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Ziprasidone hcl 20 mg: Ziprasidone Oral: Uses, Side Effects, Interactions, Pictures, Warnings & Dosing

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Ziprasidone Oral: Uses, Side Effects, Interactions, Pictures, Warnings & Dosing

Warnings:

There may be a slightly increased risk of serious, possibly fatal side effects (such as stroke, heart failure, fast/irregular heartbeat, pneumonia) when this medication is used by older adults with dementia. This medication is not approved for the treatment of dementia-related behavior problems. Discuss the risks and benefits of this medication, as well as other effective and possibly safer treatments for dementia-related behavior problems, with the doctor.

If you are using ziprasidone in combination with other medication to treat depression, also carefully read the drug information for the other medication.

Warnings:

There may be a slightly increased risk of serious, possibly fatal side effects (such as stroke, heart failure, fast/irregular heartbeat, pneumonia) when this medication is used by older adults with dementia. This medication is not approved for the treatment of dementia-related behavior problems. Discuss the risks and benefits of this medication, as well as other effective and possibly safer treatments for dementia-related behavior problems, with the doctor.

If you are using ziprasidone in combination with other medication to treat depression, also carefully read the drug information for the other medication.

… Show More

Uses

This medication is used to treat certain mental/mood disorders (schizophrenia, bipolar disorder). This medication can decrease hallucinations and help you to think more clearly and positively about yourself, feel less agitated, and take a more active part in everyday life.Ziprasidone belongs to a class of drugs called atypical antipsychotics. It works by helping to restore the balance of certain natural substances in the brain.

How to use Ziprasidone Hcl

Read the Patient Information Leaflet if available from your pharmacist before you start taking ziprasidone and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth with food as directed by your doctor, usually twice daily. Swallow the capsules whole. Do not open, crush, or chew the capsules.

The dosage is based on your medical condition and response to treatment. To reduce your risk of side effects, your doctor may direct you to start this medication at a low dose and gradually increase your dose. Follow your doctor’s instructions carefully.

Take this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day. Keep taking this medication even if you feel well. Do not stop taking this medication without consulting your doctor.

Tell your doctor if your condition lasts or gets worse.

Side Effects

Drowsiness, dizziness, lightheadedness, weakness, nausea, vomiting, runny nose, and cough may occur. If any of these effects last or get worse, tell your doctor promptly.

Dizziness and lightheadedness can increase the risk of falling. Get up slowly when rising from a sitting or lying position.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: difficulty swallowing, muscle spasms, shaking (tremor), mental/mood changes (such as restlessness), vision changes, interrupted breathing during sleep.

This drug may rarely make your blood sugar rise, which can cause or worsen diabetes. Tell your doctor right away if you have symptoms of high blood sugar such as increased thirst/urination. If you already have diabetes, check your blood sugar regularly as directed and share the results with your doctor. Your doctor may need to adjust your diabetes medication, exercise program, or diet.

This drug may also rarely cause significant weight gain and a rise in your blood cholesterol (or triglyceride) levels. These effects, along with diabetes, may increase your risk for developing heart disease. Discuss the risks and benefits of treatment with your doctor.

This drug may rarely cause a condition known as tardive dyskinesia. In some cases, this condition may be permanent. Tell your doctor right away if you develop any unusual/uncontrolled movements (especially of the face, mouth, tongue, arms, or legs).

This medication may increase a certain natural substance (prolactin) made by your body. For females, this increase in prolactin may result in unwanted breast milk, missed/stopped periods, or difficulty becoming pregnant. For males, it may result in decreased sexual ability, inability to produce sperm, or enlarged breasts. If you develop any of these symptoms, tell your doctor right away.

Get medical help right away if you have any very serious side effects, including: severe dizziness, fainting, seizures, signs of liver damage (such as nausea/vomiting that doesn’t stop, loss of appetite, stomach/abdominal pain, yellowing eyes/skin).

This medication may rarely cause a very serious condition called neuroleptic malignant syndrome (NMS). Get medical help right away if you have any of the following symptoms: fever, muscle stiffness/pain/tenderness/weakness, severe tiredness, severe confusion, sweating, fast/irregular heartbeat, dark urine, signs of kidney problems (such as change in the amount of urine).

Rarely, males may have a painful or prolonged erection lasting 4 or more hours. If this occurs, stop using this drug and get medical help right away, or permanent problems could occur.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: fever, swollen lymph nodes, rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US – Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada – Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

Before taking ziprasidone, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: dementia, seizures, low white blood cell count, difficulty swallowing, heart disease (such as coronary artery disease, irregular heartbeat), diabetes (including family history), obesity, breathing trouble during sleep (sleep apnea).

Ziprasidone may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can rarely cause serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away.

The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may cause QT prolongation. Before using ziprasidone, tell your doctor or pharmacist of all the drugs you take and if you have any of the following conditions: certain heart problems (heart failure, recent heart attack, slow heartbeat, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death).

Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/”water pills”) or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using ziprasidone safely.

This drug may make you dizzy or drowsy. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Avoid alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

This medication may make you sweat less, making you more likely to get heat stroke. Avoid doing things that may cause you to overheat, such as hard work or exercise in hot weather, or using hot tubs. When the weather is hot, drink a lot of fluids and dress lightly. If you overheat, quickly look for a place to cool down and rest. Get medical help right away if you have a fever that does not go away, mental/mood changes, headache, or dizziness.

