Generic Name: phenylephrine (FEN il EFF rin)
Brand Names: Ah-Chew D, Dimetapp Cold Drops, Lusonal, Nasop, Nasop12, PediaCare Children’s Decongestant, Phenyl-T, Sudafed PE, Sudafed PE Children’s Nasal Decongestant, Sudafed PE Quick Dissolve, Sudogest PE, Triaminic Thin Strips Cold

What is Lusonal (phenylephrine)?

Phenylephrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).

Phenylephrine is used to treat nasal congestion and sinus pressure caused by allergies, the common cold, or the flu. Phenylephrine may be used to treat congestion of the tubes that drain fluid from your inner ears, called the eustachian (yoo-STAY-shun) tubes.

Phenylephrine may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Lusonal (phenylephrine)?

Do not give this medication to a child younger than 4 years old. Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children.

You should not use this medication if you are allergic to phenylephrine.

Do not use phenylephrine if you have used linezolid (Zyvox) or procarbazine (Matulane), or if you have taken a monoamine oxidase inhibitor (MAOI) such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) in the last 14 days. Serious, life-threatening side effects can occur if you take phenylephrine before these other drugs have cleared from your body.

Before you take phenylephrine, tell your doctor if you are allergic to any decongestants, or if you have heart disease, heart rhythm disorder, high blood pressure, circulation problems, diabetes, glaucoma, a thyroid disorder, kidney disease, an enlarged prostate or urination problems, anxiety, sleep problems, bipolar disorder or other mental illness.

Phenylephrine may interact with heart or blood pressure medications, antidepressants, diabetes medications, migraine headache medications, and other decongestants.

Never take more of the medicine than directed on the label or prescribed by your doctor.

Call your doctor if your symptoms do not improve after 7 days of using phenylephrine, or if they get worse and your also have a fever.

What should I discuss with my healthcare provider before taking Lusonal (phenylephrine)?

You should not use this medication if you are allergic to phenylephrine.

Do not use phenylephrine if you have used linezolid (Zyvox) or procarbazine (Matulane), or if you have taken a monoamine oxidase inhibitor (MAOI) such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) in the last 14 days. Serious, life-threatening side effects can occur if you take phenylephrine before these other drugs have cleared from your body.

If you have certain conditions, you may need a dose adjustment or special tests to safely use this medication. Before you take phenylephrine, tell your doctor if you are allergic to any decongestants, or if you have:

• heart disease, heart rhythm disorder;

• high blood pressure;

• circulation problems (such as Raynaud’s syndrome);

• diabetes;

• glaucoma;

• a thyroid disorder;

• kidney disease;

• an enlarged prostate or urination problems;

• sleep problems, anxiety; or

• mental illness such as bipolar disorder.

FDA pregnancy category C. Is not known whether this medication will harm an unborn baby. Before you take phenylephrine, tell doctor if you are pregnant. Phenylephrine may pass into breast milk and could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Older adults may be more likely to have side effects from this medication.

Disintegrating and liquid forms of cold medicine may contain sugar or artificial sweeteners (phenylalanine). This would be important to know if you have diabetes or phenylketonuria (PKU). Check the ingredients and warnings on the medication label if you are concerned about sugar or phenylalanine.

How should I use Lusonal (phenylephrine)?

Use this medication exactly as directed on the label, or as it has been prescribed by your doctor. Do not use the medication in larger amounts, or use it for longer than recommended. Cold medicine is usually taken only for a short time until your symptoms clear up.

Do not give this medication to a child younger than 4 years old. Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children. You may take phenylephrine with food if it upsets your stomach. Take the phenylephrine tablet with a full glass of water.

Measure the liquid form of phenylephrine with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

The chewable phenylephrine tablet must be chewed thoroughly before you swallow it.

To use the phenylephrine disintegrating strip, place one strip on your tongue and allow it to dissolve without chewing.

To use the disintegrating tablet, make sure your hands are dry and peel back the foil from the blister package. Place the tablet on your tongue. It will begin to dissolve right away. Do not swallow the tablet whole. Allow it to dissolve in your mouth without chewing.

Phenylephrine is usually taken every 4 hours. Follow the directions on the medicine label. Never take more of the medicine than directed on the label or prescribed by your doctor.

Call your doctor if your symptoms do not improve after 7 days of using phenylephrine, or if they get worse and your also have a fever.

