Precautions
Clozapine is a medication that works in the brain to treat schizophrenia. It is also known as a second generation antipsychotic (SGA) or atypical antipsychotic. Clozapine rebalances dopamine and serotonin to improve thinking, mood, and behavior. Symptoms of schizophrenia include: Hallucinations — imagined voices or images that seem real
What should I do if I overdose on clozapine?
Aug 11, 2020 · Clozapine is an antipsychotic medicine. It works by changing the actions of chemicals in the brain. Clozapine is used to treat schizophrenia after other treatments have failed. Clozapine is also used to reduce the risk of suicidal behavior in people with schizophrenia or similar disorders.
What are the side effects of clozapine?
Clozapine, the first atypical antipsychotic, is a highly effective medication for patients with schizophrenia who do not respond to other antipsychotics. Although clozapine tends not to produce extrapyramidal symptoms, other side effects of the drug (e.g., agranulocytosis, myocarditis, seizures) limit its widespread use.
How effective is clozapine for stress and anxiety?
Jul 29, 2021 · Clozapine is an antipsychotic drug used to help improve the symptoms of schizophrenia in patients who do not respond adequately to standard antipsychotic treatment. Symptoms of schizophrenia...
Does clozapine Make you Sleepy?
In this perspective paper, we present a brief review of the well-established effectiveness of clozapine in patients who clearly show lack of response to regular antipsychotic therapy. We concentrate, in particular, on the need to identify eligibility for clozapine therapy very early on following failure of treatment on 2 antipsychotic medications.
What is the major side effect of clozapine?
SIDE EFFECTS: Drooling, drowsiness, dizziness, headache, shaking (tremor), vision problems (e.g., blurred vision), weight gain, and constipation may occur. Many of these effects (especially drowsiness) lessen as your body gets used to the medication.
How does clozapine make you feel?
Clozapine may cause drowsiness, blurred vision, convulsions (seizures), or to have trouble with thinking or controlling body movements, which may lead to falls, fractures or other injuries.
What is clozapine prescribed for?
Clozapine is a medication that works in the brain to treat schizophrenia. It is also known as a second generation antipsychotic (SGA) or atypical antipsychotic. Clozapine rebalances dopamine and serotonin to improve thinking, mood, and behavior.
Is clozapine a high risk medication?
High risk medicines: clozapine.Aug 14, 2020
What drug is similar to clozapine?
Loxapine can be an excellent alternative to clozapine. It is comparable to clozapine in efficacy, cost-effectiveness, and a better side effect profile with more administration routes.Jan 26, 2021
Does clozapine shorten your life?
The study found that clozapine, use of which is normally restricted to those patients resistant to two or more other antipsychotics and requires regular blood monitoring, is associated with reduced mortality compared with other antipsychotics.
Does clozapine help with anxiety?
The drug Clozapine helps manage symptoms of depression and anxiety by binding to receptor molecules in the brain that respond to neurotransmitters -- chemicals used by nerve cells to communicate with each other. Clozapine mainly targets receptors for the neurotransmitters serotonin and dopamine.Feb 28, 2017
Is clozapine a sleeping pill?
Although lack of a control group limits interpretation of these results, they are in general agreement with studies in other psychiatric populations, and support the view that clozapine is primarily a NREM sleep enhancer. The improvement in restedness may be of positive clinical consequence.
Does clozapine help you sleep?
Clozapine significantly improved sleep continuity. In addition, non-rapid eye movement (NREM) sleep and in particular stage 2 sleep increased significantly, while the amounts of stage 4 and slow-wave sleep decreased significantly.
Does clozapine cause memory loss?
These data show that clozapine can cause memory impairment and it potentiates rather than reverses hippocampal lesion-induced deficits. There are critical sex-related differences in these effects.
Can clozapine cause hair loss?
Considering rising trend of AEC and its associated complications, clozapine therapy was withdrawn, which was followed by gradual decrease in AEC to 240/mm3 in next 3 weeks with no further hair loss. There was hair regrowth reported after around 6-8 weeks of withdrawing clozapine therapy.
How long can you stay on clozapine?
However, research has shown that long-term use (7–11 years) of any antipsychotic treatment by people with schizophrenia is associated with lower mortality than no drug use and clozapine is associated with lower mortality than other commonly used first- and second-generation antipsychotic agents.Mar 11, 2021
Before Taking This Medicine
You should not take clozapine if you have ever developed a severe infection or severe allergic reaction while taking this medicine.Clozapine is not...
How Should I Take Clozapine?
Take clozapine exactly as prescribed by your doctor. Follow all directions on your prescription label. Your doctor may occasionally change your dos...
What Happens If I Miss A Dose?
Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to...
What Should I Avoid While Taking Clozapine?
Clozapine can cause severe dizziness, slow heartbeats, fainting, or seizures. Do not take more of this medicine than recommended. Be careful if you...
Clozapine Dosing Information
Usual Adult Dose for Schizophrenia:Initial dose: 12.5 mg orally once or twice a dayTitration and Maintenance: May increase total daily dose in incr...
What Other Drugs Will Affect Clozapine?
Clozapine can cause a serious heart problem, especially if you use certain medicines at the same time. Tell your doctor about all medicines you use...
What is clozapine used for?
Clozapine is used to treat schizophrenia after other treatments have failed. Clozapine is also used to reduce the risk of suicidal behavior in people with schizophrenia or similar disorders. Clozapine is available only from a certified pharmacy under a special program.
What are the side effects of a syringe?
headache, drowsiness; nausea, constipation; dry mouth, or increased salivation; vision problems; or. fever, increased sweating. This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What are the symptoms of a syringe?