Older adults may be more sensitive to the side effects of this drug, especially drowsiness, dizziness, lightheadedness, uncontrolled movements, and QT prolongation (see above). Drowsiness, dizziness, and lightheadedness can increase the risk of falling.

During pregnancy, this medication should be used only when clearly needed. 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. If you notice any of these symptoms in your newborn especially during their first month, tell the doctor right away.

Since untreated mental/mood problems (such as schizophrenia, bipolar disorder, depression) can be a serious condition, do not stop taking this medication unless directed by your doctor. If you are planning pregnancy, become pregnant, or think you may be pregnant, immediately discuss with your doctor the benefits and risks of using this medication during pregnancy.

It is unknown if this drug passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.

Interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor’s approval.

Some products that may interact with this drug are: dolasetron, metoclopramide, saquinavir.

Many drugs besides ziprasidone may affect the heart rhythm (QT prolongation), including amiodarone, dofetilide, moxifloxacin, pimozide, procainamide, quinidine, sotalol, tacrolimus, thioridazine, among others.

Tell your doctor or pharmacist if you are taking other products that cause drowsiness such as opioid pain or cough relievers (such as codeine, hydrocodone), alcohol, marijuana (cannabis), drugs for sleep or anxiety (such as alprazolam, lorazepam, zolpidem), muscle relaxants (such as carisoprodol, cyclobenzaprine), or antihistamines (such as cetirizine, diphenhydramine).

Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely.

Does Ziprasidone Hcl interact with other drugs you are taking?

Enter your medication into the WebMD interaction checker

Overdose

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: severe drowsiness, unusual/uncontrolled movements.

Do not share this medication with others.

Lab and/or medical tests (such as blood mineral levels, blood sugar, EKG) should be done while you are taking this medication. Keep all medical and lab appointments. Consult your doctor for more details.

If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Images

ziprasidone 40 mg capsule

Color: purpleShape: oblongImprint: APO ZIP 40

This medicine is a purple, oblong, capsule imprinted with “APO ZIP” and “40”.

ziprasidone 20 mg capsule

Color: white,purpleShape: oblongImprint: APO ZIP 20

This medicine is a purple, oblong, capsule imprinted with “APO ZIP” and “40”.

ziprasidone 80 mg capsule

Color: off-white,blueShape: oblongImprint: X 66

This medicine is a purple, oblong, capsule imprinted with “APO ZIP” and “40”.

ziprasidone 60 mg capsule

Color: off-whiteShape: oblongImprint: F 39

This medicine is a purple, oblong, capsule imprinted with “APO ZIP” and “40”.

ziprasidone 40 mg capsule

Color: blueShape: oblongImprint: F 38

This medicine is a purple, oblong, capsule imprinted with “APO ZIP” and “40”.

ziprasidone 80 mg capsule

Color: white,blueShape: oblongImprint: G 2004 G 2004

This medicine is a purple, oblong, capsule imprinted with “APO ZIP” and “40”.

ziprasidone 40 mg capsule

Color: blueShape: oblongImprint: G 2002 G 2002

This medicine is a purple, oblong, capsule imprinted with “APO ZIP” and “40”.

ziprasidone 60 mg capsule

Color: whiteShape: oblongImprint: LU V53

This medicine is a purple, oblong, capsule imprinted with “APO ZIP” and “40”.

ziprasidone 20 mg capsule

Color: dark blue,whiteShape: oblongImprint: LU V51

This medicine is a purple, oblong, capsule imprinted with “APO ZIP” and “40”.

ziprasidone 80 mg capsule

Color: white,purpleShape: oblongImprint: APO ZIP 80

This medicine is a purple, oblong, capsule imprinted with “APO ZIP” and “40”.

ziprasidone 60 mg capsule

Color: whiteShape: oblongImprint: APO ZIP 60

This medicine is a purple, oblong, capsule imprinted with “APO ZIP” and “40”.

ziprasidone 80 mg capsule

Color: peach,light turquoiseShape: oblongImprint: RDY 259

This medicine is a purple, oblong, capsule imprinted with “APO ZIP” and “40”.

ziprasidone 60 mg capsule

Color: peachShape: oblongImprint: RDY 258

This medicine is a purple, oblong, capsule imprinted with “APO ZIP” and “40”.

ziprasidone 40 mg capsule

Color: light turquoise,lavenderShape: oblongImprint: RDY 257

This medicine is a purple, oblong, capsule imprinted with “APO ZIP” and “40”.

ziprasidone 20 mg capsule

Color: peach,lavenderShape: oblongImprint: RDY 256

This medicine is a purple, oblong, capsule imprinted with “APO ZIP” and “40”.

ziprasidone 80 mg capsule

Color: white,blueShape: oblongImprint: CL65 80 mg

This medicine is a purple, oblong, capsule imprinted with “APO ZIP” and “40”.

ziprasidone 20 mg capsule

Color: white,blueShape: oblongImprint: G 2001 G 2001

This medicine is a purple, oblong, capsule imprinted with “APO ZIP” and “40”.

