Clonazepam 0.5 mg high
Side effects, dosage, uses, and more
- Clonazepam oral tablet is available as a generic drug and a brand-name drug, Klonopin.
- Clonazepam comes as both an oral tablet and an oral disintegrating (dissolving) tablet.
- Clonazepam is used to treat panic disorder and seizures.
Clonazepam oral tablet is a prescription drug that’s available as the brand-name drug Klonopin. It’s also available as a generic drug. Generic drugs usually cost less. In some cases, they may not be available in every strength or form as the brand-name version.
Clonazepam comes as both an oral tablet and an oral disintegrating (dissolving) tablet.
Clonazepam is a controlled substance.
Why it’s used
Clonazepam is used to treat panic disorder. It’s also used to stop seizures.
Clonazepam may be used as part of a combination therapy. This means a person may need to take it with other medications.
How it works
Clonazepam belongs to a class of drugs called benzodiazepines. A class of drugs is a group of medications that work in a similar way. These drugs are often used to treat similar conditions.
Clonazepam works by increasing the activity of gamma aminobutyric acid (GABA). This is a chemical that sends signals throughout a person’s nervous system. If a person does not have enough GABA, their body may be in an excited state. This may cause them to have panic attacks or seizures. When a person takes this drug, they will have more GABA in their body. This will help them have fewer panic attacks and seizures.
Clonazepam can cause mild or serious side effects. The following list contains some of the key side effects that may occur while taking clonazepam. This list does not include all possible side effects.
For more information on the possible side effects of clonazepam, or tips on how to deal with a troubling side effect, a person should talk with their doctor or pharmacist.
Common side effects
The more common side effects of clonazepam oral tablet can include:
- drowsiness
- problems with walking and coordination
- dizziness
- depression
- fatigue
- problems with memory
If these effects are mild, they may go away within a few days or a couple of weeks.
If they’re more severe or don’t go away, a person should talk to their doctor or pharmacist.
Serious side effects
A person should call their doctor right away if they have serious side effects. They should call 911 if their symptoms feel life-threatening or if they think they are having a medical emergency. Serious side effects and their symptoms can include the following:
- depressed mood or thoughts of suicide (harming themself)
- seizures (these are more likely to happen if a person stops taking this drug too quickly, or if they already have a seizure disorder)
The clonazepam dosage a doctor prescribes will depend on several factors. These include:
- the type and severity of the condition the person is using clonazepam to treat
- the person’s age
- the form of clonazepam they take
- other medical conditions they may have
Typically, a doctor will start a person on a low dosage and adjust it over time to reach the dosage that’s right for them.
They’ll ultimately prescribe the smallest dosage that provides the desired effect.
The following information describes dosages that are commonly used or recommended. However, a person should be sure to take the dosage the doctor prescribes for them.
A doctor will determine the best dosage to suit a person’s needs.
Forms and strengths
Generic: Clonazepam
- Form: oral tablet
- Strengths: 0.5 mg, 1 mg, 2 mg
- Form: oral disintegrating tablet
- Strengths: 0.125 mg, 0.25, 0.5 mg, 1 mg, 2 mg
Brand: Klonopin
- Form: oral tablet
- Strengths: 0.5 mg, 1 mg, 2 mg
Dosage for panic disorder
Adult dosage (ages 18 to 64 years)
- Typical starting dose: 0.25 mg taken twice per day
- Dose increases: A doctor may increase the dose to 0.
5 mg taken two times per day after three days. - Maximum dose: 4 mg per day.
- Dose reduction: A doctor should decrease a person’s dose slowly when stopping treatment with this drug. They should decrease the dose by no more than 0.125 mg every three days. For example, if the person was taking 2 mg two times per day, their doctor would start by decreasing the dose to 1.875 mg, taken two times per day.
Child dosage (ages 0 to 17 years)
It hasn’t been confirmed that clonazepam is safe and effective for use in people younger than 18 years for this condition.
Senior dosage (ages 65 years and older)
The kidneys of older adults may not work as well as they used to. This can cause their body to process drugs more slowly. As a result, more of a drug stays in their body for a longer time. This raises their risk of side effects. Their doctor may start them on a lowered dose or a different dosing schedule. This can help keep levels of this drug from building up too much in their body.
Dosage for seizures
Adult dosage (ages 18 to 64 years)
- Typical starting dose: 0.5 mg taken three times per day
- Dose increases: A doctor may increase a person’s dose by 0.5 to 1 mg every three days until their seizures are controlled.
- Maximum dose: 20 mg per day, taken in divided doses.
Child dosage (ages 11 to 17 years)
- Typical starting dose: 0.5 mg taken three times per day
- Dose increases: A doctor may increase a child’s dose by 0.5 to 1 mg every three days until their seizures are controlled.
- Maximum dose: 20 mg per day, taken in divided doses.
Child dosage (ages 0 to 10 years or children who weigh 66 lbs. [30 kg] or less)
- Typical starting dose: 0.01 to 0.03 mg/kg of body weight per day. The dose shouldn’t be more than 0.05 mg/kg per day given in two to three divided doses.
- Dose increases: A doctor may increase a child’s dose by 0.
25 to 0.5 mg every three days until their seizures are controlled. - Maximum dose: 0.1–0.2 mg/kg per day taken in divided doses.
Senior dosage (ages 65 years and older)
The kidneys of older adults may not work as well as they used to. This can cause their body to process drugs more slowly. As a result, more of a drug stays in their body for a longer time. This raises their risk of side effects. Their doctor may start them on a lowered dose or a different dosing schedule. This can help keep levels of this drug from building up too much in their body.
Clonazepam oral tablet is used for short-term treatment. It comes with risks if a person does not take it as prescribed.
If a person stops taking the drug suddenly or doesn’t take it at all: If a person does not take this drug, their panic disorder or seizures won’t get better and may get worse. If they stop taking it suddenly, they may have symptoms of withdrawal. These include irritability, trouble sleeping, and anxiety.
If a person misses doses or doesn’t take the drug on schedule: They may have withdrawal symptoms if they don’t take the drug on schedule.
If a person takes too much: They could have dangerous levels of the drug in their body. Symptoms of an overdose of this drug can include:
- sleepiness or drowsiness
- confusion
- trouble with coordination or slow reflexes
- coma (being unconscious for a long time)
If a person thinks they have taken too much of this drug, they should call their doctor or local poison control center. If their symptoms are severe, they should call 911 or go to the nearest emergency room right away.
What to do if a person misses a dose: A person usually should take a missed dose as soon as they remember. But if they remember just a few hours before their next scheduled dose, take only one dose. They should never try to catch up by taking two doses at once. This could result in dangerous side effects.
How to tell if the drug is working: A person should have fewer panic attacks or seizures.
This drug comes with several warnings.
FDA warnings
- This drug has a black box warning. This is the most serious warning from the Food and Drug Administration (FDA). A black box warning alerts doctors and patients about drug effects that may be dangerous.
- Using clonazepam with opioid drugs can cause dangerous effects. These can include severe drowsiness, slowed breathing, coma, and death. If your doctor prescribes clonazepam with an opioid, they will monitor you closely. Examples of opioids include hydrocodone, codeine, and tramadol.
- Risk of dependence: Using Clonazepam, even as prescribed, can lead to physical dependence and withdrawal if you stop taking the drug suddenly. Withdrawal can be life threatening. Taking this drug can also lead to misuse and addiction. Misuse of Clonazepam increases your risk of overdose and death.
- Follow the prescription: Only take this drug as your doctor prescribes. Talk with your healthcare provider if you have any concerns about safely taking this drug.
Clonazepam is a central nervous system (CNS) depressant. This type of drug can slow down the brain’s activity and interfere with a person’s judgment, thinking, and reaction time. A person should not drink alcohol or use other drugs that can also slow down their brain’s activity while they are taking this medication. They also shouldn’t drive, use machinery, or do other activities that require alertness until they know how this drug affects them.
Suicidal thoughts and behavior
Clonazepam can increase the risk of suicidal thoughts or behavior (thoughts or actions of harming oneself). A person should tell their doctor if they have worsening depression, suicidal thoughts or behavior, or any unusual changes in mood or behavior.
Alcohol interaction
The use of drinks that contain alcohol can increase a person’s risk of sedative effects from clonazepam. A person may have slowed reflexes, poor judgment, and sleepiness. This can be dangerous. If a person drinks alcohol, they should talk to their doctor.
Allergy warning
Clonazepam can cause a severe allergic reaction. Symptoms can include:
- trouble breathing
- swelling of the throat or tongue
If a person has an allergic reaction, they should call their doctor or local poison control center right away. If their symptoms are severe, call 911 or go to the nearest emergency room. A person should not take this drug again they have ever had an allergic reaction to it. Taking it again could be fatal (cause death).
Warnings for people with certain health conditions
For people with depression: A person’s depression might get worse while they are taking this drug. If a person has worsening symptoms of depression or any suicidal thoughts (thoughts of harming themself), call the doctor right away.