Call your doctor at once if you have: 1 uncontrolled muscle movements in your face (chewing, lip smacking, frowning, tongue movement, blinking or eye movement); 2 a seizure (blackout-out or convulsions); 3 severe constipation; 4 dry or hard bowel movements, or painful gas; 5 nausea, vomiting, stomach pain or bloating; 6 heart problems - chest pain, fast or pounding heartbeats, fluttering in your chest, slow heartbeats, shortness of breath, and sudden dizziness (like you might pass out); 7 liver problems - loss of appetite, stomach pain (upper right side), tiredness, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); 8 severe nervous system reaction - very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, feeling like you might pass out; or 9 signs of a blood clot in the lung - chest pain, sudden cough, wheezing, rapid breathing, coughing up blood.
How much titration for 12.5 mg?
Initial dose: 12.5 mg orally once or twice a day#N#Titration and Maintenance dose: May increase total daily dose in increments of 25 mg to 50 mg per day to a target dose of 300 mg to 450 mg per day (administered in divided doses) by the end of week 2. Subsequent dose increases can be in increments of up to 100 mg once or twice weekly.#N#Maximum dose: 900 mg per day#N#Comments:#N#-The absolute neutrophil count (ANC) must be 1500/microL or greater for the general population and at least 1000/microL for patients with documented Benign Ethnic Neutropenia (BEN) prior to initiating treatment; to continue therapy, the ANC must be monitored regularly.#N#-A low starting dose, gradual titration, and divided doses are necessary to minimize the risk of orthostatic hypotension, bradycardia, and syncope.#N#-When therapy is interrupted for 2 or more days, re-initiate with 12.5 mg once or twice a day; based on tolerability, a dose that is restarted may be increased to a previously therapeutic dose more quickly than it was for initial treatment.#N#Uses:#N#-For the treatment of severely ill patients with schizophrenia who fail to respond adequately to standard antipsychotic treatment#N#-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
Can Clozapine cause a seizure?
Call your doctor if you have a fever, sore throat, weakness, or lack of energy. Clozapine can increase your risk of seizure, especially at high doses. Avoid any activity that could be dangerous if you have a seizure or lose consciousness. Clozapine can cause serious heart problems.
What is a heart attack?
a heart attack or stroke (including "mini-stroke"); long QT syndrome (in you or a family member); an electrolyte imbalance (such as low levels of potassium or magnesium in your blood); a seizure, head injury, or brain tumor; diabetes, or risk factors such as being overweight or having a family history of diabetes;
Can you take Clozapine with food?
Your doctor may occasionally change your dose. You may take clozapine with or without food. Shake the oral suspension (liquid) for 10 seconds before you measure a dose. Use the dosing syringe provided, or use a medicine dose-measuring device (not a kitchen spoon).
What is the best medication for schizophrenia?
Antipsychotic drugs are the mainstay of treatment, but not all patients with schizophrenia respond to treatment with these agents. Clozapine, the first atypical antipsychotic, is a highly effective medication for patients with schizophrenia who do not respond to other antipsychotics.
What are the side effects of antipsychotics?
The major side effects of the antipsychotics, extrapyramidal symptoms (e.g., muscle rigidity, tremor, tardive dyskinesia), were assumed to be a necessary fellow traveler with an effect antipsychotic drug.
Is schizophrenia a neuropsychiatric disorder?
Schizoph renia is a heterogenous and complex neuropsychiatric disorder that affects nearly 1% of the population worldwide and includes a composite of positive, negative and cognitive symptom domains (Andreasen, 2000). The introduction of the antipsychotic drugs, beginning with chlorpromazine in the 1950s dramatically changed the nature ...
Does Clozapine help with schizophrenia?
In addition to its effects in treatment resistant schizophrenia, clozapine has been shown to decrease suicidality, which occurs at an increased rate in patients with schizophrenia.
Q1. What is Clozapine?
A1. Clozapine is an antipsychotic drug used to help improve the symptoms of schizophrenia in patients who do not respond adequately to standard antipsychotic treatment. Symptoms of schizophrenia include hearing voices or seeing things that are not there and being suspicious or withdrawn.
Q2. What is a Risk Evaluation and Mitigation Strategy (REMS)?
A2. A REMS is a drug safety program that the U.S. Food and Drug Administration (FDA) can require for certain medications with serious safety concerns to help ensure the benefits of the medication outweigh its risks. REMS are designed to reinforce medication use behaviors and actions that support the safe use of that medication.
Q3. Why did the FDA approve this modification to the Clozapine REMS?
A3. The modifications were necessary to ensure safe use of clozapine while maintaining patient access. The Clozapine Products Manufacturers Group proposed a modification to the REMS to remove the use of telecommunication verification (the switch system) for pharmacies to verify safe use conditions.
Q4. What should patients know about the new requirements in the Clozapine REMS program?
A4. There are no changes to requirements for patients. Patients do not need to take any action. Patients will continue to have blood tests (ANC monitoring). Because of the significant changes in the REMS program, prescribers must re-enroll their patients who will continue treatment with clozapine. .
Q5. What actions do prescribers need to take to continue to participate in the new Clozapine REMS?
A5. Health care professionals who prescribe clozapine therapy for outpatient use and/or initiate treatment for inpatients will need to re-certify and re-enroll all patients continuing on clozapine treatment in the Clozapine REMS program by November 15, 2021.
Q6. What should prescribers know about the new requirements in the Clozapine REMS program?
A6. Beginning November 15, 2021, prescribers will no longer need to submit ANC results according to the patient’s monitoring frequency. Instead ANC results will be submitted monthly through a new Patient Status Form.
Q7. What actions do pharmacists and authorized representatives of pharmacies need to take to continue to participate in the new Clozapine REMS?
A7. By November 15, 2021, all pharmacies must re-certify in the Clozapine REMS in order to dispense clozapine. The authorized representative will be responsible for recertifying the pharmacy.
