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INDICATIONS

Arimidex is used for treating breast cancer in women who have been through menopause, including women with disease progression after tamoxifen therapy. Arimidex is an aromatase inhibitor. It works by lowering blood estradiol concentrations, which may decrease the size and growth of the tumor.

INSTRUCTIONSВ 

Use Arimidex as directed by your doctor.

  • Take Arimidex by mouth with or without food.
  • If you miss a dose of Arimidex, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once. If more than one dose is missed, contact your doctor or pharmacist.

Ask your health care provider any questions you may have about how to use Arimidex.

STORAGE

Store Arimidex at room temperature, between 68 and 77 degrees F (20 and 25 degrees C) in a tightly closed container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Arimidex out of the reach of children and away from pets.

MORE INFO:

Active Ingredient: Anastrozole.

Do NOT use Arimidex if:

  • you are allergic to any ingredient in Arimidex
  • you have not gone through menopause
  • you are pregnant
  • you are taking estrogen (eg, birth control pills, hormone replacement therapy) or tamoxifen.

Contact your doctor or health care provider right away if any of these apply to you.

Some medical conditions may interact with Arimidex. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have liver problems, osteoporosis (weak bones), heart problems, or high cholesterol or lipid levels.

Some medicines may interact with Arimidex. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Estrogen (eg, birth control pills, hormone replacement therapy) or tamoxifen because they may decrease Arimidex’s effectiveness.

This may not be a complete list of all interactions that may occur. Ask your health care provider if Arimidex may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

Important safety information:

  • Arimidex may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Arimidex with caution. Do not drive or perform other possible unsafe tasks until you know how you react to it.
  • Lab tests, including blood cholesterol or bone mineral density, may be performed while you use Arimidex. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Arimidex should be used with extreme caution in children; safety and effectiveness in children have not been confirmed.
  • Pregnancy and breast-feeding: Arimidex has been shown to cause harm to the fetus. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Arimidex while you are pregnant. It is not known if Arimidex is found in breast milk. If you are or will be breast-feeding while you use Arimidex, check with your doctor. Discuss any possible risks to your baby.

All medicines may cause side effects, but many people have no, or minor, side effects.

Check with your doctor if any of these most common side effects persist or become bothersome:

Anxiety; back, bone, breast, joint, or pelvic pain; constipation; cough; diarrhea; dizziness; flu-like symptoms (eg, muscle aches, tiredness); headache; hot flashes; loss of appetite; nausea; sore throat; stomach pain or upset; sweating; tingling or burning sensation; trouble sleeping; vaginal dryness; vomiting; weakness; weight gain.

Seek medical attention right away if any of these severe side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing or swallowing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); calf pain, swelling, or tenderness; chest pain; dark urine; depression; fainting; fever, chills, or persistent sore throat; frequent or painful urination; mental or mood changes; numbness of an arm or leg; one-sided weakness; red, swollen, blistered, or peeling skin; severe or persistent bone pain; severe or persistent dizziness or headache; severe or persistent nausea, vomiting, or stomach pain; severe or persistent tiredness or weakness; shortness of breath; speech problems; sudden, severe headache; swelling of the arms or legs; swollen lymph nodes; vaginal bleeding or unusual discharge; vision changes; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider.

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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

Arimidex is used for treating breast cancer in women who have been through menopause, including women with disease progression after tamoxifen therapy. Arimidex is an aromatase inhibitor. It works by lowering blood estradiol concentrations, which may decrease the size and growth of the tumor.

INSTRUCTIONSВ 

Use Arimidex as directed by your doctor.

  • Take Arimidex by mouth with or without food.
  • If you miss a dose of Arimidex, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once. If more than one dose is missed, contact your doctor or pharmacist.

Ask your health care provider any questions you may have about how to use Arimidex.

STORAGE

Store Arimidex at room temperature, between 68 and 77 degrees F (20 and 25 degrees C) in a tightly closed container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Arimidex out of the reach of children and away from pets.

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Active Ingredient: Anastrozole.

Do NOT use Arimidex if:

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  • you have not gone through menopause
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Contact your doctor or health care provider right away if any of these apply to you.

Some medical conditions may interact with Arimidex. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

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  • if you have allergies to medicines, foods, or other substances
  • if you have liver problems, osteoporosis (weak bones), heart problems, or high cholesterol or lipid levels.