For people with acute narrow angle glaucoma: A person should not take this drug if they have acute narrow angle glaucoma. It can make the condition worse.
For people with liver disease: If a person has liver problems, their body may not be able to clear this drug well. This can cause the drug to build up in the body. This puts them at a higher risk for side effects.
Warnings for other groups
For pregnant women: Clonazepam is a category D pregnancy drug. That means two things:
- Studies show a risk of adverse effects to the fetus when the mother takes the drug.
- This drug should only be used during pregnancy in serious cases where it’s needed to treat a dangerous condition in the mother.
A person should talk to their doctor if they are pregnant or planning to become pregnant. This drug should be used only if the potential benefit justifies the potential risk to the fetus. A person should call their doctor right away if they become pregnant while taking this drug.
For women who are breastfeeding: Clonazepam passes into breast milk and causes side effects in a child who is breastfed. A person should talk to their doctor if they breastfeed their child. They may need to decide whether to stop breastfeeding or stop taking this medication.
For seniors: The kidneys of older adults may not work as well as they used to. This can cause their body to process drugs more slowly. As a result, more of a drug stays in their body for a longer time. This raises their risk of side effects.
For children: This medication hasn’t been studied in children with panic disorders. It shouldn’t be used for the treatment of this condition in people younger than 18 years.
Clonazepam can interact with several other medications. Different interactions can cause different effects. For instance, some can interfere with how well a drug works, while others can cause increased side effects.
Below is a list of medications that can interact with Clonazepam.
This list does not contain all drugs that may interact with Clonazepam.
Before taking Clonazepam, a person should be sure to tell their doctor and pharmacist about all prescription, over-the-counter, and other drugs they take. They should also tell them about any vitamins, herbs, and supplements they use. Sharing this information can help avoid potential interactions.
If a person has questions about drug interactions that may affect them, they should ask their doctor or pharmacist.
Drugs that increase the risk of side effects
Taking clonazepam with certain other medications may cause more side effects. Examples of these drugs include:
- Benzodiazepines, such as lorazepam, clonazepam, triazolam, and midazolam. A person may feel more sedated and drowsy.
- Opioids, such as codeine and hydrocodone. Taking these drugs with clonazepam puts a person at serious risk of severe drowsiness, slowed breathing, coma, or death.
- Barbiturate and nonbarbiturate sleep drugs, such as amobarbital, butabarbital, eszopiclone, pentobarbital, zaleplon, and zolpidem. A person may feel more sedated and drowsy.
- Other drugs used to treat anxiety, such as buspirone and hydroxyzine. A person may feel more sedated and drowsy.
- Tricyclic antidepressants, such as amitriptyline and nortriptyline. A person may feel more sedated and drowsy.
- Other drugs used to treat seizures, such as gabapentin and pregabalin. A person may feel more sedated and drowsy.
Keep these considerations in mind if a doctor prescribes clonazepam oral tablet.
General
- A person can take clonazepam with or without food.
- They should take this drug at the times recommended by a doctor.
- A person can cut or crush the tablet.
- Not every pharmacy stocks this drug. When filling a prescription, be sure to call ahead.
Storage
- Store clonazepam between 59°F and 86°F (15°C and 30°C).
- Don’t store this medication in moist or damp areas, such as bathrooms.
Refills
A prescription for this medication is refillable. However, clonazepam is a schedule IV controlled substance. Therefore, a prescription for this drug may be refilled no more than five times. Also, a person can only get refills for six months after the date their doctor wrote the original prescription. After that time, they will need a new prescription.
Travel
When traveling with medication, a person should:
- Always carry their medication with them. When flying, they should never put it into a checked bag and instead keep it in a carry-on bag.
- Not worry about airport X-ray machines. They can’t hurt the medication.
- Always carry the original prescription-labeled box, as they may need to show airport staff the pharmacy label for their medication.
- Not put this medication in a car’s glove compartment or leave it in the car. They should be especially sure to avoid doing this when the weather is very hot or very cold.
Clinical monitoring
A person and their doctor should monitor certain health issues. This can help make sure they stay safe while they take this drug. These issues include:
- Kidney function. A doctor may do blood tests to check how well a person’s kidneys are working. If their kidneys aren’t working well, the doctor may lower the person’s dose.
- Mental health and behavioral problems. A person and their doctor should watch for any unusual changes in their behavior and mood. This drug can cause new mental health and behavior problems. It can also make problems a person already has worse.
- Seizures. If a person is taking this drug for seizures, they and their doctor should monitor the number of seizures they have.
Insurance
Many insurance companies require a prior authorization for this drug.
This means a doctor will need to get approval from a person’s insurance company before the insurance company will pay for the prescription.
There are other drugs available to treat a person’s condition. Some may be better suited for that person than others. A person should talk to their doctor about other drug options that may work for them.
Disclaimer: Medical News Today has made every effort to make certain that all information is factually correct, comprehensive, and up-to-date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or other healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.
Side effects, dosage, uses, and more
- Clonazepam oral tablet is available as a generic drug and a brand-name drug, Klonopin.
- Clonazepam comes as both an oral tablet and an oral disintegrating (dissolving) tablet.
- Clonazepam is used to treat panic disorder and seizures.
Clonazepam oral tablet is a prescription drug that’s available as the brand-name drug Klonopin. It’s also available as a generic drug. Generic drugs usually cost less. In some cases, they may not be available in every strength or form as the brand-name version.
Clonazepam comes as both an oral tablet and an oral disintegrating (dissolving) tablet.
Clonazepam is a controlled substance.
Why it’s used
Clonazepam is used to treat panic disorder. It’s also used to stop seizures.
Clonazepam may be used as part of a combination therapy. This means a person may need to take it with other medications.
How it works
Clonazepam belongs to a class of drugs called benzodiazepines.
A class of drugs is a group of medications that work in a similar way. These drugs are often used to treat similar conditions.
Clonazepam works by increasing the activity of gamma aminobutyric acid (GABA). This is a chemical that sends signals throughout a person’s nervous system. If a person does not have enough GABA, their body may be in an excited state. This may cause them to have panic attacks or seizures. When a person takes this drug, they will have more GABA in their body. This will help them have fewer panic attacks and seizures.
Clonazepam can cause mild or serious side effects. The following list contains some of the key side effects that may occur while taking clonazepam. This list does not include all possible side effects.
For more information on the possible side effects of clonazepam, or tips on how to deal with a troubling side effect, a person should talk with their doctor or pharmacist.
Common side effects
The more common side effects of clonazepam oral tablet can include:
- drowsiness
- problems with walking and coordination
- dizziness
- depression
- fatigue
- problems with memory
If these effects are mild, they may go away within a few days or a couple of weeks.
If they’re more severe or don’t go away, a person should talk to their doctor or pharmacist.
Serious side effects
A person should call their doctor right away if they have serious side effects. They should call 911 if their symptoms feel life-threatening or if they think they are having a medical emergency. Serious side effects and their symptoms can include the following:
- depressed mood or thoughts of suicide (harming themself)
- seizures (these are more likely to happen if a person stops taking this drug too quickly, or if they already have a seizure disorder)
The clonazepam dosage a doctor prescribes will depend on several factors. These include:
- the type and severity of the condition the person is using clonazepam to treat
- the person’s age
- the form of clonazepam they take
- other medical conditions they may have
Typically, a doctor will start a person on a low dosage and adjust it over time to reach the dosage that’s right for them.
They’ll ultimately prescribe the smallest dosage that provides the desired effect.
The following information describes dosages that are commonly used or recommended. However, a person should be sure to take the dosage the doctor prescribes for them.
A doctor will determine the best dosage to suit a person’s needs.
Forms and strengths
Generic: Clonazepam
- Form: oral tablet
- Strengths: 0.5 mg, 1 mg, 2 mg
- Form: oral disintegrating tablet
- Strengths: 0.125 mg, 0.25, 0.5 mg, 1 mg, 2 mg
Brand: Klonopin
- Form: oral tablet
- Strengths: 0.5 mg, 1 mg, 2 mg
Dosage for panic disorder
Adult dosage (ages 18 to 64 years)
- Typical starting dose: 0.25 mg taken twice per day
- Dose increases: A doctor may increase the dose to 0.
5 mg taken two times per day after three days. - Maximum dose: 4 mg per day.
- Dose reduction: A doctor should decrease a person’s dose slowly when stopping treatment with this drug. They should decrease the dose by no more than 0.125 mg every three days. For example, if the person was taking 2 mg two times per day, their doctor would start by decreasing the dose to 1.875 mg, taken two times per day.
Child dosage (ages 0 to 17 years)
It hasn’t been confirmed that clonazepam is safe and effective for use in people younger than 18 years for this condition.
Senior dosage (ages 65 years and older)
The kidneys of older adults may not work as well as they used to. This can cause their body to process drugs more slowly. As a result, more of a drug stays in their body for a longer time. This raises their risk of side effects. Their doctor may start them on a lowered dose or a different dosing schedule. This can help keep levels of this drug from building up too much in their body.
