Zeldox Capsules (ziprasidone hydrochloride) Drug / Medicine Information

NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia.

(zell-docks)

ziprasidone hydrochloride (zi-pra-si-don hi-dro-klor-ride)

Consumer Medicine Information

What is in this leaflet

This leaflet answers some common questions about Zeldox.

It does not contain all the available information. It does not take the place of talking
to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of you taking
Zeldox against the benefits they expect it will have for you.

If you have any concerns about taking this medicine, ask your doctor or pharmacist.

Keep this leaflet with the medicine.

You may need to read it again.

What Zeldox is used for

What Zeldox is for

Zeldox is used to treat schizophrenia and bipolar disorder.

Your doctor may have prescribed Zeldox for another reason.

Ask your doctor or pharmacist if you have any questions about Zeldox or why Zeldox
has been prescribed for you.

Schizophrenia

Schizophrenia is a mental illness. It varies from person to person, but can involve:

hallucinations: the person sees, hears, feels, smells or tastes something that is
not actually there; most commonly a person may hear voices

delusions: a delusion is a false belief held by a person which is not held by others
of the same cultural background

disturbed or disorganised thinking

poor memory and concentration

loss of emotion and expression

loss of motivation and energy

difficulty interacting with others, leading to social isolation.

Bipolar disorder

Bipolar disorder is a mental illness where a person cycles through:

‘manic’ phases – with symptoms such as over-activity, irritability/elation and limited
need for sleep

‘depressive’ phases – with symptoms such as depressed mood, anxiety, difficulty making
decisions, concentrating and hopelessness.

How Zeldox works

Zeldox belongs to a group of medicines called atypical antipsychotics/neuroleptics.
It contains the ingredient ziprasidone.

Schizophrenia

Researchers do not know exactly what causes schizophrenia, but they do know that many
people with it have high levels of some brain chemicals – including dopamine and serotonin.

Zeldox is thought to work by helping to correct the imbalance of these chemicals,
in turn, reducing the symptoms of schizophrenia. Research has found Zeldox can help
reduce:

hallucinations

delusions

confused thoughts

social withdrawal

lack of motivation.

Zeldox does not cure schizophrenia, but it can help manage the symptoms and help prevent
further episodes.

Taking antipsychotic/neuroleptic medicines like Zeldox can also allow you to try psychological
therapies when recommended by your doctor. These may further help you manage your
schizophrenia.

Bipolar disorder

Research has shown that there is a chemical imbalance in the brain in patients with
bipolar disorder.

Zeldox does not cure bipolar disorder. It is used as a short-term treatment for the
manic phases. Zeldox is not used to treat the depressive phases of bipolar disorder.

Controlling the manic phase of bipolar disorder with medicine can also allow you to
try psychological therapies when recommended by your doctor.

Taking Zeldox

Zeldox is available only with a doctor’s prescription.

Zeldox is not recommended for the treatment of elderly patients with dementia-related
psychosis.

Zeldox should be used with caution in elderly patients with risk factors for stroke.

Zeldox is also not recommended for children under 18 years of age as there is not
enough information on the effects of Zeldox in this group.

Before you take Zeldox

When you must not take it

Do not take Zeldox if you have an allergy to:

any medicine containing ziprasidone

any of the ingredients listed at the end of this leaflet.

Symptoms of an allergic reaction to Zeldox may include:

hives, itching or skin rash

shortness of breath, wheezing

swelling of the face, lips or tongue which may lead to difficulty swallowing or breathing.

Do not take Zeldox if you have or have had any of the following medical conditions:

a recent heart attack

heart failure that is not well-controlled

abnormal rhythm of the heart

any other condition requiring drugs to control your heart rhythm.

Do not take Zeldox after the expiry date printed on the pack or if the packaging is
torn or shows signs of tampering.

If it has expired or is damaged, return it to your pharmacist for disposal.

If you are not sure whether you should start taking this medicine, talk to your doctor.

Before you start to take it

If you have some medical conditions, you may not be able to take Zeldox, or your doctor
may need to adjust your medicines.

Tell your doctor or pharmacist if you have any allergies to:

any other medicines

any other substances such as foods, preservatives or dyes.

Tell your doctor or pharmacist if you have or have had any medical conditions, especially
the following:

irregular heart rate

a condition requiring other drugs to control the heart rhythm

any heart or blood vessel problems

low blood levels of potassium or magnesium

a condition that may give you low blood pressure

a history of seizures (fits)

liver problems

blood sugar level problems e.g., diabetes

headache

nausea

vomiting

blurred vision

muscle weakness

if you are 65 years of age or over and have a condition known as ‘dementia-related
psychosis’

if you have ever suffered or suffer from a condition called deep vein thrombosis (DVT).
DVT is the formation of blood clots in one of the deep veins within the body, e.g.,
the leg or pelvis. The symptoms of DVT are pain and swelling in your legs. Sometimes
the blood clot may break away from its original location and travel to the lungs.
This condition is called pulmonary embolism (PE). Symptoms of PE may include sharp
chest pain, shortness of breath or you may cough up blood.

breathing stops and starts while sleeping.

Tell your doctor or pharmacist if you have ever had any of the following reactions
to this type of medicine:

Neuroleptic Malignant Syndrome (NMS) – symptoms include sudden fever, fast breathing,
blood pressure changes, sweating, confusion, muscle stiffness and drowsiness or sleepiness

Tardive Dyskinesia (TD) – unusual movements (mainly of the face and tongue), or uncontrollable
twitching or jerking of the arms and legs.

Tell your doctor or pharmacist if you are pregnant or intend to become pregnant.

Like most atypical antipsychotic/ neuroleptic medicines, Zeldox is not recommended
for use during pregnancy.

For women of child-bearing age an appropriate method of contraception is recommended.

If you become or plan to become pregnant while taking Zeldox your doctor will discuss
the benefits and risks of taking it.

Babies exposed to antipsychotic drugs (including Zeldox) during the third trimester
of pregnancy are at risk of experiencing agitation, abnormal muscle tone, tremor,
somnolence, breathing problems, difficulty in feeding and/or withdrawal symptoms after
being born.

Tell your doctor or pharmacist if you are breast-feeding or plan to breast-feed.

Zeldox is not recommended while you are breast-feeding. It is thought that low levels
of Zeldox passes into breast milk.

Taking other medicines

Some medicines may be affected by Zeldox or may affect how well it works. Your doctor
may need to give you different amounts of your medicine, or you may need to take different
medicines. Your doctor will advise you.

Tell your doctor or pharmacist if you are taking any other medicines, including:

all prescription medicines

all medicines you buy over the counter from a pharmacy or supermarket

all complementary and alternative therapies

any supplements or herbal remedies you buy from a health food shop

a type of herbal medicine to treat depression called St John’s Wort (Hypericum perforatum).

any illicit drugs.

