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INDICATIONS

Benadryl is used for preventing or treating symptoms of hay fever and other upper respiratory allergies or the common cold, such as runny nose, sneezing, itching of the nose and throat, and itchy, watery eyes, and relieving cough.

INSTRUCTIONS

Do not take Benadryl if you have taken a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate) in the last 14 days. A very dangerous drug interaction could occur, leading to serious side effects.

Before taking Benadryl, tell your doctor if you have:

  • glaucoma or increased pressure in the eye;
  • a stomach ulcer;
  • an enlarged prostate, bladder problems or difficulty urinating;
  • an overactive thyroid (hyperthyroidism);
  • hypertension or any type of heart problems; or
  • asthma.

You may not be able to take Benadryl, or you may require a lower dose or special monitoring during treatment if you have any of the conditions listed above.

Take Benadryl exactly as directed on the package or as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

Take each dose with a full glass of water. Benadryl can be taken with or without food.

For motion sickness, a dose is usually taken 30 minutes before motion, then with meals and at bedtime for the duration of exposure.

As a sleep aid, Benadryl should be taken approximately 30 minutes before bedtime.

To ensure that you get a correct dose, measure the liquid forms of Benadryl with a special dose-measuring spoon or cup, not with a regular tablespoon. If you do not have a dose-measuring device, ask your pharmacist where you can get one.

Never take more of Benadryl than is prescribed for you. The maximum amount of diphenhydramine that you should take in any 24-hour period is 300 mg.

Take the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and take only the next regularly scheduled dose. Do not take a double dose of Benadryl unless otherwise directed by your doctor.

DOSAGE

Do NOT use more than directed.

Adults and children 12 years of age and over – 25 mg to 50 mg (1 to 2 capsules).

Children 6 to under 12 years of age – 12.5 mg ** to 25 mg (1 capsule).

Children under 6 years of age – consult a doctor.

STORAGE

Store Benadryl at room temperature between 68 and 77 degrees F (20 and 25 degrees C) in a tightly closed container. Brief periods at temperatures of 59 to 86 degrees F (15 to 30 degrees C) are permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Benadryl out of the reach of children and away from pets.

Before taking diphenhydramine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: breathing problems (e.g., asthma, emphysema), glaucoma, heart problems, high blood pressure, liver disease, mental/mood changes, seizures, stomach problems (e.g., ulcers, obstruction), an overactive thyroid gland, difficulty urinating (e.g., due to an enlarged prostate gland).

Benadryl is in the FDA pregnancy category B. This means that it is not expected to be harmful to an unborn baby. Do not take Benadryl without first talking to your doctor if you are pregnant. Infants are especially sensitive to the effects of antihistamines, and side effects could occur in a breast-feeding baby. Do not take Benadryl without first talking to your doctor if you are nursing a baby.

If you are over 60 years of age, you may be more likely to experience side effects from Benadryl. You may require a lower dose of Benadryl.

Stop taking Benadryl and seek emergency medical attention if you experience an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives).

Other, less serious side effects may be more likely to occur. Continue to take Benadryl and talk to your doctor if you experience:

  • sleepiness, fatigue, or dizziness;
  • headache;
  • dry mouth; or
  • difficulty urinating or an enlarged prostate.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

When using this product:

  • marked drowsiness may occur
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • excitability may occur, especially in children
  • be careful when driving a motor vehicle or operating machinery

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INDICATIONS

Prometrium is used for protecting the lining of the uterus in certain women who are also taking estrogen. It is used to treat certain women who have do not have a menstrual period because of decreased progesterone in the body. Prometrium is a hormone. It works by changing the lining of the uterus.

INSTRUCTIONS

Use Prometrium as directed by your doctor.

  • Take Prometrium by mouth with or without food.
  • If you miss a dose of Prometrium, 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.

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

STORAGE

Store Prometrium at 77 degrees F (25 degrees C) in a tight, light-resistant container. Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Prometrium out of the reach of children and away from pets.

MORE INFO:

Active Ingredient: Progesterone.

Do NOT use Prometrium if:

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  • you have a history of cancer of the breast, ovary, lining of the uterus, cervix, or vagina; vaginal bleeding of unknown cause; blood clots or clotting problems; or liver disease; you have had a recent miscarriage; or you have had a stroke or heart attack within the past year
  • you are pregnant.