ziprasidone 20 mg capsule

Color: white,blueShape: oblongImprint: CL 62 20 mg

This medicine is a purple, oblong, capsule imprinted with “APO ZIP” and “40”.

ziprasidone 60 mg capsule

Color: whiteShape: oblongImprint: CL64 60 mg

This medicine is a purple, oblong, capsule imprinted with “APO ZIP” and “40”.

ziprasidone 40 mg capsule

Color: blueShape: oblongImprint: CL63 40 mg

This medicine is a purple, oblong, capsule imprinted with “APO ZIP” and “40”.

ziprasidone 60 mg capsule

Color: whiteShape: oblongImprint: G 2003 G 2003

This medicine is a purple, oblong, capsule imprinted with “APO ZIP” and “40”.

ziprasidone 80 mg capsule

Color: dark blue,whiteShape: oblongImprint: LU V54

This medicine is a purple, oblong, capsule imprinted with “APO ZIP” and “40”.

ziprasidone 40 mg capsule

Color: dark blueShape: oblongImprint: LU V52

This medicine is a purple, oblong, capsule imprinted with “APO ZIP” and “40”.

ziprasidone 20 mg capsule

Color: off-white,blueShape: oblongImprint: F 26

This medicine is a purple, oblong, capsule imprinted with “APO ZIP” and “40”.

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Selected from data included with permission and copyrighted by First Databank, Inc. This copyrighted material has been downloaded from a licensed data provider and is not for distribution, except as may be authorized by the applicable terms of use.

CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment.

Ziprasidone (Geodon) | NAMI: National Alliance on Mental Illness

Download PDF

Generic name: ziprasidone (zi PRAS i done)

  • Oral capsule: 20 mg, 40 mg, 60 mg, 80 mg
  • Intramuscular injection (short-acting): 20 mg/mL

Brand name:​ Geodon®

  • Oral capsules: 20 mg, 40 mg, 60 mg, 80 mg
  • Intramuscular injection (short-acting): 20 mg/mL

All FDA black box warnings are at the end of this fact sheet. Please review before taking this medication.

What is Ziprasidone and what does it treat?

Ziprasidone is a medication that works in the brain to treat schizophrenia. It is also known as a second generation antipsychotic (SGA) or atypical antipsychotic. Ziprasidone rebalances dopamine and serotonin to improve thinking, mood, and behavior.

Symptoms of schizophrenia include:

  • Hallucinations – imagined voices or images that seem real
  • Delusions – beliefs that are not true (e.g., other people are reading your thoughts)
  • Disorganized thinking or trouble organizing your thoughts and making sense
  • Little desire to be around other people
  • Trouble speaking clearly
  • Lack of motivation

Ziprasidone may help some or all of these symptoms.

Ziprasidone is also FDA approved for the following indications:

  • Acute treatment of manic or mixed episodes of bipolar disorder
  • Maintenance (long-term) treatment of bipolar disorder (when used with lithium or valproate)
  • Acute treatment of agitation in schizophrenia

This medication sheet will focus primarily on schizophrenia. You can find more information about bipolar disorder here.

Ziprasidone may also be helpful when prescribed “off-label” for schizoaffective disorder. “Off-label” means that it hasn’t been approved by the Food and Drug Administration for this condition. Your mental health provider should justify his or her thinking in recommending an “off-label” treatment. They should be clear about the limits of the research around that medication and if there are any other options.

What is the most important information I should know about Ziprasidone?

Schizophrenia requires long-term treatment. Do not stop taking ziprasidone, even when you feel better.

With input from you, your health care provider will assess how long you will need to take the medication.

Missing doses of ziprasidone may increase your risk for a relapse in your symptoms.

Do not stop taking ziprasidone or change your dose without talking with your health care provider first.

For ziprasidone to work properly, it should be taken every day as ordered by your health care provider.

Are there specific concerns about Ziprasidone and pregnancy?

If you are planning on becoming pregnant, notify your health care provider to best manage your medications. People living with schizophrenia who wish to become pregnant face important decisions. This is a complex decision since untreated schizophrenia has risks to the fetus, as well as the mother. It is important to discuss the risks and benefits of treatment with your doctor and caregivers.

Antipsychotic use during the third trimester of pregnancy has a risk for abnormal muscle movements (extrapyramidal symptoms [EPS]) and/or withdrawal symptoms in newborns following delivery. Symptoms in the newborn may include agitation, feeding disorder, hypertonia, hypotonia, respiratory distress, somnolence, and tremor; these effects may be self-limiting or require hospitalization.

Caution is advised with breastfeeding since ziprasidone does pass into breast milk.

What should I discuss with my health care provider before taking Ziprasidone?