Dosage for seizures
Adult dosage (ages 18 to 64 years)
- Typical starting dose: 0.5 mg taken three times per day
- Dose increases: A doctor may increase a person’s dose by 0.5 to 1 mg every three days until their seizures are controlled.
- Maximum dose: 20 mg per day, taken in divided doses.
Child dosage (ages 11 to 17 years)
- Typical starting dose: 0.5 mg taken three times per day
- Dose increases: A doctor may increase a child’s dose by 0.5 to 1 mg every three days until their seizures are controlled.
- Maximum dose: 20 mg per day, taken in divided doses.
Child dosage (ages 0 to 10 years or children who weigh 66 lbs. [30 kg] or less)
- Typical starting dose: 0.01 to 0.03 mg/kg of body weight per day. The dose shouldn’t be more than 0.05 mg/kg per day given in two to three divided doses.
- Dose increases: A doctor may increase a child’s dose by 0.
25 to 0.5 mg every three days until their seizures are controlled. - Maximum dose: 0.1–0.2 mg/kg per day taken in divided doses.
Senior dosage (ages 65 years and older)
The kidneys of older adults may not work as well as they used to. This can cause their body to process drugs more slowly. As a result, more of a drug stays in their body for a longer time. This raises their risk of side effects. Their doctor may start them on a lowered dose or a different dosing schedule. This can help keep levels of this drug from building up too much in their body.
Clonazepam oral tablet is used for short-term treatment. It comes with risks if a person does not take it as prescribed.
If a person stops taking the drug suddenly or doesn’t take it at all: If a person does not take this drug, their panic disorder or seizures won’t get better and may get worse. If they stop taking it suddenly, they may have symptoms of withdrawal. These include irritability, trouble sleeping, and anxiety.
If a person misses doses or doesn’t take the drug on schedule: They may have withdrawal symptoms if they don’t take the drug on schedule.
If a person takes too much: They could have dangerous levels of the drug in their body. Symptoms of an overdose of this drug can include:
- sleepiness or drowsiness
- confusion
- trouble with coordination or slow reflexes
- coma (being unconscious for a long time)
If a person thinks they have taken too much of this drug, they should call their doctor or local poison control center. If their symptoms are severe, they should call 911 or go to the nearest emergency room right away.
What to do if a person misses a dose: A person usually should take a missed dose as soon as they remember. But if they remember just a few hours before their next scheduled dose, take only one dose. They should never try to catch up by taking two doses at once. This could result in dangerous side effects.
How to tell if the drug is working: A person should have fewer panic attacks or seizures.
This drug comes with several warnings.
FDA warnings
- This drug has a black box warning. This is the most serious warning from the Food and Drug Administration (FDA). A black box warning alerts doctors and patients about drug effects that may be dangerous.
- Using clonazepam with opioid drugs can cause dangerous effects. These can include severe drowsiness, slowed breathing, coma, and death. If your doctor prescribes clonazepam with an opioid, they will monitor you closely. Examples of opioids include hydrocodone, codeine, and tramadol.
- Risk of dependence: Using Clonazepam, even as prescribed, can lead to physical dependence and withdrawal if you stop taking the drug suddenly. Withdrawal can be life threatening. Taking this drug can also lead to misuse and addiction. Misuse of Clonazepam increases your risk of overdose and death.
- Follow the prescription: Only take this drug as your doctor prescribes. Talk with your healthcare provider if you have any concerns about safely taking this drug.
Clonazepam is a central nervous system (CNS) depressant. This type of drug can slow down the brain’s activity and interfere with a person’s judgment, thinking, and reaction time. A person should not drink alcohol or use other drugs that can also slow down their brain’s activity while they are taking this medication. They also shouldn’t drive, use machinery, or do other activities that require alertness until they know how this drug affects them.
Suicidal thoughts and behavior
Clonazepam can increase the risk of suicidal thoughts or behavior (thoughts or actions of harming oneself). A person should tell their doctor if they have worsening depression, suicidal thoughts or behavior, or any unusual changes in mood or behavior.
Alcohol interaction
The use of drinks that contain alcohol can increase a person’s risk of sedative effects from clonazepam. A person may have slowed reflexes, poor judgment, and sleepiness. This can be dangerous. If a person drinks alcohol, they should talk to their doctor.
Allergy warning
Clonazepam can cause a severe allergic reaction. Symptoms can include:
- trouble breathing
- swelling of the throat or tongue
If a person has an allergic reaction, they should call their doctor or local poison control center right away. If their symptoms are severe, call 911 or go to the nearest emergency room. A person should not take this drug again they have ever had an allergic reaction to it. Taking it again could be fatal (cause death).
Warnings for people with certain health conditions
For people with depression: A person’s depression might get worse while they are taking this drug. If a person has worsening symptoms of depression or any suicidal thoughts (thoughts of harming themself), call the doctor right away.
For people with acute narrow angle glaucoma: A person should not take this drug if they have acute narrow angle glaucoma. It can make the condition worse.
For people with liver disease: If a person has liver problems, their body may not be able to clear this drug well. This can cause the drug to build up in the body. This puts them at a higher risk for side effects.
Warnings for other groups
For pregnant women: Clonazepam is a category D pregnancy drug. That means two things:
- Studies show a risk of adverse effects to the fetus when the mother takes the drug.
- This drug should only be used during pregnancy in serious cases where it’s needed to treat a dangerous condition in the mother.
A person should talk to their doctor if they are pregnant or planning to become pregnant. This drug should be used only if the potential benefit justifies the potential risk to the fetus. A person should call their doctor right away if they become pregnant while taking this drug.
For women who are breastfeeding: Clonazepam passes into breast milk and causes side effects in a child who is breastfed. A person should talk to their doctor if they breastfeed their child. They may need to decide whether to stop breastfeeding or stop taking this medication.
For seniors: The kidneys of older adults may not work as well as they used to. This can cause their body to process drugs more slowly. As a result, more of a drug stays in their body for a longer time. This raises their risk of side effects.
For children: This medication hasn’t been studied in children with panic disorders. It shouldn’t be used for the treatment of this condition in people younger than 18 years.
Clonazepam can interact with several other medications. Different interactions can cause different effects. For instance, some can interfere with how well a drug works, while others can cause increased side effects.
Below is a list of medications that can interact with Clonazepam.
This list does not contain all drugs that may interact with Clonazepam.
Before taking Clonazepam, a person should be sure to tell their doctor and pharmacist about all prescription, over-the-counter, and other drugs they take. They should also tell them about any vitamins, herbs, and supplements they use. Sharing this information can help avoid potential interactions.
If a person has questions about drug interactions that may affect them, they should ask their doctor or pharmacist.
Drugs that increase the risk of side effects
Taking clonazepam with certain other medications may cause more side effects. Examples of these drugs include:
- Benzodiazepines, such as lorazepam, clonazepam, triazolam, and midazolam. A person may feel more sedated and drowsy.
- Opioids, such as codeine and hydrocodone. Taking these drugs with clonazepam puts a person at serious risk of severe drowsiness, slowed breathing, coma, or death.
- Barbiturate and nonbarbiturate sleep drugs, such as amobarbital, butabarbital, eszopiclone, pentobarbital, zaleplon, and zolpidem. A person may feel more sedated and drowsy.
- Other drugs used to treat anxiety, such as buspirone and hydroxyzine. A person may feel more sedated and drowsy.
- Tricyclic antidepressants, such as amitriptyline and nortriptyline. A person may feel more sedated and drowsy.
- Other drugs used to treat seizures, such as gabapentin and pregabalin. A person may feel more sedated and drowsy.
Keep these considerations in mind if a doctor prescribes clonazepam oral tablet.
General
- A person can take clonazepam with or without food.
- They should take this drug at the times recommended by a doctor.
- A person can cut or crush the tablet.
- Not every pharmacy stocks this drug. When filling a prescription, be sure to call ahead.
Storage
- Store clonazepam between 59°F and 86°F (15°C and 30°C).
- Don’t store this medication in moist or damp areas, such as bathrooms.
Refills
A prescription for this medication is refillable. However, clonazepam is a schedule IV controlled substance. Therefore, a prescription for this drug may be refilled no more than five times. Also, a person can only get refills for six months after the date their doctor wrote the original prescription. After that time, they will need a new prescription.
Travel
When traveling with medication, a person should:
- Always carry their medication with them. When flying, they should never put it into a checked bag and instead keep it in a carry-on bag.
- Not worry about airport X-ray machines. They can’t hurt the medication.
- Always carry the original prescription-labeled box, as they may need to show airport staff the pharmacy label for their medication.
- Not put this medication in a car’s glove compartment or leave it in the car. They should be especially sure to avoid doing this when the weather is very hot or very cold.
Clinical monitoring
A person and their doctor should monitor certain health issues. This can help make sure they stay safe while they take this drug. These issues include:
- Kidney function. A doctor may do blood tests to check how well a person’s kidneys are working. If their kidneys aren’t working well, the doctor may lower the person’s dose.
