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Clozapine

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WARNING

A dangerous blood problem may be brought on by clozapine. Before you begin therapy, during treatment, and for at least 4 weeks after treatment, your doctor will order specific lab tests. Once a week at start, your doctor will order the lab tests; as your therapy progresses, he or she might order them less frequently. Call your doctor right away if you have any of the following symptoms: Extreme fatigue; weakness; fever, sore throat, chills, or other flu- or infection-related symptoms; unusual vaginal discharge or itching; sores in your mouth or throat; chronically infected wounds; burning or pain while urinating; sores or pain in or around your rectal area; or abdominal pain.

Clozapine is only accessible through a unique restricted distribution method due to the hazards associated with using this medicine. The Clozapine Risk Evaluation and Mitigation Strategies (REMS) Program was established by the clozapine producers to ensure that users do not take the medication without the required monitoring. The Clozapine REMS programme requires that both your doctor and your pharmacist register, and neither will give your prescription until he or she has seen the results of your blood tests. For additional information about this programme and how you will receive your medication, speak with your doctor.

Seizures may be triggered by clozapine. If you have seizures now or ever had them, let your doctor know. While using clozapine, avoid engaging in activities that could cause danger to you or others if you abruptly lose consciousness, such as operating machinery, climbing, swimming, or driving a car. Call your doctor right away if you have a seizure, or seek emergency medical attention.

Clozapine may result in cardiomyopathy or myocarditis, a potentially deadly enlargement of the heart muscle (enlarged or thickened heart muscle that stops the heart from pumping blood normally). Call your doctor right away if you have any of the following symptoms: Extreme fatigue, symptoms of the flu, breathing problems or rapid breathing, fever, chest pain, or a rapid, irregular, or pounding heartbeat.

When you stand up, clozapine may make you feel faint, lightheaded, or dizzy, especially when you first start taking it or when your dose is increased. If you are taking medication for high blood pressure or if you have had a heart attack, heart failure, or a slow, irregular heartbeat, let your doctor know. Moreover, let your doctor know if you are currently experiencing severe diarrhoea or vomiting, or if you exhibit any other symptoms of dehydration. In order to allow your body time to adjust to the drug and reduce the likelihood that you may suffer this side effect, your doctor will likely start you on a low dose of clozapine and gradually raise your dose. If you stop taking clozapine for more than two days, consult your doctor. Most likely, your physician will advise you to restart your therapy with a modest dose of clozapine.

Usage in Senior Citizens:

Studies have shown that older adults who take antipsychotics (medications for mental illness) like clozapine have an increased risk of dying while receiving treatment. Dementia is a brain disorder that affects memory, thinking clearly, communication, and daily activities as well as possibly causing changes in mood and personality.

The Food and Drug Administration (FDA) has not approved clozapine for the management of behavioural issues in dementia-affected older individuals. If you, a member of your family, or a person you are caring for has dementia and is taking clozapine, speak with the doctor who recommended it. Visit the FDA website at http://www.fda.gov/Drugs for further details.

Why is this medication prescribed?

When other medications haven’t worked or a patient has attempted suicide and is likely to do so again, clozapine is used to treat the symptoms of schizophrenia, a mental condition that causes abnormal or strange thinking, lack of interest in life, and intense or inappropriate emotions. Atypical antipsychotics are a class of drugs that includes the drug clozapine. It functions by altering the way that a few organic brain chemicals behave.

How should this medicine be used?

There are three different forms of clozapine available for oral administration: tablets, tablets that dissolve fast in the mouth, and liquids. Typically, it is taken once or twice a day. Use clozapine every day at around the same time(s). Ask your doctor or pharmacist to explain any instructions on your prescription label that you are unsure about following. Clozapine should be taken as prescribed. Never take it in larger or less amounts or more frequently than directed by your doctor.

Try not to force the foil packaging of the orally disintegrating tablet through. Instead, pull back the foil with your dry hands. Take the tablet out right away, and put it on your tongue. The tablet can be ingested with saliva and will immediately dissolve. To take dissolving tablets, no water is necessary.

