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Zedan Tablet

Generic Name(s): Aripiprazole

Why it's used

Zedan Tablet is used to treat schizophrenia, irritability associated with a serious developmental disorder, illness of the brain and moderate to severe manic episodes in bipolar I disorder. It is a prescription medicine. This medicine works by altering the activity of certain natural chemicals in the brain. Zedan is also used for the acute treatment of manic and mixed episodes associated with bipolar I disorder in adults. It is also used for the adjunctive treatment of major depressive disorder. Zedan is also used to treat agitation associated with schizophrenia or bipolar mania (for injection). Zedan Tablet is also used to prevent new manic episode in adults who previously experienced manic episodes.
Zedan Tablet may also be taken in combination with other medicines to treat certain conditions as recommended by the doctor. Zedan Tablet is used together with antidepressants to treat major depressive disorder. Zedan is also used with Lithium, or Valproate to treat bipolar mania.
When not to use
Zedan Tablet cannot be used to treat dementia-related psychosis.
Atypical Antipsychotics
Zedan belongs to a class of medicines called Atypical Antipsychotics. Atypical antipsychotics are a group of antipsychotic drugs used to treat psychiatric conditions. These medicines are used to treat schizophrenia, bipolar disorder, autism, and used along with other medicines in the treatment of major depressive disorder.

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How to use

Read the directions on the product label, patient guide, or medicine guide provided by the medicine company or your pharmacist before starting to use Zedan Tablet. If you have any questions related to this medicine, ask your doctor or pharmacist. Use this medicine as recommended by your doctor.
Zedan Tablet is used with or without food. Swallow the whole tablet with water. This medicine should be taken once a daily without regard to meals.

Typical Dosage

The typical dose of Zedan is 5-15 mg/day (not more than 30 mg in one day). The usual dose for children is 5-10 mg/day without regard to meals. The maximum adult dose of Zedan is 30 mg/day in a day.
You should continue to use this medicine as directed by the doctor even if you feel well.
To decrease the possibility of side-effects, you might be recommended to use the extended-release form of this medicine by your doctor. The extended-release medicine helps in maintaining a steady level of the medicine in your body for a longer period of time. Do not crush or chew the medicine, unless indicated on the package or by your doctor.
If using the orally-disintegrating form of this medicine, make sure you do not consume any food or fluid 5 minutes before or after taking this medicine. Before taking the medicine out of the package, wash your hands thoroughly. Place the medicine on the tongue. Make sure you do not chew or swallow the medicine. You do not need to drink water after consuming the medicine. In certain cases, the medicine can taste slightly bitter. Also, ensure that you do not break or split the medicine.
Zedan injection is indicated for intramuscular use only. Injection should be injected slowly and deeply into the muscle mass. The injection form of the medicine should not be used on the vein, or under the skin
If using the liquid form of this medicine, measure the dose using the provided measuring cup, spoon, or dropper. Before pouring the medicine into the measuring device, you should check the measurement markings carefully. Then, pour the dose amount into the device. After use, clean and store the measuring device in a safe place for your next use. You should not use a tablespoon or teaspoon as the dose measuring devices since it can result in an incorrect dose. If indicated on the product package, shake the medicine before use.

Talk to Your Doctor

Talk to your doctor if your condition persists or worsens or if you develop new symptoms. Tell your doctor if thoughts about suicide or dying, depression, anxiety, feeling very agitated or restless, panic attacks, insomnia, irritability, a sudden feeling or desire, an extreme increase in activity and talking, and other unusual changes in behavior or mood. You should consult with your doctor before stopping the use of Zedan.
Your doctor may recommend a lower initial dose of this medicine to see the impact of this medicine on the body. Please follow your doctor's directions. Taking a higher dose of this medicine may increase the risk of side-effects. Older patients may see an increase in the incidence of side-effects with this medicine. As a result, a lower dose may be recommended for older patients.
When stopping this medicine, you may experience withdrawal symptoms such as involuntary body movements (tardive dyskinesia), agitation, increased muscle tone (hypertonia), decreased muscle tone (hypotonia), tremor, drowsiness, trouble breathing (respiratory distress), and feeding disorder. You may need to gradually decrease the dose of this medicine before stopping.

Use in Children

If you are giving Zedan Tablet to a child, be sure to use a product that is meant for children. Before giving this medicine to a child, use the child's weight or age to find the right dose from the product package. You can also read the dosage section of this page to know the correct dose for your child. Else, consult with your doctor and follow their recommendation.

Avoid Alcohol

Avoid the consumption of alcohol with Zedan. Avoid grapefruit juice while using Zedan. Consult with the doctor about drinking grapefruit juice while taking Zedan therapy.