- Mental health and behavioral problems. A person and their doctor should watch for any unusual changes in their behavior and mood. This drug can cause new mental health and behavior problems. It can also make problems a person already has worse.
- Seizures. If a person is taking this drug for seizures, they and their doctor should monitor the number of seizures they have.
Insurance
Many insurance companies require a prior authorization for this drug.
This means a doctor will need to get approval from a person’s insurance company before the insurance company will pay for the prescription.
There are other drugs available to treat a person’s condition. Some may be better suited for that person than others. A person should talk to their doctor about other drug options that may work for them.
Disclaimer: Medical News Today has made every effort to make certain that all information is factually correct, comprehensive, and up-to-date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or other healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.
tablets, 0.5 mg 0.027 ‰
Analogs Order in pharmacies Order
drug
Choice of description
| Lec. form | Dosage |
|---|---|
| nine0002 tablets | 0.5 mg 2 mg nine0024 |
tablets
0.
5 mg 2 mg
All forms of release, dosages, registration certificates, drug manufacturers, drug characteristics nine0004
Clonazepam (tablets, 2 mg), instructions for medical use RU No. LP-004450
Active substance
Active ingredient
Clonazepam* (Clonazepam*)
ATX
N03AE01 Clonazepam
Nosological classification (ICD-10)
ICD-10 code list
- F34.
0 Cyclothymia nine0053 - G40 Epilepsy
- G40.3 Generalized idiopathic epilepsy and epileptic syndromes nine0053
- R45.1 Restlessness and agitation
Pharmacological group
Antiepileptic drugs
Dosage form
Tablets
Composition
Composition per tablet for 0.5 mg dosage
Active substance:
clonazepam — 0.
5 mg
Auxiliaries substances:
starch potato - 30.0 mg,
mannitol (mannitol) - 51.5 mg,
lactose monohydrate - 50.0 mg,
crospovidone (polyplasdone XL-10) - 9.0 mg,
povidone type K-25 (medium molecular weight polyvinylpyrrolidone) - 4.5 mg,
silicon colloidal dioxide (aerosil) - 3.0 mg, magnesium stearate - 1.5 mg.
Composition per tablet for 2.0 mg dosage
Active substance:
clonazepam — 2.0 mg
Auxiliaries substances:
starch potato - 30.0 mg,
mannitol (mannitol) - 50.0 mg,
lactose monohydrate - 50.0 mg,
crospovidone (polyplasdone XL-10) - 9.0 mg,
povidone type K-25 (medium molecular weight polyvinylpyrrolidone) - 4.5 mg,
silicon colloidal dioxide (aerosil) - 3.0 mg,
magnesium stearate - 1.5 mg.
Dosage form description
Round flat-cylindrical tablets of white or almost white color with a chamfer and cross risk.
nine0004
Pharmacokinetics
Absorption: at Orally administered clonazepam is well absorbed from the gastrointestinal tract. tract (GIT), reaching the maximum concentration max "> C max in blood plasma after 1-4 hours after taking. Bioavailability is about 90%.
Allocation: 85% clonazepam binds to plasma proteins. Average volume of distribution is 3 l/kg. It is assumed that clonazepam penetrates through the blood-brain and placental barriers, penetrates into breast milk. nine0004
Metabolism: clonazepam biotransformation involves oxidative hydroxylation and restoration of the 7-nitro group in the liver with the formation of 7-amino or 7-acetylamino compounds with a small amount of 3-hydroxy derivatives all three compounds and their glucuronide and sulfate conjugates. Nitro compounds have pharmacological activity, and amino compounds - no. The equilibrium concentration in the blood is reached after 4-6 days.
Output: output in the form of metabolites in the urine (50-70%) and through the gastrointestinal tract (10-30%).
About 0.5% of the dose taken is excreted unchanged by the kidneys. Period the half-life of T 1/2 is 20-60 hours.
Pharmacodynamics
Clonazepam belongs to the group of benzodiazepine derivatives. Possesses anticonvulsant, sedative, central muscle relaxant and anxiolytic action. Enhances the inhibitory effect of gamma-aminobutyric acid (a mediator of pre- and postsynaptic inhibition in all parts of the central nervous system (CNS)) for the transmission of nerve impulses. nine0004
Electroencephalographic studies have shown that clonazepam rapidly suppresses paroxysmal activity of various types, including spike-wave complexes in absence seizures (petit mal), slow and generalized complexes "spike-wave", "spikes" of the temporal and other localizations, as well as irregular "spikes" and "waves". Effective for focal and generalized forms of epilepsy. Anxiolytic action due to influence on the amygdala complex of the limbic system and manifests itself in reducing emotional stress, easing anxiety, fear, anxiety.
The sedative effect is due to the effect on the reticular formation of the brain stem brain and nonspecific nuclei of the thalamus and is manifested by a decrease in symptoms neurotic origin (anxiety, fear). nine0004
Indications
All clinical forms of epilepsy and seizures in children and adults, including absences (small epileptic seizure), including atypical absences; primary or secondary generalized clonic-tonic (grand epileptic seizure), tonic or clonic convulsions; simple or compound partials (focal) convulsions; various forms of myoclonic seizures, myoclonus and associated pathological movements.
Syndromes paroxysmal fear, a state of fear in phobias, for example, agoraphobia (not use in patients under 18 years of age). nine0004
States psychomotor agitation against the background of reactive psychoses.
Contraindications
- Increased sensitivity to any of the components of the drug or to others benzodiazepines.
- Violation breathing of central origin and severe respiratory conditions insufficiency, regardless of cause.
- Syndrome sleep apnea.
- closed angle form of glaucoma. nine0004
- Myasthenia.
- Violation consciousness.
- heavy liver failure.
- hereditary lactose intolerance, lactase deficiency, glucose-galactose malabsorption.
- Children's age up to 3 years.
C caution
Cerebellar or spinal ataxia, liver failure, impaired renal function, and liver, cirrhosis of the liver, chronic diseases of the respiratory system, cardiac failure, depression, history of suicidal thoughts and attempts, psychosis, chronic alcoholism, history of drug dependence (including narcotic), porphyria, old age, with acute alcohol intoxication or drugs. nine0004
Use in pregnancy and lactation
Fertility
According to available data from preclinical studies, clonazepam has toxic effect on reproductive function. Epidemiological estimates prove the teratogenic effect of anticonvulsants.
During preclinical studies, there was a two-fold increase in the frequency the occurrence of birth defects, when using doses exceeding 3.9and 18 times the therapeutic dose for humans, compared with control groups. Due to the teratogenic properties of clonazepam, patients of childbearing potential effective contraceptive methods must be used throughout the period treatment and two weeks after the end of treatment.
Pregnancy
Clonazepam has an adverse pharmacological effect on pregnancy and the fetus / newborn child. Administration of high doses in the last trimester of pregnancy or during childbirth can cause fetal cardiac arrhythmias and hypothermia, hypotension, mild respiratory depression and a weak sucking reflex in the newborn. At children whose mothers constantly in the later stages of pregnancy took benzodiazepines, possible development of physical dependence, also such children may be at some risk of developing a "withdrawal" syndrome in the postnatal period.
Therefore, clonazepam should only be used during pregnancy. in the event that the benefit to the mother clearly outweighs the risk to the fetus. nine0004
Breastfeeding feeding
Established that clonazepam passes into breast milk in small amounts. That's why Clonazepam should only be used in breastfeeding mothers if if the benefit to the mother clearly outweighs the risk to the baby.
Dosage and administration
Inside.
Recommended dose
Divisible tablets 0.5 mg allows the introduction of lower daily doses per initial stages of treatment (if necessary). nine0004
Dose and the duration of therapy is determined individually by the doctor.
Treatment start with low doses and increase them gradually until optimal therapeutic effect.
For epilepsy
Adults
Starting dose should be no more than 1.5 mg / day, divided into 3 doses (according to 0.5 mg 3 times a day).
The dose should be gradually increased by 0.5-1 mg every 3 days. The maintenance dose is set individually for each patient depending on the therapeutic effect (usually 4-8 mg/day in 3-4 divided doses). nine0004
Maximum the daily dose is 20 mg.
Children
The optimal dosage in children should be 0.5 mg tablets.
Children aged 3 to 5 years
Starting dose — 0.25 mg/day.
Support dose - 1-3 mg / day.
Children aged 5 to 12 years
Starting dose — 0.5 mg/day.
Support dose 3–6 mg/day. nine0004
Maximum the daily dose for children is 0.2 mg/kg/day.
Patients old age
Due to the fact that Elderly patients are particularly sensitive to the effects of drugs that depress the central nervous system, as well as due to the occurrence of confusion when using the drug, the initial dose of clonazepam in this category recommended as no more than 0.5 mg/day.
Long treatment
Total daily allowance the dose should be divided into 3 or 4 doses at intervals throughout the day.