Some medicines may interact with Arimidex. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Estrogen (eg, birth control pills, hormone replacement therapy) or tamoxifen because they may decrease Arimidex’s effectiveness.

This may not be a complete list of all interactions that may occur. Ask your health care provider if Arimidex may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

Important safety information:

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  • Lab tests, including blood cholesterol or bone mineral density, may be performed while you use Arimidex. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Arimidex should be used with extreme caution in children; safety and effectiveness in children have not been confirmed.
  • Pregnancy and breast-feeding: Arimidex has been shown to cause harm to the fetus. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Arimidex while you are pregnant. It is not known if Arimidex is found in breast milk. If you are or will be breast-feeding while you use Arimidex, check with your doctor. Discuss any possible risks to your baby.

All medicines may cause side effects, but many people have no, or minor, side effects.

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Anxiety; back, bone, breast, joint, or pelvic pain; constipation; cough; diarrhea; dizziness; flu-like symptoms (eg, muscle aches, tiredness); headache; hot flashes; loss of appetite; nausea; sore throat; stomach pain or upset; sweating; tingling or burning sensation; trouble sleeping; vaginal dryness; vomiting; weakness; weight gain.

Seek medical attention right away if any of these severe side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing or swallowing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); calf pain, swelling, or tenderness; chest pain; dark urine; depression; fainting; fever, chills, or persistent sore throat; frequent or painful urination; mental or mood changes; numbness of an arm or leg; one-sided weakness; red, swollen, blistered, or peeling skin; severe or persistent bone pain; severe or persistent dizziness or headache; severe or persistent nausea, vomiting, or stomach pain; severe or persistent tiredness or weakness; shortness of breath; speech problems; sudden, severe headache; swelling of the arms or legs; swollen lymph nodes; vaginal bleeding or unusual discharge; vision changes; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider.

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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

Cyklokapron is used for reducing or preventing excessive bleeding and reducing the need for blood clotting factor transfusions during or after tooth extractions in patients with hemophilia. It is also used to prevent or reduce bleeding during certain medical procedures (eg, cervical surgery) and to treat certain bleeding problems (eg, nosebleeds, bleeding inside the eye, heavy menstrual periods) in patients whose blood does not clot well. It is also used to treat hereditary angioneurotic edema. It may also be used for other conditions as determined by your doctor.

INSTRUCTIONS

Use Cyklokapron as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Cyklokapron is usually given as an injection at your doctor’s office, hospital, or clinic. If you will be using Cyklokapron at home, a health care provider will teach you how to use it. Be sure you understand how to use Cyklokapron. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
Do not use Cyklokapron if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.
Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.
Continue to use Cyklokapron for the full course of treatment even if you feel well. Do not miss any doses.
If you miss a dose of Cyklokapron, contact your doctor immediately.

Ask your health care provider any questions you may have about how to use Cyklokapron.

DOSAGE

Take exactly as directed. Dosage is generally two to four times daily by mouth. Length of treatment is based on your condition and response.

STORAGE

Store at room temperature between 36 and 86 degrees F (2-30 degrees C) away from sunlight and moisture.

Cyklokapron is an antifibrinolytic. It works by preventing blood clots from breaking down too quickly. This helps to reduce excessive bleeding.

Do NOT use Cyklokapron if:

  • you are allergic to any ingredient in Cyklokapron
  • you have blood clots (eg, in the leg, lung, eye, brain), a history of blood clots, or conditions that may increase your risk of blood clots (eg, certain heart valve problems, certain types of irregular heartbeat, certain blood clotting problems)
  • you have bleeding in the brain, blood in the urine, or bleeding related to kidney problems
  • you have a disturbance of color vision
  • you have irregular menstrual bleeding of unknown cause
  • you are using medicine to help your blood clot (eg, factor IX complex concentrates or anti-inhibitor coagulant concentrates)

Contact your doctor or health care provider right away if any of these apply to you.