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

Some medical conditions may interact with Prometrium. 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 heart or blood vessel problems, bleeding problems, high blood pressure, high cholesterol or lipid levels, diabetes, kidney problems, asthma, migraine headaches, or lupus
  • if you have a history of seizures, depression or other mental or mood problems, cancer, or tobacco use
  • if you have a family history of blood clots
  • if you are very overweight.

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

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This may not be a complete list of all interactions that may occur. Ask your health care provider if Prometrium 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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  • This product has peanut oil in it. Do not take Prometrium if you are allergic to peanuts.
  • Diabetes patients – Prometrium may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
  • Prometrium may increase your risk of developing blood clots. If you will be having surgery or be confined to a bed or chair for a long period of time (such as a long plane flight), notify your doctor beforehand. Special precautions may be needed in these circumstances while you are taking Prometrium.
  • Prometrium may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking Prometrium.
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  • Prometrium should not be used in children; safety and effectiveness in children have not been confirmed.
  • Pregnancy and breast-feeding: Do not use Prometrium if you are pregnant unless your doctor tells you otherwise. If you think you may be pregnant, contact your doctor. Prometrium is found in breast milk. If you are or will be breast-feeding while you use Prometrium, 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:

Bloating; breast tenderness; diarrhea; dizziness; drowsiness; dry mouth; fluid retention; headache; heartburn; irritability; muscle pain; nausea; stomach pain or cramping; tiredness; 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); abnormal vaginal bleeding; bulging eyes; coughing up blood; dark urine; double vision; fainting; gallstones; mental or mood changes (eg, depression or worry); migraine; numbness of an arm or leg; pain or lumps in the breast; one-sided weakness; pounding in the chest; seizures or tremors; severe stomach pain; speech problems; stomach pain, swelling, or tenderness; sudden, severe chest pain or numbness; sudden, severe headache; sudden, severe vomiting, dizziness, or fainting; sudden sharp pain or swelling in the calf or leg; sudden shortness of breath; swelling of the ankles or fingers; vision problems or changes (including sudden, partial, or full loss of vision); yellowing of the eyes or skin.

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.

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

Premarin is a mixture of estrogen hormones used to treat symptoms of menopause such as hot flashes, and vaginal dryness, burning, and irritation. Other uses include prevention of osteoporosis in postmenopausal women, and replacement of estrogen in women with ovarian failure or other conditions that cause a lack of natural estrogen in the body. Premarin is sometimes used as part of cancer treatment in women and men. Premarin should not be used to prevent heart disease or dementia, because this medication may actually increase your risk of developing these conditions.

INSTRUCTIONS

Use Premarin as directed by your doctor.

  • Do not use the medication in larger amounts, or use it for longer than recommended by your doctor.
  • Premarin is taken on a daily basis. For certain conditions, Premarin is given in a cycle, such as 25 days on followed by 5 days. Follow the directions on your prescription label.
  • Premarin may be taken by mouth with or without food.
  • Take Premarin with a full glass of water.
  • Try to take the medicine at the same time each day.
  • Have regular physical exams and self-examine your breasts for lumps on a monthly basis while using Premarin.
  • It is important to take Premarin regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.
  • To be sure this medication is not causing harmful effects, your blood will need to be tested on a regular basis. Your thyroid function may also need to be tested. Do not miss any scheduled appointments.
  • If you need to have any type of surgery, tell the surgeon ahead of time that you are taking Premarin. You may need to stop using the medicine for a short time.
  • This medication can affect the results of certain medical tests. Tell any doctor who treats you that you are using Premarin.
  • If you miss a dose of Premarin, 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.

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

STORAGE

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

MORE INFO

Premarin (conjugated estrogens tablets) for oral administration contains a mixture of conjugated estrogens obtained exclusively from natural sources, occurring as the sodium salts of water-soluble estrogen sulfates blended to represent the average composition of material derived from pregnant mares’ urine. It is a mixture of sodium estrone sulfate and sodium equilin sulfate. It contains as concomitant components, as sodium sulfate conjugates, 17О±-dihydroequilin, 17О±- estradiol, and 17ОІ-dihydroequilin.

Estrogen is a female sex hormone produced by the ovaries. Estrogen is necessary for many processes in the body.

Premarin tablets also contain the following inactive ingredients: calcium phosphate tribasic, hydroxypropyl cellulose, microcrystalline cellulose, powdered cellulose, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, sucrose, and titanium dioxide.