  • Symptoms of your condition that bother you the most
  • If you have thoughts of suicide or harming yourself
  • Medications you have taken in the past for your condition, whether they were effective or caused any adverse effects
  • If you ever had muscle stiffness, shaking, tardive dyskinesia, neuroleptic malignant syndrome, or weight gain caused by a medication
  • If you experience side effects from your medications, discuss them with your provider. Some side effects may pass with time, but others may require changes in the medication.
  • Any psychiatric or medical problems you have, such as heart rhythm problems, long QT syndrome, heart attacks, diabetes, high cholesterol, or seizures
  • If you have a family history of diabetes or heart disease
  • All other medications you are currently taking (including over the counter products, herbal and nutritional supplements) and any medication allergies you have
  • Other non-medication treatment you are receiving, such as talk therapy or substance abuse treatment. Your provider can explain how these different treatments work with the medication.
  • If you are pregnant, plan to become pregnant, or are breastfeeding
  • If you smoke, drink alcohol, or use illegal drugs

How should I take Ziprasidone?

Ziprasidone is usually taken 2 times per day with food (at least 500 calories).

Typically patients begin at a low dose of medication and the dose is increased slowly over several weeks.

The dose usually ranges from 40 to 80 mg twice daily. Only your health care provider can determine the correct dose for you.

Use a calendar, pillbox, alarm clock, or cell phone alert to help you remember to take your medication. You may also ask a family member a friend to remind you or check in with you to be sure you are taking your medication.

What happens if I miss a dose of Ziprasidone?

If you miss a dose of ziprasidone, take it as soon as you remember, unless it is closer to the time of your next dose. Discuss this with your health care provider. Do not double your next dose or take more than what is prescribed.

What should I avoid while taking Ziprasidone?

Avoid drinking alcohol or using illegal drugs while you are taking ziprasidone. They may decrease the benefits (e.g., worsen your confusion) and increase adverse effects (e.g., sedation) of the medication.

What happens if I overdose with Ziprasidone?

If an overdose occurs call your doctor or 911. You may need urgent medical care. You may also contact the poison control center at 1-800-222-1222.

A specific treatment to reverse the effects of ziprasidone does not exist.

What are the possible side effects of Ziprasidone?

Common side effects

Drowsiness, extrapyramidal symptoms, headache, dizziness, nausea, constipation, restlessness

Rare/serious side effects

Ziprasidone may increase the blood levels of a hormone called prolactin. Side effects of increased prolactin levels include females losing their period, production of breast milk and males losing their sex drive or possibly experiencing erectile problems. Long term (months or years) elevated prolactin levels can lead to osteoporosis, or increased risk of bone fractures.

Some people may develop muscle related side effects while taking ziprasidone. The technical terms for these are “extrapyramidal symptoms” (EPS) and “tardive dyskinesia” (TD). Symptoms of EPS include restlessness, tremor, and stiffness. TD symptoms include slow or jerky movements that one cannot control, often starting in the mouth with tongue rolling or chewing movements.

Temperature regulation: Impaired core body temperature regulation may occur; caution with strenuous exercise, heat exposure, and dehydration.

Second generation antipsychotics (SGAs) increase the risk of weight gain, high blood sugar, and high cholesterol. This is also known as metabolic syndrome. Your health care provider may ask you for a blood sample to check your cholesterol, blood sugar, and hemoglobin A1c (a measure of blood sugar over time) while you take this medication.

SGAs have been linked with higher risk of death, strokes, and transient ischemic attacks (TIAs) in elderly people with behavior problems due to dementia.

All antipsychotics have been associated with the risk of sudden cardiac death due to an arrhythmia (irregular heart beat). To minimize this risk, antipsychotic medications should be used in the smallest effective dose when the benefits outweigh the risks. Your doctor may order an EKG to monitor for irregular heartbeat.

Neuroleptic malignant syndrome is a rare, life threatening adverse effect of antipsychotics which occurs in <1% of patients. Symptoms include confusion, fever, extreme muscle stiffness, and sweating. If any of these symptoms occur, contact your health care provider immediately.

All antipsychotics can cause sedation, dizziness, or orthostatic hypotension (a drop in blood pressure when standing up from sitting or lying down). These side effects may lead to falls which could cause bone fractures or other injuries. This risk is higher for people with conditions or other medications that could worsen these effects. If falls or any of these symptoms occur, contact your health care provider.

Severe skin reactions have been reported with ziprasidone. These include Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) and Stevens-Johnson Syndrome which can be fatal. Seek emergency treatment immediately if a severe skin reaction occurs.

Are there any risks For taking Ziprasidone for long periods of time?

Tardive dyskinesia (TD) is a side effect that develops with prolonged use of antipsychotics. Medications such as ziprasidone have been shown to have a lower risk of TD compared to older antipsychotics, such as Haldol® (haloperidol). If you develop symptoms of TD, such as grimacing, sucking, and smacking of lips, or other movements that you cannot control, contact your health care provider immediately. All patients taking either first or second generation antipsychotics should have an Abnormal Involuntary Movement Scale (AIMS) completed regularly by their health care provider to monitor for TD.

Second generation antipsychotics (SGAs) increase the risk of diabetes, weight gain, high cholesterol, and high triglycerides. (See “Serious Side Effects” section for monitoring recommendations).

What other medications may interact with Ziprasidone?

Ziprasidone may block the effects of agents used to treat Parkinson’s disease such as levodopa/carbidopa (Sinemet®), bromocriptine, pramipexole (Mirapex®), ropinirole (Requip®), and others.

