Fazaclo ODT (Generic Clozapine)
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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 program 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 program 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 myocarditis, a potentially serious swelling of the heart muscle, or cardiomyopathy, an enlargement or thickening of the heart muscle that prevents 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 initially start taking clozapine or your dose is increased, as well as when it is given in higher doses, these side effects are more likely to occur. If you are taking medicine for high blood pressure, have had or are having a heart attack, heart failure, a slow, irregular heartbeat, or any of these conditions, let your doctor know. Tell your doctor right once if you have severe diarrhoea or vomiting, or if you are showing any indications of dehydration, or if you start to experience these symptoms at any point while you are receiving treatment. To allow your body time to get used 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 increase it. 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.
Use 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 behavioral 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?
In people who have not found relief from other medications or who have attempted suicide and are likely to do so again, clozapine is used to treat the symptoms of schizophrenia (a mental illness that results in disturbed or unusual thinking, loss of interest in life, and strong or inappropriate emotions). Atypical antipsychotics, of which clozapine is a member, are a class of drugs. It affects the way some natural brain chemicals behave in order to work.
How should this medicine be used?
For oral use, clozapine is available as a tablet, an oral disintegrating tablet (a tablet that breaks down fast in the mouth), and an oral suspension. Most people take it once or twice a day. Every day, take clozapine at around the same time(s). Ask your doctor or pharmacist to explain any instructions on your prescription label that you do not understand, and carefully follow their instructions. Exactly as prescribed, take clozapine. Never take it in quantities or frequencies other than those recommended by your doctor.
Try not to force the foil packaging of the orally disintegrating tablet through. Instead, peel back the foil using 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.
Follow these instructions to measure clozapine oral suspension:
- Turn the cap of the oral suspension container clockwise (to the right) to make sure it is securely fastened. Before using, shake the bottle vigorously for ten seconds.
- By pressing down on the bottle cap, turn it counterclockwise (to the left) to remove it. 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 milliliter.
- Draw back the plunger to add air to the oral syringe. Next, insert the adaptor with the oral syringe’s open tip. By pressing down on the plunger, force all of the 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. As the liquid enters your mouth, tightly seal your lips around the oral syringe and slowly push 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. Request a list of the ingredients 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 listed in the IMPORTANT WARNING section. antibiotics such ciprofloxacin (Cipro) and erythromycin (E.E.S., E-Mycin, and others); benztropine (Cogentin); antihistamines like diphenhydramine (Benadryl); cyclobenzaprine (Amrix), escitalopram (Lexapro), bupropion (Aplenzin, Wellbutrin, Zyban, and Contrave), cimetidine (Tagamet), drugs for nausea, motion sickness, high blood pressure, mental disorders, and anxiety; oral contraceptives; drugs for irregular heartbeat like encainide, flecainide, propafenone (Rythmol), and quinidine (in Nuedexta); sedatives; anticonvulsants such as rifampin (Rifadin, Rimactane, in Rifamate, in Rifater); drugs for seizures such as carbamazepine (Equetro, Tegretol, Teril, others) or phenytoin (Dilantin, Phenytek); SSRIs, or selective serotonin reuptake inhibitors, include fluvoxamine (Luvox), fluoxetine (Prozac), duloxetine (Cymbalta), sleeping medications, terbinafine (Lamisil), tranquilizers, and the antidepressants paroxetine (Brisdelle, Paxil, 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.
- Tell your doctor if you or anyone in your family has ever experienced diabetes, prolonged QT interval (a rare heart issue that can cause abnormal heartbeat, fainting, or sudden death), or any of the conditions mentioned in the IMPORTANT WARNING section. Inform your doctor if you experience any of the following symptoms: constipation, nausea, vomiting, stomach pain, or distension; urinary system or prostate (a male reproductive gland) issues now or ever; elevated cholesterol levels from dyslipidemia; paralytic ileus, which prevents food from passing through the intestines; glaucoma, high or low blood pressure, dizziness, or illnesses of the heart, kidneys, lungs, or liver. Additionally, let your doctor know if you’ve ever had to stop taking a mental health medication due to serious side 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, using this drug may cause hyperglycemia (increases in blood sugar). The use of clozapine or related drugs may increase the chance of developing diabetes if you have schizophrenia, which increases your risk compared to persons without the condition. If you have any of the following signs while taking clozapine, call your doctor right away: excessive hunger, frequent urination, hazy vision, or weakness. Because high blood sugar can result in the serious condition known as ketoacidosis, it is crucial that you contact your doctor as soon as you experience any of these symptoms. If ketoacidosis is not treated at an early stage, it could turn fatal. Ketoacidosis symptoms include dry mouth, nausea, vomiting, shortness of breath, a fruity odor to the breath, and a loss of consciousness.
- 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:
- Feeling lightheaded, unstable, or having difficulties balancing
- Higher salivation
- Mouth ache
Some adverse effects can be very harmful. Call your doctor right away if you have any of the following symptoms or those detailed in the IMPORTANT WARNINGS or SPECIAL PRECAUTIONS sections:
- Nausea, vomiting, stomach pain or swelling, and diarrhea
- Shaking hands in an uncontrollable manner
- Inability to control one’s bladder or difficulties urinating
- Alterations to vision
- Extreme muscular twitching
- 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
Other 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 program online at http://www.fda.gov/Safety/MedWatch or by phone at 1-800-332-1088 if you have a serious side event.
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. It should not be kept in the bathroom. Store it at room temperature, away from light, excessive heat, and moisture. Avoid freezing or cooling the oral suspension.
As 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
To make sure that pets, kids, and other people cannot take leftover pharmaceuticals, they should be disposed of in a specific manner. You shouldn’t flush this medication down the toilet, though. The best option to get rid of your medication is instead through a medication take-back program. To find out about take-back initiatives in your neighborhood, speak with your pharmacist or get in touch with your city’s waste/recycling department. If you do not have access to a take-back program, you can find more information at the FDA’s Safe Disposal of Medicines website (http://goo.gl/c4Rm4p).
In case of emergency/overdose
Call the poison control hotline at 1-800-222-1222 in the event of an overdose. Additionally, 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:
- 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.
- FazaClo® ODT