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INDICATIONS

Keppra is used to treat partial onset seizures in adults and children who are at least 1 month old.
It is also used to treat tonic-clonic seizures in adults and children who are at least 6 years old, and myoclonic seizures in adults and children who are at least 12 years old.

INSTRUCTIONS

Take Keppra exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Your doctor may occasionally change your dose to make sure you get the best results.

Keppra is usually taken twice per day. Take the medicine at the same time each day. You may take Keppra with or without food.

Measure liquid medicine with a special dose-measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.
Do not crush, chew, or break a controlled release, delayed-release, or extended-release tablet. Swallow it whole. Breaking the pill may cause too much of the drug to be released at one time.

Use Keppra regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

Do not stop using Keppra without first talking to your doctor, even if you feel fine. You may have increased seizures if you stop using this medicine suddenly. You may need to use less and less before you stop the medication completely.

Seizures are often treated with a combination of different drugs. Use all medications as directed by your doctor. Read the medication guide or patient instructions provided with each medication. Do not change your doses or medication schedule without your doctor’s advice. .

Wear a medical alert tag or carry an ID card stating that you take Keppra. Any medical care provider who treats you should know that you take seizure medication.

To be sure Keppra is not causing harmful effects, your kidney function may need to be tested. Visit your doctor regularly.

If you missed a dose – take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

DOSAGE

Important Administration Instructions

Keppra is given orally with or without food. The Keppra dosing regimen depends on the indication, age group, dosage form (tablets or oral solution), and renal function.

Prescribe the oral solution for pediatric patients with body weight ≤ 20 kg. Prescribe the oral solution or tablets for pediatric patients with body weight above 20 kg.

When using the oral solution in pediatric patients, dosing is weight-based (mg per kg) using a calibrated measuring device (not a household teaspoon or tablespoon).
Keppra tablets should be swallowed whole. Keppra tablets should not be chewed or crushed.

Pediatric Patients

• 1 Month To < 6 Months

Treatment should be initiated with a daily dose of 14 mg/kg in 2 divided doses (7 mg/kg twice daily). The daily dose should be increased every 2 weeks by increments of 14 mg/kg to the recommended daily dose of 42 mg/kg (21 mg/kg twice daily). In the clinical trial, the mean daily dose was 35 mg/kg in this age group. The effectiveness of lower doses has not been studied.

• 6 Months To < 4 Years

Treatment should be initiated with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg twice daily). The daily dose should be increased in 2 weeks by an increment of 20 mg/kg to the recommended daily dose of 50 mg/kg (25 mg/kg twice daily). If a patient cannot tolerate a daily dose of 50 mg/kg, the daily dose may be reduced. In the clinical trial, the mean daily dose was 47 mg/kg in this age group.

• 4 Years To < 16 Years

Treatment should be initiated with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg twice daily). The daily dose should be increased every 2 weeks by increments of 20 mg/kg to the recommended daily dose of 60 mg/kg (30 mg/kg twice daily). If a patient cannot tolerate a daily dose of 60 mg/kg, the daily dose may be reduced. In the clinical efficacy trial, the mean daily dose was 44 mg/kg. The maximum daily dose was 3000 mg/day.

For Keppra tablet dosing in pediatric patients weighing 20 to 40 kg, treatment should be initiated with a daily dose of 500 mg given as twice daily dosing (250 mg twice daily). The daily dose should be increased every 2 weeks by increments of 500 mg to a maximum recommended daily dose of 1500 mg (750 mg twice daily).

For Keppra tablet dosing in pediatric patients weighing more than 40 kg, treatment should be initiated with a daily dose of 1000 mg/day given as twice daily dosing (500 mg twice daily). The daily dose should be increased every 2 weeks by increments of 1000 mg/day to a maximum recommended daily dose of 3000 mg (1500 mg twice daily).

Partial Onset Seizures

Adults 16 Years And Older

In clinical trials, daily doses of 1000 mg, 2000 mg, and 3000 mg, given as twice-daily dosing were shown to be effective. Although in some studies there was a tendency toward greater response with higher dose [see Clinical Studies], a consistent increase in response with increased dose has not been shown.

Treatment should be initiated with a daily dose of 1000 mg/day, given as twice-daily dosing (500 mg twice daily). Additional dosing increments may be given (1000 mg/day additional every 2 weeks) to a maximum recommended daily dose of 3000 mg. Doses greater than 3000 mg/day have been used in open-label studies for periods of 6 months and longer. There is no evidence that doses greater than 3000 mg/day confer additional benefit.

