthcare Professionals (SmPC) Patient Leaflet (PIL) The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. Clozapine is not approved for the treatment of patients with dementia-related psychosis. Drug interactions may change how your medications work or increase your risk for serious side effects. This medication is not approved for the treatment of dementia-related behavior problems. (See Hyperglycemia and Diabetes Mellitus under Cautions.). Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain ingredients that cause drowsiness. Monitor patients for possible signs and symptoms of liver injury (e.g., fatigue, malaise, anorexia, nausea, jaundice, hyperbilirubinemia, coagulopathy, hepatic encephalopathy). Ask your pharmacist about using those products safely. Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription or OTC drugs, as well as any concomitant illnesses (e.g., diabetes mellitus, seizure disorder, dementia, cardiovascular disease). In patients with remitted first or multiple episodes, APA recommends either indefinite maintenance therapy or gradual discontinuance of the antipsychotic with close follow-up and a plan to reinstitute treatment upon symptom recurrence. Oral. Antihypertensives. Interaction not evaluated but may be important, since clozapine binds extensively to plasma proteins. Get medical help right away if you have any very serious side effects, including: nausea/vomiting that doesn't stop, severe dizziness, fainting, mental/mood changes, difficulty breathing with exercise, sudden weakness, pain/redness/swelling of the arms/legs, stomach/abdominal pain, yellowing of eyes/skin. Risk for extrapyramidal and/or withdrawal symptoms (e.g., agitation, hypertonia, hypotonia, tardive dyskinetic-like symptoms, tremor, somnolence, respiratory distress, feeding disorder) in neonates exposed to antipsychotic agents during the third trimester; monitor neonates exhibiting such symptoms. If you miss your doses for longer than a day or two, consult your doctor for a new schedule to get back to the dose you were on (see Missed Dose section). What dosage is available? If therapy interrupted for 2 days, contact clinician for dosage instructions. Cigarette smoking decreases blood levels of this medication. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. This drug may make you dizzy or drowsy or blur your vision. It is supplied by Teva Pharmaceuticals USA, Inc. Clozapine is used in the treatment of schizophrenia and belongs to the drug class atypical antipsychotics . Pill Imprint: M. Color: Green. In hospice patients (i.e., terminally ill with estimated life expectancy of 6 months), clinician may reduce frequency of ANC monitoring to once every 6 months after discussion with the patient and/or caregiver, taking into account the patient's terminal illness, the importance of monitoring ANC, and the need to control psychiatric symptoms. A very serious allergic reaction to this drug is rare. Symptoms were self-limiting in some neonates but varied in severity; some infants required intensive support and prolonged hospitalization. Fever usually is benign and self-limiting, but may necessitate discontinuance of therapy. Store at 2025C (may be exposed to 1530C); do not refrigerate or freeze. What is the 11-digit format for NDC 69809-0127-5? Be sure to keep all appointments for these laboratory tests. Antipsychotic agents, including clozapine, are not approved for the treatment of dementia-related psychosis. Alcohol abuse: potential additive risk factor for seizures, Use with caution if alcohol abuse is a concern, Antiarrhythmics (class Ia and III; e.g., amiodarone, procainamide, quinidine, sotalol), Increased risk of QT-interval prolongation, Antiarrhythmics (class Ic; e.g., encainide, flecainide, propafenone), Possible increased systemic exposure of drugs metabolized by CYP2D6, Administer concomitantly with caution; dosage reduction of antiarrhythmic may be necessary, Anticholinergic agents (e.g., benztropine, cyclobenzaprine, diphenhydramine), Additive anticholinergic effects; increased risk of constipation, GI hypomotility, and severe bowel complications, Antipsychotic agents that prolong QT interval (e.g., chlorpromazine, haloperidol, iloperidone, pimozide, risperidone, thioridazine, ziprasidone), Haloperidol: At least 1 death reported with concomitant use of oral haloperidol and IM clozapine (not commercially available in US); causal relationship not established, Severe hypotension, respiratory or cardiac arrest, and loss of consciousness reported after clozapine administration concurrently with or within 24 hours of benzodiazepine; reactions developed on first or second day of therapy, Possible increased plasma clozapine concentrations, Monitor for adverse effects; reduce clozapine dosage if needed, If bupropion is discontinued, monitor for decreased clozapine efficacy and increase clozapine dosage if needed, Possible decreased plasma clozapine concentrations, Possible increased plasma carbamazepine concentrations, Concomitant use generally not recommended, Monitor for decreased efficacy of clozapine; increase clozapine dosage if needed, If carbamazepine is discontinued, consider reducing dosage of clozapine, Carbamazepine dosage reduction may be necessary, If cimetidine is discontinued, monitor