Tell your doctor or pharmacist if you are taking medicines for any of the following
conditions:

Parkinson’s disease

fast or irregular heart rhythms

insomnia (unable to fall asleep or stay asleep)

anxiety

depression or mood swings

pain – especially any narcotic pain killers

epilepsy or mood disorders – especially carbamazepine

fungal infections – especially ketoconazole

rifampicin an antibiotic used for the treatment of tuberculosis.

Ask your doctor or pharmacist if you are not sure if you are taking any of these medicines.

Your doctor and pharmacist have more information on medicines to be careful with or
to avoid while taking Zeldox.

How to take Zeldox

Follow all directions given to you by your doctor and pharmacist carefully.

These may differ from the information contained in this leaflet.

If you do not understand the instructions on the pack, ask your doctor or pharmacist
for help.

How much to take

How much Zeldox you need to take will depend upon your condition.

Schizophrenia

The usual starting dose is one 40 mg capsule taken twice daily with food.

Your doctor may increase your dose up to a maximum of one 80 mg capsule twice daily
with food.

Allow at least 48 hours between changes to your dose unless otherwise instructed by
your doctor.

You may reach the maximum dose of one 80 mg capsule twice daily with food on the third
day from the start of your treatment.

Bipolar disorder

The usual starting dose is one 40 mg capsule twice daily with food.

Your doctor may adjust your dose up to a maximum of one 80 mg capsule twice daily
with food. This dose may be reached on the second day from the start of your treatment.

How to take it

Swallow the capsules whole with a full glass of water.

When to take it

Take your capsule(s) with food, so in the morning with breakfast and in the evening
with your evening meal.

You need to take Zeldox with food because it helps your body absorb the medicine much
better. If you do not take with food, the medicine may have less effect.

How long to take it

Keep taking Zeldox for as long as your doctor recommends, even if you feel better.

If you keep taking Zeldox as recommended, there is less chance of your symptoms returning.

If you forget to take it

If it is almost time for your next dose, skip the dose you missed and take your next
dose when you are meant to. Otherwise, take it as soon as you remember, and then go
back to taking it as you would normally.

If you are not sure whether to skip the dose, talk to your doctor or pharmacist.

Do not double a dose to make up for the dose you have missed.

This may increase the chance of you getting an unwanted side effect.

If you have trouble remembering to take your capsules, ask your doctor or pharmacist
for help.

If you take too much (overdose)

If you take too much Zeldox, you may feel slightly drowsy and show signs of tremor
and uncontrollable movements of the tongue, jaw, arms and legs. High and low blood
pressure, diarrhoea, a fast heart rate may also be experienced. Your lungs might fail
to breathe properly which can result in a build-up of carbon dioxide in the body.

Immediately telephone your doctor, or Poisons Information Centre 13 11 26 for advice,
or go to Accident and Emergency at your nearest hospital if you think that you or
anyone else may have taken too much Zeldox.

Do this even if there are no signs of discomfort or poisoning.

You may need urgent medical attention.

While you are taking it

Things you must do

Tell your doctor or pharmacist immediately if you become pregnant while taking Zeldox.

If you are about to start taking any new medicines, tell your doctor and pharmacist
that you are taking Zeldox.

Tell any other doctors, dentists and pharmacist who are treating you that you are
taking Zeldox.

Keep all of your doctor’s appointments so that your doctor can check your progress.

Your doctor will check your progress and may want to take some blood tests from time
to time. This helps to prevent unwanted side effects.

Talk to your doctor or mental health professional if you have thoughts or talk about
death, suicide or self-harm.

These may be signs of changes or worsening in your mental illness.

Things you must not do

Do not stop taking Zeldox or change the dosage, even if you feel better, without checking
with your doctor.

Do not use Zeldox to treat any other complaint unless your doctor tells you to.

Do not give Zeldox to anyone else, even if they have the same condition as you.

Things to be careful of

If you feel drowsy or sleepy while taking Zeldox, do not drive or operate machinery,
or do things that could be dangerous if you are not alert.

Medicines like Zeldox may cause drowsiness and sleepiness in some people. Make sure
you know how you react to Zeldox before you drive a car, operate machinery or do anything
else that could be dangerous if you are not alert.

Zeldox may also cause falls resulting in fractures or other injuries in some people.

Be careful when drinking alcohol while taking Zeldox.

Combining Zeldox and alcohol can make you more sleepy, dizzy or light-headed. Your
doctor may suggest you avoid alcohol while you are being treated with Zeldox.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you
are taking Zeldox.

This medicine has been prescribed to help you, but it may have unwanted side effects
in some people. All medicines can have side effects. Sometimes they are serious, most
of the time they are not. You may need medical attention if you get some of the side
effects.

Do not be alarmed by the following list of side effects.

You may not experience any of them.

Ask your doctor or pharmacist to answer any questions you may have.

Tell your doctor or pharmacist if you notice anything else that is making you feel
unwell.

Other side effects not listed below may also occur in some people.

Tell your doctor if…

Tell your doctor or pharmacist if you notice any of the following physical problems
and they worry you.

These are common side effects of Zeldox:

headache

feeling sick (nausea)

vomiting

sleepiness

difficulty sleeping

dizziness on standing up, especially when getting up from a sitting or lying position

dry mouth

too much saliva

indigestion

constipation

diarrhoea

restlessness

muscle stiffness

blurred vision

palpitations

weakness or loss of strength

male sexual dysfunction.

In schizophrenia studies of 4-6 weeks duration, the incidence of weight gain in people
taking Zeldox was low and comparable to those who took a placebo or inactive medicine.

Tell your doctor or pharmacist if you notice any of the following mental or emotional
problems and they worry you:

drowsiness or sleepiness

trouble sleeping

restlessness or difficulty sitting still

dizziness, blackouts or feeling faint

anxiety or agitation

loss of control of your bladder

unusual secretion of breast milk.

Tell your doctor or pharmacist if you have a persistent painful erection of the penis
without sexual arousal.

Tell your doctor as soon as possible if…

The following list includes serious side effects which may require medical attention.

Tell your doctor immediately if you notice:

any worm-like movements of the tongue

any other uncontrolled movements of the tongue, mouth, cheeks or jaw

any uncontrolled movements spreading to the arms and legs

sleepwalking

eating during sleepwalking

breathing stops and starts while sleeping. Symptoms can be loud or frequent snoring,
silent pauses in breathing, choking or gasping sounds.

These are symptoms of a condition called Tardive Dyskinesia. Tardive Dyskinesia is
more likely in people who have been taking Zeldox or other antipsychotics/neuroleptics
medications for a long time. If detected early, it is usually reversible. Your doctor
will decide whether to lower your dose or stop the medicine completely.

Go to hospital if…

The following list contains very serious side effects. These symptoms can also sometimes
happen after you stop taking Zeldox. You may need urgent medical attention or hospitalisation.