Myoclonic Seizures In Patients 12 Years of Age and Older With Juvenile Myoclonic Epilepsy

Treatment should be initiated with a dose of 1000 mg/day, given as twice-daily dosing (500 mg twice daily). Dosage should be increased by 1000 mg/day every 2 weeks to the recommended daily dose of 3000 mg. The effectiveness of doses lower than 3000 mg/day has not been studied.

Primary Generalized Tonic-Clonic Seizures

Adults 16 Years And Older
Treatment should be initiated with a dose of 1000 mg/day, given as twice-daily dosing (500 mg twice daily). Dosage should be increased by 1000 mg/day every 2 weeks to the recommended daily dose of 3000 mg. The effectiveness of doses lower than 3000 mg/day has not been adequately studied.

Pediatric Patients Ages 6 To < 16 Years

Treatment should be initiated with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg twice daily). The daily dose should be increased every 2 weeks by increments of 20 mg/kg to the recommended daily dose of 60 mg/kg (30 mg/kg twice daily). The effectiveness of doses lower than 60 mg/kg/day has not been adequately studied. Patients with body weight ≤ 20 kg should be dosed with oral solution. Patients with body weight above 20 kg can be dosed with either tablets or oral solution. Only whole tablets should be administered.

Adult Patients With Impaired Renal Function

Keppra dosing must be individualized according to the patient’s renal function status.

STORAGE

Store Keppra at room temperature away from moisture, heat, and light.

You should not use Keppra if you are allergic to levetiracetam.

To make sure you can safely take Keppra, tell your doctor if you have kidney disease or high blood pressure.

You may have thoughts about suicide while taking this medicine. Tell your doctor if you have symptoms of depression or suicidal thoughts during the first several weeks of treatment, or whenever your dose is changed.

Your family or other caregivers should also be alert to changes in your mood or symptoms. Your doctor will need to check you at regular visits.

FDA pregnancy category C. It is not known whether Keppra will harm an unborn baby, but having a seizure during pregnancy could harm both the mother and the baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. Do not start or stop taking Keppra during pregnancy without your doctor’s advice. Seizure control is very important during pregnancy. The benefit of preventing seizures may outweigh any risks posed by taking Keppra. Follow your doctor’s instructions about taking Keppra while you are pregnant. Levetiracetam can pass into breast milk and may harm a nursing baby. You should not breast-feed while you are using Keppra. Do not give this medication to a child without the advice of a doctor. Your child’s dose needs are based on age and weight. The child should remain under the care of a doctor while using this medicine.

Do not stop using Keppra without first talking to your doctor, even if you feel fine. You may have increased seizures if you stop using Keppra suddenly. You may need to use less and less before you stop the medication completely.

You may have thoughts about suicide while taking Keppra. Your doctor will need to check you at regular visits. Do not miss any scheduled appointments.

Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, depression, anxiety, or if you feel agitated, hostile, irritable, hyperactive (mentally or physically), or have thoughts about suicide or hurting yourself.

Wear a medical alert tag or carry an ID card stating that you take Keppra. Any medical care provider who treats you should know that you take seizure medication.

Keppra may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. Do not start or stop taking Keppra during pregnancy without your doctor’s advice. Having a seizure during pregnancy could harm both the mother and the baby. Seizure control is very important during pregnancy and the benefits of preventing seizures may outweigh any risks posed by using Keppra.

Avoid drinking alcohol. It can increase some of the side effects of Keppra and may also increase the risk of seizures. This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Get emergency medical help if you have any of these signs of an allergic reaction to Keppra: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, depression, anxiety, or if you feel agitated, hostile, irritable, hyperactive (mentally or physically), or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have a serious side effect such as:

• hallucinations, unusual thoughts or behavior;
• bruising, severe tingling, numbness, pain, muscle weakness;
• feeling very weak or tired;
• fever, chills, body aches, flu symptoms, sores in your mouth and throat;
• problems with walking or movement;
• the first sign of any skin rash, no matter how mild; or
• severe skin reaction — fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Less serious Keppra side effects may include:

• В mild dizziness or drowsiness;
• mild tired feeling;
• loss of appetite; or
• stuffy nose.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect.