At necessary, higher doses may be used as prescribed by the doctor, up to a maximum of 20 mg per day for adults. The maintenance dose should applied 2-4 weeks after the start of treatment.
Some patients, some forms of epilepsy may no longer be adequately controlled clonazepam. Control can be re-established by increasing the dose or interruption of clonazepam treatment for 2 or 3 weeks. During a break in therapy may require close monitoring and use of other drugs drugs. nine0004
Daily dose should be divided into 3 equal parts. If you divide the dose into three equal parts is not possible, the largest of them should be taken at bedtime. Once maintenance dose level reached, daily dose can be taken in the evening once.
Simultaneous use of more than one antiepileptic drug is common practice in the treatment of epilepsy and can be used when applying clonazepam. The dose of each drug should be adjusted to achieve optimal effect. It is necessary to analyze the dosing regimen and the rationality of the selected therapy in the event of an epileptic status in a patient receiving oral clonazepam.
Before adding clonazepam to existing anticonvulsant therapy, it should be taken into account that the use of several anticonvulsants may lead to increased unwanted effects. nine0004
Syndrome paroxysmal fear
Adults
Average the dose used is 1 mg/day. The maximum daily dose - 4 mg/day.
Children
Safety and efficacy of clonazepam in children under 18 years of age with paroxysmal fear has not been established.
Patients elderly
Necessary be careful when using clonazepam. Dose reduction recommended especially in patients with imbalance and reduced motor abilities. nine0004
Patients with impaired renal and hepatic function, chronic respiratory diseases
May be necessary to reduce the dose of the drug.
Cannot be sharp cancel the drug; it is always necessary to gradually, supervised by a doctor, dose reduction. Abrupt withdrawal of the drug can cause sleep disturbance, mood, and psychiatric disorders.
During treatment clonazepam and within 3 days after its completion, you can not use any alcohol. nine0004
Side effects
Clonazepam well tolerated. Adverse reactions are usually mild and reversible.
Classification WHO adverse reactions by frequency of development:
very often -> 1/10; often - from 1/100 to 1/10; infrequently - from 1/1000 to 1/100; rarely - from 1/10000 to 1/1000; very rare - <1/10000 including individual messages.
Violations from the blood and lymphatic system:
Rarely - as with other benzodiazepines, isolated cases have been reported blood dyscrasias.
Mental violations :
Often — decreased concentration, restlessness, confusion and disorientation. Anterograde amnesia may occur with the use of benzodiazepines in therapeutic dose, the risk increases at higher doses. Development of amnesia can be determined by the unusual behavior of the patient.
nine0004
Uncommon — the use of benzodiazepines can lead to the development of physical and mental drug addiction. The risk of addiction increases with an increase in the dose of the drug and the duration of its use, as well as in patients suffering from alcoholism and / or having a history of narcotic addiction.
Rarely — depression (may also be associated with an underlying illness).
Violations from the nervous system:
Often — dizziness, ataxia, drowsiness and incoordination;
Rarely — (especially with long-term use or when treated with high doses) development reversible disorders such as slow or slurred speech (dysarthria), impaired coordination of movements and gait (ataxia). Predisposed patients may develop seizures (see "Special Instructions").
Violations on the part of the organ of vision:
Often — nystagmus;
Rarely — diplopia.
Violations from the side of the heart:
Rarely - heart failure, including cardiac arrest.
Violations from the respiratory system, chest organs and mediastinum:
Rarely - respiratory depression (may occur with intravenous administration of clonazepam, this effect may be exacerbated by prior airway obstruction or brain damage, or when taken with other respiratory depressants). Typically, this violation can be avoided. by dose selection until the optimal therapeutic effect is obtained. nine0004
Gastrointestinal violations:
Rarely — symptoms of gastrointestinal disturbances, including nausea.
Violations from the liver and biliary tract:
Rarely - changes in liver function tests.
Violations from the skin and subcutaneous tissues:
Rarely - hives, itching, temporary hair loss and pigmentation changes. It was reported that allergic reactions, including very rare cases of anaphylaxis and angioedema, may occur with the use of benzodiazepines.
nine0004
Violations from the side of muscle, skeletal and connective tissue:
Often - muscle weakness and muscle hypotension.
Violations from the side of the kidneys and urinary tract:
Rarely - urinary incontinence.
Violations from the reproductive system and mammary glands:
Rarely - decreased sex drive (loss of libido) and impotence, reversible premature appearance of secondary sexual characteristics in children (incomplete precocious puberty). nine0004
Interaction
Yes how alcohol can trigger epileptic seizures, regardless of therapy, patients should under no circumstances use alcohol during treatment with clonazepam. Alcohol in combination with clonazepam may affect the effects of the drug, adversely affect the success of therapy or cause unpredictable side effects.
At the use of clonazepam in combination with other antiepileptic drugs side effects such as sedation and lethargy, toxicity may be more obvious, especially when used together with hydantoins, phenobarbital and their combinations.
This requires special care when adjusting the dose for initial stages of treatment. The combination of clonazepam and sodium valproate occasionally associated with the development of status epilepticus of small seizures. Although some patients are tolerant and well tolerate this combination of drugs, this potential hazard should be taken into account when deciding on its use. nine0004
Antiepileptics drugs such as phenytoin, phenobarbital, carbamazepine, and valproate may induce the metabolism of clonazepam, providing higher clearance and more low plasma concentrations of clonazepam in combination therapy.
Selective serotonin reuptake inhibitors such as sertraline and fluoxetine affect the pharmacokinetics of clonazepam when used together.
Known liver enzyme inhibitors, such as cimetidine, have been shown to reduce the clearance of benzodiazepines and may enhance their effect, and known hepatic enzyme inducers, such as rifampicin, may increase clearance benzodiazepines.
nine0004
At concomitant treatment with phenytoin or primidone has occasionally been observed the change is usually an increase in the serum concentration of these two substances.
Simultaneous use of clonazepam and other centrally acting drugs, such as other anticonvulsants (antiepileptic) drugs, anesthetics, sleeping pills, psychotropic drugs and some analgesics, and also muscle relaxants can lead to mutual potentiation of medicinal effects. This is especially true in the presence of alcohol. With combined therapy with centrally acting drugs, the dose of each drug should be adjusted for optimal effect. nine0004
Overdose
Symptoms
Symptoms overdose or intoxication vary greatly from person to person depending on on age, body weight and individual response to the drug. Benzodiazepines usually cause drowsiness, ataxia, dysarthria, and nystagmus. Overdose clonazepam is rarely life-threatening if the drug is taken in as monotherapy, but can lead to coma, aflexia, apnea, hypotension and cardiorespiratory depression.
The coma usually lasts only a few hours, but older people, it can be longer and cyclical. Effects of oppression breathing with benzodiazepines are more severe in patients with severe chronic obstructive airway disease. nine0004
Benzodiazepines potentiate the effects of other CNS depressants, including alcohol.
Treatment
Maintenance airway and adequate ventilation, if indicated.
1. The benefit of gastric lavage has not been established. Appropriate application activated charcoal (50 g for an adult, 10–15 g for a child) adults or children who have taken more than 0.4 mg/kg in 1 hour in the absence of severe drowsiness. nine0004
2. Gastric lavage is not necessary if have been taken only these drugs.
3. In patients without symptoms within 4 hours, further symptoms are unlikely.
4. Supportive measures based on clinical the patient's condition. In particular, patients may need symptomatic treatment of cardiorespiratory reactions or reactions from the central nervous system.
5. Flumazenil, a benzodiazepine antagonist, is used rare, because it has a short half-life (about 1 hour). Flumazenil is not used in case of an overdose of several drugs at the same time. drugs, and also as a "diagnostic test". nine0004
Special instructions
- Suicidal thoughts and behaviors have been reported in patients treated with antiepileptic drugs for several indications. Meta-analysis randomized placebo-controlled trials of antiepileptic drugs also showed a slight increase in the risk of suicidal thoughts and behavior. The mechanism by which this risk develops is unknown, but the available data do not exclude the possibility of an increased risk with clonazepam. nine0004
Therefore patients should be monitored for suicidal thoughts and behavior and appropriate treatment should be considered. Patients (and individuals caregivers) should seek medical attention if signs of suicidal thoughts or behavior.
- Patients with depression and/or a history of suicide attempts should be under close observation.
- When certain forms of epilepsy may increase the frequency of seizures with long-term treatment. Clonazepam is usually beneficial in behavioral disorders in patients with epilepsy. In some cases, they may paradoxical effects occur, such as aggressiveness, excitability, nervousness, hostility, restlessness, sleep disturbances, nightmares, realistic dreams, irritability, agitation, psychotic disorders and activation of new types of seizures. If this happens, then the benefits of continuing the use of this drug should be evaluated in comparison with undesirable effect. It may be necessary to add to the treatment regimen another suitable medicinal product or, in some cases, it may be appropriate discontinuation of clonazepam therapy. nine0004
- Clonazepam should be used with caution in patients with chronic pulmonary insufficiency or impaired function of the kidneys or liver, as well as in the elderly or debilitated patients. In these cases, the dose should generally be reduced.