Lab Tests

Your doctor may request that specific lab tests be performed before you start using Zedan Tablet. You may need to have Blood Glucose test. Blood glucose should be checked before starting the treatment because high blood sugar can happen during the therapy.

Storage

You should store Zedan Tablet at 25°C (77°F), and away from moisture. Store the medicine away from the reach of children and pets.
Medicines may be prescribed for uses other than those listed in the medicine guide. Do not use Zedan Tablet for conditions for which it was not prescribed. Do not give Zedan Tablet to other people who might have the same conditions or symptoms that you have. Self-medication may harm them.

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How to take Zedan

Your dose may depend on several personal factors. You should consult with your doctor to find out the dose that is best for you. The dose of Zedan depends on the following factors:
  • patient's age
  • patient's weight
  • medicines recommended by your doctor
  • any other medicines in use
  • herbal supplements consumed

Zedan Dosage

Dosage for schizophrenia

Adult
  • Recommended: 10-15 mg/day and maintenance dose 15 mg/day
  • Initial: 10-15 mg/day
  • Maximum: 30 mg/day
Children (13-17 years)
  • Recommended: 10 mg/day
  • Initial: 2 mg/day
  • Maximum: 30 mg/day

Dosage for manic episodes in bipolar I disorder

Adult
  • Recommended: 15 mg/day as monotherapy or as combined therapy with lithium or valproate
  • Initial: 15 mg/day as monotherapy and 10-15 mg/day as combined therapy with lithium or valproate
  • Maximum: 30 mg/day
Children (10 to 17 years)
  • Recommended: 10 mg/day as monotherapy or as combined therapy with lithium or valproate
  • Initial: 2 mg/day as monotherapy or as combined therapy with lithium or valproate
  • Maximum: 30 mg/day

Dosage for adjunctive treatment of major depressive disorder

Adult
  • Recommended: 5-10 mg/day
  • Initial: 2-5 mg/day
  • Maximum: 15 mg/day

Dosage for irritability associated with developmental disorder

Children (6 to 17 years)
  • Recommended: 5 to 15 mg/day
  • Initial: 2 mg/day
  • Maximum: 15 mg/day

Dosage for illness of the brain (Tourette’s disorder)

Children (6 to 18 years)
  • Recommended: 5 mg/day in patients <50 kg (<22.7 lb)
  • Initial: 2 mg/day in patients <50 kg (<22.7 lb)
  • Maximum: 10 mg/day in patients <50 kg (<22.7 lb)
Children (6 to 18 years)
  • Recommended: 10 mg/day in patients ≥50 kg (≥22.7 lb)
  • Initial: 2 mg/day in patients ≥50 kg (≥22.7 lb)
  • Maximum: 20 mg/day in patients ≥50 kg (≥22.7 lb)

Dosage for agitation associated with schizophrenia/bipolar mania

Adult
  • Recommended: 5.25 to 15 mg/day
  • Initial: 9.75 mg/1.3 ml (injection in the muscle)
  • Maximum: 30 mg/day

Dosage calculation for children

To calculate the dosage for children please use the weight based dose calculator to calculate the appropriate dosage as per the weight of your child.

Forms

Tablet, orally disintegrating
Strength: 10 mg, 15 mg, and 30 mg
Tablet
Strength: 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg
Solution
Strength: 1 mg/mL
Injection, powder, lyophilized, for suspension, extended release
Strength: 300 mg/1.5 ml, 400 mg/2.0 ml
Injection, powder, for suspension, extended release
Strength: 300 mg, 400 mg
Injection, solution
Strength: 9.75 mg/1.3 ml

Special Instructions

Injection (in the muscles)
Wait at least 2 hours between doses. The maximum daily dose is 30 mg/day.
Oral formulations
Drink plenty of water every day while taking Zedan.
Orally disintegrating tablet
Do not push the tablet through the foil. Use dry hands during handling the tablet. Immediately take out the tablet from the package and place the whole tablet on the tongue. The tablet will rapidly dissolve in saliva and this medicine can be swallowed without liquid. However, if necessary, the tablet can be taken with liquid. Do not attempt to split the tablet.
Oral solution
Oral solution can be used for up to 6 months after opening.

Missed Dose

A missed dose should be taken as early as you remember it. However, if the time for the next dose is almost there, then the missed dose should be skipped, and the regular dosing schedule should be continued. Avoid taking a repeated dose to make up for a missed dose.

