Prexal Tablet

Generic Name(s): Olanzapine

Why it's used

Prexal Tablet is used for the short-term treatment and maintenance of a severe mental illness that affects a person's ability to think, feel, and behave (schizophrenia). This medicine works by altering the activity of certain natural substances in the brain. Prexal is also used for the short-term treatment and maintenance of mood disorder (mania associated with bipolar-I disorder), and to treat excessive brain activity associated with mental illness and mood swings (agitation related to schizophrenia and bipolar-I disorder associated mania).
Prexal Tablet may also be used together with other medicines to treat certain conditions as recommended by the doctor. It is used in combination with Lithium or Valproate for the short-term treatment of mood swings and mixed episodes of major depression related to bipolar-I disorder in adults. It is also used with Fluoxetine to treat depressive episodes and the condition in which patients are unable to respond to antidepressant therapy associated with Bipolar I Disorder in adult patients.
When not to use
Prexal Tablet will not work to treat the patients suffering from abnormal thinking and memory disabilities (Alzheimer's disease). Prexal should not be used to treat the patients suffering from hallucinations (dementia-related psychosis).
Atypical Antipsychotics
Prexal is a prescription medicine that 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.

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 Prexal Tablet. If you have any questions related to this medicine, ask your doctor or pharmacist. Use this medicine as recommended by your doctor.
Prexal Tablet is used with or without food.
The typical dose of Prexal is 10 mg once a day. The maximum adult dose of Prexal is 20 mg in a day. Prexal is commonly used at the same time every day. This medicine is not known to be habit-forming.
This medicine is to be used for longer periods of time. Prexal maybe prescribed for the long-term use for the maintenance and treatment with an appropriate dose and to reevaluate the usefulness of the drug for the individual patient. You should continue to use this medicine as directed by the doctor even if you feel well.
Talk to your doctor if your condition persists or worsens or if you develop new symptoms. Tell your doctor if dehydration, feeling of hotness, dry mouth, inability to produce urine, feeling thirsty, low blood pressure while standing from the sitting position, dizziness, fast or slow heartbeat, fainting, stroke, temporary disruption of the blood supply to a part of the brain, increased body temperature, muscle rigidity, irregular pulse or blood pressure, and heart problems. If you have issues with the health of your liver, An initial dose of 2.5-5 mg of Prexal with fluoxetine 20 mg should be considered for patients with liver damage. You should consult with your doctor before stopping the use of Prexal.
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. A lower dose of this medicine may be recommended to reduce 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.
You may need to gradually decrease the dose of this medicine before stopping.
The safety and effectiveness of using Prexal Tablet in children has not been established. The safety and efficacy of Prexal in children have not been established.
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.
The injection form of the medicine may be used on the muscle mass. Prexal injection is intended for intramuscular use only which is injected slowly, deep into the muscle mass. It is not intended to be given intravenously or subcutaneously. The injection form of the medicine should not be used on the vein, or under skin The contents of the vial are dissolved with 2.1 ml of high-quality water used in the injection (sterile water for injection) resulting in a solution that contains approximately 5 mg/ml of Prexal. The resulting solution should be clear and yellow and should be used within one hour after its preparation. Any unused portion should be discarded.
Limit the consumption of alcohol with Prexal.
Your doctor may request that specific lab tests be performed before you start using Prexal Tablet. You may need to have Blood Glucose test. The fasting blood glucose test is recommended in patients undergoing treatment with Prexal to prevent the worsening of glucose control. Your doctor may request Lipid Panel test. Fasting blood lipid testing is recommended in patients undergoing treatment with Prexal due to undesirable changes in lipid levels. Before starting this medicine, your doctor would require you to undergo medical or laboratory tests (Blood Glucose, and Lipid Panel) to monitor for side-effects. Once the administration of the medicine starts, your doctor should monitor you for these medical and laboratory tests to make sure that the side-effects of this medicine are not impacting your health.
You should store Prexal Tablet 20°C to 25°C (68°F to 77°F), away from moisture, and away from light. 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 Prexal Tablet for conditions for which it was not prescribed. Do not give Prexal 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 Prexal