Do NOT use Premarin if:

  • you are allergic to any ingredient in Premarin
  • you are pregnant or suspect you may be pregnant
  • you have a history of known or suspected breast cancer (unless directed by your doctor) or other cancers that are estrogen-dependent
  • you have abnormal vaginal bleeding of unknown cause
  • you have liver problems or liver disease, or the blood disease porphyria
  • you have recently (within the last year) had a stroke or heart attack
  • you have blood clots or circulation disorders.

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

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

  • if you are 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 an abnormal mammogram
  • if you have asthma (wheezing), a benign breast nodule, bone cancer, depression, diabetes, endometriosis or endometrial (uterine) cancer, epilepsy (seizures), gallbladder disease, heart problems, high blood pressure, kidney problems, liver problems or a history of yellowing of the skin or eyes, lupus, migraines, obesity, pancreatitis, uterine fibroids, thyroid problems or have high calcium levels in your blood
  • if you use tobacco, you are going to have surgery, or you will be on bed rest
  • if you have a personal or family history of high cholesterol, lipid, calcium, or triglyceride levels; or breast cancer.

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

  • Hydantoins (eg, phenytoin) or rifampin because they may decrease Premarin’s effectiveness.

This may not be a complete list of all interactions that may occur. Ask your health care provider if Premarin 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:

  • Premarin may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Premarin with caution. Do not drive or perform other possible unsafe tasks until you know how you react to it.
  • Smoking while taking Premarin may increase your risk of blood clots (especially in women older than 35 years of age).
  • Before using Premarin, you will need to have a complete medical and family history exam, which will include blood pressure, breast, stomach, and pelvic organ exams and a Pap smear.
  • You should have periodic mammograms as determined by your doctor. Follow your doctor’s instructions for examining your own breasts, and report any lumps immediately.
  • If you have other medical conditions and are prescribed estrogens for more than one condition, consult your doctor about your treatment plan and its options.
  • Diabetes patients – Premarin may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
  • Premarin may cause dark skin patches on your face (melasma). Exposure to the sun may make these patches darker, and you may need to avoid prolonged sun exposure and sunlamps. Consult your doctor regarding the use of sunscreens and protective clothing.
  • If you wear contact lenses and you develop problems with them, contact your doctor.
  • If you will be having surgery or will be confined to a chair or bed for a long period of time (eg, a long plane flight), notify your doctor beforehand. Special precautions may need to be taken in these circumstances while you are taking Premarin.
  • Premarin may interfere with certain lab tests. Be sure your doctor and lab personnel know you are using Premarin.
  • Lab tests, including a lipid profile, may be performed while you use Premarin. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Premarin may affect growth rate in children and teenagers in some cases. They may need regular growth checks while they use Premarin.
  • Pregnancy and breast-feeding: Do not use Premarin if you are pregnant. Avoid becoming pregnant while you are taking it. If you think you may be pregnant, contact your doctor right away. Premarin is found in breast milk. If you are or will be breast-feeding while you use Premarin, 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:

Back pain; bloating; breast pain; depression; diarrhea; dizziness; flu syndrome; gas; hair loss; headache; increased cough; increased/decreased interest in sex; indigestion; infection; irregular vaginal bleeding or spotting; itching; joint pain; lightheadedness; leg cramps; muscle aches; nausea; nervousness; pain; runny nose; sinus inflammation; sleeplessness; sore throat; stomach pain; upper respiratory tract infection; vaginal inflammation; weakness; weight changes.

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); abnormal bleeding from the vagina; breast lumps; changes in vision or speech; chest pain; confusion; dizziness; fainting; hoarseness; mental/mood changes; one-sided weakness; pain or tenderness in the upper abdomen; pain or tenderness in the calves; severe headache; sudden shortness of breath; swelling of the hands or feet; unusual vaginal discharge/itching/odor; vomiting; weakness or numbness of an arm or leg; 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

Prometrium is used for protecting the lining of the uterus in certain women who are also taking estrogen. It is used to treat certain women who have do not have a menstrual period because of decreased progesterone in the body. Prometrium is a hormone. It works by changing the lining of the uterus.

INSTRUCTIONS

Use Prometrium as directed by your doctor.

  • Take Prometrium by mouth with or without food.
  • If you miss a dose of Prometrium, 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.

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

STORAGE

Store Prometrium at 77 degrees F (25 degrees C) in a tight, light-resistant container. Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Prometrium out of the reach of children and away from pets.

MORE INFO:

Active Ingredient: Progesterone.