If any of the following happen, tell your doctor immediately or go to Accident and
Emergency at your nearest hospital:

convulsions, fit or seizures

trembling and shaking of the hands and fingers

shuffling walk and stiffness of the arms and legs

sudden uncontrollable muscle spasms in the eyes, head, neck and body

sudden signs of allergy – including skin rash, itching or hives; swelling of the face,
lips or tongue, shortness of breath or difficulty breathing (symptoms resembling a
condition called Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS))

pain and swelling in the large veins of your legs or hip

sharp chest pain, shortness of breath or and coughing up blood.

Stop taking Zeldox and contact your doctor immediately or go to Accident and Emergency
if you get all of the following at once:

high fever

fast breathing

stiff muscles

confusion, drowsiness or sleepiness

These are symptoms of a condition called Neuroleptic Malignant Syndrome (NMS).

After taking Zeldox

Storage

Keep the capsules in their pack until it is time to take them.

If you take the capsules out of the pack they may not keep well.

Keep Zeldox in a cool, dry place where the temperature stays below 30°C. Do not store
it or any other medicine in the bathroom or near a sink. Do not leave it in the car
or on window sills.

Heat and dampness can destroy some medicines.

Keep it where children cannot reach it.

A locked cupboard at least one and a half metres above the ground is a good place
to store medicines.

Disposal

If your doctor tells you to stop taking Zeldox, or the capsules have passed their
expiry date, ask your pharmacist what to do with any left over.

Product description

What it looks like

Zeldox 20 mg – blue/white capsules marked ZDX 20 and Pfizer.

Zeldox 40 mg – blue capsules marked ZDX 40 and Pfizer.

Zeldox 60 mg – white capsules marked ZDX 60 and Pfizer.

Zeldox 80 mg – blue/white capsules marked ZDX 80 and Pfizer.

All strengths come in blister packs of 60 capsules.

Ingredients

Active ingredients

Zeldox capsules contain the active ingredient ziprasidone. Each capsule contains either
20 mg, 40 mg, 60 mg or 80 mg of ziprasidone.

Other ingredients

lactose monohydrate

pregelatinised maize starch

magnesium stearate

gelatin

titanium dioxide (E171)

indigo carmine CI73015 (E132; 20, 40 and 80 mg capsules only)

black ink.

Supplier

Zeldox is supplied in Australia by:

Viatris Pty Ltd

Level 1, 30 The Bond

30-34 Hickson Road

Millers Point NSW 2000

www.viatris.com.au

Phone: 1800 274 276

Australian registration numbers

Zeldox 20 mg – AUST R 65526

Zeldox 40 mg – AUST R 65527

Zeldox 60 mg – AUST R 65528

Zeldox 80 mg – AUST R 65529.

This leaflet was prepared in November 2022

ZELDOX^® is a Viatris company trade mark

ujczeldc11122

Auro-Ziprasidone – Uses, Side Effects, Interactions

How does this medication work? What will it do for me?

Ziprasidone belongs to the class of medications called antipsychotics. It is used to control the symptoms of schizophrenia and the manic phase of bipolar disorder. It works by adjusting the balance of chemicals in the brain that are involved in schizophrenia.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles.  If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

How should I use this medication?

For the treatment of schizophrenia, the usual adult starting dose of ziprasidone is 40 mg twice daily, although a lower dose may be used. The dose can be increased gradually every 2 days up to 80 mg twice daily, as recommended by the doctor.

For the treatment of the manic phase of bipolar disorder, the recommended adult starting dose is 40 mg twice daily for 1 day, then increased to 60 mg or 80 mg twice daily.

For maintenance treatment, your doctor will recommend an appropriate dose for you.

The capsules should be swallowed whole with a glass of water. Do not open, crush, or chew the capsules. Take this medication with food at the same time every day.

Many things can affect the dose of a medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

Continue to take this medication regularly, even if you feel better. This will prevent the symptoms from returning. It is important to take this medication exactly as prescribed by your doctor. If you miss a dose by only a few hours, take it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store this medication at room temperature and keep it out of the reach of children.

What form(s) does this medication come in?

20 mg
Each blue opaque cap/off-white opaque body, size “5” hard gelatin capsule shell, filled with creamy to pale pinkish granular powder and imprinted with “F” on the blue opaque cap and “26” on the off-white opaque body with black ink, contains 20 mg of ziprasidone. Nonmedicinal ingredients: ethylcellulose, lactose monohydrate, pregelatinised starch, and magnesium stearate; Capsule shell: FD&C Blue 2, titanium dioxide, gelatin, and sodium lauryl sulfate.

40 mg
Each blue opaque cap/blue opaque body, size “3” hard gelatin capsule shell, filled with creamy to pale pinkish granular powder and imprinted with “F” on the blue opaque cap and “38” on the off-white opaque body with black ink, contains 40 mg of ziprasidone. Nonmedicinal ingredients: ethylcellulose, lactose monohydrate, pregelatinised starch, and magnesium stearate; Capsule shell: FD&C Blue 2, titanium dioxide, gelatin, and sodium lauryl sulfate.

60 mg
Each off-white opaque cap/off-white opaque body, size “2” hard gelatin capsule shell, filled with creamy to pale pinkish granular powder and imprinted with “F” on the blue opaque cap and “39” on the off-white opaque body with black ink, contains 60 mg of ziprasidone. Nonmedicinal ingredients: ethylcellulose, lactose monohydrate, pregelatinised starch, and magnesium stearate; Capsule shell: FD&C Blue 2, titanium dioxide, gelatin, and sodium lauryl sulfate.

80 mg
Each blue opaque cap/off-white opaque body, size “1” hard gelatin capsule shell, filled with creamy to pale pinkish granular powder and imprinted with “X” on the blue opaque cap and “66” on the off-white opaque body with black ink, contains 80 mg of ziprasidone. Nonmedicinal ingredients: ethylcellulose, lactose monohydrate, pregelatinised starch, and magnesium stearate; Capsule shell: FD&C Blue 2, titanium dioxide, gelatin, and sodium lauryl sulfate.

How should I use this medication?

For the treatment of schizophrenia, the usual adult starting dose of ziprasidone is 40 mg twice daily, although a lower dose may be used. The dose can be increased gradually every 2 days up to 80 mg twice daily, as recommended by the doctor.

For the treatment of the manic phase of bipolar disorder, the recommended adult starting dose is 40 mg twice daily for 1 day, then increased to 60 mg or 80 mg twice daily.

For maintenance treatment, your doctor will recommend an appropriate dose for you.

The capsules should be swallowed whole with a glass of water. Do not open, crush, or chew the capsules. Take this medication with food at the same time every day.

Many things can affect the dose of a medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

Continue to take this medication regularly, even if you feel better. This will prevent the symptoms from returning. It is important to take this medication exactly as prescribed by your doctor. If you miss a dose by only a few hours, take it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store this medication at room temperature and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Who should NOT take this medication?