The following medications may increase the risk of heart problems when used with ziprasidone:

  • Antipsychotics, including chlorpromazine (Thorazine®), thioridizine (Mellaril®), asenapine (Saphris®), iloperidone (Fanapt®), paliperidone (Invega®), and quetiapine (Seroquel®)
  • Antiarrhythmics (heart rhythm medications), including procainamide, quinidine, amiodarone (Cordarone®), dronedarone (Multaq®), and sotalol (Betapace®)

The following medications may increase the levels and effects of ziprasidone: fluoxetine (Prozac®), ketoconazole (Nizoral®), and paroxetine (Paxil®).

Carbamazepine (Tegretol®) may decrease the levels and effects of ziprasidone.

How long does it take for Ziprasidone to work?

It is very important to tell your doctor how you feel things are going during the first few weeks after you start taking ziprasidone. It will probably take several weeks to see big enough changes in your symptoms to decide if ziprasidone is the right medication for you.

Antipsychotic treatment is generally needed lifelong for persons with schizophrenia. Your doctor can best discuss the duration of treatment you need based on your symptoms and illness.

  • Hallucinations, disorganized thinking, and delusions may improve in the first 1-2 weeks
  • Sometimes these symptoms do not completely go away
  • Motivation and desire to be around other people can take at least 1-2 weeks to improve
  • Symptoms continue to get better the longer you take ziprasidone
  • It may take 2-3 months before you get the full benefit of ziprasidone

Summary of FDA Black Box Warnings

Increased mortality in elderly patients with dementia related psychosis

  • Both first generation (typical) and second generation (atypical) antipsychotics are associated with an increased risk of mortality in elderly patients when used for dementia related psychosis.
  • Although there were multiple causes of death in studies, most deaths appeared to be due to cardiovascular causes (e. g., sudden cardiac death) or infection (e.g., pneumonia).
  • Antipsychotics are not indicated for the treatment of dementia related psychosis.

 

Provided by

(January 2023)

©2022 The American Association of Psychiatric Pharmacists (AAPP) and the National Alliance on Mental Illness (NAMI). AAPP and NAMI make this document available under the Creative Commons Attribution-No Derivatives 4.0 International License. Last Updated: January 2016.

This information is being provided as a community outreach effort of the American Association of Psychiatric Pharmacists. This information is for educational and informational purposes only and is not medical advice. This information contains a summary of important points and is not an exhaustive review of information about the medication. Always seek the advice of a physician or other qualified medical professional with any questions you may have regarding medications or medical conditions. Never delay seeking professional medical advice or disregard medical professional advice as a result of any information provided herein. The American Association of Psychiatric Pharmacists disclaims any and all liability alleged as a result of the information provided herein.

Ziprasidone

Ziprasidone is an atypical antipsychotic drug effective for the treatment of schizophrenia and bipolar disorders, with satisfactory tolerability and low potential for drug interactions.

Russian synonyms

Zeldox, Zipsila.

English synonyms

Ziprasidone, Geodon, Zeldox.

Research method

Polarization fluoroimmunoassay (FPIA).

Units

Ng/mL (nanograms per milliliter).

What biomaterial can be used for research?

Venous blood.

How to properly prepare for an examination?

  • Do not eat for 2-3 hours before the examination, you can drink pure non-carbonated water.
  • Do not smoke for 30 minutes before the test.

General information about the study

Ziprasidone is an atypical antipsychotic (neuroleptic) used to treat schizophrenia and schizotypal disorders, to relieve psychomotor agitation in patients with schizophrenia. There are clinical data on the effectiveness of the drug in depression, bipolar disorders, anxiety, aggression, dementia, attention deficit hyperactivity disorder, obsessive-compulsive disorders, autism and post-traumatic stress.

The drug interacts with dopamine and serotonin receptors, has a moderate affinity for serotonin and norepinephrine transporters, H1-histamine and alpha-1-adrenergic receptors. It has antipsychotic, antidepressant activity and has an anxiolytic (anti-anxiety) effect.

The bioavailability of the drug taken orally after a meal is 60%, with intramuscular injection – 100%. With regular use of ziprasidone, its stable concentration in the blood is reached within 3 days. Regardless of the concentration, it is 99% bound to blood proteins.

Ziprasidone is metabolized in the liver by CYP 3A4, thiomethyltransferase and non-cytochrome P450 aldehyde oxidase. The drug has a low potential for drug interactions. Its main metabolites are benzisothiazole piperazine (BITP) sulfoxide, BITP sulfone, ziprasidone sulfoxide and S-methyldihydroziprasidone. The half-life of the drug with parenteral administration is 2 hours, with oral administration – 6.6 hours. Approximately 20% of the metabolites and less than 1% of unchanged ziprasidone are excreted in the urine and, respectively, 66% and less than 4% in the feces. In case of impaired renal function, no significant changes in metabolism are observed, and mild and moderate violations of liver function against the background of cirrhosis increase the concentration of the drug in the blood by 30% and lengthen the half-life by 2 hours.

Side effects of ziprasidone may include nausea, vomiting, dry mouth, increased salivation, dizziness, dystonia, sleep disturbances, asthenia, convulsions, extrapyramidal disorders (motor disturbances), increased blood pressure, orthostatic hypotension, QT interval prolongation, elevated prolactin in the blood. The drug can be dangerous for elderly patients with psychosis on the background of dementia. With the only registered overdose, a sedative (calming) effect of the drug, speech slowing and transient arterial hypertension were noted.