Overdose

What to do if you overdose on Zedan?
An electrocardiogram should be done in case of overdose and, if abnormal heart rhythm occurs, heart monitoring should be considered. Ventilation, oxygenation, adequate airway, and symptoms management along with supportive therapy should be considered in the management of overdose. Monitoring and medical supervision should be continued until the condition of the patient improves. The harmful effects of Zedan are also be reduced by taking activated charcoal which preventing the absorption of Zedan.
Symptoms of an overdose of Zedan
If you use too much of this medicine, it could lead to dangerous levels of the medicine in your body. In such cases, symptoms of an overdose may include:
If you think you have overdosed on Zedan Tablet, call a poison control center immediately. You can look up the poison control center information from the Poison Center Finder at TabletWise.com.

Precautions while using Zedan

Before you use Zedan, tell your doctor of your medical and health history including the following:
  • a family history of suicide, bipolar disorder, and depression
  • attention-deficit/hyperactivity disorder
  • blood clots
  • blood vessel related heart and brain diseases
  • build up of phenylalanine in the body (phenylketonuria)
  • drug abuse
  • excessive gambling
  • high blood glucose
  • high cholesterol levels (dyslipidemia)
  • learning abnormalities (Alzheimer's dementia)
  • low levels of white blood cells and neutrophils
  • mental disorder associated with learning abnormality (dementia-related psychosis)
  • obesity
  • patients taking antidepressants, antifungal, anticonvulsants, antibiotics, antihistamines, quinidine, sleeping pills or other medicines used to treat human immunodeficiency virus infection, irritable bowel syndrome, anxiety, high blood pressure, urinary problems, mental illness, or ulcers
  • schizophrenia
  • seizure
  • thyroid or pituitary tumor
  • uncontrollable and reoccurring thoughts (obsessive-compulsive disorder)
Patients with a history of depression or other serious brain illness are at increased risk of suicidal thoughts and actions when using Zedan. Zedan may cause low or high blood pressure in patients with a history of heart disease. Obese patients or patients with a history of high blood sugar may experience an increased level of glucose and acids in the blood (diabetic ketoacidosis) or complication due to high blood sugar (hyperosmolar coma) when using Zedan. Weight gain can occur in patients with a history of thyroid or pituitary cancer (adenoma) when using Zedan. This may also occur in schizophrenic and bipolar mania patients when using Zedan. Elderly patients with a mental disorder associated learning abnormality (dementia-related psychosis) using Zedan are at an increased risk of lack of energy (lethargy), drowsiness, involuntary passage of urine (urinary incontinence), lightheadedness and stroke/transient ischemic attack, which can be possibly fatal. Patients with a history of learning abnormalities (Alzheimer's dementia) are at increased risk of complications due to inhalation of food, acid, and saliva (aspiration pneumonia) when using Zedan.
Before you use Zedan Tablet, tell your doctor if you are allergic to it or its ingredients. Your doctor may prescribe an alternative medicine and update your medical records to record this information.
Before having any surgery when using Zedan, tell your doctor and dentist about all the medicinal products you use including prescription and non-prescription medicines, and any herbal supplements.
The use of this medicine may change blood sugar. Zedan may cause high blood sugar or worsen the blood sugar in patients taking Zedan or in patients with high blood sugar respectively. These patients should be observed for symptoms and signs of high blood sugar such as weakness, increased thirst or urine passage and excessive eating.
The use of Zedan Tablet may change fat levels. Zedan may cause an abnormal increase in the levels of lipids (cholesterol and triglycerides) in the blood.
The use of this medicine may change body weight. Zedan may cause an increase or decrease in weight in patients taking this medicine.
The use of this medicine may change heart rate and blood pressure. Zedan may cause a decrease in blood pressure and increase in heart rate on quickly standing up.
The use of Zedan Tablet may change white blood cells. Zedan may decrease the number of leukocytes (leukopenia), granulocytes, or neutrophils in the blood. This medicine should be discontinued on the occurrence of neutropenia.

Alcohol

Avoid the consumption of alcohol with Zedan Tablet. Drinking alcohol may cause sedation, and drowsiness.

Use in Pregnancy

Zedan Tablet should be used in pregnancy only when required. When pregnant women use Zedan during the third trimester of pregnancy, it may cause side effects such as birth defects, anxiety, increased or decreased muscle tone, tremor, trouble breathing (respiratory distress), drowsiness, and feeding disorder in the neonates. Neonates should be monitored for side effects. Zedan should be used during pregnancy only after considering the potential benefits and risks to the fetus.

Use while Breastfeeding

Zedan should be used while breastfeeding only when required. Zedan may pass into breast milk which may cause harmful effects to the infants. A decision to discontinue Zedan or nursing should be made after considering the importance of Zedan to the mother.