- As and when using other antiepileptic drugs, therapy with clonazepam, even if it is short-term, it should not be abruptly interrupted, but should be canceled by gradually reducing the dose, taking into account the risk of developing epileptic status. In these cases, a combination with other antiepileptic drugs. This precaution should also be taken into account when stopping another drug while the patient is still on therapy clonazepam. nine0004
- Long the use of benzodiazepines can lead to the development of dependence with the syndrome "cancellation" when you stop using.
- Clonazepam should only be used with extreme caution in patients with spinal or cerebellar ataxia, with acute intoxication with alcohol or drugs, and in patients with severe liver damage (eg cirrhosis of the liver).
- Follows avoid using clonazepam while consuming alcohol and/or drugs CNS depressant. This combined use can potentially enhance clinical effects of clonazepam, including severe sedation, clinically significant oppression of the respiratory and / or cardiovascular systems.
nine0004
- Benzodiazepines should be used with extreme caution in patients with alcoholic or drug addiction.
- U children and young children clonazepam may cause an increase in saliva production and bronchial secretions. Therefore, special attention should be paid to maintaining airway patency.
Impact on the respiratory system may be exacerbated by previous obstruction respiratory tract or brain damage or joint use with other drugs that depress breathing. As a rule, this effect can be avoided by carefully adjusting the dose until satisfaction individual needs. nine0004
Dosage clonazepam should be carefully adjusted to individual needs of patients with pre-existing respiratory diseases (eg, chronic obstructive pulmonary disease) or liver and in patients treated with other centrally acting drugs or anticonvulsant (antiepileptic) drugs.
- Exist conflicting data on the effect or lack of effect of clonazepam on patients with porphyria. Therefore, in this group of patients, clonazepam should be apply with caution.
nine0004
- As and all drugs of similar action, clonazepam, may affect patient responses (eg, ability to drive a vehicle, driving behavior) (see section "Influence on the ability to drive vehicles and mechanisms).
- U in patients with an uncomplicated bereavement reaction, the use of benzodiazepines may slow down psychological adjustment.
- Dependency and withdrawal syndrome. The use of benzodiazepines can lead to the development physical and mental drug dependence. In particular, long-term or high-dose therapy can lead to reversible disorders such as dysarthria, decreased coordination of movements and gait disturbance (ataxia), nystagmus and visual impairment (diplopia). nine0004
Over In addition, the risk of anterograde amnesia, which may occur with the use of benzodiazepines in therapeutic doses, increases with the use of more high doses. Amnestic effects may be associated with inappropriate behavior. In certain forms of epilepsy, an increase in the frequency is possible seizures during long-term treatment.
The risk of addiction increases with increasing the dose and duration of treatment; it is also higher in patients with history of alcohol and/or drug addiction. nine0004
How only physical dependence develops, abrupt discontinuation of treatment accompanied by a withdrawal syndrome. With long-term treatment, the syndrome "Cancellation" may develop after a long period of use, especially when high doses, or if the daily dose is rapidly reduced or suddenly stop using the drug. Symptoms include tremors, sweating, agitation, sleep disturbances and anxiety, headaches, muscle pain, extreme anxiety, tension, confusion, irritability and epileptic seizures, which may be associated with the underlying disease. AT in severe cases, the following symptoms may be observed: derealization, depersonalization, hyperacusis, numbness and tingling of the extremities, hypersensitivity to light, noise and physical contact or hallucinations. Since the risk of developing a "withdrawal" syndrome is higher with an abrupt cessation of treatment, abrupt discontinuation of the drug should be avoided, and treatment, even if it is short-term nature, should be stopped, gradually reducing the daily dose.
The risk of developing a "withdrawal" syndrome increases if benzodiazepines are used in conjunction with daytime sedatives (cross tolerance). nine0004
- Patients receiving benzodiazepines are at increased risk falls and fractures. The risk is increased in those who receive both sedatives (including including alcoholic beverages) and in the elderly.
Influence on the ability to drive vehicles, mechanisms
Patients with epilepsy is not allowed to drive a car. Even with adequate control epilepsy with clonazepam, it should be remembered that any increase in dosage or changing the timing of the dose of the drug can change the response of patients in depending on individual susceptibility. Even if you take clonazepam as intended, it can slow down the reaction so that the ability to driving a vehicle or operating machinery. This effect aggravated by alcohol. Therefore, driving, operating mechanisms and other hazardous activities should be avoided.
nine0004
Presentation
Tablets 0.5 mg and 2.0 mg.
By 10 tablets in a blister pack made of PVC film and aluminum foil printed lacquered or flexible based packaging aluminum foil.
3 each blister packs together with instructions for use in a pack of cardboard.
Terms of dispensing from pharmacies
on prescription.
Storage conditions
According to rules for the storage of psychotropic substances included in List III of the "List narcotic drugs, psychotropic substances and their precursors subject to control in the Russian Federation. nine0004
The information provided on drug prices is not an offer to sell or buy goods.
The information is intended solely for comparing prices in stationary pharmacies operating in in accordance with Article 55 of the Federal Law "On the Circulation of Medicines" dated April 12, 2010 No. 61-FZ.
tablets, 0.5 mg nine0003 0.
027 ‰ Analogs Order in pharmacies Order
drug
Choice of description
| Lec. form | Dosage |
|---|---|
| tablets | nine0025 0.5 mg 2 mg nine0024
tablets
0.
5 mg 2 mg
All forms of release, dosages, registration certificates, drug manufacturers, drug characteristics nine0004
Clonazepam (tablets, 2 mg), instructions for medical use RU No. LP-004450
Active substance
Active ingredient
Clonazepam* (Clonazepam*)
ATX
N03AE01 Clonazepam
Nosological classification (ICD-10)
ICD-10 code list
- F34.
0 Cyclothymia nine0053 - G40 Epilepsy
- G40.3 Generalized idiopathic epilepsy and epileptic syndromes nine0053
- R45.1 Restlessness and agitation
Pharmacological group
Antiepileptic drugs
Dosage form
Tablets
Composition
Composition per tablet for 0.5 mg dosage
Active substance:
clonazepam — 0.
5 mg
Auxiliaries substances:
starch potato - 30.0 mg,
mannitol (mannitol) - 51.5 mg,
lactose monohydrate - 50.0 mg,
crospovidone (polyplasdone XL-10) - 9.0 mg,
povidone type K-25 (medium molecular weight polyvinylpyrrolidone) - 4.5 mg,
silicon colloidal dioxide (aerosil) - 3.0 mg, magnesium stearate - 1.5 mg.
Composition per tablet for 2.0 mg dosage
Active substance:
clonazepam — 2.0 mg
Auxiliaries substances:
starch potato - 30.0 mg,
mannitol (mannitol) - 50.0 mg,
lactose monohydrate - 50.0 mg,
crospovidone (polyplasdone XL-10) - 9.0 mg,
povidone type K-25 (medium molecular weight polyvinylpyrrolidone) - 4.5 mg,
silicon colloidal dioxide (aerosil) - 3.0 mg,
magnesium stearate - 1.5 mg.
Dosage form description
Round flat-cylindrical tablets of white or almost white color with a chamfer and cross risk.
nine0004
Pharmacokinetics
Absorption: at Orally administered clonazepam is well absorbed from the gastrointestinal tract. tract (GIT), reaching the maximum concentration max "> C max in blood plasma after 1-4 hours after taking. Bioavailability is about 90%.
Allocation: 85% clonazepam binds to plasma proteins. Average volume of distribution is 3 l/kg. It is assumed that clonazepam penetrates through the blood-brain and placental barriers, penetrates into breast milk. nine0004
Metabolism: clonazepam biotransformation involves oxidative hydroxylation and restoration of the 7-nitro group in the liver with the formation of 7-amino or 7-acetylamino compounds with a small amount of 3-hydroxy derivatives all three compounds and their glucuronide and sulfate conjugates. Nitro compounds have pharmacological activity, and amino compounds - no. The equilibrium concentration in the blood is reached after 4-6 days.
Output: output in the form of metabolites in the urine (50-70%) and through the gastrointestinal tract (10-30%).
About 0.5% of the dose taken is excreted unchanged by the kidneys. Period the half-life of T 1/2 is 20-60 hours.
Pharmacodynamics
Clonazepam belongs to the group of benzodiazepine derivatives. Possesses anticonvulsant, sedative, central muscle relaxant and anxiolytic action. Enhances the inhibitory effect of gamma-aminobutyric acid (a mediator of pre- and postsynaptic inhibition in all parts of the central nervous system (CNS)) for the transmission of nerve impulses. nine0004
Electroencephalographic studies have shown that clonazepam rapidly suppresses paroxysmal activity of various types, including spike-wave complexes in absence seizures (petit mal), slow and generalized complexes "spike-wave", "spikes" of the temporal and other localizations, as well as irregular "spikes" and "waves". Effective for focal and generalized forms of epilepsy. Anxiolytic action due to influence on the amygdala complex of the limbic system and manifests itself in reducing emotional stress, easing anxiety, fear, anxiety.