Atypical antipsychotics require blockade of 60-80% of dopamine (D2) receptors to achieve clinical effect. In the course of studies, it was found that for the blockade of 60 D2 receptors, a concentration of ziprasidone in the blood plasma of 50 ng / ml is required, which corresponds to a dose of 120 mg / day. According to clinical trials, the optimal dose of ziprasidone is 120-160 mg / day.

What is research used for?

  • For monitoring drug concentration in the blood;
  • to adjust the dose of the drug for violations of liver function;
  • to select the optimal clinically effective dose of the drug;
  • to detect violations in the drug regimen.

When is the test ordered?

  • When prescribing ziprasidone, especially in patients with cirrhosis of the liver;
  • if the patient is suspected of non-compliance with the drug regimen;
  • with persistence of symptoms or exacerbation of the disease while taking ziprasidone;
  • for suspected drug overdose.

What do the results mean?

Reference values: 50 – 130 ng/ml.

What can influence the result?

  • The level of the drug in the blood increases when taking ketoconazole, with impaired liver function.
  • Carbamazepine reduces the concentration of ziprasidone in the blood.

Important notes

  • It is unacceptable to independently adjust the dose and regimen of taking ziprasidone without the participation of a doctor. The selection of the dose, its correction and control over the level of the drug in the blood is carried out by the attending physician, taking into account the clinical condition of the patient and individual tolerance.

Also recommended

  • Complete blood count (without WBC and ESR)
  • Alanine aminotransferase (ALT)
  • Aspartate aminotransferase (AST)
  • Bilirubin total
  • Cholesterol, total
  • Plasma glucose
  • Prolactin

Who orders the examination?

Psychiatrist, clinical pharmacologist.

Literature

  • Capilletti S.G. Ziprasidone is a new effective and safe antipsychotic / / Journal “Difficult Patient”, No. 11. – 2007.
  • State Register of Medicines. Official publication: in 2 volumes – M .: Medical Council, 2009. – Vol. 2, part 1 – 568 p.; part 2. – 560 p.
  • Burton S., Heslop K., Harrison K. et al. Ziprasidone overdose // Am J Psychiatry 2000; 157:835.
  • Caley C.F., Cooper C.K. Ziprasidone: the fifth atypical antipsychotic // Ann Pharmacother. 2002; 36:5:839-851.
  • Murray S., Siu C., Romano S.J. et al. Optimal dosing of oral ziprasidone: analysis of clinical trial data (abstract). Presented at the 156th annual meeting of the American Psychiatric Association; May 17-23, 2003; San Francisco.

Ivabradine Canon tablet film 5 mg x56

Active ingredient: ivabradine (ivabradine)

Rec.INN registered by WHO

Presentation form, packaging and composition

901 65 Film-coated tablets orange, heart-shaped, with risks on both sides, almost white in cross section.

1 tab.
ivabradine hydrochloride 5.39 mg,
177

5 mg

Excipients : pregelatinized corn starch 24.0 mg, colloidal silicon dioxide 1.0 mg, anhydrous lactose 77.010 mg, maltodextrin 12.0 mg, magnesium stearate 0.60 mg.

Film coating composition: Opadry orange 4 mg, incl. hypromellose – 1.35 mg, hyprolose 1.35 mg, talc – 0.8 mg, titanium dioxide – 0.4472, iron dye yellow oxide – 0.044 mg, iron dye red oxide – 0.0088 mg.


Film-coated tablets orange, round, biconvex, almost white in cross section.

1 tab.
ivabradine hydrochloride 8.085 mg 7.5 mg

Excipients : pregelatinized corn starch 36.0 mg, colloidal silicon dioxide 1.5 mg, anhydrous lactose 115.515 mg, maltodextrin 18.0 mg, magnesium stearate 0.90 mg.

Film coating composition: Opadry orange 6 mg, incl. hypromellose – 2.025 mg, hyprolose 2.025 mg, talc – 1.2 mg, titanium dioxide – 0.6708, iron dye yellow oxide – 0.066 mg, iron dye red oxide – 0.0132 mg.

Clinical and pharmacological group: Selective inhibitor of If-channels of the sinus node, regulating heart rate

Pharmacological action

Antianginal agent. The mechanism of action is the selective and specific inhibition of If channels of the sinus node that control spontaneous diastolic depolarization in the sinus node and regulate heart rate.

Ivabradine has a selective effect on the sinus node, without affecting the conduction time of impulses along the intra-atrial, atrioventricular and intraventricular pathways, as well as myocardial contractility and ventricular repolarization.

The main pharmacodynamic property of ivabradine is a specific, dose-dependent decrease in heart rate. Analysis of the dependence of the magnitude of the decrease in heart rate at a dose of more than 20 mg 2 times / day revealed a tendency to achieve a plateau effect, which reduces the risk of developing severe, poorly tolerated bradycardia (heart rate less than 40 bpm).

When used at recommended doses, the reduction in heart rate is approximately 10-15 bpm at rest and during exercise. As a result, the work of the heart decreases and myocardial oxygen demand decreases.