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INDICATIONS

Keppra is used to treat partial onset seizures in adults and children who are at least 1 month old.
It is also used to treat tonic-clonic seizures in adults and children who are at least 6 years old, and myoclonic seizures in adults and children who are at least 12 years old.

INSTRUCTIONS

Take Keppra exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Your doctor may occasionally change your dose to make sure you get the best results.

Keppra is usually taken twice per day. Take the medicine at the same time each day. You may take Keppra with or without food.

Measure liquid medicine with a special dose-measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.
Do not crush, chew, or break a controlled release, delayed-release, or extended-release tablet. Swallow it whole. Breaking the pill may cause too much of the drug to be released at one time.

Use Keppra regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

Do not stop using Keppra without first talking to your doctor, even if you feel fine. You may have increased seizures if you stop using this medicine suddenly. You may need to use less and less before you stop the medication completely.

Seizures are often treated with a combination of different drugs. Use all medications as directed by your doctor. Read the medication guide or patient instructions provided with each medication. Do not change your doses or medication schedule without your doctor’s advice. .

Wear a medical alert tag or carry an ID card stating that you take Keppra. Any medical care provider who treats you should know that you take seizure medication.

To be sure Keppra is not causing harmful effects, your kidney function may need to be tested. Visit your doctor regularly.

If you missed a dose – take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

DOSAGE

Important Administration Instructions

Keppra is given orally with or without food. The Keppra dosing regimen depends on the indication, age group, dosage form (tablets or oral solution), and renal function.

Prescribe the oral solution for pediatric patients with body weight ≤ 20 kg. Prescribe the oral solution or tablets for pediatric patients with body weight above 20 kg.

When using the oral solution in pediatric patients, dosing is weight-based (mg per kg) using a calibrated measuring device (not a household teaspoon or tablespoon).
Keppra tablets should be swallowed whole. Keppra tablets should not be chewed or crushed.

Pediatric Patients

• 1 Month To < 6 Months

Treatment should be initiated with a daily dose of 14 mg/kg in 2 divided doses (7 mg/kg twice daily). The daily dose should be increased every 2 weeks by increments of 14 mg/kg to the recommended daily dose of 42 mg/kg (21 mg/kg twice daily). In the clinical trial, the mean daily dose was 35 mg/kg in this age group. The effectiveness of lower doses has not been studied.

• 6 Months To < 4 Years

Treatment should be initiated with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg twice daily). The daily dose should be increased in 2 weeks by an increment of 20 mg/kg to the recommended daily dose of 50 mg/kg (25 mg/kg twice daily). If a patient cannot tolerate a daily dose of 50 mg/kg, the daily dose may be reduced. In the clinical trial, the mean daily dose was 47 mg/kg in this age group.

• 4 Years To < 16 Years

Treatment should be initiated with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg twice daily). The daily dose should be increased every 2 weeks by increments of 20 mg/kg to the recommended daily dose of 60 mg/kg (30 mg/kg twice daily). If a patient cannot tolerate a daily dose of 60 mg/kg, the daily dose may be reduced. In the clinical efficacy trial, the mean daily dose was 44 mg/kg. The maximum daily dose was 3000 mg/day.

For Keppra tablet dosing in pediatric patients weighing 20 to 40 kg, treatment should be initiated with a daily dose of 500 mg given as twice daily dosing (250 mg twice daily). The daily dose should be increased every 2 weeks by increments of 500 mg to a maximum recommended daily dose of 1500 mg (750 mg twice daily).

For Keppra tablet dosing in pediatric patients weighing more than 40 kg, treatment should be initiated with a daily dose of 1000 mg/day given as twice daily dosing (500 mg twice daily). The daily dose should be increased every 2 weeks by increments of 1000 mg/day to a maximum recommended daily dose of 3000 mg (1500 mg twice daily).

Partial Onset Seizures

Adults 16 Years And Older

In clinical trials, daily doses of 1000 mg, 2000 mg, and 3000 mg, given as twice-daily dosing were shown to be effective. Although in some studies there was a tendency toward greater response with higher dose [see Clinical Studies], a consistent increase in response with increased dose has not been shown.

Treatment should be initiated with a daily dose of 1000 mg/day, given as twice-daily dosing (500 mg twice daily). Additional dosing increments may be given (1000 mg/day additional every 2 weeks) to a maximum recommended daily dose of 3000 mg. Doses greater than 3000 mg/day have been used in open-label studies for periods of 6 months and longer. There is no evidence that doses greater than 3000 mg/day confer additional benefit.