The dose and frequency of using Prexal will depend on the following factors:
  • age of the patient
  • patient's health
  • the health of the patient's kidneys
  • medicines recommended by the doctor
  • any other medicines being used
  • herbal supplements being used
  • response to the medicine

Prexal Dosage

Dosage for a severe mental illness that affects a person's ability to think, feel, and behave (schizophrenia)

Adult
  • Recommended: 10 mg/day
  • Initial: 5-10 mg once a day
  • Maximum: 20 mg/day

Dosage for mood disorder (mania associated with the bipolar-I disorder)

Adult
  • Recommended: 5-20 mg/day
  • Initial: 10-15 mg once a day
  • Maximum: 20 mg/day

Dosage for mania or mixed episodes related to bipolar-I disorder in adults in combination with lithium or valproate

Adult
  • Recommended: 5-20 mg/day
  • Initial: 10 mg once daily
  • Maximum: 20 mg/day

Dosage for excessive brain activity associated with mental illness and mood swings (agitation related to schizophrenia and bipolar-I disorder associated mania)

Adult
  • Recommended: 10 mg
  • Initial: 5-20 mg/day
  • Maximum: 30 mg
Older Adults
  • Recommended: 5 mg/injection
  • Initial: 2.5 mg/injection

Dosage for depression related to bipolar-I disorder in combination with fluoxetine

Adult
  • Initial: 5 mg of Prexal with 20 mg fluoxetine once daily in the evening
  • Maximum: 18 mg of Prexal with 75 mg of fluoxetine

Dosage for depression which is resistant to treatment in combination with fluoxetine

Adult
  • Initial: 5 mg of Prexal with 20 mg of fluoxetine once daily in the evening
  • Maximum: 18 mg of Prexal with fluoxetine 75 mg

Forms

Tablet
Strength: 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg and 20 mg
Orally disintegrating tablets
Strength: 5 mg, 7.5 mg, 10 mg, 15 mg and 20 mg
Intramuscular injection
Strength: 10 mg vial
Tablet, Coated
Strength: 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg

Special Instructions

Oral formulation
Take a tablet once a day without regards to meals.
The oral formulation in combination with fluoxetine
Take a tablet once a day in the evening without regards to meals.
Intramuscular injection
Use the intramuscular solution immediately within 1 hour after reconstitution.

Missed Dose

The missed dose should be taken as soon as you remember but if it is the time for the next dose, the missed dose should be skipped and the next dose should be taken. Two doses should not be taken to make up for the missed dose.

Overdose

What to do if you overdose on Prexal?
No specific antidote is available for an overdose of Prexal. The harmful effects can be reduced by cleaning out the harmful substances of the stomach (gastric lavage). Use of activated charcoal can be considered as an alternative treatment. Activated charcoal is a form of carbon that has small and low-volume pores. These pores help trap chemicals as in the case of poisoning. Appropriate supportive measures should be started involving the use of intravenous fluids and sympathomimetic agents excluding, epinephrine, dopamine, or other sympathomimetics with beta-agonist activity. Medical supervision and close monitoring should be done until the patient shows recovery.
Symptoms of an overdose of Prexal
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:
  • a condition where food, liquids, saliva or vomit is breathed into the airways (aspiration)
  • agitation/aggressiveness
  • cardiopulmonary arrest
  • convulsion
  • delirium
  • difficult or ineffective breathing
  • high blood pressure
  • increased heartbeat
  • increased or decreased heartbeat
  • low blood pressure
  • rare reaction to antipsychotic drugs
  • reduced level of consciousness ranging from sedation to coma
  • speech disorder
If you think you have overdosed on Prexal 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 Prexal