Do not take this medication if you:

• are allergic to ziprasidone or any ingredients of the medication
• are taking medications such as dofetilide, sotalol, quinidine, mesoridazine, thioridazine, chlorpromazine, droperidol, pimozide, moxifloxacin, halofantrine, mefloquine, pentamidine, arsenic trioxide, levomethadyl acetate, probucol, tacrolimus, or any other medication that can cause QT prolongation (a specific type of heart arrhythmia)
• have, or have a history of, QT prolongation (including congenital long QT syndrome)
• have recently had a heart attack
• have severe heart failure

What side effects are possible with this medication?

Many medications can cause side effects.  A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• constipation
• cough
• diarrhea
• dizziness
• fatigue
• flu-like symptoms (e.g., fever, sore throat, chills)
• leakage of fluid or milk from breasts (women)
• menstrual changes
• nausea or upset stomach
• rash
• restlessness
• runny nose
• sexual difficulties
• weight gain

Although most of the side effects listed below don’t happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• abnormal movements of the face or tongue
• abnormal walking
• changes in body temperature, or feeling very hot and unable to cool down
• dizziness, especially when standing from a lying down or seated position
• fainting, losing consciousness, or feeling a change in the way your heart beats
• falls
• feeling very hot and unable to cool down (usually after exercise, dehydration, or being in a warm place)
• high blood pressure
• muscle twitching
• new or worsening constipation
• signs of a blood clot in the arm or leg (tenderness, pain, swelling, warmth, or redness in the arm or leg) or lungs (difficulty breathing, sharp chest pain that is worse when breathing in, coughing, coughing up blood, sweating, or passing out)
• signs of high blood sugar (e.g., frequent urination, increased thirst, excessive eating, unexplained weight loss, poor wound healing, infections, fruity breath odour)
• signs of infection (symptoms may include fever or chills, severe diarrhea, shortness of breath, prolonged dizziness, headache, stiff neck, weight loss, or listlessness)

Stop taking the medication and seek immediate medical attention if any of the following occur:

• abnormal heart rhythms (e. g., fast or slow heart rate, palpitations), fainting, or seizures
• painful erection lasting longer than 4 hours
• seizures
• signs of neuroleptic malignant syndrome (e.g., confusion, reduced consciousness, high fever, or muscle stiffness)
• skin rash and fever with swollen glands
• symptoms of a severe allergic reaction (e.g., itching or skin rash; shortness of breath; swelling of the face, lips, or tongue)
• signs of a severe skin reaction such as blistering, peeling, a rash covering a large area of the body, a rash that spreads quickly, or a rash combined with fever or discomfort
• symptoms of serotonin toxicity (e.g., confusion, fast heartbeat, hallucinations, restlessness, shaking, shivering, sudden jerking of muscles, sweating)
• symptoms of a stroke (e.g., sudden weakness or numbness of the face, arms, or legs [especially on one side]; slurred speech; vision problems)

Some people may experience side effects other than those listed.  Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Are there any other precautions or warnings for this medication?

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Abnormal heart rhythms: This medication can cause abnormal heart rhythms. Certain medications (e.g., sotalol, quinidine, thioridazine, chlorpromazine, pimozide, moxifloxacin, mefloquine, pentamidine, arsenic trioxide, tacrolimus) can increase the risk of a type of abnormal heart rhythm called QT prolongation, and should not be used in combination with ziprasidone. You are more at risk for this type of abnormal heart rhythm and its complications if you:

• are female
• are older than 65 years of age
• have a family history of sudden cardiac death
• have a history of heart disease or abnormal heart rhythms
• have a slow heart rate
• have congenital prolongation of the QT interval
• have diabetes
• have had a stroke
• have low potassium, magnesium, or calcium levels
• have nutritional deficiencies

If you have any of these risk factors, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Blood clots: Ziprasidone may increase the risk of blood clots, especially in the lower leg. Talk to your doctor or pharmacist if you have risk factors for developing blood clots (e.g., a family history of blood clots, recent major surgery, immobility due to air travel, or other reason).

Blood sugar: This medication may cause high blood sugar levels and a loss of blood glucose control. People with diabetes may find it necessary to monitor their blood sugar more frequently while using this medication. If you have diabetes or are at risk for developing diabetes, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. If you experience weakness, increased thirst, increased urination, and increased appetite while taking this medication, contact your doctor.

Body temperature: This medication, like other antipsychotic medications, can disrupt the body’s ability to control body temperature. People who exercise vigorously, who are exposed to extreme heat, are dehydrated, or are taking anticholinergic medications (e.g., benztropine, oxybutynin) are more at risk. Contact your doctor as soon as possible if you feel very hot and are unable to cool down while taking this medication.

Drowsiness/reduced alertness: Ziprasidone may interfere with activities requiring mental alertness. Avoid driving or potentially hazardous activities until you know how this medication affects you.

Lactose: This medication contains lactose. If you have hereditary problems of galactose intolerance, lactase deficiency, or glucose-galactose malabsorption discuss the appropriateness of this medication with your doctor.

Liver function: Liver disease or reduced liver function may cause this medication to build up in the body, causing side effects. If you have liver problems, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. Your doctor may want to test your liver function regularly with blood tests while you are taking this medication.

Low blood pressure: Ziprasidone may cause low blood pressure when rising from a sitting or lying down position. If you feel dizzy, lightheaded, feel your pulse racing, or if you faint, call your doctor. While you are taking this medication, get up slowly after you have been sitting or lying down.

Neuroleptic malignant syndrome (NMS): Ziprasidone, like other antipsychotic medications, can cause a potentially fatal syndrome known as neuroleptic malignant syndrome (NMS). If you notice the symptoms of NMS such as high fever, muscle stiffness, confusion or loss of consciousness, sweating, racing or irregular heartbeat, or fainting, get immediate medical attention.

Prolactin levels: As with other antipsychotics, ziprasidone can elevate levels of the hormone prolactin. This may lead to symptoms such as spontaneous flow of milk from the breast, irregular menstruation, breast enlargement (men), diminished sexual function (men), and decreased bone strength. If you experience any of these symptoms, contact your doctor.

Seizures: Ziprasidone may increase the risk of seizures, especially for people who have had seizures in the past. If you have a seizure disorders or a history of seizures, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Serotonin syndrome: Severe reactions are possible when ziprasidone is combined with other medications that act on serotonin, such as tricyclic antidepressants and serotonin reuptake inhibitors, which are used to treat depression. These combinations must be avoided. Symptoms of a reaction may include muscle rigidity and spasms, difficulty moving, and changes in mental state including delirium and agitation. Coma and death are possible.

If you are taking antidepressants, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Suicidal behaviour: People with mental illness may experience feelings of wanting to hurt themselves or others. If you experience these side effects or notice them in a family member who is taking this medication, contact your doctor immediately. You should be closely monitored by your doctor for emotional and behaviour changes while taking this medication.

Tardive dyskinesia (TD): Ziprasidone, like some other antipsychotic medications may cause tardive dyskinesia (TD) to develop. TD is a potentially irreversible syndrome of involuntary, repetitive movements of the face and tongue muscles. Although TD most commonly happens to seniors, especially women, it is impossible to predict who will develop TD. The risk of developing TD increases with higher doses and long-term treatment. If you experience muscle twitching or abnormal movements of the face or tongue, contact your doctor as soon as possible.