Use these instructions to measure clozapine oral suspension:

  • By rotating the cap in a clockwise direction, make sure the oral suspension container is tightly sealed (to the right). Before using, shake the bottle vigorously for ten seconds.
  • Push down on the bottle cap to release it, then turn it in the opposite direction (to the left). When opening a brand-new bottle for the first time, insert the adaptor so that its top lines up with the top of the container.
  • Use the smaller (1 mL) oral syringe if your dose is 1 mL or less. Use the bigger (9 mL) oral syringe if your dose is greater than one millilitre.
  • By pulling back the plunger, you can add air to the oral syringe. Next put the oral syringe’s open tip into the adaptor. By depressing the plunger, force every last bit of air from the oral syringe into the container.
  • Turn the bottle upside down slowly while holding the oral syringe in place. Pulling back on the plunger will allow you to transfer some of the medication from the bottle into the oral syringe. Take caution not to fully extend the plunger.
  • The oral syringe’s plunger will have a small quantity of air near the end. To get the drug back into the bottle and get rid of the air, press the plunger. To accurately dosage your medication, pull back on the plunger on the oral syringe.
  • Turn the bottle carefully upwards while still holding the oral syringe in it so that it is on top. Without pressing on the plunger, remove the oral syringe from the bottle neck adaptor. As soon as you have drawn the medication into the oral syringe, take it. Avoid preparing a dose and putting it in the syringe to use later.
  • Insert the oral syringe’s open tip into one side of your mouth. After the liquid enters your mouth, tightly seal your lips around the oral syringe and slowly press the plunger down. As you put the medication in your mouth, slowly swallow it.
  • In the bottle, keep the adaptor. Reapply the cap to the bottle and tighten it by turning it clockwise (to the right).
  • After each usage, rinse the oral syringe with warm tap water. Place the oral syringe’s tip into a cup of water that has been filled with water. Draw water into the oral syringe by pulling back on the plunger. To clean the oral syringe, squeeze the plunger and dispense water into a sink or another container. Discard any remaining rinse water and let the oral syringe dry naturally.

While not a cure, clozapine manages schizophrenia. Before you get the full advantages of clozapine, it can take a few weeks or longer. Despite feeling good, keep taking clozapine. Never discontinue taking clozapine without consulting your doctor first. Your doctor will likely want to progressively reduce your dose.

Other uses for this medicine

Ask your doctor or pharmacist for more details if you want to use this drug for something else.

What special precautions should I follow?

Before taking clozapine,

  • If you have an allergy to clozapine, any other medications, or any of the ingredients in clozapine tablets, let your doctor and pharmacist know right away. Get a list of the components from your pharmacist.
  • Inform your doctor and pharmacist about all prescription and over-the-counter drugs, vitamins, dietary supplements, and herbal products that you are now taking or intend to use. Mention any of the following as well as the items specified in the IMPORTANT CAUTION section. such as diphenhydramine (Benadryl), antihistamines; antibiotics such erythromycin (E.E.S., E-Mycin, and others), bupropion (Aplenzin, Wellbutrin, Zyban, in Contrave), benztropine (Cogentin), cimetidine (Tagamet), antibiotics like ciprofloxacin (Cipro), cyclobenzaprine (Amrix), and others; drugs for anxiety, high blood pressure, mental disease, motion sickness, or nausea; escitalopram (Lexapro); oral contraceptives, medications for seizures such as carbamazepine (Equetro, Tegretol, Teril, others) or phenytoin (Dilantin, Phenytek), rifampin (Rifadin, Rimactane, in Rifamate, in Rifater), sedatives; medications for irregular heartbeat such as encainide, flecainide, propafenone (Rythmol), and quinidine (in Nuedexta); sleeping pills, terbinafine (Lamisil), tranquillizers, and selective serotonin reuptake inhibitors (SSRIs) such duloxetine (Cymbalta), fluoxetine (Prozac, Sarafem, Selfemra, and others), fluvoxamine (Luvox), paroxetine (Brisdelle, Paxil, and Pexeva), and sertraline (Zoloft). Your physician might need to adjust the dosage of your drugs or keep a close eye on you for side effects.
  • Please let your doctor know if you are taking any herbal supplements, especially St. John’s wort.
  • In addition to the ailment mentioned in the IMPORTANT CAUTION section, let your doctor know if you or anyone in your family has ever experienced diabetes or a prolonged QT interval, a rare heart disorder that can result in an irregular heartbeat, fainting, or sudden death. Inform your doctor if you experience any of the following symptoms: constipation, nausea, vomiting, stomach pain or distension; problems with your urinary system or prostate (a male reproductive gland); dyslipidemia (high cholesterol levels); paralytic ileus (condition where food cannot pass through the intestines); glaucoma; high or low blood pressure; trouble balancing; or heart, kidney, lung, or liver disease. Moreover, let your doctor know if you’ve ever had to stop using a mental health medicine due to serious adverse effects.
  • Inform your doctor if you are expecting, especially if you are in the last few months of your pregnancy. Also let them know if you plan to get pregnant or if you are nursing a baby. Call your doctor if you get pregnant while taking clozapine. If clozapine is taken in the final months of pregnancy, it may have negative effects on babies after birth.
  • Inform your doctor or dentist that you are taking clozapine if you are having surgery, including dental surgery.
  • Alcohol may intensify the drowsiness brought on by this prescription, so you should be aware of that.
  • If you use tobacco products, let your doctor know. Smoking cigarettes may make this medication less effective.
  • You should be aware that even if you do not currently have diabetes, you could develop hyperglycemia (increases in blood sugar) while taking this drug. Those with schizophrenia are more likely to develop diabetes than those without the disorder, and taking clozapine or other similar drugs may make this risk worse. If you have any of the following side effects while taking clozapine: severe thirst, frequent urination, intense hunger, blurred vision, or weakness, call your doctor right away. Calling your doctor as soon as you experience any of these symptoms is crucial because elevated blood sugar can result in the deadly disease known as ketoacidosis. If ketoacidosis is not treated right away, it could become life-threatening. Dry mouth, nausea, vomiting, shortness of breath, fruity-smelling breath, and diminished consciousness are all signs of ketoacidosis.
  • You should be aware that the orally disintegrating pills contain aspartame, a substance that converts to phenylalanine if you have phenylketonuria (PKU), a genetic disorder that requires adherence to a particular diet to prevent brain damage that can result in severe intellectual incapacity.