The sedative effect is due to the effect on the reticular formation of the brain stem brain and nonspecific nuclei of the thalamus and is manifested by a decrease in symptoms neurotic origin (anxiety, fear). nine0004
Indications
All clinical forms of epilepsy and seizures in children and adults, including absences (small epileptic seizure), including atypical absences; primary or secondary generalized clonic-tonic (grand epileptic seizure), tonic or clonic convulsions; simple or compound partials (focal) convulsions; various forms of myoclonic seizures, myoclonus and associated pathological movements.
Syndromes paroxysmal fear, a state of fear in phobias, for example, agoraphobia (not use in patients under 18 years of age). nine0004
States psychomotor agitation against the background of reactive psychoses.
Contraindications
- Increased sensitivity to any of the components of the drug or to others benzodiazepines.
- Violation breathing of central origin and severe respiratory conditions insufficiency, regardless of cause.
- Syndrome sleep apnea.
- closed angle form of glaucoma. nine0004
- Myasthenia.
- Violation consciousness.
- heavy liver failure.
- hereditary lactose intolerance, lactase deficiency, glucose-galactose malabsorption.
- Children's age up to 3 years.
C caution
Cerebellar or spinal ataxia, liver failure, impaired renal function, and liver, cirrhosis of the liver, chronic diseases of the respiratory system, cardiac failure, depression, history of suicidal thoughts and attempts, psychosis, chronic alcoholism, history of drug dependence (including narcotic), porphyria, old age, with acute alcohol intoxication or drugs. nine0004
Use in pregnancy and lactation
Fertility
According to available data from preclinical studies, clonazepam has toxic effect on reproductive function. Epidemiological estimates prove the teratogenic effect of anticonvulsants.
During preclinical studies, there was a two-fold increase in the frequency the occurrence of birth defects, when using doses exceeding 3.9and 18 times the therapeutic dose for humans, compared with control groups. Due to the teratogenic properties of clonazepam, patients of childbearing potential effective contraceptive methods must be used throughout the period treatment and two weeks after the end of treatment.
Pregnancy
Clonazepam has an adverse pharmacological effect on pregnancy and the fetus / newborn child. Administration of high doses in the last trimester of pregnancy or during childbirth can cause fetal cardiac arrhythmias and hypothermia, hypotension, mild respiratory depression and a weak sucking reflex in the newborn. At children whose mothers constantly in the later stages of pregnancy took benzodiazepines, possible development of physical dependence, also such children may be at some risk of developing a "withdrawal" syndrome in the postnatal period.
Therefore, clonazepam should only be used during pregnancy. in the event that the benefit to the mother clearly outweighs the risk to the fetus. nine0004
Breastfeeding feeding
Established that clonazepam passes into breast milk in small amounts. That's why Clonazepam should only be used in breastfeeding mothers if if the benefit to the mother clearly outweighs the risk to the baby.
Dosage and administration
Inside.
Recommended dose
Divisible tablets 0.5 mg allows the introduction of lower daily doses per initial stages of treatment (if necessary). nine0004
Dose and the duration of therapy is determined individually by the doctor.
Treatment start with low doses and increase them gradually until optimal therapeutic effect.
For epilepsy
Adults
Starting dose should be no more than 1.5 mg / day, divided into 3 doses (according to 0.5 mg 3 times a day).
The dose should be gradually increased by 0.5-1 mg every 3 days. The maintenance dose is set individually for each patient depending on the therapeutic effect (usually 4-8 mg/day in 3-4 divided doses). nine0004
Maximum the daily dose is 20 mg.
Children
The optimal dosage in children should be 0.5 mg tablets.
Children aged 3 to 5 years
Starting dose — 0.25 mg/day.
Support dose - 1-3 mg / day.
Children aged 5 to 12 years
Starting dose — 0.5 mg/day.
Support dose 3–6 mg/day. nine0004
Maximum the daily dose for children is 0.2 mg/kg/day.
Patients old age
Due to the fact that Elderly patients are particularly sensitive to the effects of drugs that depress the central nervous system, as well as due to the occurrence of confusion when using the drug, the initial dose of clonazepam in this category recommended as no more than 0.5 mg/day.
Long treatment
Total daily allowance the dose should be divided into 3 or 4 doses at intervals throughout the day.
At necessary, higher doses may be used as prescribed by the doctor, up to a maximum of 20 mg per day for adults. The maintenance dose should applied 2-4 weeks after the start of treatment.
Some patients, some forms of epilepsy may no longer be adequately controlled clonazepam. Control can be re-established by increasing the dose or interruption of clonazepam treatment for 2 or 3 weeks. During a break in therapy may require close monitoring and use of other drugs drugs. nine0004
Daily dose should be divided into 3 equal parts. If you divide the dose into three equal parts is not possible, the largest of them should be taken at bedtime. Once maintenance dose level reached, daily dose can be taken in the evening once.
Simultaneous use of more than one antiepileptic drug is common practice in the treatment of epilepsy and can be used when applying clonazepam. The dose of each drug should be adjusted to achieve optimal effect. It is necessary to analyze the dosing regimen and the rationality of the selected therapy in the event of an epileptic status in a patient receiving oral clonazepam.
Before adding clonazepam to existing anticonvulsant therapy, it should be taken into account that the use of several anticonvulsants may lead to increased unwanted effects. nine0004
Syndrome paroxysmal fear
Adults
Average the dose used is 1 mg/day. The maximum daily dose - 4 mg/day.
Children
Safety and efficacy of clonazepam in children under 18 years of age with paroxysmal fear has not been established.
Patients elderly
Necessary be careful when using clonazepam. Dose reduction recommended especially in patients with imbalance and reduced motor abilities. nine0004
Patients with impaired renal and hepatic function, chronic respiratory diseases
May be necessary to reduce the dose of the drug.
Cannot be sharp cancel the drug; it is always necessary to gradually, supervised by a doctor, dose reduction. Abrupt withdrawal of the drug can cause sleep disturbance, mood, and psychiatric disorders.
During treatment clonazepam and within 3 days after its completion, you can not use any alcohol. nine0004
Side effects
Clonazepam well tolerated. Adverse reactions are usually mild and reversible.
Classification WHO adverse reactions by frequency of development:
very often -> 1/10; often - from 1/100 to 1/10; infrequently - from 1/1000 to 1/100; rarely - from 1/10000 to 1/1000; very rare - <1/10000 including individual messages.
Violations from the blood and lymphatic system:
Rarely - as with other benzodiazepines, isolated cases have been reported blood dyscrasias.
Mental violations :
Often — decreased concentration, restlessness, confusion and disorientation. Anterograde amnesia may occur with the use of benzodiazepines in therapeutic dose, the risk increases at higher doses. Development of amnesia can be determined by the unusual behavior of the patient.
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Uncommon — the use of benzodiazepines can lead to the development of physical and mental drug addiction. The risk of addiction increases with an increase in the dose of the drug and the duration of its use, as well as in patients suffering from alcoholism and / or having a history of narcotic addiction.
Rarely — depression (may also be associated with an underlying illness).
Violations from the nervous system:
Often — dizziness, ataxia, drowsiness and incoordination;
Rarely — (especially with long-term use or when treated with high doses) development reversible disorders such as slow or slurred speech (dysarthria), impaired coordination of movements and gait (ataxia). Predisposed patients may develop seizures (see "Special Instructions").
Violations on the part of the organ of vision:
Often — nystagmus;
Rarely — diplopia.
Violations from the side of the heart:
Rarely - heart failure, including cardiac arrest.
Violations from the respiratory system, chest organs and mediastinum:
Rarely - respiratory depression (may occur with intravenous administration of clonazepam, this effect may be exacerbated by prior airway obstruction or brain damage, or when taken with other respiratory depressants). Typically, this violation can be avoided. by dose selection until the optimal therapeutic effect is obtained. nine0004
Gastrointestinal violations:
Rarely — symptoms of gastrointestinal disturbances, including nausea.
Violations from the liver and biliary tract:
Rarely - changes in liver function tests.
Violations from the skin and subcutaneous tissues:
Rarely - hives, itching, temporary hair loss and pigmentation changes. It was reported that allergic reactions, including very rare cases of anaphylaxis and angioedema, may occur with the use of benzodiazepines.
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Violations from the side of muscle, skeletal and connective tissue:
Often - muscle weakness and muscle hypotension.
Violations from the side of the kidneys and urinary tract:
Rarely - urinary incontinence.
Violations from the reproductive system and mammary glands:
Rarely - decreased sex drive (loss of libido) and impotence, reversible premature appearance of secondary sexual characteristics in children (incomplete precocious puberty). nine0004
Interaction
Yes how alcohol can trigger epileptic seizures, regardless of therapy, patients should under no circumstances use alcohol during treatment with clonazepam. Alcohol in combination with clonazepam may affect the effects of the drug, adversely affect the success of therapy or cause unpredictable side effects.