Do NOT use Prometrium if:

  • you are allergic to any ingredient in Prometrium or to peanuts
  • you have a history of cancer of the breast, ovary, lining of the uterus, cervix, or vagina; vaginal bleeding of unknown cause; blood clots or clotting problems; or liver disease; you have had a recent miscarriage; or you have had a stroke or heart attack within the past year
  • you are pregnant.

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

Some medical conditions may interact with Prometrium. 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 heart or blood vessel problems, bleeding problems, high blood pressure, high cholesterol or lipid levels, diabetes, kidney problems, asthma, migraine headaches, or lupus
  • if you have a history of seizures, depression or other mental or mood problems, cancer, or tobacco use
  • if you have a family history of blood clots
  • if you are very overweight.

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

  • Rifampin because it may decrease Prometrium’s effectiveness.

This may not be a complete list of all interactions that may occur. Ask your health care provider if Prometrium 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:

  • Prometrium may cause drowsiness, dizziness, blurred vision, or lightheadedness. These effects may be worse if you take it with alcohol or certain medicines. Use Prometrium with caution. Do not drive or perform other possible unsafe tasks until you know how you react to it.
  • This product has peanut oil in it. Do not take Prometrium if you are allergic to peanuts.
  • Diabetes patients – Prometrium may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
  • Prometrium may increase your risk of developing blood clots. If you will be having surgery or be confined to a bed or chair for a long period of time (such as a long plane flight), notify your doctor beforehand. Special precautions may be needed in these circumstances while you are taking Prometrium.
  • Prometrium may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking Prometrium.
  • Lab tests, including monthly breast self-exams, yearly breast exams, Pap smears, and pelvic exams, may be performed while you use Prometrium. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Prometrium should not be used in children; safety and effectiveness in children have not been confirmed.
  • Pregnancy and breast-feeding: Do not use Prometrium if you are pregnant unless your doctor tells you otherwise. If you think you may be pregnant, contact your doctor. Prometrium is found in breast milk. If you are or will be breast-feeding while you use Prometrium, 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:

Bloating; breast tenderness; diarrhea; dizziness; drowsiness; dry mouth; fluid retention; headache; heartburn; irritability; muscle pain; nausea; stomach pain or cramping; tiredness; 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); abnormal vaginal bleeding; bulging eyes; coughing up blood; dark urine; double vision; fainting; gallstones; mental or mood changes (eg, depression or worry); migraine; numbness of an arm or leg; pain or lumps in the breast; one-sided weakness; pounding in the chest; seizures or tremors; severe stomach pain; speech problems; stomach pain, swelling, or tenderness; sudden, severe chest pain or numbness; sudden, severe headache; sudden, severe vomiting, dizziness, or fainting; sudden sharp pain or swelling in the calf or leg; sudden shortness of breath; swelling of the ankles or fingers; vision problems or changes (including sudden, partial, or full loss of vision); yellowing of the eyes or skin.

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

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

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

Premarin is a mixture of estrogen hormones used to treat symptoms of menopause such as hot flashes, and vaginal dryness, burning, and irritation. Other uses include prevention of osteoporosis in postmenopausal women, and replacement of estrogen in women with ovarian failure or other conditions that cause a lack of natural estrogen in the body. Premarin is sometimes used as part of cancer treatment in women and men. Premarin should not be used to prevent heart disease or dementia, because this medication may actually increase your risk of developing these conditions.

INSTRUCTIONS

Use Premarin as directed by your doctor.

  • Do not use the medication in larger amounts, or use it for longer than recommended by your doctor.
  • Premarin is taken on a daily basis. For certain conditions, Premarin is given in a cycle, such as 25 days on followed by 5 days. Follow the directions on your prescription label.
  • Premarin may be taken by mouth with or without food.
  • Take Premarin with a full glass of water.
  • Try to take the medicine at the same time each day.
  • Have regular physical exams and self-examine your breasts for lumps on a monthly basis while using Premarin.
  • It is important to take Premarin regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.
  • To be sure this medication is not causing harmful effects, your blood will need to be tested on a regular basis. Your thyroid function may also need to be tested. Do not miss any scheduled appointments.
  • If you need to have any type of surgery, tell the surgeon ahead of time that you are taking Premarin. You may need to stop using the medicine for a short time.
  • This medication can affect the results of certain medical tests. Tell any doctor who treats you that you are using Premarin.
  • If you miss a dose of Premarin, 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.