Impact on Fertility

Zedan Tablet is known to be safe for use in women who are trying to conceive a baby. Zedan does not affect the conceiving ability as per the data based on the reproductive studies.

Seizures

Zedan Tablet can make you feel sleepy. Be careful while driving, using machinery, or doing any other activity that needs you to be alert. The consumption of alcohol with Zedan Tablet can make you feel more sleepy. Zedan Tablet may cause seizures in some people. Discuss with your doctor if you perform activities where a loss of consciousness may cause you or others harm.

Increased Risk

This medicine may increase your sensitivity to sunlight. If this happens, limit your time outdoors and prevent sunburns. Cover your skin or use a sunscreen.

Side-effects in Children

Zedan Tablet may cause an increased risk of side-effects in younger patients. Children using this medicine may see an increased risk of suicidal thinking and behavior.

Side-effects in Older Patients

Zedan Tablet may increase side-effects in older patients. Elderly patients may see an increased risk of stroke, heart failure, lung infection (pneumonia), possibly fatal, involuntary body movements (tardive dyskinesia), respiratory complication due to inhalation of food, acid or saliva in the lung (aspiration pneumonia), lack of energy (lethargy), drowsiness, involuntary passage of urine, excessive salivation, and lightheadedness.

What precautions should be taken during Pregnancy and Nursing, and administering Zedan to Children or the Older Adults?

Pregnant Women

Only when required
Warning: When pregnant women use Zedan during the third trimester of pregnancy, it may cause side effects such as birth defects, anxiety, increased or decreased muscle tone, tremor, trouble breathing (respiratory distress), drowsiness, and feeding disorder in the neonates. Neonates should be monitored for side effects. Zedan should be used during pregnancy only after considering the potential benefits and risks to the fetus.

Breastfeeding

Only when required
Warning: Zedan may pass into breast milk which may cause harmful effects to the infants. A decision to discontinue Zedan or nursing should be made after considering the importance of Zedan to the mother.

Younger Adults Population

Precaution
Warning: Zedan should not be used in children suffering from depression because it may cause worsening of the depression, suicide-related behaviors or unusual changes in the behavior. Symptoms occurring in the patients during Zedan therapy are agitation, anxiety, panic attacks, irritability, sleeplessness, aggressiveness, unfriendly, acting instantly without thinking, movement disorder, hypomania, and mania. Safety and efficacy of Zedan in children with depression, schizophrenia or bipolar disorder have not been established.

Older Adults Population

Precaution
Warning: Zedan should not be used in patients suffering from a mental disorder associated learning abnormality (dementia-related psychosis) because it may increase the risk of stroke, heart failure or lung infection which can be possibly fatal. These patients are also at an increased risk of involuntary body movements (tardive dyskinesia), lack of energy, drowsiness, an involuntary passage of urine, excessive salivation, lightheadedness, or complication due to inhalation of food, acid, and saliva (aspiration pneumonia). This may especially occur in elderly women and patients with memory problems.