Ivabradine is also able to interact with the Ih channels of the retina, similar to the If channels of the heart. The Ih channel is involved in the occurrence of a temporary change in the resolution of the visual system, since reduces the retinal response to bright light stimuli. Under provoking circumstances (e.g., rapid brightness changes), ivabradine partially inhibits the Ih electrical impulse, which in some patients sometimes leads to light sensations (phosphenes), which are described as a short-term sensation of increased brightness in a limited part of the visual field.

The use of ivabradine in patients with CHF II-IV functional class according to the NYHA classification with LVEF less than 35% showed a clinically and statistically significant reduction in the relative risk of complications (the frequency of deaths from cardiovascular diseases and a decrease in the frequency of hospitalizations due to increased symptoms of the course of CHF) by 18%. The absolute risk reduction was 4.2%. A pronounced therapeutic effect was observed 3 months after the start of therapy.

Pharmacokinetics

The pharmacokinetics of ivabradine at a dose of 0.5 to 24 mg is linear.

After oral administration, ivabradine is rapidly and almost completely absorbed from the gastrointestinal tract. C max in plasma is reached approximately 1 hour after ingestion on an empty stomach. Bioavailability is approximately 40% due to the “first pass” effect through the liver. Eating increases the absorption time by approximately 1 hour and increases plasma concentration by 20-30%. Plasma protein binding – about 70%. V d is about 100 liters. C ss max in plasma after prolonged use at the recommended dose of 5 mg 2 times / day is approximately 20 ng / ml (CV = 29%). Average C ss in plasma is 10 ng/ml (CV=38%).

Ivabradine is extensively metabolized in the liver and intestines by oxidation in the presence of the CYP3A4 isoenzyme. The main active metabolite is the N-desmethylated derivative (S18982), accounting for 40% of the dose of the parent compound. The metabolism of the active metabolite of ivabradine also occurs in the presence of the CYP3A4 isoenzyme.

T 1/2 ivabradine is 2 hours (70-75% AUC) and effective T 1/2 is 11 hours. The total clearance is approximately 400 ml / min, renal – about 70 ml / min. Excretion of metabolites occurs at the same rate with urine and feces. Approximately 4% of an oral dose is excreted unchanged in the urine.

In patients with renal insufficiency (CC 15-60 ml / min), changes in pharmacokinetic parameters are minimal due to the low participation of renal clearance (about 20%) in the total elimination of ivabradine and its main metabolite S18982.

In patients with mild hepatic insufficiency (up to 7 points on the Child-Pugh scale), the AUC of ivabradine and its active metabolite is 20% higher than with normal liver function.

Indications

5200505361751493=”46″> Treatment of stable angina in patients with normal sinus rhythm: with intolerance or contraindications to the use of beta-blockers, in combination with beta-blockers with inadequate control of stable angina against the background of an optimal dose of beta-adreno blocker.

Chronic heart failure: to reduce the incidence of cardiovascular complications in patients with chronic heart failure, in sinus rhythm and a heart rate of at least 70 bpm.

ICD-10 codes

902 03

Dosing regimen

factors. The optimal dosage regimen is determined by the doctor. Compliance of the dosage form of a particular drug with indications for use and dosing regimen should be strictly observed.

The average recommended starting dose of ivabradine is 5 mg 2 times / day (10 mg / day). Depending on the therapeutic effect, after 3-4 weeks of use, the dose may be increased to 7. 5 mg 2 times / day (15 mg / day).

If, during therapy, the heart rate decreases to values ​​​​less than 50 bpm or symptoms associated with bradycardia (such as dizziness, fatigue or arterial hypotension) occur, a lower dose should be selected, if necessary, the dose can be reduced to 2.5 mg 2 times/day If the heart rate remains less than 50 beats / min and the symptoms of bradycardia do not go away, then the treatment is stopped.

In elderly patients, it is recommended to start treatment with an initial dose of 2.5 mg 2 times / day. In the future, it is possible to increase the daily dose depending on the patient’s condition.

Side effects

From the senses: very often – changes in light perception (photopsia), often – blurred vision, infrequently – vertigo, unspecified frequency – diplopia, visual impairment.

From the side of the cardiovascular system: often – bradycardia, AV blockade of the first degree, ventricular extrasystole, short-term increase in blood pressure, infrequently – palpitations, supraventricular extrasystole, very rarely – atrial fibrillation, AV blockade of the II and III degree, SSS, unspecified frequency – a pronounced decrease in blood pressure, possibly associated with bradycardia.

From the digestive system: infrequently – nausea, constipation, diarrhea.

From the side of the central nervous system: often – headache (especially in the first month of therapy), dizziness, possibly associated with bradycardia, unspecified frequency – fainting, possibly associated with bradycardia.

From the respiratory system: infrequently – shortness of breath.