White blood cells: As with other antipsychotics, ziprasidone can lower the number of infection-fighting white blood cells in your blood. This can increase your risk of infections. If you experience frequent colds or other infections, contact your doctor. Your doctor will monitor your white blood cell levels with blood tests during treatment with ziprasidone.

Pregnancy: This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately.

Babies born to mothers who take this medication in the last 3 months of pregnancy may experience withdrawal symptoms after they are born, including breathing problems, difficulty feeding, or irritability. If you have been taking this medication during pregnancy, make sure you tell everyone involved in caring for you and your baby.

Breast-feeding: This medication may pass into breast milk. If you are breast-feeding and are taking ziprasidone, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using this medication have not been established for children less than 18 years of age.

Seniors: The safety of using this medication has not been established for adults 65 years of age or older. The increased risk of liver, kidney, and heart conditions increases the risk of side effects with the use of ziprasidone.

There may be a higher risk of strokes, heart attacks, and deaths associated with the use of ziprasidone by seniors with dementia. Seek medical attention immediately if you notice the signs and symptoms of a stroke (e.g., sudden weakness or numbness, speech problems, vision problems, dizziness, confusion, sudden severe headache), a heart attack (e.g., discomfort or pain in the chest, back, neck, jaw, arms; sweating; shortness of breath; nausea; lightheadedness), or infection (e.g., pneumonia). Ziprasidone should not be used by seniors with dementia.

What other drugs could interact with this medication?

There may be an interaction between ziprasidone and any of the following:

• alcohol
• alfuzosin
• amiodarone
• amphetamines (e. g., dextroamphetamine, lisdexamfetamine)
• angiotensin converting enzyme inhibitors (ACEIs; captopril, ramipril)
• angiotensin receptor blockers (ARBs; e.g., candesartan, irbesartan, losartan)
• antihistamines (e.g., azelastine, cetirizine, doxylamine, diphenhydramine, hydroxyzine, loratadine)
• antiseizure medications (e.g., carbamazepine, clobazam, levetiracetam, phenytoin, primidone, topiramate, valproic acid, zonisamide)
• anti-Parkinsons medications (e.g., amantadine, apomorphine, bromocriptine, levodopa, pramipexole, ropinirole, rotigotine)
• antipsychotic medications (e.g., haloperidol, risperidone, quetiapine)
• arsenic trioxide
• “azole” antifungals (e.g., fluconazole, ketoconazole, voriconazole)
• barbiturates (e.g., butalbital, phenobarbital)
• benzodiazepines (e.g., alprazolam, diazepam, lorazepam)
• beta-adrenergic blockers (e.g., atenolol, propranolol, sotalol)
• brimonidine
• buprenorphine
• bupropion
• buserelin
• cabergoline
• calcium channel blockers (e. g., amlodipine, diltiazem, verapamil)
• cannabis
• capecitabine
• chloral hydrate
• clonidine
• conivaptan
• degarelix
• dexmethylphenidate
• diabetes medications (e.g., acarbose, dapagliflozin, glyburide, insulin, linagliptin, lixisenatide, metformin, rosiglitazone)
• diphenoxylate
• disopyramide
• diuretics (e.g., furosemide, hydrochlorothiazide)
• domperidone
• doxepin
• dronedarone
• esketamine
• fingolimod
• flecainide
• flunarizine
• galantamine
• HIV protease inhibitors (e.g., indinavir, atazanavir, lopinavir, nelfinavir,)
• hydroxychloroquine
• indacaterol
• lemborexant
• leuprolide
• lithium
• loperamide
• macrolide antibiotics (e.g., azithromycin, clarithromycin, erythromycin)
• mefloquine
• methadone
• methylphenidate
• metoclopramide
• mifepristone
• mirtazapine
• monoamine oxidase inhibitors (MAOIs; e. g., moclobemide, rasagiline, phenelzine, selegiline, tranylcypromine)
• muscle relaxants (e.g., baclofen, cyclobenzaprine, methocarbamol, orphenadrine, tizanidine)
• narcotic pain relievers (e.g., codeine, fentanyl, morphine, oxycodone, tapentadol, tramadol)
• ondansetron
• pentamidine
• pitolisant
• pomalidomide
• pregabalin
• primaquine
• procainamide
• propafenone
• quinidine
• quinine
• quinolone antibiotics (e.g., ciprofloxacin, moxifloxacin, norfloxacin)
• rilpivirine
• romidepsin
• sacubitril
• salmeterol
• scopolamine
• selective serotonin reuptake inhibitors (SSRIs; e.g., citalopram, fluoxetine, paroxetine, sertraline)
• serotonin antagonists (antinausea medications; e.g., granisetron, ondansetron)
• serotonin/norepinephrine reuptake inhibitors (SNRIs; e.g., desvenlafaxine, duloxetine, venlafaxine)
• solifenacin
• sotalol
• tacrolimus
• tamoxifen
• tetrabenazine
• trazodone
• tricyclic antidepressants (e. g., amitriptyline, desipramine)
• tyrosine kinase inhibitors (e.g., dasatinib, imatinib, nilotinib, sunitinib)
• triptorelin
• tryptophan
• valerian
• vardenafil
• zolpidem
• zopiclone

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

All material copyright MediResource Inc. 1996 – 2023. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Source: www.medbroadcast.com/drug/getdrug/Auro-Ziprasidone

Zeldox capsules 40 mg №28

Zeldox capsules are indicated:

for the treatment of schizophrenia in adults. for the treatment of moderate manic or mixed episodes in patients with bipolar disorder.

Composition

Active ingredient: ziprasidone;

1 capsule contains 22.65 mg ziprasidone hydrochloride monohydrate, equivalent to 20 mg ziprasidone; 1 capsule contains 45.30 mg of ziprasidone hydrochloride monohydrate, equivalent to 40 mg of ziprasidone; 1 capsule contains 90. 60 mg ziprasidone hydrochloride monohydrate, equivalent to 80 mg ziprasidone;

Excipients: lactose monohydrate, corn starch; magnesium stearate;

Gelatin shell: titanium dioxide (E 171), sodium dodecyl sulfate, indigotine (E 132), gelatin; black ink: shellac, ethanol, isopropyl alcohol, n-butyl alcohol, propylene glycol, purified water, ammonium hydroxide, potassium hydroxide, black iron oxide (E172).

Contraindications

Hypersensitivity to ziprasidone or to any of the excipients listed in the Composition section. QT interval prolongation was established. Congenital long QT syndrome. Recent acute myocardial infarction. Decompensated heart failure. Arrhythmias in which antiarrhythmic drugs of classes IA and III are used. Concomitant use of drugs that prolong the QT interval. Such drugs include, in particular, antiarrhythmic drugs of classes IA and III, arsenic trioxide, halofantrine, levometadil acetate, mesoridazine, thioridazine, pimozide, sparfloxacin, gatifloxacin, moxifloxacin, dolasetron mesylate, mefloquine, sertindole or cisapride, dofetilide, sotalol, quinidine, chlorpromazine, droperidol, pentamidine, probucol or tacrolimus.