Zedan Side-effects

The following side-effects may commonly occur when using Zedan Tablet. If any of these side-effects worsen or last for a long time, you should consult with your doctor:
The following side-effects may commonly occur in older patients on the use of Zedan Tablet. Discuss with your doctor if any of these side-effects last for a long time or are severe:
  • drowsiness
  • excessive salivation
  • involuntary passage of urine (urinary incontinence)
  • lack of energy
  • lightheadedness
  • possibly fatal
  • stroke
The following side-effects may commonly occur in children when using Zedan Tablet. Discuss with your doctor if any of these side-effects last for a long time or are severe:
Rarely, the use of Zedan Tablet may cause the following side-effects:
  • abdominal discomfort
  • abnormal coordination
  • acid reflux (gastroesophageal reflux disease)
  • aggression
  • behavioural syndrome marked by an inability to move normally (catatonia)
  • bleeding from the nasal cavity
  • breast pain
  • chest pain
  • choreoathetosis
  • cogwheel rigidity
  • cough
  • decreased ability to move (mobility)
  • diarrhea
  • difficulty in breathing
  • disturbance in attention
  • double vision (diplopia)
  • drug induced prolonged and uncontrolled moved eye in an upward direction
  • dry tongue
  • enlargement of the breast glands
  • erectile dysfunction
  • excessive sweating
  • excessive urination at night (nocturia)
  • extreme sensitivity to light (photophobia)
  • fainting
  • fall
  • fluid buildup in lower limbs
  • hair loss
  • hiccups
  • hives
  • impulse-control disorders such as gambling
  • incraesed sexual desire
  • increase and decrease in levels of prolactin in the blood
  • increased blood urea
  • increased glycosylated hemoglobin
  • increased levels of prolactin in the blood
  • increased liver enzyme
  • increased or decreased sexual drive
  • involuntary body movements (tardive dyskinesia)
  • involuntary muscle contractions (dystonia)
  • involuntary muscle jerk
  • irregular heartbeat
  • irregular or absence of menstruation
  • joint pain (arthralgia)
  • memory problems
  • muscle pain
  • muscle tightness
  • muscular contraction of the throat (oropharyngeal spasm) and neck muscles
  • muscular weakness
  • nasal congestion
  • nervousness
  • pain
  • pain in the pharynx and larynx (pharyngolaryngeal pain)
  • partial or complete loss of muscle movement (hypokinesia)
  • poriomania
  • prolonged abnormal contractions of muscle
  • prolonged erection of the penis
  • protrusion of the tongue
  • rash
  • recurrent episodes of eating large quantities of food (binge or compulsive eating)
  • regular difficulty reaching orgasm (anorgasmia)
  • repetitive, nonrhythmic motor movement
  • severe itching
  • sleep walking and talking
  • speech disorder
  • speech disorder
  • stiffness
  • swallowing difficulty
  • swelling in the face
  • swelling of the lower layer of the skin
  • thinking of killing another person
  • tightness of the throat
  • tongue spasm
  • toothache
  • unintentional passing of urine
  • unwanted male-pattern hair growth in women (hirsutism)
  • weakness
The following severe side-effects may also occur when using Zedan Tablet:
  • Metabolism and nutrition disorders (possibly fatal)
    Symptoms: high or low blood sugar, low levels of sodium in the blood, eating disorder (anorexia), low potassium levels in the blood, weight gain, a complication of high blood sugar (diabetic hyperosmolar coma), increased level of glucose and acids in the blood (diabetic ketoacidosis) increased blood lactate dehydrogenase
  • Brain disorders (possibly fatal)
    Symptoms: depression, suicide attempt, suicidal ideation and completed suicide, anxiety/agitation, delirium, stroke/transient ischemic attack, involuntary body movements (tardive dyskinesia), abnormal electrical activity in the brain (grand mal convulsion), serotonin-inducing symptoms (serotonin syndrome), heat stroke slow movement disorder (parkinsonism)
    Patients taking Zedan should be observed closely for the inherency of suicide attempt. If symptoms of tardive dyskinesia occur, discontinue the use of Zedan.
  • Heart disorders
    Symptoms: increased or decreased heartbeat (bradycardia, or atrial fibrillation), abnormal heart rhythm (Torsades de pointes/QT prolongation/atrial flutter), unexpected loss of functioning of heart (cardiac arrest/cardiopulmonary failure), blood clotting in the leg, arms, or groin (venous thromboembolism), high blood pressure, sudden loss of heart function and breathing (cardio-respiratory arrest), heart block (atrioventricular block), damage to major heart's blood vessel (myocardial ischemia) heart attack
  • Blood and blood vessels disorders
    Symptoms: low blood pressure on quickly standing up, abnormally low count of neutrophils thrombocytes and white blood cells
    Patients should be monitored for the signs and symptoms of low levels of neutrophils, blood pressure. If these symptoms occur, discontinue the use of Zedan.
  • Immune system disorders
    Symptoms: allergic reaction life-threatening allergic reaction (anaphylactic reaction)
  • Kidney disorders
    Symptoms: increased kidney enzymes such as creatine phosphokinase, increased blood creatinine inability to completely empty the bladder
  • Symptoms: respiratory complication due to inhalation of food, acid or saliva in the lung (aspiration pneumonia), muscular contraction of the vocal cord (laryngospasm) difficulty in breathing (dyspnea)
  • Stomach and intestinal disorders
    Symptoms: swelling of the pancreas (pancreatitis) difficulty in swallowing (dysphagia)
  • Liver disorders
    Symptoms: liver failure, swelling in the liver (hepatitis), yellowing of the skin (jaundice), increased alanine and aspartate aminotransferase, increased gamma-glutamyltransferase, increased alkaline phosphatase increased blood bilirubin
  • Drug-induced life-threatening reaction (neuroleptic malignant syndrome) (possibly fatal)
    Symptoms: fever, muscle rigidity, altered mental status, evidence of autonomic instability (irregular pulse or blood pressure), increased heartbeat, sweating, abnormal heart rhythm, elevated creatine phosphokinase, the presence of myoglobin in the urine due to muscle destruction (myoglobinuria rhabdomyolysis), kidney failure, confusion blood pressure
    Contact your doctor immediately, if any of these symptoms occur.
Your doctor has prescribed this medicine because they judge that the benefit is greater than the risk posed by side-effects. Many people using this medicine do not have serious cases of side-effects. This page does not contain a complete list of all possible side-effects.
If you experience side-effects or notice other side-effects not listed above, contact your doctor for medical advice. You may also report side-effects to your local food and drug administration authority. You can look up the drug authority contact information from the Drug Authority Finder at TabletWise.com.