Myoclonic Seizures In Patients 12 Years of Age and Older With Juvenile Myoclonic Epilepsy

Treatment should be initiated with a dose of 1000 mg/day, given as twice-daily dosing (500 mg twice daily). Dosage should be increased by 1000 mg/day every 2 weeks to the recommended daily dose of 3000 mg. The effectiveness of doses lower than 3000 mg/day has not been studied.

Primary Generalized Tonic-Clonic Seizures

Adults 16 Years And Older
Treatment should be initiated with a dose of 1000 mg/day, given as twice-daily dosing (500 mg twice daily). Dosage should be increased by 1000 mg/day every 2 weeks to the recommended daily dose of 3000 mg. The effectiveness of doses lower than 3000 mg/day has not been adequately studied.

Pediatric Patients Ages 6 To < 16 Years

Treatment should be initiated with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg twice daily). The daily dose should be increased every 2 weeks by increments of 20 mg/kg to the recommended daily dose of 60 mg/kg (30 mg/kg twice daily). The effectiveness of doses lower than 60 mg/kg/day has not been adequately studied. Patients with body weight ≤ 20 kg should be dosed with oral solution. Patients with body weight above 20 kg can be dosed with either tablets or oral solution. Only whole tablets should be administered.

Adult Patients With Impaired Renal Function

Keppra dosing must be individualized according to the patient’s renal function status.

STORAGE

Store Keppra at room temperature away from moisture, heat, and light.

You should not use Keppra if you are allergic to levetiracetam.

To make sure you can safely take Keppra, tell your doctor if you have kidney disease or high blood pressure.

You may have thoughts about suicide while taking this medicine. Tell your doctor if you have symptoms of depression or suicidal thoughts during the first several weeks of treatment, or whenever your dose is changed.

Your family or other caregivers should also be alert to changes in your mood or symptoms. Your doctor will need to check you at regular visits.

FDA pregnancy category C. It is not known whether Keppra will harm an unborn baby, but having a seizure during pregnancy could harm both the mother and the baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. Do not start or stop taking Keppra during pregnancy without your doctor’s advice. Seizure control is very important during pregnancy. The benefit of preventing seizures may outweigh any risks posed by taking Keppra. Follow your doctor’s instructions about taking Keppra while you are pregnant. Levetiracetam can pass into breast milk and may harm a nursing baby. You should not breast-feed while you are using Keppra. Do not give this medication to a child without the advice of a doctor. Your child’s dose needs are based on age and weight. The child should remain under the care of a doctor while using this medicine.

Do not stop using Keppra without first talking to your doctor, even if you feel fine. You may have increased seizures if you stop using Keppra suddenly. You may need to use less and less before you stop the medication completely.

You may have thoughts about suicide while taking Keppra. Your doctor will need to check you at regular visits. Do not miss any scheduled appointments.

Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, depression, anxiety, or if you feel agitated, hostile, irritable, hyperactive (mentally or physically), or have thoughts about suicide or hurting yourself.

Wear a medical alert tag or carry an ID card stating that you take Keppra. Any medical care provider who treats you should know that you take seizure medication.

Keppra may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. Do not start or stop taking Keppra during pregnancy without your doctor’s advice. Having a seizure during pregnancy could harm both the mother and the baby. Seizure control is very important during pregnancy and the benefits of preventing seizures may outweigh any risks posed by using Keppra.

Avoid drinking alcohol. It can increase some of the side effects of Keppra and may also increase the risk of seizures. This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Get emergency medical help if you have any of these signs of an allergic reaction to Keppra: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, depression, anxiety, or if you feel agitated, hostile, irritable, hyperactive (mentally or physically), or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have a serious side effect such as:

• hallucinations, unusual thoughts or behavior;
• bruising, severe tingling, numbness, pain, muscle weakness;
• feeling very weak or tired;
• fever, chills, body aches, flu symptoms, sores in your mouth and throat;
• problems with walking or movement;
• the first sign of any skin rash, no matter how mild; or
• severe skin reaction — fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Less serious Keppra side effects may include:

• В mild dizziness or drowsiness;
• mild tired feeling;
• loss of appetite; or
• stuffy nose.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect.

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