If you need to have any type of surgery, tell the surgeon ahead of time if you have taken a cold medicine within the past few days.

Store phenylephrine at room temperature away from moisture and heat. Keep the disintegrating tablets or strips in their package until you are ready to take one.

Throw away any unused phenylephrine after the expiration date on the label has passed. Do not flush this medication down a toilet. Ask your pharmacist about the safest way to dispose of unused medicines.

What happens if I miss a dose?

Cold medicine is usually taken only as needed, so you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at your next regularly scheduled time. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include feeling restless or nervous, severe dizziness, sweating, vomiting, hallucinations, fast or uneven heart rate, fainting, seizure (convulsions), and weak or shallow breathing.

What should I avoid while using Lusonal (phenylephrine)?

Do not use any other over-the-counter cold, allergy, or cough medication without first asking your doctor or pharmacist. Phenylephrine is contained in many medicines available over the counter. If you take certain products together you may accidentally take too much phenylephrine. Read the label of any other medicine you are using to see if it contains phenylephrine or another decongestant.

Avoid taking diet pills, caffeine pills, or other stimulants (such as ADHD medications) without your doctor’s advice. Taking a stimulant together with a decongestant can increase your risk of unpleasant side effects.

Avoid smoking. It can add to the effects of phenylephrine in decreasing blood flow, which can lead to uncomfortable symptoms. Avoid drinking alcohol while you are taking phenylephrine.

Lusonal (phenylephrine) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using phenylephrine and call your doctor at once if you have a serious side effect such as:

• severe dizziness, restless feeling, nervousness, or insomnia;

• unusual thoughts or behavior;

• feeling like you might pass out;

• fast, pounding, or uneven heartbeat;

• tremors or shaking;

• numbness, tingling, or cold feeling in your hands or feet; or

• urinating less than usual or not at all.

Less serious side effects may include:

• headache, dizziness;

• feeling excited or restless (especially in children);

• upset stomach; or

• mild sleep problems.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Lusonal (phenylephrine)?

Tell your doctor about all other medications you use, especially:

• other decongestants, including nasal sprays;

• digoxin (digitalis, Lanoxin);

• medicine to treat diabetes;

• medicines to treat high blood pressure such as reserpine, methyldopa (Aldomet), and others;

• migraine headache medicine such as ergotamine (Ergomar), naratriptan (Amerge), sumatriptan (Imitrex) or zolmitriptan (Zomig);

• an antidepressant such as amitriptyline (Elavil), clomipramine (Anafranil), imipramine (Janimine, Tofranil), and others;

• a beta-blocker such as atenolol (Tenormin), carvedilol (Coreg), metoprolol (Lopressor, Toprol), propranolol (Inderal), sotalol (Betapace), and others; or

• a calcium channel blocker such as amlodipine (Norvasc), diltiazem (Tiazac, Cartia, Cardizem), felodipine (Plendil), nifedipine (Procardia, Adalat), verapamil (Calan, Covera, Isoptin, Verelan), and others.

This list is not complete and there may be other drugs that can interact with phenylephrine. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

Where can I get more information?

• Your pharmacist can provide more information about phenylephrine.

• Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
• Every effort has been made to ensure that the information provided by Cerner Multum, Inc. (‘Multum’) is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum’s drug information does not endorse drugs, diagnose patients or recommend therapy. Multum’s drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2006 Cerner Multum, Inc. Version: 6.01. Revision Date: 08/12/2009 2:10:44 PM.

Generic Name: fluoride (FLOR ide)
Brand Names: Altaflor, Ethedent Chewable, Fluor-A-Day, Fluoritab, Flura-Drops, Flura-Loz, Flura-Tab, Karidium, Lozi-Flur, Luride, Nafrinse, Pharmaflur, Pharmaflur 1.1

What is Luride (fluoride)?

Fluoride is a substance that strengthens tooth enamel. This helps to prevent dental cavities.

Fluoride is used as a medication to prevent tooth decay in people that have a low level of fluoride in their drinking water. Fluoride is also used to prevent tooth decay in people who undergo radiation of the head and/or neck, which may cause dryness of the mouth and an increased incidence of tooth decay.

Fluoride may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Luride (fluoride)?

You should not use fluoride if the level of fluoride in your drinking water is greater than 0.7 parts per million (ppm).