Side-effects and Allergic Reactions of Zedan by Severity and Frequency

Common Side-effects

Following are the common side-effects of this medicine:

Infrequent and Rare Side-effects

Following are the infrequent and rare side-effects of this medicine:

Severe Side-effects

Following are the severe side-effects of this medicine:

Side-effects in Older Adults

Following are the side-effects of this medicine in elderly patients:

Side-effects in Children

Following are the side-effects of this medicine in young patients:

Serious Allergic Reactions

Following are the symptoms of serious allergic reactions to this medicine:
If such symptoms occur, contact the doctor immediately.
If you experience side-effects or notice other side-effects not listed above, contact your doctor for medical advice. You may also report side-effects to your local food and drug administration authority. You can look up the drug authority contact information from the Drug Authority Finder at TabletWise.com.

Warnings

Elderly Patients

Elderly patients suffering from a mental disorder associated learning abnormality (dementia related psychosis) are at an increased risk when using Zedan. These patients may experience an increased incidence of stroke, heart failure or lung infection, lack of energy, drowsiness, involuntary passage of urine, excessive salivation, or lightheadedness, which can be possibly fatal. Zedan should not be used in such patients.

Suicidal Thoughts and Behaviors

Children and young adults (age 18 to 24 years) or patients with depression/psychotics disorders are at an increased risk when using Zedan. These patients may experience worsening of the depression and suicide-related/unusual changes in behaviors. Symptoms occurring in the patients during Zedan therapy are agitation, anxiety, panic attacks, irritability etc. Patients should be monitored closely for suicide-related/unusual changes in behaviors in the starting of therapy or during dose adjustment. Discontinuation of Zedan, the lowest effective dose or changes in the therapy should be considered in such patients. Caregivers/family should be informed about the need to monitor the patients daily for the symptoms occurring during Zedan therapy.

Schizophrenia and Major Depressive Episode

Patients with schizophrenia and major depressive episode are at an increased risk when using Zedan. Treating such patients with Zedan alone may increase the occurrence of a mixed/manic episode and also increased suicide attempt and weight gain. Weight gain usually occurs in patients with risk factors such as a history of thyroid disorders/non-cancerous growth in the pituitary gland. Before starting Zedan therapy, patients should be examined for the risk of bipolar disorder. The lowest effective dose should be used in these patients. Also, monitoring of the weight gain/dose reduction should be considered in children with bipolar disorder.

Neuroleptic Malignant Syndrome

Patients taking Zedan are at an increased risk. Drug-induced life-threatening reaction (neuroleptic malignant syndrome) may occur in these patients. They may experience symptoms of a neuroleptic malignant syndrome such as high fever, abnormal mental status, muscle rigidity, increased or abnormal heart rhythm, sweating, increased creatinine phosphokinase, kidney failure, and myoglobin in the urine. Monitoring and treatment of neuroleptic malignant syndrome, discontinuation of Zedan or other drugs not required for the combined therapy should be considered. Antipsychotic drug therapy should be reintroduced after recovery from the neuroleptic malignant syndrome.

Tardive Dyskinesia

Patients taking Zedan, elderly patients especially elderly women are at an increased risk. These patients may experience irreversible and involuntary body movements (tardive dyskinesia). This risk increases as the treatment duration increases. Long-term antipsychotic treatment should be given in patients with serious illness. The smallest dose for the shortest duration should be used in such patients. Zedan should be discontinued or dose reduction should be considered in patients developing symptoms of involuntary body movements.

Metabolic Changes

Obese patients or patients with high blood sugar, or taking Zedan are at an increased risk. These patients may experience an increased level of glucose and acids in the blood, abnormally increased fats in the body, a complication of high blood sugar (diabetic hyperosmolar coma) or fatality. These patients should be observed for symptoms and signs of high blood sugar such as weakness, increased thirst or urine passage and excessive eating (polyphagia). Patients with high blood sugar should be monitored regularly for worsening of sugar level. Fasting blood sugar test should be performed in the starting and during the treatment with Zedan.