At the use of clonazepam in combination with other antiepileptic drugs side effects such as sedation and lethargy, toxicity may be more obvious, especially when used together with hydantoins, phenobarbital and their combinations.
This requires special care when adjusting the dose for initial stages of treatment. The combination of clonazepam and sodium valproate occasionally associated with the development of status epilepticus of small seizures. Although some patients are tolerant and well tolerate this combination of drugs, this potential hazard should be taken into account when deciding on its use. nine0004
Antiepileptics drugs such as phenytoin, phenobarbital, carbamazepine, and valproate may induce the metabolism of clonazepam, providing higher clearance and more low plasma concentrations of clonazepam in combination therapy.
Selective serotonin reuptake inhibitors such as sertraline and fluoxetine affect the pharmacokinetics of clonazepam when used together.
Known liver enzyme inhibitors, such as cimetidine, have been shown to reduce the clearance of benzodiazepines and may enhance their effect, and known hepatic enzyme inducers, such as rifampicin, may increase clearance benzodiazepines.
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At concomitant treatment with phenytoin or primidone has occasionally been observed the change is usually an increase in the serum concentration of these two substances.
Simultaneous use of clonazepam and other centrally acting drugs, such as other anticonvulsants (antiepileptic) drugs, anesthetics, sleeping pills, psychotropic drugs and some analgesics, and also muscle relaxants can lead to mutual potentiation of medicinal effects. This is especially true in the presence of alcohol. With combined therapy with centrally acting drugs, the dose of each drug should be adjusted for optimal effect. nine0004
Overdose
Symptoms
Symptoms overdose or intoxication vary greatly from person to person depending on on age, body weight and individual response to the drug. Benzodiazepines usually cause drowsiness, ataxia, dysarthria, and nystagmus. Overdose clonazepam is rarely life-threatening if the drug is taken in as monotherapy, but can lead to coma, aflexia, apnea, hypotension and cardiorespiratory depression.
The coma usually lasts only a few hours, but older people, it can be longer and cyclical. Effects of oppression breathing with benzodiazepines are more severe in patients with severe chronic obstructive airway disease. nine0004
Benzodiazepines potentiate the effects of other CNS depressants, including alcohol.
Treatment
Maintenance airway and adequate ventilation, if indicated.
1. The benefit of gastric lavage has not been established. Appropriate application activated charcoal (50 g for an adult, 10–15 g for a child) adults or children who have taken more than 0.4 mg/kg in 1 hour in the absence of severe drowsiness. nine0004
2. Gastric lavage is not necessary if have been taken only these drugs.
3. In patients without symptoms within 4 hours, further symptoms are unlikely.
4. Supportive measures based on clinical the patient's condition. In particular, patients may need symptomatic treatment of cardiorespiratory reactions or reactions from the central nervous system.
5. Flumazenil, a benzodiazepine antagonist, is used rare, because it has a short half-life (about 1 hour). Flumazenil is not used in case of an overdose of several drugs at the same time. drugs, and also as a "diagnostic test". nine0004
Special instructions
- Suicidal thoughts and behaviors have been reported in patients treated with antiepileptic drugs for several indications. Meta-analysis randomized placebo-controlled trials of antiepileptic drugs also showed a slight increase in the risk of suicidal thoughts and behavior. The mechanism by which this risk develops is unknown, but the available data do not exclude the possibility of an increased risk with clonazepam. nine0004
Therefore patients should be monitored for suicidal thoughts and behavior and appropriate treatment should be considered. Patients (and individuals caregivers) should seek medical attention if signs of suicidal thoughts or behavior.
- Patients with depression and/or a history of suicide attempts should be under close observation.
- When certain forms of epilepsy may increase the frequency of seizures with long-term treatment. Clonazepam is usually beneficial in behavioral disorders in patients with epilepsy. In some cases, they may paradoxical effects occur, such as aggressiveness, excitability, nervousness, hostility, restlessness, sleep disturbances, nightmares, realistic dreams, irritability, agitation, psychotic disorders and activation of new types of seizures. If this happens, then the benefits of continuing the use of this drug should be evaluated in comparison with undesirable effect. It may be necessary to add to the treatment regimen another suitable medicinal product or, in some cases, it may be appropriate discontinuation of clonazepam therapy. nine0004
- Clonazepam should be used with caution in patients with chronic pulmonary insufficiency or impaired function of the kidneys or liver, as well as in the elderly or debilitated patients. In these cases, the dose should generally be reduced.
- As and when using other antiepileptic drugs, therapy with clonazepam, even if it is short-term, it should not be abruptly interrupted, but should be canceled by gradually reducing the dose, taking into account the risk of developing epileptic status. In these cases, a combination with other antiepileptic drugs. This precaution should also be taken into account when stopping another drug while the patient is still on therapy clonazepam. nine0004
- Long the use of benzodiazepines can lead to the development of dependence with the syndrome "cancellation" when you stop using.
- Clonazepam should only be used with extreme caution in patients with spinal or cerebellar ataxia, with acute intoxication with alcohol or drugs, and in patients with severe liver damage (eg cirrhosis of the liver).
- Follows avoid using clonazepam while consuming alcohol and/or drugs CNS depressant. This combined use can potentially enhance clinical effects of clonazepam, including severe sedation, clinically significant oppression of the respiratory and / or cardiovascular systems.
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- Benzodiazepines should be used with extreme caution in patients with alcoholic or drug addiction.
- U children and young children clonazepam may cause an increase in saliva production and bronchial secretions. Therefore, special attention should be paid to maintaining airway patency.
Impact on the respiratory system may be exacerbated by previous obstruction respiratory tract or brain damage or joint use with other drugs that depress breathing. As a rule, this effect can be avoided by carefully adjusting the dose until satisfaction individual needs. nine0004
Dosage clonazepam should be carefully adjusted to individual needs of patients with pre-existing respiratory diseases (eg, chronic obstructive pulmonary disease) or liver and in patients treated with other centrally acting drugs or anticonvulsant (antiepileptic) drugs.
- Exist conflicting data on the effect or lack of effect of clonazepam on patients with porphyria. Therefore, in this group of patients, clonazepam should be apply with caution.
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- As and all drugs of similar action, clonazepam, may affect patient responses (eg, ability to drive a vehicle, driving behavior) (see section "Influence on the ability to drive vehicles and mechanisms).
- U in patients with an uncomplicated bereavement reaction, the use of benzodiazepines may slow down psychological adjustment.
- Dependency and withdrawal syndrome. The use of benzodiazepines can lead to the development physical and mental drug dependence. In particular, long-term or high-dose therapy can lead to reversible disorders such as dysarthria, decreased coordination of movements and gait disturbance (ataxia), nystagmus and visual impairment (diplopia). nine0004
Over In addition, the risk of anterograde amnesia, which may occur with the use of benzodiazepines in therapeutic doses, increases with the use of more high doses. Amnestic effects may be associated with inappropriate behavior. In certain forms of epilepsy, an increase in the frequency is possible seizures during long-term treatment.
The risk of addiction increases with increasing the dose and duration of treatment; it is also higher in patients with history of alcohol and/or drug addiction. nine0004
How only physical dependence develops, abrupt discontinuation of treatment accompanied by a withdrawal syndrome. With long-term treatment, the syndrome "Cancellation" may develop after a long period of use, especially when high doses, or if the daily dose is rapidly reduced or suddenly stop using the drug. Symptoms include tremors, sweating, agitation, sleep disturbances and anxiety, headaches, muscle pain, extreme anxiety, tension, confusion, irritability and epileptic seizures, which may be associated with the underlying disease. AT in severe cases, the following symptoms may be observed: derealization, depersonalization, hyperacusis, numbness and tingling of the extremities, hypersensitivity to light, noise and physical contact or hallucinations. Since the risk of developing a "withdrawal" syndrome is higher with an abrupt cessation of treatment, abrupt discontinuation of the drug should be avoided, and treatment, even if it is short-term nature, should be stopped, gradually reducing the daily dose.
The risk of developing a "withdrawal" syndrome increases if benzodiazepines are used in conjunction with daytime sedatives (cross tolerance). nine0004
- Patients receiving benzodiazepines are at increased risk falls and fractures. The risk is increased in those who receive both sedatives (including including alcoholic beverages) and in the elderly.
Influence on the ability to drive vehicles, mechanisms
Patients with epilepsy is not allowed to drive a car. Even with adequate control epilepsy with clonazepam, it should be remembered that any increase in dosage or changing the timing of the dose of the drug can change the response of patients in depending on individual susceptibility. Even if you take clonazepam as intended, it can slow down the reaction so that the ability to driving a vehicle or operating machinery. This effect aggravated by alcohol. Therefore, driving, operating mechanisms and other hazardous activities should be avoided.