Before using fluoride, tell your dentist and doctor if you are on a low salt or a salt free diet. You may not be able to use fluoride, or you may need special tests while you are using it.

Do not take fluoride with milk, other dairy products, or calcium supplements. Calcium can make it harder for your body to absorb fluoride.

Avoid using antacids without your doctor’s advice. Use only the specific type of antacid your doctor recommends. Many antacids contain calcium, which can interfere with fluoride absorption.

What should I discuss with my healthcare provider before taking Luride (fluoride)?

You should not use fluoride if the level of fluoride in your drinking water is greater than 0.7 parts per million (ppm).

Before using fluoride, tell your dentist and doctor if you are on a low salt or a salt free diet. You may not be able to use fluoride, or you may need special tests while you are using it.

Talk to your doctor and dentist before taking fluoride if you are pregnant or could become pregnant during treatment. Talk to your doctor and dentist before taking fluoride if you are breast-feeding. The American Dental Association’s Council on Dental Therapeutics recommends the use of fluoride by children up to 13 years of age; the American Academy of Pediatrics recommends fluoride supplementation by children until the age of 16 years of age. Do not give a 1-mg tablet to a child younger than 3 years old, or when your drinking water fluoride content is equal to or greater than 0.3 ppm.

How should I take Luride (fluoride)?

Use this medication exactly as directed on the label, or as prescribed by your doctor. Do not use it in larger amounts or for longer than recommended.

Take this medicine with a full glass of water. Do not take fluoride with milk or other dairy products. Calcium can make it harder for your body to absorb fluoride.

Suck on the fluoride lozenge until it dissolves completely in your mouth. Do not chew the lozenge or swallow it whole.

The chewable forms of fluoride can be chewed, swallowed, dissolved in the mouth, added to drinking water or fruit juice, or added to water for use in infant formula or other food.

The fluoride drops can be taken by mouth undiluted, or mixed with fluid or food.

If you mix fluoride with food or water, drink or eat this mixture right away. Do not save it for later use.

It is important to take fluoride regularly to get the most benefit.

Store fluoride at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to take the medicine and skip the missed dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include nausea, vomiting, stomach pain, diarrhea, drooling, numbness or tingling, loss of feeling anywhere in your body, muscle stiffness, or seizure (convulsions).

What should I avoid while taking Luride (fluoride)?

Do not take fluoride with milk, other dairy products, or calcium supplements. Calcium can make it harder for your body to absorb fluoride.

Avoid using antacids without your doctor’s advice. Use only the specific type of antacid your doctor recommends. Many antacids contain calcium, which can interfere with fluoride absorption.

Luride (fluoride) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor if you have any of the following side effects:

• discolored teeth;

• weakened tooth enamel; or

• any changes in the appearance of your teeth.

Less serious side effects may include:

• stomach upset;

• headache; or

• weakness.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Luride (fluoride)?

There may be other drugs that can interact with fluoride. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

Where can I get more information?

• Your pharmacist can provide more information about fluoride.

• Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed
• Every effort has been made to ensure that the information provided by Cerner Multum, Inc. (‘Multum’) is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum’s drug information does not endorse drugs, diagnose patients or recommend therapy. Multum’s drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2006 Cerner Multum, Inc. Version: 4.03. Revision Date: 11/19/2009 8:45:06 AM.

Generic Name: Sodium Fluoride (SO-dee-uhm FLOR-ide)
Brand Name: Examples include Fluor-A-Day and Luride

Luride Chewable Tablets are used for:

Preventing cavities in children older than 6 months old when the amount of fluoride in the water supply is too low.

Luride Chewable Tablets are a mineral. It works by strengthening the teeth and decreasing the effects of acid and bacteria on the teeth.

Do NOT use Luride Chewable Tablets if:

• you are allergic to any ingredient in Luride Chewable Tablets
• your drinking water has a fluoride content greater than 0.6 parts per million (ppm)

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

Before using Luride Chewable Tablets:

Some medical conditions may interact with Luride Chewable Tablets. 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 joint pain, severe kidney problems, or stomach or intestinal ulcers

Some MEDICINES MAY INTERACT with Luride Chewable Tablets. However, no specific interactions with Luride Chewable Tablets are known at this time.

Ask your health care provider if Luride Chewable Tablets 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.