Low Blood Pressure on Quickly Standing

Patients taking Zedan are at an increased risk. Zedan may cause a blood clot in the leg, arms, or groin (venous thromboembolism) or low blood pressure on quickly standing up in these patients. Precaution should be taken in patients with low blood volume, low body fluid, high blood pressure or taking antihypertensive drugs. Also, caution is required in patients with blood vessel related heart and brain diseases. When the use of benzodiazepines injection with Zedan injection is necessary, sedation and low blood pressure on quickly standing up should be monitored. Patients should be examined for the risk of blood clot (venous thromboembolism) in the starting or during Zedan therapy.

Low Levels of White Blood Cells

Patients with history or already low levels of white blood cells count/absolute neutrophil count, or taking Zedan are at an increased risk. Zedan may decrease the number of leukocytes (leukopenia), granulocytes, or neutrophils in these patients. Complete blood count test should be performed in such patients in the initial period of drug therapy. On the occurrence of low white blood cell or neutrophil count, Zedan should be discontinued. Patients should be monitored and treated for symptoms of infection such as fever.

Seizures

Elderly patients, patients with a history of seizures or condition associated with seizures, or taking Zedan are at an increased risk. Zedan may cause seizures in these patients. Precaution should be taken in such patients.

Memory and Movement Problems

Patients taking Zedan are at an increased risk. Zedan may cause drowsiness, sedation, and abnormality in thinking, judgment or movements. Patients should take necessary precaution while operating heavy machines such as automobiles.

Regulation of Body Temperature

Patients taking Zedan are at an increased risk. Zedan may affect the body's capacity to decrease the body temperature. Care should be taken in the patients who get exposed to excess heat or are taking medicines having reduced muscle spasm (anticholinergic) activity. This should also be considered in dehydrated patients or in patients doing hard exercise.

Difficulty in Swallowing (Dysphagia)

Patients taking Zedan or elderly patients especially those with learning abnormality are at an increased risk. Zedan may cause decreased muscles activity in the digestive tract and complication due to inhalation of food, acid or saliva (aspiration pneumonia). This may occur in elderly patients and in patients having memory problems. Precaution should be taken in such patients.

Abnormal Heart Rhythm

Patients with a family history of abnormal heart rhythm (QT prolongation) or taking Zedan are at an increased risk. Precaution should be taken in such patients.

Drug-Induced Movement Disorders

Patients taking Zedan or children are at an increased risk. These patients may experience a sensation restlessness and movement disorder. Dose reduction along with clinical monitoring should be considered in such patients.

Allergic Reactions

Patients taking Zedan are at an increased risk. These patients may experience allergic reactions such as swelling of the lower layer of the skin, severe itching or hives, life-threatening reactions, muscular contraction of the vocal cord and throat or swelling of the tongue.

Interactions with Zedan

When two or more medicines are taken together, it can change how the medicines work and increase the risk of side-effects. In medical terms, this is called as a Drug Interaction.
This page does not contain all the possible interactions of Zedan Tablet. Share a list of all medicines that you use with your doctor and pharmacist. Do not start, stop, or change the dose of any medicines without the approval of your doctor.

Strong CYP3A4 Inhibitors

Zedan Tablet may interact with CYP3A4 inhibitors (itraconazole, diltiazem, or ketoconazole) HIV protease. When Zedan is used with strong CYP3A4 Inhibitors and CYP2D6 poor metabolizers, it may increase the level of Zedan as compared to using drug alone. The dose reduction to one-half along with an evaluation of the potential benefits and risks of Zedan should be considered when using this combination. Upon discontinuation of the CYP2D6 inhibitor, the dose of Zedan should be increased before starting the combination therapy. Also, the dose of Zedan should be decreased to quarter half in CYP2D6 poor metabolizers.

Strong CYP2D6 Inhibitors

There may be an interaction of Zedan with CYP2D6 inhibitors (quinidine, fluoxetine, or escitalopram). When Zedan is used with strong CYP2D6 inhibitors, it may increase the level of Zedan as compared to using drug alone. Dose reduction to one-half of Zedan should be considered when using this combination. Also, the dose should be decreased to a quarter half when CYP2D6 inhibitors and CYP3A4 inhibitors are used with Zedan. Upon discontinuation of the CYP3A4 inhibitor, the dose of Zedan should be increased to the level before starting the combination therapy.

Strong CYP3A4 Inducers

Zedan Tablet interacts with Strong CYP3A4 inducers (carbamazepine, primidone, or rifampin). When Zedan is used with carbamazepine, it may decrease the levels of Zedan in the body as compared to using drug alone. The dose of Zedan should be increased in the patient using this combination. Also, reduction of the Zedan dose should be considered when discontinuing the use of CYP3A4 inducers.