Before you use Prexal, tell your doctor of your medical history including cigarette smoking, increased blood sugar levels, high levels of ketones in the blood (ketoacidosis), an inherited amino acid metabolism disorder (phenylketonuria), low white blood cell count, abnormally low levels of neutrophils, history of seizures, brain disorder associated with abnormal thinking and memory loss (Alzheimer's disease), or heart diseases (heart attack, heart failure and, conduction abnormalities). Before having any surgery when using Prexal, 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 level. The use of this medicine may lead to an increase in the level of blood sugar. Patients using Prexal should be monitored regularly through fasting blood glucose testing to prevent the worsening of glucose control.
The use of Prexal Tablet may change lipid levels. Undesirable changes in lipids have been observed by using Prexal.
The use of this medicine may change body weight. Patients receiving Prexal should be regularly monitored for weight gain.
Avoid the consumption of alcohol with Prexal Tablet. Drinking alcohol may cause low blood pressure while standing from the sitting position.
Consult with your doctor on the use of Prexal Tablet during pregnancy. Use of Prexal may cause problems in newborns during delivery if it is taken during the last months of pregnancy. Prexal Tablet is not safe for use in women who are breastfeeding. If you are breastfeeding, discuss with your doctor if you should either discontinue breastfeeding or stop using this medicine while breastfeeding. This medicine may pass into breast milk. Consult with your doctor on the use of Prexal Tablet, if you are trying to conceive.
Prexal 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 Prexal Tablet can make you feel more sleepy. Prexal 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.
This medicine may increase your sensitivity to sunlight. If this happens, limit your time outdoors and do not tan to prevent sunburns. Cover your skin when you are outdoors or use a sunscreen. In case you get a sunburn, consult with your doctor.
Prexal Tablet may increase side-effects in older patients. Elderly patients may see an increased risk of stroke, transient ischemic attack, and fatal conditions.

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

Pregnant Women

Only When Necessary
Warning: Use this medicine only if the potential benefit outweighs its potential risk to the fetus.

Breastfeeding

Contraindicated or Not Recommended
Warning: This medicine may pass into breast milk, so it is not recommended for use in breastfeeding.

Younger Adults Population

No Known Risk
Warning: The safety and effectiveness data in children has not been established.

Older Adults Population

Precaution
Warning: The starting dose of Prexal should be lower in such patients.

Prexal Side-effects

The following side-effects may commonly occur when using Prexal Tablet. If any of these side-effects worsen or last for a long time, you should consult with your doctor:
Rarely, the use of Prexal Tablet may cause the following side-effects:
The following severe side-effects may also occur when using Prexal Tablet:
  • digestive system disorders
    Symptoms: nausea, vomiting, tongue swelling, intestinal obstruction, fat deposits in the liver, thirst increased salivation
  • blood and lymphatic system disorders
    Symptoms: decreased white blood cells, low levels of thrombocytes discoloration of the skin (ecchymosis)
  • nervous system disorders
    Symptoms: body movement disorder, slurred speech, decreased sexual desire, unconsciousness or insensibility, coma, drowsiness, tremor, dizziness, memory loss (amnesia), abnormal sensation in the body, lack of interest (apathy), confusion, intense state of excitement (euphoria), incoordination, increased muscle tone (hypertonia), speech disorder, movement disorder, walking abnormality depression
  • skin and appendages disorders
    Symptoms: hair loss, sweating, acne dryness of skin
  • urogenital system disorders
    Symptoms: absence of menstruation (amenorrhea), breast pain, decreased menstruation, impotence, increased menstruation, abnormally heavy bleeding at menstruation, abnormal bleeding from the uterus (metrorrhagia), excessive production of urine, increased urine frequency, bladder does not empty completely, unstoppable urge to urinate (urinary urgency), inflammation of the vagina (vaginitis) painful periods (dysmenorrhea)
  • heart disorders
    Symptoms: fainting, stroke, dilation of blood vessels (vasodilation), decreased blood pressure, low blood pressure while standing from the sitting position, high blood pressure increased heartbeat
  • metabolic and nutritional disorders
    Symptoms: increased creatine phosphokinase, increased alkaline phosphatase, high levels of bilirubin (bilirubinemia), abnormally low level of protein (hypoproteinemia), lower limbs swelling weight gain
  • musculoskeletal system disorders
    Symptoms: weakening of bones (osteoporosis) joint pain
  • respiratory system disorders
    Symptoms: nosebleed (epistaxis), lung swelling, inflammation of the pharynx (pharyngitis), shortness of breath (dyspnea), increased cough inflammation of the mucous membrane (rhinitis)
  • eye disorders
    Symptoms: abnormality of the eye, dry eyes, dilation of the pupil of the eye, abnormal vision decreased eyesight (amblyopia)
Your doctor has prescribed Prexal Tablet because they judge that the benefit is greater than the risk posed by side-effects. Many people using this medicine do not have serious side-effects. This page does not list all possible side-effects of Prexal Tablet.
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 Prexal 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:

Mild Allergic Reactions

Following are the symptoms of mild allergic reactions to this medicine:

Serious Allergic Reactions

Following are the symptoms of serious allergic reactions to this medicine:
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

Increased levels of prolactin hormone (hyperprolactinemia)

Patients who are on treatment with Prexal may experience an increased risk of elevated prolactin levels. Hyperprolactinemia may lead to reduced reproductive function in both males and females patients which further results in decreased bone density.

Abnormal functioning of the brain

The patients who are on treatment with Prexal are at an increased risk to experience sleepiness along with problems in thinking, memory, and movement functions. Prexal should be used with caution due to its effects on memory and movement functions, and therefore the use of machinery and automobiles should be done cautiously.

Body temperature regulation

Patients using Prexal may experience disrupted ability of the body to reduce body temperature during heavy exercise, exposure to extreme heat, receiving medicine in combination with anticholinergic activity, and dehydration. Appropriate care is advised when Prexal is prescribed to patients who may experience increased body temperature.

Patients with existing illness

Patients with enlarged prostate gland (prostatic hypertrophy), eye disorder (narrow-angle glaucoma), blockage of intestine due to paralysis of intestinal muscles (history of paralytic ileus), and elderly patients with dementia-related psychosis are at an increased risk when using this medicine. Such patients may experience symptoms such as falls, sleepiness, accumulation of the fluid in the body, abnormal gait, unintentional passage of urine (urinary incontinence), drowsiness, increased weight, lack of energy, fever, lung infection (pneumonia), dry mouth and visual hallucinations. The use of Prexal is not recommended for the treatment of patients with dementia-related psychosis.

Seizures

Patients who are on treatment with antipsychotic drugs including Prexal and patients who have a history of seizures are at an increased risk when using this medicine. Prexal should be used with caution in patients who have a history of seizures or conditions that lower the susceptibility of patients to seizures (seizure threshold) such as Alzheimer’s dementia.

Weight gain

The patients who are on treatment with Prexal are at an increased risk to experience weight gain. Patients who are on treatment with Prexal should undergo regular monitoring of body weight.

Involuntary body movements (tardive dyskinesia)

Elderly patients, especially elderly women are at an increased risk when using this medicine. Such patients may develop involuntary body movements when using this medicine. If any of these symptoms appear, discontinue the use of this medicine.

Low blood pressure while standing up from sitting or lying posture

Patients with known history of heart problems and those who are on treatment with other drugs are at an increased risk when using this medicine. Such patients may experience symptoms such as dizziness, increased or decreased heartbeat and fainting. Take necessary precautions while using this medicine in such patients.

Patients with history of drug induced leukopenia/neutropenia

Patients who are on treatment with antipsychotic drugs, who have low white blood cell count and patients who have a history of blood disorders are at an increased risk when using this medicine. Such patients should be monitored adequately for the presence of any infection or fever. Discontinue the use of Prexal in patients suffering from severe neutropenia.

Difficulty in swallowing (dysphagia)

Patients using Prexal are at an increased risk of developing dysphagia and a condition where food, liquids, saliva or vomit is breathed into the airways (aspiration) and dysphagia.

Elderly patients with dementia-related psychosis

Elderly patients who have dementia-related psychosis and who are undergoing treatment with antipsychotic drugs are at an increased risk when using this medicine. Such patients are at an increased risk of side-effect such as stroke, temporary disruption in the supply of blood to a part of the brain (transient ischemic attack) and fatal conditions. The use of this medicine is not recommended in such patients.

Suicidal ideation and thoughts

The possibility to attempt suicide is seen frequently in patients who have schizophrenia and bipolar-I disorder. Close supervision of patients at high risk should be done along with drug therapy. Prescription for Prexal should be written for the smallest quantity which is consistent with good patient management, so as to reduce the risk of overdose.