How to use Luride Chewable Tablets:

Use Luride Chewable Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Luride Chewable Tablets by mouth with or without food. Do not eat or drink dairy products within 1 hour before or 2 hours after you take Luride Chewable Tablets.
• Do not take an antacid that has aluminum, calcium, or magnesium in it for several hours after you take Luride Chewable Tablets.
• Chew Luride Chewable Tablets well before you swallow it.
• If you miss a dose of Luride Chewable Tablets, 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 Luride Chewable Tablets.

Important safety information:

• Do not exceed the dose recommended by your doctor or dentist.
• Notify your dentist if your teeth become spotted or stained.
• Luride Chewable Tablets are not recommended for use in CHILDREN younger than 6 months old; safety and effectiveness in this age group have not been confirmed.
• Caution is advised when using Luride Chewable Tablets in CHILDREN younger than 6 years old. The appropriate dose of Luride Chewable Tablets depends on the child’s age and the amount of fluoride in the drinking water. Talk with your doctor if you have questions about the appropriate dose for your child or the amount of fluoride in your drinking water.
• PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Luride Chewable Tablets, contact your doctor. You will need to discuss the benefits and risks of using Luride Chewable Tablets while pregnant. It is not known if Luride Chewable Tablets are found in breast milk. If you are or will be breast-feeding while you are using Luride Chewable Tablets, check with your doctor. Discuss the risks to your baby.

Possible side effects of Luride Chewable Tablets:

All medicines may cause side effects, but many people have no, or minor, side effects. When used in small doses, no COMMON side effects have been reported with Luride Chewable Tablets. 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).

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. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately. Symptoms may include diarrhea; extreme thirst; increased drooling; muscle weakness; nausea; paleness of the skin; seizures; shallow, rapid breathing; shaking; stomach pain; vomiting; weak or fast heartbeat.

Proper storage of Luride Chewable Tablets:

Store Luride Chewable Tablets at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). 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 Luride Chewable Tablets out of the reach of children and away from pets.

General information:

• If you have any questions about Luride Chewable Tablets, please talk with your doctor, pharmacist, or other health care provider.
• Luride Chewable Tablets are to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Luride Chewable Tablets. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Generic Name: Leuprolide Depot (LOO-proe-lide)
Brand Name: Lupron Depot 11.25 mg

Lupron Depot 11.25 mg Suspension is used for:

Treating endometriosis. It may be used alone or with other medicines (eg, norethindrone). It is used with iron therapy to improve anemia before surgery in patients with fibroids of the uterus. It may also be used for other conditions as determined by your doctor.

Lupron Depot 11.25 mg Suspension is a gonadotropin-releasing hormone (GnRH) agonist. It works by decreasing levels of certain hormones and preventing the growth of certain tumors that need these hormones to grow.

Do NOT use Lupron Depot 11.25 mg Suspension if:

• you are allergic to any ingredient in Lupron Depot 11.25 mg Suspension, to GnRH, or to another GnRH analog (eg, histrelin)
• you are pregnant, able to become pregnant, or are breast-feeding
• you have unusual vaginal bleeding of an unknown cause
• you have a history of blood clots or clotting problems, vein inflammation caused by a blood clot, a stroke or other bleeding in the brain, or moderate to severe liver or kidney problems

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

Before using Lupron Depot 11.25 mg Suspension:

Some medical conditions may interact with Lupron Depot 11.25 mg Suspension. 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 or other substances
• if you drink alcohol, smoke, or use tobacco regularly
• if you have a history of mood or mental problems (eg, depression, mental disorders, memory problems) or high cholesterol (lipids)
• if you have bone problems (eg, osteoporosis, brittle bones) or a family history of bone problems, urinary problems (eg, blockage of the bladder or ureters), spinal cord problems, or abnormal growths on or near the spinal cord
• if you take corticosteroids (eg, prednisone), anticonvulsants (eg, carbamazepine), or other medicines that may reduce bone strength

Some MEDICINES MAY INTERACT with Lupron Depot 11.25 mg Suspension. However, no specific interactions with Lupron Depot 11.25 mg Suspension are known at this time.

Ask your health care provider if Lupron Depot 11.25 mg Suspension 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.

How to use Lupron Depot 11.25 mg Suspension:

Use Lupron Depot 11.25 mg Suspension as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• An extra patient leaflet is available with Lupron Depot 11.25 mg Suspension. Talk to your pharmacist if you have questions about this information.
• Lupron Depot 11.25 mg Suspension is usually administered every 3 months as an injection at your doctor’s office, hospital, or clinic. It must be administered under the supervision of a doctor.
• 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.
• The suspension settles very quickly following reconstitution; therefore, it should be used immediately after mixing.
• If you miss a dose of Lupron Depot 11.25 mg Suspension, contact your doctor right away.