Some medical conditions may interact with Cyklokapron. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have a history of kidney problems, diabetes, polycystic ovary syndrome, bleeding or blood clotting problems, a certain blood problem called disseminated intravascular coagulation (DIC), eye or vision problems, or bleeding in the brain
  • if you are very overweight
  • if you have a personal or family history of blood clots or endometrial cancer
  • if you also take estrogen or tamoxifen

Some MEDICINES MAY INTERACT with Cyklokapron. Tell your health care provider if you are taking any other medicines, especially any of the following:
Hormonal birth control (eg, birth control pills), medicines to help your blood clot (eg, anti-inhibitor coagulant concentrates, factor IX complex concentrates), or tretinoin (all-trans retinoic acid) because the risk of blood clots may be increased
Desmopressin, hydrochlorothiazide, nitroglycerin, ranitidine, or sulbactam-ampicillin because the risk of heart attack may be increased
Anticoagulants (eg, warfarin) because they may decrease Cyklokapron’s effectiveness

This may not be a complete list of all interactions that may occur. Ask your health care provider if Cyklokapron may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Cyklokapron while you are pregnant. Cyklokapron is found in breast milk. If you are or will be breast-feeding while you are using Cyklokapron, check with your doctor. Discuss any possible risks to your baby.

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Diarrhea; nausea; vomiting.
Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); calf or leg pain, swelling, or tenderness; chest pain; confusion; coughing up blood; decreased urination or difficulty urinating; eye problems; fainting; numbness of an arm or leg; one-sided weakness; pain, swelling, or redness at the injection site; seizures; severe or persistent dizziness or light-headedness; shortness of breath; slurred speech; sudden, severe headache or vomiting; vision changes or problems (eg, disturbance of color vision, sharpness, or field of vision).

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects.

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INDICATIONS

Arimidex is used for treating breast cancer in women who have been through menopause, including women with disease progression after tamoxifen therapy. Arimidex is an aromatase inhibitor. It works by lowering blood estradiol concentrations, which may decrease the size and growth of the tumor.

INSTRUCTIONSВ 

Use Arimidex as directed by your doctor.

  • Take Arimidex by mouth with or without food.
  • If you miss a dose of Arimidex, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once. If more than one dose is missed, contact your doctor or pharmacist.

Ask your health care provider any questions you may have about how to use Arimidex.

STORAGE

Store Arimidex at room temperature, between 68 and 77 degrees F (20 and 25 degrees C) in a tightly closed container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Arimidex out of the reach of children and away from pets.

MORE INFO:

Active Ingredient: Anastrozole.

Do NOT use Arimidex if:

  • you are allergic to any ingredient in Arimidex
  • you have not gone through menopause
  • you are pregnant
  • you are taking estrogen (eg, birth control pills, hormone replacement therapy) or tamoxifen.

Contact your doctor or health care provider right away if any of these apply to you.

Some medical conditions may interact with Arimidex. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have liver problems, osteoporosis (weak bones), heart problems, or high cholesterol or lipid levels.

Some medicines may interact with Arimidex. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Estrogen (eg, birth control pills, hormone replacement therapy) or tamoxifen because they may decrease Arimidex’s effectiveness.

This may not be a complete list of all interactions that may occur. Ask your health care provider if Arimidex may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

Important safety information:

  • Arimidex may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Arimidex with caution. Do not drive or perform other possible unsafe tasks until you know how you react to it.
  • Lab tests, including blood cholesterol or bone mineral density, may be performed while you use Arimidex. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Arimidex should be used with extreme caution in children; safety and effectiveness in children have not been confirmed.
  • Pregnancy and breast-feeding: Arimidex has been shown to cause harm to the fetus. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Arimidex while you are pregnant. It is not known if Arimidex is found in breast milk. If you are or will be breast-feeding while you use Arimidex, check with your doctor. Discuss any possible risks to your baby.

All medicines may cause side effects, but many people have no, or minor, side effects.

Check with your doctor if any of these most common side effects persist or become bothersome:

Anxiety; back, bone, breast, joint, or pelvic pain; constipation; cough; diarrhea; dizziness; flu-like symptoms (eg, muscle aches, tiredness); headache; hot flashes; loss of appetite; nausea; sore throat; stomach pain or upset; sweating; tingling or burning sensation; trouble sleeping; vaginal dryness; vomiting; weakness; weight gain.

Seek medical attention right away if any of these severe side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing or swallowing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); calf pain, swelling, or tenderness; chest pain; dark urine; depression; fainting; fever, chills, or persistent sore throat; frequent or painful urination; mental or mood changes; numbness of an arm or leg; one-sided weakness; red, swollen, blistered, or peeling skin; severe or persistent bone pain; severe or persistent dizziness or headache; severe or persistent nausea, vomiting, or stomach pain; severe or persistent tiredness or weakness; shortness of breath; speech problems; sudden, severe headache; swelling of the arms or legs; swollen lymph nodes; vaginal bleeding or unusual discharge; vision changes; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider.

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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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