Contraindications

Bradycardia (resting heart rate below 60 bpm before treatment), cardiogenic shock, acute myocardial infarction, severe arterial hypotension (systolic blood pressure below 90 mmHg and diastolic blood pressure below 50 mm Hg), severe liver failure (more than 9 points on the Child-Pugh scale), SSSU, sinoatrial blockade, chronic heart failure III and IV functional class according to the NYHA classification, the presence of an artificial pacemaker operating in the mode of constant stimulation, unstable angina, III degree AV blockade, pregnancy, lactation (breastfeeding), children and adolescents under 18 years of age, simultaneous use with strong inhibitors of the CYP3A4 isoenzyme, such as antifungal agents of the azole group (ketoconazole, itraconazole), antibiotics of the macrolide group ( clarithromycin, oral erythromycin, josamycin, telithromycin), HIV protease inhibitors (nelfinavir, ritonavir) and nefazodone, hypersensitivity to ivabradine.

Use during pregnancy and lactation

Use during pregnancy and lactation (breastfeeding) is contraindicated.

Use in hepatic impairment

Contraindicated in severe hepatic impairment. Caution should be used in patients with moderate hepatic impairment.

Use for impaired renal function

Use with caution in patients with CC below 15 ml/min.

Pediatric use

Not recommended for use in children and adolescents under 18 years of age.

Special instructions

Use with caution in moderate hepatic insufficiency (less than 9 points on the Child-Pugh scale), severe renal insufficiency (CC &lt, 15 ml / min), congenital prolongation of the QT interval, simultaneously with taking drugs that prolong the QT interval (risk of developing severe ventricular arrhythmia of the “pirouette” type), while taking moderate inhibitors and inducers of CYP3A4 isoenzymes and grapefruit juice, with AV blockade of the II degree, recent stroke, retinitis pigmentosa (retinitis pigmentosa), arterial hypotension, chronic heart failure of the IV functional class according to the NYHA classification, simultaneously with the intake of slow calcium channel blockers that slow down the heart rate, such as verapamil or diltiazem, simultaneously with the intake of non-potassium-sparing diuretics.

Ivabradine is not effective in the treatment or prevention of arrhythmias. Its effectiveness falls against the background of the development of tachyarrhythmias (for example, ventricular or supraventricular paroxysmal tachycardia).

Not recommended for use in patients with atrial fibrillation (atrial fibrillation) or other types of arrhythmias associated with sinus node function.

During therapy with ivabradine, it is recommended to regularly monitor the patient’s condition for the development of atrial fibrillation (paroxysmal or permanent ) . If clinically indicated (for example, worsening of angina pectoris, palpitations, irregular heartbeat), ECG should be monitored regularly.

The risk of developing atrial fibrillation may be higher in patients with chronic heart failure taking ivabradine. Atrial fibrillation was more common among patients who were taking amiodarone or class I antiarrhythmic drugs concomitantly with ivabradine.

Heart failure must be stable before deciding whether to use ivabradine. Patients with chronic heart failure and intraventricular conduction disorders (left or right bundle branch block) and ventricular dyssynchrony require constant medical monitoring.

There is no evidence of an increased risk of severe bradycardia with ivabradine when sinus rhythm is restored during pharmacological cardioversion. However, due to the lack of sufficient data, if it is possible to delay elective electrical cardioversion, ivabradine should be discontinued 24 hours before it.

A decrease in heart rate due to the use of ivabradine can exacerbate the prolongation of the QT interval, which, in turn, can provoke the development of a severe form of arrhythmia, in particular, polymorphic ventricular tachycardia of the “pirouette” type.

Influence on the ability to drive vehicles and control mechanisms

During the period of treatment, the patient should be careful when engaging in potentially hazardous activities that require a high speed of psychomotor reactions in situations where sudden changes in illumination can occur, especially at night.

Drug interactions pentamidine, cisapride, erythromycin c), it is possible to increase the decrease in heart rate and additional lengthening of the QT interval. If simultaneous therapy is necessary, ECG parameters should be carefully monitored (such combinations are not recommended).

Ivabradine is metabolized in the liver with the participation of the CYP3A4 isoenzyme and is a very weak inhibitor of this isoenzyme. Ivabradine does not significantly affect the metabolism and plasma concentrations of other substrates (strong, moderate and weak inhibitors) of cytochrome CYP3A4. At the same time, inhibitors and inducers of the CYP3A4 isoenzyme can interact with ivabradine and have a clinically significant effect on its metabolism and pharmacokinetic properties. It was found that inhibitors of the isoenzyme CYP3A4 increase, and inducers of the isoenzyme CYP3A4 reduce plasma concentrations of ivabradine. Increasing the concentration of ivabradine in the blood plasma may increase the risk of developing severe bradycardia.

Simultaneous use with strong CYP3A4 inhibitors, such as azole antifungals (ketoconazole, itraconazole), macrolide antibiotics (clarithromycin, oral erythromycin, josamycin, telithromycin), HIV protease inhibitors (nelfinavir, ritonavir, nefazodone) is contraindicated due to an increase in the concentration of ivabradine in the blood plasma and the risk of developing excessive bradycardia.

Simultaneous use of ivabradine and moderate inhibitors of the CYP3A4 isoenzyme diltiazem or verapamil (heart rate slowing agents) in healthy volunteers and patients was accompanied by an increase in AUC of ivabradine by 2-3 times and an additional decrease in heart rate by 5 bpm. These combinations are not recommended.

CYP3A4 inducers such as rifampicin, barbiturates, phenytoin, and herbal preparations containing St. . With the combined use of ivabradine and preparations containing St.

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I20 Angina [angina]