Rare, life-threatening and unusual reaction to antipsychotic drugs (neuroleptic malignant syndrome, NMS)

Patients who are on treatment with antipsychotic drugs are at an increased risk when using this medicine. Such patients may experience an increased risk of elevated body temperature, muscle rigidity, altered mental status, irregular pulse or blood pressure, sweating (diaphoresis), increased or decreased heartbeat, increased enzyme levels (creatinine phosphokinase), the presence of myoglobin in the urine (myoglobinuria) and kidney damage. Careful medical monitoring, as well as treatment according to symptoms, is required in such patients.

High blood sugar levels (hyperglycemia)

Patients undergoing therapy with Prexal are at an increased risk of high blood sugar levels. Such patients may develop symptoms such as the feeling of extreme thirstiness (polydipsia), abnormally large production of urine, excessive eating with increased appetite (polyphagia), and weakness. Patients who develop these symptoms while undergoing treatment with atypical antipsychotics should undergo fasting blood glucose testing to monitor the worsening of glucose control.

High levels of lipids in the blood (hyperlipidemia)

Undesirable changes in lipid levels have been observed in patients who are on treatment with Prexal. Such patients should undergo monitoring of lipid levels in the blood.

Interactions with Prexal

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.
Your doctor's guidelines may need to be followed while taking this medicine along with diazepam, which is used to treat anxiety, alcohol withdrawal, muscle spasms, and seizures. When diazepam is taken with Prexal, severe fall in blood pressure may occur in such patients.
Prexal Tablet interacts with levodopa, which is used to treat Parkinson's disease. Use of Prexal with levodopa may oppose the action of levodopa.
There may be an interaction of Prexal with dopamine, which is used to treat very low blood pressure. Use of Prexal with dopamine may oppose the action of dopamine.
Prexal Tablet may interact with fluvoxamine, which is used to treat major depressive and anxiety disorders. Fluvoxamine may lead to increased levels of Prexal in the blood due to a decrease in the removal of Prexal from the body. The lower dose of Prexal should be considered in patients receiving combined therapy with fluvoxamine.
Special instructions need to be followed while taking this medicine along with antihypertensive agents, which are used to lower the high blood pressure conditions. Prexal enhances the effects of antihypertensive agents because of its potential for inducing low blood pressure.
Your doctor's guidelines may need to be followed while taking this medicine along with central nervous system acting drugs, which affect the central nervous system (CNS). The patient should be cautious when Prexal is taken in combination with other centrally acting drugs.
Prexal Tablet interacts with omeprazole, which is used to treat various stomach and intestinal ulcers. Omeprazole may cause an increase in the removal of Prexal from the body.
Special instructions need to be followed while taking this medicine along with rifampin, which is used to treat bacterial infections. Rifampicin may cause an increase in the removal of Prexal from the body.
There may be an interaction of Prexal with fluoxetine, which is used in the treatment of a major depressive disorder. Use of fluoxetine may lead to an increased level of Prexal, and a small decrease in the removal of Prexal from the body is observed in such patients. Dose modification is not recommended routinely.
Prexal Tablet may interact with alcohol, which is used to depress the central nervous system. When alcohol (ethanol) is taken with Prexal, severe fall in blood pressure may observe in such patients. Take necessary precautions while using Prexal with alcohol.
Prexal Tablet may interact with Lorazepam, which is used to treat anxiety disorders. When lorazepam and Prexal injection is taken intramuscularly, it may the risk of sleepiness.
There may be an interaction of Prexal with carbamazepine, which is used to prevent seizures. When carbamazepine is used in combination with Prexal, it may increases the removal of Prexal from the body.
This page does not contain all the possible interactions of Prexal 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.

Interactions of Prexal 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 Prexal be not used?

Combination therapy of Prexal with fluoxetine, lithium and valproate

When Prexal is used in combination with these medicines, the patient should refer the section of the package inserted for combined use of Prexal with these medicinal products.

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 Prexal 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 Prexal Tablet .
Mental Disorders
Schizophrenia
Mood Disorders
Bipolar Disorder

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