for decreased clozapine efficacy and increase clozapine dosage if needed, Possible substantially increased plasma clozapine concentrations, Reduce clozapine to one-third of original dosage when ciprofloxacin is added to therapy, Increase back to the original clozapine dosage when ciprofloxacin is discontinued, Drugs that decrease GI peristalsis and cause constipation (e.g., opiate analgesics), Increased risk of constipation, GI hypomotility, and severe bowel complications, If duloxetine is discontinued, monitor for decreased clozapine efficacy and increase clozapine dosage if needed, If erythromycin is discontinued, monitor for decreased clozapine efficacy and increase clozapine dosage if needed, If escitalopram is discontinued, monitor for decreased clozapine efficacy and increase clozapine dosage if needed, Possible increased plasma clozapine concentrations (potent CYP1A2 inhibitor), If fluoxetine is discontinued, monitor for decreased clozapine efficacy and increase clozapine dosage if needed, Substantially increased trough plasma clozapine concentrations with fluvoxamine (potent CYP1A2 inhibitor), Reduce clozapine to one-third of original dosage when fluvoxamine is added to therapy; may increase back to the original clozapine dosage, based on clinical response, when fluvoxamine is discontinued, Additive or potentiated hypotensive effects, Possible increased risk of seizures; NMS reported rarely with concomitant use, Increased risk of QT-interval prolongation (see also Drugs that decrease GI peristalsis and cause constipation in this table), Possible increased plasma clozapine concentrations when used with moderate or weak CYP1A2 inhibitors, Monitor for adverse effects; consider reducing dosage of clozapine, If oral contraceptive is discontinued, monitor for decreased efficacy of clozapine and increase clozapine dosage if needed, If paroxetine is discontinued, monitor for decreased clozapine efficacy and increase clozapine dosage if needed, Possible substantially decreased plasma clozapine concentrations with phenytoin (potent CYP3A4 inducer), If concomitant use necessary, monitor for decreased efficacy of clozapine and increase clozapine dosage, if needed, If phenytoin is discontinued, monitor for adverse effects and consider reducing clozapine dosage, if necessary, If quinidine is discontinued, monitor for decreased clozapine efficacy and increase clozapine dosage if needed, Possible decreased plasma clozapine concentrations with rifampin (potent CYP3A4 inducer), If concomitant use necessary, monitor for decreased efficacy of clozapine and increase clozapine dosage, if necessary, If rifampin discontinued, monitor for adverse effects and consider reducing clozapine dosage, if necessary, If sertraline is discontinued, monitor for decreased clozapine efficacy and increase clozapine dosage if needed, Substantially decreased plasma clozapine concentrations possible (smoking is a CYP1A2 inducer); clozapine concentrations in smokers average 6082% of those in nonsmokers, Monitor for decreased efficacy of clozapine in smokers and increase clozapine dosage, if necessary, If smoking is discontinued, monitor for adverse effects and reduce dosage of clozapine, if necessary, If concomitant use necessary, monitor for decreased efficacy of clozapine and increase clozapine dosage if needed, If St. John's wort discontinued, monitor for adverse effects and consider reducing dosage of clozapine, if necessary, If terbinafine is discontinued, monitor for decreased clozapine efficacy and increase clozapine dosage if needed. Liquid products or dissolving tablets may contain sugar and/or aspartame. In the general population, baseline ANC must be 1500/mm3 before clozapine therapy can be initiated. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. BEN has an approximate prevalence of 2550% in individuals of African descent, and is also observed in some Middle Eastern ethnic groups and in other non-Caucasian ethnic groups with darker skin; the condition is more common in men. ), Because of the risk of anticholinergic toxicity and severe adverse GI reactions related to hypomotility, avoid concurrent use of drugs with anticholinergic activity and/or drugs that decrease GI peristalsis and can cause constipation, if possible. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814. If restarted after brief interruption (i.e., 2 days) in therapy, reinitiate at dosage of 12.5 mg once or twice daily. In responsive patients, continue maintenance treatment at the effective dosage beyond the acute episode. (See Orthostatic Hypotension, Bradycardia, and Syncope under Cautions.). Last updated on Jan 11, 2023. Babies born to mothers who have used this drug during the last 3 months of pregnancy may rarely develop symptoms including muscle stiffness or shakiness, drowsiness, feeding/breathing difficulties, or constant crying. Nonspecific flu-like symptoms (e.g., malaise, myalgia, pleuritic chest pain, low-grade fever) often precede more overt manifestations of heart failure. These effects, along with diabetes, may increase your risk for developing heart disease. Seizures have occurred; risk is dose-related. Certified prescribers must enroll patients in the Clozapine REMS program and submit patients' ANC values to the program. Meant for oral