Ask your health care provider any questions you may have about how to use Lupron Depot 11.25 mg Suspension.

Important safety information:

• Lupron Depot 11.25 mg Suspension may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Lupron Depot 11.25 mg Suspension with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Lupron Depot 11.25 mg Suspension may cause birth defects or fetal or newborn death if you take it while you are pregnant. You should have a negative a pregnancy test before you start Lupron Depot 11.25 mg Suspension. Talk with your doctor for more information.
• Lupron Depot 11.25 mg Suspension usually stops menstruation (periods). Missing doses of Lupron Depot 11.25 mg Suspension may cause breakthrough bleeding. Notify your doctor if regular menstruation continues.
• Ovulation usually stops while using Lupron Depot 11.25 mg Suspension, but this is not a reliable form of birth control because breakthrough ovulation may occur during treatment. Birth control pills may also not be effective. To prevent pregnancy, a nonhormonal form of birth control (eg, condom, diaphragm) should be used during treatment with Lupron Depot 11.25 mg Suspension.
• Certain hormone levels may increase during the first few weeks of treatment with Lupron Depot 11.25 mg Suspension. You may notice an increase in symptoms or onset of new symptoms during this time. Tell your doctor if any new symptoms occur or if you have worsened symptoms that last longer than a few weeks after you start to use Lupron Depot 11.25 mg Suspension.
• Lupron Depot 11.25 mg Suspension lowers the amount of certain hormones in your body. This may result in certain effects such as changes in breast size, breast soreness or tenderness, testicular changes, decreased sexual ability, hot flashes, or night sweats. Discuss any questions or concerns with your doctor.
• Lupron Depot 11.25 mg Suspension may cause your bones to weaken (decreased bone density), especially if you use it for a long time. Contact your doctor if you notice bone pain or if you have questions or concerns.
• A serious pituitary gland problem (pituitary apoplexy) has rarely been reported with the use of Lupron Depot 11.25 mg Suspension. Most cases developed within 2 weeks after the first dose. Contact your doctor immediately if you experience a sudden headache, vomiting, fainting, mental or mood changes, eye weakness, inability to move your eyes, or vision changes.
• Lab tests, including liver function and bone density tests, may be performed while you use Lupron Depot 11.25 mg Suspension. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• Lupron Depot 11.25 mg Suspension may interfere with certain lab tests, including certain hormone tests and pituitary gland function tests. Be sure your doctors and lab personnel know you are using Lupron Depot 11.25 mg Suspension.
• Lupron Depot 11.25 mg Suspension should not be used in ELDERLY patients older than 65 years of age.
• Lupron Depot 11.25 mg Suspension is not recommended for use in CHILDREN younger than 18 years of age; safety and effectiveness in these children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: Lupron Depot 11.25 mg Suspension may cause birth defects/fetal and newborn death if you take it while you are pregnant. If you think you may be pregnant, contact your doctor right away. It is not known if Lupron Depot 11.25 mg Suspension is found in breast milk. Do not breast-feed while using Lupron Depot 11.25 mg Suspension.

Possible side effects of Lupron Depot 11.25 mg Suspension:

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:

Acne; changes in weight; dizziness; general body pain; injection-site irritation (eg, mild burning, itching, pain, stinging, swelling); nausea or vomiting; trouble sleeping; weakness.

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); black, tarry stools; blood in urine; chest pain; confusion; decreased hearing; fainting; mood or mental changes (eg, anxiety, delusions, depression, memory problems, nervousness); numbness or tingling of the arms or legs; seizures; severe dizziness or lightheadedness; severe drowsiness; severe headache; shortness of breath; slow, fast, or irregular heartbeat; symptoms of infection (eg, chills, fever); trouble urinating (eg, loss of bladder control, unable to urinate, painful urination); unusual or one-sided weakness; vision changes or blurred vision; vomit that looks like coffee grounds.

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. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately.

Proper storage of Lupron Depot 11.25 mg Suspension:

Store Lupron Depot 11.25 mg Suspension at 77 degrees F (25 degrees C). 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 Lupron Depot 11.25 mg Suspension out of the reach of children and away from pets.