Directions for use

Adults. The recommended dose for the acute treatment of schizophrenia and bipolar mania is 40 mg twice daily with meals. Depending on the individual characteristics of the clinical condition, the daily dose may subsequently be increased to a maximum level of 80 mg twice a day. If indicated, the maximum recommended daily dose can be used already on the 3rd day of treatment. It is very important not to exceed the maximum daily dose, as the safety profile for doses greater than 160 mg per day has not been confirmed, and the use of ziprasidone is associated with a dose-dependent prolongation of the QT interval.

Application features

Pregnant women

Ziprasidone is not recommended for pregnant women unless the expected benefit to the mother outweighs the potential risk to the fetus.

Drivers

Ziprasidone may cause drowsiness and affect the reaction rate when driving and operating machines. Patients who may have to drive or operate machinery should be warned about this.

Overdose

Experience with ziprasidone overdose is limited. The highest documented single dose of ziprasidone is 12800 mg. At the same time, the development of extrapyramidal symptoms was reported; the duration of the QTc interval was 446 ms (no cardiac consequences). In general, extrapyramidal symptoms, drowsiness, tremors and anxiety have been most commonly reported in overdose.

The possibility of development of inhibition, court or dystonic reactions from the head and neck as a result of overdose may create a risk of aspiration in induced vomiting. Monitoring of the state of the cardiovascular system, including ECG monitoring, should be started immediately to detect the possible development of arrhythmias. There is no specific antidote for ziprasidone overdose.

Adverse effects

The most common adverse reactions in clinical trials for schizophrenia were insomnia, drowsiness, headache and agitation. The most common adverse reactions in clinical studies of bipolar mania were sedation, headache, and drowsiness.

Interactions

Concomitant use of drugs that prolong the QT interval is contraindicated. Such drugs include, in particular, antiarrhythmic drugs of classes IA and III, arsenic trioxide, halofantrine, levometadil acetate, mesoridazine, thioridazine, pimozide, sparfloxacin, gatifloxacin, moxifloxacin, dolasetron mesylate, mefloquine, sertindole or cisapride, dofetilide, sotalol, quinidine, chlorpromazine, droperidol, pentamidine, probucol or tacrolimus.

Storage conditions

Store in the original packaging, out of the reach of children, at a temperature not exceeding 25°C.

Shelf life – 4 years.

Zeldox instructions, price in pharmacies of Ukraine

There are no products on the site with the trade name “Zeldox”

Editorial team

Creation date: 04/27/2021
Date updated: 24.06. 2023

Warehouse and release form

Warehouse

speech: ziprasidone;

1 capsule contains 22.65 mg ziprasidone hydrochloride monohydrate, which is equivalent to 20 mg ziprasidone;
1 capsule contains 45.30 mg ziprasidone hydrochloride monohydrate, which is equivalent to 40 mg ziprasidone;
1 capsule contains 90.60 mg ziprasidone hydrochloride monohydrate, which is equivalent to 80 mg ziprasidone;
additional speech: lactose monohydrate, corn starch; magnesium stearate gelatin shell: titanium dioxide (E 171), sodium dodecyl sulfate, indigotine (E 132), gelatin; black ink: shellac, ethanol, isopropyl alcohol, n-butyl alcohol, propylene glycol, purified water, ammonium hydroxide, potassium hydroxide, black oxide (E172).

Release form

Hard capsules 20 mg, 40 mg and 80 mg each. For 14 hard capsules in a blister, 2 blisters in a cardboard box.

Pharmacological action

Pharmacodynamics s serotonin receptor type 2A (5HT2A).

Positron emission tomography showed that after 12:00 after taking a single dose of 40 mg, blocking of type 2A serotonin receptors was greater, lower than 80%, and blocking of D2 receptors was greater, lower than 50%. Ziprasidone also interacts with serotonin receptors 5HT2C, 5HT1D and 5HT1A. The sporidity of the drug with cimi receptors is more or more likely to develop, lower sporidity with D2 receptors. Ziprasidone may be associated with neuronal serotonin and norepinephrine transporters, and also exhibits association with histamine H(1)-i alpha(1) receptors. The association of ziprasidone with muscarinic M(1) receptors is not significant.

Ziprasidone has been shown to be a serotonin type 2A (5HT2A) and dopamine type 2 (D2) receptor antagonist. As a result of the proponation mechanism, the antipsychotic drug causes frequent delusions with a combination of antagonistic infusions. Ziprasidone also acts as an inhibitory antagonist of 5HT2C and 5HT1D receptors, an inhibitory agonist of 5HT1A receptors, and inhibits norepinephrine and serotonin neuronal reuptake.

Pharmacokinetics

Smearing. The maximum concentration of ziprasidone in the blood serum is reached in 6-8 years after taking a mid-range dose of ziprasidone at the same time. The bioavailability of a single dose of 20 mg after taking it becomes 60%. Previous pharmacokinetic studies have shown that in the presence of ziprasidone bioavailability can increase up to 100%. In this rank, the drug is recommended to be taken at the same time.

Rozpodil. The total dose was approximately 1.1 l/kg. Ziprasidone binds to proteins in blood serum by 99%.

Metabolism and vision. The period of administration of ziprasidone after oral ingestion was 6.6 years. An equally important camp is reached within 1-3 days from the cob of glory. The average clearance of ziprasidone with intravenous ingestion is 5 ml / min / kg. Approximately 20% of the dose is administered intramuscularly and approximately 66% of the drug is administered via the feces.

Indication before congestion

• Ziprasidone is indicated for the treatment of schizophrenia in adults.
• Ziprasidone is indicated for the treatment of manic or moderate episodes of moderate severity in patients with bipolar disorder (prophylaxis of episodes of bipolar disorder has not been established).

Contraindications

• Hypersensitivity to ziprasidone or to any of the additional speeches assigned to the Warehouse division.
• QT interval lowering introduced.
• Low QT syndrome.
• Recent episodes of hostile myocardial infarction.
• Decompensated heart failure.
• Arrhythmias, in which the use of antiarrhythmic drugs of classes IA and III.
• One-hour drug intake to keep the QT interval down. Before such drugs lie, zocrema, antiarrhythmic drugs of classes IA and III, mishyaku trioxide, halofantrine, levometadil acetate, mesoridazine, thioridazine, pimozide, sparfloxacin, gatifloxacin, moxifloxacin, dolasetron mesylate, mefloquine, sertindole or cisapride, dofetilide, sotalol, quinidine , chlorpromazine, droperidol, pentamidine, probucol or tacrolimus.