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

STORAGE

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

MORE INFO

Premarin (conjugated estrogens tablets) for oral administration contains a mixture of conjugated estrogens obtained exclusively from natural sources, occurring as the sodium salts of water-soluble estrogen sulfates blended to represent the average composition of material derived from pregnant mares’ urine. It is a mixture of sodium estrone sulfate and sodium equilin sulfate. It contains as concomitant components, as sodium sulfate conjugates, 17О±-dihydroequilin, 17О±- estradiol, and 17ОІ-dihydroequilin.

Estrogen is a female sex hormone produced by the ovaries. Estrogen is necessary for many processes in the body.

Premarin tablets also contain the following inactive ingredients: calcium phosphate tribasic, hydroxypropyl cellulose, microcrystalline cellulose, powdered cellulose, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, sucrose, and titanium dioxide.

Do NOT use Premarin if:

  • you are allergic to any ingredient in Premarin
  • you are pregnant or suspect you may be pregnant
  • you have a history of known or suspected breast cancer (unless directed by your doctor) or other cancers that are estrogen-dependent
  • you have abnormal vaginal bleeding of unknown cause
  • you have liver problems or liver disease, or the blood disease porphyria
  • you have recently (within the last year) had a stroke or heart attack
  • you have blood clots or circulation disorders.

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

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

  • if you are 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 an abnormal mammogram
  • if you have asthma (wheezing), a benign breast nodule, bone cancer, depression, diabetes, endometriosis or endometrial (uterine) cancer, epilepsy (seizures), gallbladder disease, heart problems, high blood pressure, kidney problems, liver problems or a history of yellowing of the skin or eyes, lupus, migraines, obesity, pancreatitis, uterine fibroids, thyroid problems or have high calcium levels in your blood
  • if you use tobacco, you are going to have surgery, or you will be on bed rest
  • if you have a personal or family history of high cholesterol, lipid, calcium, or triglyceride levels; or breast cancer.

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

  • Hydantoins (eg, phenytoin) or rifampin because they may decrease Premarin’s effectiveness.

This may not be a complete list of all interactions that may occur. Ask your health care provider if Premarin 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:

  • Premarin may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Premarin with caution. Do not drive or perform other possible unsafe tasks until you know how you react to it.
  • Smoking while taking Premarin may increase your risk of blood clots (especially in women older than 35 years of age).
  • Before using Premarin, you will need to have a complete medical and family history exam, which will include blood pressure, breast, stomach, and pelvic organ exams and a Pap smear.
  • You should have periodic mammograms as determined by your doctor. Follow your doctor’s instructions for examining your own breasts, and report any lumps immediately.
  • If you have other medical conditions and are prescribed estrogens for more than one condition, consult your doctor about your treatment plan and its options.
  • Diabetes patients – Premarin may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
  • Premarin may cause dark skin patches on your face (melasma). Exposure to the sun may make these patches darker, and you may need to avoid prolonged sun exposure and sunlamps. Consult your doctor regarding the use of sunscreens and protective clothing.
  • If you wear contact lenses and you develop problems with them, contact your doctor.
  • If you will be having surgery or will be confined to a chair or bed for a long period of time (eg, a long plane flight), notify your doctor beforehand. Special precautions may need to be taken in these circumstances while you are taking Premarin.
  • Premarin may interfere with certain lab tests. Be sure your doctor and lab personnel know you are using Premarin.
  • Lab tests, including a lipid profile, may be performed while you use Premarin. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Premarin may affect growth rate in children and teenagers in some cases. They may need regular growth checks while they use Premarin.
  • Pregnancy and breast-feeding: Do not use Premarin if you are pregnant. Avoid becoming pregnant while you are taking it. If you think you may be pregnant, contact your doctor right away. Premarin is found in breast milk. If you are or will be breast-feeding while you use Premarin, 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:

Back pain; bloating; breast pain; depression; diarrhea; dizziness; flu syndrome; gas; hair loss; headache; increased cough; increased/decreased interest in sex; indigestion; infection; irregular vaginal bleeding or spotting; itching; joint pain; lightheadedness; leg cramps; muscle aches; nausea; nervousness; pain; runny nose; sinus inflammation; sleeplessness; sore throat; stomach pain; upper respiratory tract infection; vaginal inflammation; weakness; weight changes.

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); abnormal bleeding from the vagina; breast lumps; changes in vision or speech; chest pain; confusion; dizziness; fainting; hoarseness; mental/mood changes; one-sided weakness; pain or tenderness in the upper abdomen; pain or tenderness in the calves; severe headache; sudden shortness of breath; swelling of the hands or feet; unusual vaginal discharge/itching/odor; vomiting; weakness or numbness of an arm or leg; 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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