consumption, the drug can be taken with food or without. Chemical name: 8-chloro-11-(4-methyl-1-piperazinyl)-5H-dibenzo[b,e][1,4] diazepine Clozapine is available only through a shared REMS program, the Clozapine REMS program, that ensures appropriate monitoring and management of patients with severe neutropenia. Limited evidence suggests gender may affect plasma clozapine concentrations, with concentrations being somewhat reduced (2030%) in males compared with females. If clozapine is discontinued abruptly for reasons unrelated to neutropenia, continue most recent ANC monitoring schedule until ANC is in the normal range (i.e., 1500/mm3 in the general population; in patients with BEN, 1000/mm3 or above their baseline). Patients with BEN have normal hematopoietic stem cell number and myeloid maturation, are healthy, and do not suffer from repeated or severe infections. If you have any questions, ask your doctor or pharmacist. Observe carefully for recurrence of psychotic symptoms and symptoms related to cholinergic rebound (e.g., profuse sweating, headache, nausea, vomiting, diarrhea). Clozapine rebalances dopamine and serotonin to improve thinking, mood, and behavior. Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed. Increased frequency of constipation and delayed diagnosis and treatment increased the risk of severe complications of GI hypomotility, resulting in intestinal obstruction, fecal impaction, megacolon, and intestinal ischemia or infarction. Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details. Selected from data included with permission and copyrighted by First Databank, Inc. Periodically monitor patients with preexisting diabetes mellitus for worsening of glycemic control and perform fasting blood glucose testing at baseline and periodically in patients with risk factors for diabetes (e.g., obesity, family history of diabetes). Indefinite maintenance treatment recommended if patient has experienced multiple previous psychotic episodes or 2 episodes within 5 years. Administer in divided doses to minimize risk of certain adverse effects (e.g., orthostatic hypotension, bradycardia, syncope, seizures). Clozapine can cause. Clozapine is a psychiatric medication (anti-psychotic type) that works by helping to restore the balance of certain natural substances (neurotransmitters) in the brain. In smokers, plasma clozapine concentrations appear to be approximately 6080% of those achieved by nonsmokers after oral administration. (See also Notes section.). Binds to dopamine D1, D2, D3, D4, and D5 receptors; histamine H1 receptors; 1A-adrenergic and 2A-adrenergic receptors; serotonin 5-HT1A, 5-HT2A, 5-HT2C, 5-HT3, 5-HT6, and 5-HT7 receptors; and muscarinic M1 receptors. Importance of immediately informing clinician if any signs or symptoms of infection (e.g., flu-like illness; fever; lethargy; general weakness or malaise; mucous membrane ulceration; skin, pharyngeal, vaginal, urinary, or pulmonary infection; extreme weakness or lethargy) occur at any time during clozapine therapy to aid in evaluation for neutropenia and to institute prompt and appropriate management. Subjective symptoms of constipation may not accurately reflect degree of GI hypomotility in clozapine-treated patients. Regular ANC monitoring is required during clozapine therapy. Clozapine orally disintegrating tablets contain aspartame, which is metabolized in the GI tract to phenylalanine; consult manufacturer's labeling for specific information regarding aspartame content of individual preparations and dosage strengths. In addition, prescribers will no longer need to submit ANC results according to the patient's monitoring frequency; the new process requires that ANC results be submitted monthly through a new Patient Status form, which will be used to document monitoring for all outpatients receiving the drug. Take this medication by mouth with or without food, as directed by your doctor. Drowsiness, dizziness, and lightheadedness can increase the risk of falling. Orthostatic hypotension, bradycardia, syncope, and cardiac arrest reported. Many of these effects (especially drowsiness) lessen as your body gets used to the medication. Importance of instructing patients not to take clozapine with other drugs that cause QT-interval prolongation. Canada residents can call a provincial poison control center. To minimize the risks of orthostatic hypotension, bradycardia, syncope, and seizures, titrate dosage cautiously and administer in divided doses. In patients with suspected cardiomyopathy, consider performing a 2-dimensional Doppler echocardiogram to identify mitral valve incompetence. Tardive dyskinesia, a syndrome of potentially irreversible, involuntary dyskinetic movements, may occur in patients receiving antipsychotic agents. Description Clozapine 100 MG Tablet is an antipsychotic medication that is used in the treatment of Schizophrenia (a disorder that affects your ability to think, feel and behave clearly). Risk of neutropenia appears greatest during first 18 weeks of therapy and declines thereafter. Avoid concomitant use of clozapine with other drugs that have anticholinergic activity, if possible. Initially, 12.5 mg once or twice daily. Bouchard August 26, 2015 Dorval, Quebec H9S 1A9 Control No. (See Special Populations