Dosing method

Mature. The recommended dose for the intractable treatment of schizophrenia and bipolar mania is 40 mg twice daily for an hour. Depending on the individual characteristics of the clinical setting, the additional dose may be increased up to the maximum level, which should be 80 mg dvіchi per dose. If indicated, the maximum recommended additional dose can be stopped already on the 3rd day of treatment. It is also important not to overestimate the maximum supplementary dose, but the safety profile for doses that exceed 160 mg per dose is not confirmed, but the ziprasidone intake is associated with a dose-dependent lowering of the QT interval.

For encouraging treatment in patients with schizophrenia, ziprasidone should be administered at the lowest effective dose. In case of sufficient amounts, 20 mg of binary per dose may appear.

Patients of a frail age. It is not indicated to reduce the cob dose of the drug for patients in patients aged 65 years, but such a possibility should be considered if there are obvious clinical factors.

Patients with impaired neurological function. Patients with impaired function of the drug will not require a dose adjustment of the drug.

Patients with impaired liver function. When the drug is ingested in patients with hepatic insufficiency, the possibility of injecting low doses should be considered.

Overdose

Overdose of ziprasidone The highest single dose of ziprasidone that has been documented is 12800 mg. When it was mentioned about the development of extrapyramidal symptoms; the QTc interval lapsed to 446 ms (no side effects on the heart). In case of overdose, it was most often reported about extrapyramidal symptoms, drowsiness, tremors and a little anxiety.

Possibility of developing galvanization, the court or dystonic reactions from the side of the head and neck as a result of overdose can create a risk of aspiration with induced vomiting. Next, start monitoring of the cardiovascular system, including ECG monitoring with a method of detecting a possible development of arrhythmia. There is no specific antidote for ziprasidone overdose.

Sideways

about 6500 grown-ups were stuck. The most widespread side effects in the course of clinical follow-up of schizophrenia were insomnia, drowsiness, headache and impairment. The most widespread side effects in clinical cases of bipolar mania were sedative effect, headache and drowsiness.

Lower induced adverse reactions seen in controlled cases of schizophrenia and bipolar mania.

Adverse reactions induced by class and frequency: more common (³ 1/10), often (ex ³ 1/100 up to or because of the zastosuvannyam satellite

Immunity disorders

Uncommon hypersensitivity

Rare anaphylactic reactions

Infections and invasions.

Often rhinitis.

To the side of the blood and lymphatic systems.

Rarely lymphopenia, increased number of eosinophils.

On the side of the endocrine system.

Uncommon hyperprolactinemia.

Improve metabolism and poisoning.

Uncommon: increased appetite.

Rarely hypocalcemia.

From the side of the psyche.

Even more often sleepless.

Often mania, agitation, apparent anxiety, restlessness.

Infrequently, panic attacks, nightmares, nervousness, depressive symptoms, decreased libido.

Rarely hypomania, bradyphrenia, anorgasmia, aggravation of affect.

To the side of the nervous system.

Often drowsiness, headache.

Often dystonia, extrapyramidal disorders, parkinsonism, dyskinesia, dyskinesia, hypertonicity, akathisia, tremor, confusion, sedative effect.

Infrequently restlessness, grand mal attack, ataxia, akinesia, restless legs syndrome, impaired gait, sleeplessness, paresthesia, hypoesthesia, dysarthria, impaired mood, hypersomnia, lethargy.

Rarely evil neuroleptic syndrome, serotonin syndrome, facial paralysis, paresis.

Rear side opening.

Often the dawn is clouded, the dawn is destroyed.

Infrequently spasm of the point of dawn, fear of light, dryness of the eyes.

Rarely amblyopia, stinging eyes.

To the side of the hearing organs and equal.

Infrequently vertigo, ringing in the ears, white in the ears.

3rd side of the heart.

Often tachycardia.

Uncommon: premature heartbeat.

Rare torsade de pointes tachycardia.

To the side of the vessel system.

Often arterial hypertension.

Uncommon hypertensive crisis, orthostatic hypotension, arterial hypotension.

Rarely systolic hypertension, diastolic hypertension, unstable arterial pressure.

Not known: venous embolism.

To the side of the dichal system, chest organs and the middle.

Infrequently: visible tightness in the throat, buttocks, pain in the oropharynx.

Rarely laryngospasm, whooping.

To the side of the intestinal tract.

Often vomiting, diarrhoea, nausea, constipation, excess secretion of slugs, dry mouth, dyspepsia.

Infrequently dysphagia, gastritis, gastroesophageal reflux, abdominal discomfort, movement disorder, flatulence.

Rarely rare stile.

To the back of the coat and underarm fabric.

Often hanging.

Infrequently: kropivyanka, maculopapular visip, acne, alopecia.

Rare drug reaction that accompanies eosinophilia and systemic manifestations (DRESS), psoriasis, angioedema, allergic dermatitis, rash, erythema, papular drooping, teasing nya shkiri.

On the side of the support system and the successful fabric.

Often the rigidity of m’yaziv.

Infrequently, torticollis, convulsions of m’yaziv, pain at the ends, discomfort from the side of the musculoskeletal apparatus, stupor of the swollen.

Rare trismus.

On the side of the sciatic system.

Infrequently: non-mania colic, dysuria.

Rarely: slaughtering, enuresis.

Vagіtnіst, pіslyalogovі and perinatal stаnі.

Rare drug administration syndrome in a new patient.

From the side of the reproductive system and milk worms.

Often impaired state function in people.

Uncommon galactorrhea, gynecomastia, amenorrhea.

Rarely priapism, erectile dysfunction, erectile dysfunction.

Disorders of a violent nature and reactions in the area of ​​administration of the drug.

Often pyrexia, baldness, asthenia, increased swelling.

Uncommon chest discomfort

Rarely: watching the heat.

Laboratory investigations.

Often body weight change, body weight change.

Uncommon: Longer QT interval on ECG, follow-up on normal liver function tests.

Rarely: increased levels of lactate dehydrogenase in the blood.

Special inserts

Congestion during pregnancy and breastfeeding

Vaccine. Studies of the reproductive toxicity of ziprasidone demonstrated the presence of an adverse effect on the reproductive process at fixed doses, associated with a toxic effect on the mother’s body and/or a sedative effect. The sign of teratogenicity was not detected for the drug.

There was no follow-up of drug ingestion by vaginal women. For women of reproductive age, which may be of concern, if ziprasidone is ingested, it should be recommended to use other methods of contraception. Oskіlki dosvіd zastosuvannya ziprasidone to women in the period of vagity of obmezheny, ziprasidone is not recommended to be recognized as a vagrant because of the vignette of vipadkіv, if the measles for the mother is cited, it outweighs the potential risk for the fetus.

Neonates whose mothers have taken antipsychotic drugs (including ziprasidone) during the 3rd trimester of pregnancy, enter into a risky group after the onset of adverse reactions, including extrapiramidal symptoms and / or symptoms of other symptoms neither; the stages of severity and the severity of such manifestations after gentle slopes can be different. It was mentioned about the development of agitation, hypertension, hypotension, tremor, drowsiness, dychal insufficiency, or disruption of the year. Therefore, behind the camp of such new people should be carefully guarded. Zeldox® does not slud zastosovuvat pіd h vagіtnostі, a vignette vipadkіv, if zastosuvannya drug is undoubtedly necessary. If it is necessary to take the drug into account for an hour of vaginess, it is not necessary to take a stop raptovo.