Antihypertensives

Special instructions need to be followed while taking this medicine along with antihypertensives, which are used to treat high blood pressure. When Zedan is used with antihypertensives, it may increase the blood pressure lowering effect of certain antihypertensive drugs. Dose adjustments along with monitoring of the blood pressure should be considered in patients using this combination.

Benzodiazepines

Your doctor's guidelines may need to be followed while taking this medicine along with benzodiazepines (lorazepam), which are used to treat seizures and sleeplessness. When Zedan is used with lorazepam it may increase the sedation and blood pressure lowering effect of lorazepam and Zedan respectively as compared to using these medicines alone. Dose adjustment and monitoring of the blood pressure and sedation should be considered when using this combination.

Central Nervous System Drugs

Zedan Tablet may interact with central nervous system drugs. When Zedan is used with central nervous system drugs, It may increase the sedative effects. Precaution should be taken when using this combination.

Drugs Causing Electrolyte Imbalance/QT Prolongation

There may be an interaction of Zedan with drugs causing electrolyte imbalance or prolonged heart rhythm (QT prolongation). Precaution should be taken when using Zedan with drugs causing electrolyte imbalance or QT prolongation.

Antidepressants

Zedan Tablet interacts with antidepressants (selective serotonin reuptake inhibitors or serotonin-norepinephrine reuptake inhibitors), which are used to treat depression. When Zedan is used with antidepressants, it may increase the level of Zedan and can cause serotonin-inducing symptoms (serotonin syndrome).

Interactions of Zedan by Severity

Serious

The following medicines may interact when taken together and can cause harmful effects in the body. Please consult with your doctor or pharmacist before taking these medicines together.

Moderate

The following medicines may interact when taken together and can increase your risk of harmful effects. Please consult with your doctor or pharmacist before taking these medicines together.

When should Zedan be not used?

Allergic to Zedan

This medicine should not be used in patients with a history of allergy to Zedan. Patients may experience a severe allergic reaction. These patients may have the following symptoms if they use this medicine:
  • swelling of the lower layer of skin
  • severe itching or hives
  • life-threatening reactions
  • muscular contraction of the vocal cord and throat
  • swelling of the tongue

Mental Disorder Associated Learning Abnormality

Zedan should not be used in patients with a mental disorder associated learning abnormality. Zedan may increase the occurrence of side effects related to blood vessels of the brain. These patients may have the following symptoms if they use this medicine:
  • stroke
  • lack of energy
  • drowsiness
  • involuntary passage of urine
  • excessive salivation
  • lightheadedness
  • possibly fatal

Genetic Problems

This medicine should not be used in patients with a reduced or absent activity of lactase (galactose intolerance, Lapp lactase deficiency) and abnormal absorption of glucose and galactose in the body.

Traveling With Medication

  • Ensure that you carry enough doses of each of your prescription medicines to last the entire trip. The best place to store your medicines is in the carry on baggage. However, while flying, if carrying liquid medicines, make sure you do not go over the limits imposed for carry-on liquids.
  • While traveling overseas, make sure that you can carry each of your prescription medicines legally to your destination country. One way to ensure this is by checking with your destination country's embassy or website.
  • Make sure that you carry each of your medicines in their original packaging, which should typically include your name and address, and the details of the prescribing doctor.
  • If your travel involves crossing time zones, and you are required to take your medicine as per a fixed schedule, make sure that you adjust for the change in time.

Expired Medication

Taking a single dose of expired Zedan is unlikely to cause a side-effect. However, please discuss with your doctor or pharmacist, if you feel unwell or sick. An expired medicine may become ineffective in treating your prescribed conditions. To be on the safe side, it is important not to use an expired drug. You are much safer by always keeping a fresh supply of unexpired medicines.

Safe Disposal of Medication

  • If there are disposal instructions on the package, please follow the instructions.
  • If there are medicine take-back programs in your country, you should contact the respective authority to arrange for the disposal of the medicine. For example, in the USA, the Drug Enforcement Administration regularly hosts National Prescription Drug Take-Back events.
  • If there are no take-back programs, mix the medicine with dirt and place them in a sealed plastic bag. Throw the plastic bag in your household trash. Separately, remove all personal information including the prescription label from the medicine packaging and then dispose off the container.
  • If specifically indicated on the medicine package that it needs to be flushed down the toilet when no longer needed, perform the required step.
This page provides information for Zedan Tablet .
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