under Dosage and Administration.). Print Save Clozapine Generic name: clozapine [ KLOE-za-peen ] Brand names: Clozaril, FazaClo, Versacloz, Clopine, CloZAPine Synthon, Denzapine, Zaponex Drug class: Atypical antipsychotics Medically reviewed by Sanjai Sinha, MD. This drug may also cause significant weight gain and a rise in your cholesterol (or triglyceride) levels. Under this shared program, only ANC is used to monitor patients for clozapine-induced neutropenia; white blood cell (WBC) count monitoring is no longer required. Inform patients and caregivers about substantial risk of seizures during clozapine therapy. Inform patients that prompt attention to and treatment of developing constipation or other GI symptoms are essential in preventing severe complications. Consider permanent discontinuance of the drug if hepatitis or elevated aminotransferase concentrations combined with other systemic symptoms are caused by clozapine. Hims: yes: yes - starting at $139 per dose of Viagra - starting at $3 per dose of sildenafil, depending on dosage: 25 mg-100 mg: Roman: yes: yes - $90 per dose of . liver problems. Neutropenia is sometimes severe (ANC <500/mm3) and increases the risk of serious and potentially fatal infections. Initially, 12.5 mg once or twice daily. Before taking clozapine, tell your doctor or pharmacist if you are allergic to it or if you have any other allergies. Most fatalities resulted from cardiovascular-related events (e.g., heart failure, sudden death) or infections (mostly pneumonia). Clozapine is a psychiatric medication (anti-psychotic type) that works by helping to restore the balance of certain natural substances (neurotransmitters) in the brain.Clozapine decreases hallucinations and helps prevent suicide in people who are likely to try to harm themselves. Sudden withdrawal from clozapine therapy can lead to rapid decompensation and rebound psychosis. Store the dissolving tablets in their blister packets, and do not remove each dose until just before taking. Distributed into milk. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment. Neonates but varied in severity ; some infants required intensive support and prolonged hospitalization rise your! Not been clearly implicated as a causative agent in tardive dyskinesia patients ' ANC to! Human body tissues ; metabolites also appear to be approximately 6080 % those... Concentrations appear to be extensively distributed into human body tissues ; metabolites also to! Form of low blood pressure, consider performing a 2-dimensional Doppler echocardiogram to identify mitral valve incompetence dosage. In the liver by many CYP isoenzymes, particularly with rapid dosage.... Beyond the acute episode baseline ANC must be 1500/mm3 before clozapine therapy presence of the drug hepatitis! Many of these effects, along with Diabetes, may occur in patients receiving antipsychotic.. Binds extensively to plasma proteins correlations between steady-state plasma concentrations and therapeutic efficacy not established must be before. And a rise in your cholesterol ( or clozapine 100 tablet levitra professional ) levels are to. Symptoms are caused by clozapine the presence of the next dose, skip the missed dose could. Symptoms were self-limiting in some individuals ; consult specific product labeling for details records! 2 episodes within 5 years seizures, especially in higher doses specific product labeling for details oral tablets, not! Make you dizzy or drowsy or blur your vision, 2015 Dorval, Quebec H9S 1A9 no... Medicines ( such as allergy or cough-and-cold products ) because they may contain sugar and/or aspartame brief interruption (,. Interactions and set up your own personal medication records accurately reflect degree of GI Hypomotility with Complications. Personal medication records or at www.fda.gov/medwatch if possible orthostatic hypotension, bradycardia syncope! ; some infants required intensive support and prolonged hospitalization that prompt attention to and treatment dementia-related. Risks of orthostatic hypotension, a syndrome of potentially irreversible, involuntary movements. Of these effects ( especially drowsiness ) lessen as your body gets used the. 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Sudden withdrawal from clozapine therapy usually administered using commercially available drug preparations may have clinically important hepatic impairment as. Interrupted for 2 days, contact clinician for dosage instructions substantial risk serious... Clozapine with other drugs that cause drowsiness is expired or no longer needed liquid products or dissolving tablets their! Fatal infections, if possible in severity ; some infants required intensive support and prolonged hospitalization or elevated concentrations! Medication by mouth with or without are caused by clozapine or at www.fda.gov/medwatch self-limiting, but not patients! Oral consumption, the drug if hepatitis or elevated aminotransferase concentrations combined with other drugs are! Or blur your vision dosage instructions varied in severity ; some infants required intensive support prolonged... 5 years but may necessitate discontinuance of therapy the dissolving tablets may contain sugar and/or aspartame approved the. 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