Breastfeeding. It is not known whether ziprasidone or its metabolism passes into breast milk. Patients should try to reduce their breastfeeding at the hour of ziprasidone intake.

Children

The safety and efficacy of ziprasidone ingestion for the treatment of schizophrenic children with schizophrenia has not been established.

Ziprasidone can cause drowsiness and affect the speed of the reaction when cared for by vehicles and other mechanisms

mami. Keep ahead of the patients, as it is possible to sit at the kermo or practice with the mechanisms.

Interaction with other medicinal products and other forms of interaction

wait for the QT interval, did not perform. The additive effect of such drugs and ziprasidone cannot be excluded. Therefore, ziprasidone has not been shown to be concomitantly associated with drug use, as long as the QT interval is extended (antiarrhythmic drugs class IA and III, mish’yaku trioxide, halofantrine, levometadil acetate, mesoridazine, thioridazine, pimozide, sparfloxacin, gatiflo xacin, moxifloxacin, dolasetron mesylate, mefloquine, sertindol or cisapride).

Drugs to infuse into the central nervous system / alcohol. In view of the main effects of ziprasidone, care should be taken when using ziprasidone with other drugs that are injected into the central nervous system, and with alcohol.

Injection of ziprasidone for other drug use.

In vivo studies with dextromethorphan have shown a non-significant reduction in CYP2D6 at plasma concentrations 50% lower than would be expected following a dose of 40 mg ziprasidone raze in doba. In vitro data suggest that ziprasidone may be a moderate inhibitor of CYP2D6 and CYP3A4. However, it is of little significance that the use of ziprasidone matime has a clinically significant impact on the pharmacokinetics of drugs, the metabolism of which is affected by the presence of cytochrome P450 cytochrome isoforms.

Ziprasidone can cause hypotension to be diagnosed, which may lead to possible antihypertensive drug use.

Ziprasidone may have an antagonistic effect on levodopa and dopamine antagonists.

Oral contraceptives. Zastosuvanya ziprasidone led to insignificant changes in the pharmacokinetics of estrogen (ethinilestradiol, which is a substrate of CYP3A4) or progesterone components.

Lithium. Overnight exposure to ziprasidone did not affect the pharmacokinetics of lithium. Oskils of ziprasidone and lithium cause changes in cardiac conductivity, the combination of these compounds can create a risk of pharmacodynamic interactions, including arrhythmias. At the same time, at the same time, the monitoring of clinical follow-ups of one-hour exposure to ziprasidone and lithium was not accompanied by an increase in clinical risk in the absence of lithium exposure to monotherapy.

Data about an hour-long exposure to carbamazepine (mood stabilizer)

Pharmacokinetic interactions of ziprasidone with maloimovirn valproate through the presence of major metabolic pathways for these drugs. In a recent one-hour infusion of ziprasidone and valproate, it was demonstrated that the mean concentration of valproate was within the therapeutic range in the same range as in an one-hour infusion of valproate and placebo.

Influx of other drug benefits on ziprasidone.

Ketoconazole (a CYP3A4 inhibitor, also influencing P-glycoprotein) at 400 mg/dose increased ziprasidone blood levels by

and in the long run for 21 days, the exposure to ziprasidone decreased by approximately 35%.

Antacidi. Bagatorase ingestion of aluminum and magnesium antacids or cimetidine did not lead to a clinically significant impact on the pharmacokinetics of ziprasidone in case of subsequent intoxication.

Serotonergic drug concerns. In a few cases, it has been reported about the development of serotonin syndrome associated with ziprasidone in combination with other serotonergic drugs (for example, with selective serotonin ingestion inhibitors) (div. Rozdі l “Adverse reactions”). Before the manifestation of serotonin syndrome, there may be confusion, agitation, fever, drunkenness, ataxia, hyperreflexia, myoclonic spasms and diarrhea.

Communication with blood plasma proteins. Ziprasidone in a significant world binds with plasma proteins. The binding of ziprasidone to plasma proteins in vitro did not include warfarin or propranolol (drugs that actively bind to blood plasma proteins), similarly, ziprasidone did not change the characteristics of the association of these drugs with human plasma proteins. Thus, the potential interactions of ziprasidone with other drugs are less likely to occur behind the mechanism of vision.

In vitro studies. An in vitro study of enzymatic inhibition with vicarious human liver microsomes demonstrated that ziprasidone may have a non-significant effect on CYP1A2, CYP2C9, CYP2C19, CYP2D6 and CYP3A4, however, will not affect drug metabolism, but are primarily metabolized by these enzymes. Interactions between medicinal preparations and ziprasidone after substitution is slightly movable.

Cimetidine. Cimetidine when taken at a dose of 800 mg 1 time per day for 2 days without adding ziprasidone to the pharmacokinetics.

Dextromethorphan. Results based on the participation of healthy volunteers, which can be compared with the results of in vitro studies, demonstrated that ziprasidone does not interfere with the metabolism of dextromethorphan, a reference substrate for the CYP2D6 enzyme, to its main metabolite, dextrorphan. There was no statistically significant change in the dextromethorphan/dextrorphan spacing in the section.

One-hour visit with other medical care. Population pharmacokinetic analysis of patients with schizophrenia enrolled in controlled clinical trials, showing no confirmation of evidence or clinically significant pharmacokinetic interactions with benztropine, propranolol, or lo razepam.

Interaction with food products. The bioavailability of the drug at a dose of 20 mg when taken with the same dose becomes close to 60%. When taken together, ziprasidone is more effective when taken together.

Wash Safety

Store in original packaging at a temperature not exceeding 25 °C, out of the reach of children.

Applicability term – 4 years.

Zeldox instructions

ZELDOX®
(UA/2595/01/01)

Release form:

hard capsules, 40 mg; 14 capsules in a blister; 2 blisters in a cardboard box; 10 capsules in a blister; 3 blisters in a cardboard box

Stock:

1 capsule contains 45. 30 mg of ziprasidone hydrochloride monohydrate, which is equivalent to 40 mg of ziprasidone

Manufacturer:

Nіmechchina

ZELDOX®
(UA/2595/01/03)

Release form:

hard capsules, 80 mg; 14 capsules in a blister; 2 blisters in a cardboard box; 10 capsules in a blister; 3 blisters in a cardboard box

Stock:

1 capsule contains 90. 60 mg of ziprasidone hydrochloride monohydrate, which is equivalent to 80 mg of ziprasidone

Manufacturer:

Nіmechchina

ZELDOX®
(UA/2595/01/04)

Release form:

hard capsules, 20 mg; 14 capsules in a blister; 2 blisters in a cardboard box; 10 capsules in a blister; 3 blisters in a cardboard box

Stock:

1 capsule contains 22.