What special dietary instructions should I follow?

If you plan to consume caffeine-containing beverages while taking this medication, consult your doctor.

What should I do if I forget a dose?

If you miss a dosage, take it as soon as you recall. If the next dose is soon due, skip the missed one and carry on with your regular dosing plan. To make up for a missing dose, do not take a second one.

Before taking any additional medication, notify your doctor if you miss taking clozapine for longer than two days. Your medicine might need to be restarted by your doctor at a reduced dose.

What side effects can this medication cause?

There may be adverse consequences from clozapine. If any of these symptoms are severe or do not go away, let your doctor know right once:

  • Drowsiness
  • Feeling lightheaded, unstable, or having difficulties balancing
  • Increased salivation
  • Mouth ache
  • Restlessness
  • Headache

Some adverse effects may be severe. Call your doctor right away if you encounter any of the symptoms described below or in the IMPORTANT WARNINGS or SPECIAL PRECAUTIONS sections:

  • Nausea, vomiting, stomach pain or swelling, and diarrhoea
  • Shaking hands in an uncontrollable manner
  • Fainting
  • Falling
  • Inability to control one’s bladder or difficulties urinating
  • Confusion
  • Alterations to vision
  • Shakiness
  • Extreme muscular twitching
  • Sweating
  • Alterations in conduct
  • Uncommon bruising or bleeding
  • Reduced appetite
  • Uneasy stomach
  • Eyes or skin that have a yellow tint
  • Stomach’s upper right corner hurts
  • Not enough energy

Further negative effects of clozapine are possible. If you experience any strange issues while taking this medicine, contact your doctor right away.

You or your doctor can submit a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting programme online or by phone if you have a serious side event (1-800-332-1088).

What should I know about storage and disposal of this medication?

Keep this medication tightly closed in the original container and out of the reach of children. Keep it away from light, excessive heat, and moisture at room temperature (not in the bathroom). Avoid freezing or cooling the oral suspension.

Although many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and are simple for young children to open, it is crucial to keep all medications out of sight and out of reach of children. Always lock safety caps and promptly stash medication up and away from young children where it is out of their sight and reach to prevent poisoning. http://www.upandaway.org

Unused prescriptions must be disposed of carefully to prevent pets, kids, and other people from ingesting them. You should not, however, dispose of this medication in the toilet. Instead, utilising a medicine take-back programme is the easiest approach to get rid of your medication. To find out about take-back programmes in your area, speak with your pharmacist or the garbage/recycling department in your city. If you do not have access to a take-back programme, see the FDA’s Safe Disposal of Medications website at http://goo.gl/c4Rm4p for additional information.

In case of emergency/overdose

Call the poison control hotline at 1-800-222-1222 in the event of an overdose. Moreover, information can be found online at https://www.poisonhelp.org/help. Call 911 right once if the person has collapsed, experienced a seizure, is having difficulty breathing, or cannot be roused.

Overdose signs could include the following:

  • Dizziness
  • Fainting
  • Gradual breathing
  • Alteration in heartbeat
  • Consciousness is lost

What other information should I know?

Keep all of your appointments with your physician and the lab. To monitor your body’s reaction to clozapine, your doctor will request specific lab tests.

No one else should take your medication. Any queries you may have regarding medication refills should be directed to your pharmacist.

You should keep a written record of every medication you take, including any over-the-counter (OTC) items, prescription drugs, and dietary supplements like vitamins and minerals. This list should be brought with you whenever you see a doctor or are admitted to the hospital. You should always have this information with you in case of emergencies.

Brand names

  • Clozaril®
  • FazaClo® ODT
  • Versacloz®
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