General information:

• If you have any questions about Lupron Depot 11.25 mg Suspension, please talk with your doctor, pharmacist, or other health care provider.
• Lupron Depot 11.25 mg Suspension is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Lupron Depot 11.25 mg Suspension. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Generic Name: Leuprolide (LOO-proe-lide)
Brand Name: Lupron Depot 3.75 mg

Lupron Depot 3.75 mg Suspension is used for:

Treating endometriosis. It may be used alone or with other medicines (eg, norethindrone). It is used with iron therapy to improve anemia before surgery in patients with fibroids of the uterus. It may also be used for other conditions as determined by your doctor.

Lupron Depot 3.75 mg Suspension is a gonadotropin-releasing hormone agonist. It works by decreasing levels of certain hormones produced by the testes and ovaries. This prevents the growth of certain tumors that need these hormones to grow.

Do NOT use Lupron Depot 3.75 mg Suspension if:

• you are allergic to any ingredient in Lupron Depot 3.75 mg Suspension
• you are pregnant, able to become pregnant, or are breast-feeding
• you have unusual vaginal bleeding of an unknown cause
• you have a history of blood clots or clotting problems, vein inflammation caused by a blood clot, a stroke or other bleeding in the brain, or moderate to severe liver or kidney problems

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

Before using Lupron Depot 3.75 mg Suspension:

Some medical conditions may interact with Lupron Depot 3.75 mg Suspension. 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 or other substances
• if you drink alcohol, smoke, or use tobacco regularly
• if you have a history of mood or mental problems (eg, depression, mental disorders, memory problems), or high cholesterol (lipids)
• if you have bone problems (eg, osteoporosis, brittle bones) or a family history of bone problems, urinary problems (eg, blockage of the bladder or ureters), spinal cord problems, or abnormal growths on or near the spinal cord
• if you take corticosteroids (eg, prednisone), anticonvulsants (eg, carbamazepine), or other medicines that may reduce bone strength

Some MEDICINES MAY INTERACT with Lupron Depot 3.75 mg Suspension. However, no specific interactions with Lupron Depot 3.75 mg Suspension are known at this time.

Ask your health care provider if Lupron Depot 3.75 mg Suspension 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.

How to use Lupron Depot 3.75 mg Suspension:

Use Lupron Depot 3.75 mg Suspension as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Lupron Depot 3.75 mg Suspension is usually administered once a month as an injection at your doctor’s office, hospital, or clinic. It must be administered under the supervision of a doctor.
• An extra patient leaflet is available with Lupron Depot 3.75 mg Suspension. Talk to your pharmacist if you have questions about this information.
• 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.
• The suspension settles very quickly following reconstitution; therefore, it should be used immediately after mixing.
• Do not miss any doses of Lupron Depot 3.75 mg Suspension. Missing doses will decrease the effectiveness of Lupron Depot 3.75 mg Suspension.

Ask your health care provider any questions you may have about how to use Lupron Depot 3.75 mg Suspension.

Important safety information:

• Lupron Depot 3.75 mg Suspension may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Lupron Depot 3.75 mg Suspension with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Lupron Depot 3.75 mg Suspension may cause birth defects or fetal or newborn death if you take it while you are pregnant. You should have a negative a pregnancy test before you start Lupron Depot 3.75 mg Suspension. Talk with your doctor for more information.
• Lupron Depot 3.75 mg Suspension usually stops menstruation (periods). Missing doses of Lupron Depot 3.75 mg Suspension may cause breakthrough bleeding. Notify your doctor if regular menstruation continues.
• Ovulation usually stops while using Lupron Depot 3.75 mg Suspension, but this is not a reliable form of birth control because breakthrough ovulation may occur during treatment. Birth control pills may also not be effective. To prevent pregnancy, a nonhormonal form of birth control (eg, condom, diaphragm) should be used during treatment with Lupron Depot 3.75 mg Suspension.
• Certain hormone levels may increase during the first few weeks of treatment with Lupron Depot 3.75 mg Suspension. You may notice an increase in symptoms or onset of new symptoms during this time. Tell your doctor if any new symptoms occur or if you have worsened symptoms that last longer than a few weeks after you start to use Lupron Depot 3.75 mg Suspension.
• Lupron Depot 3.75 mg Suspension lowers the amount of certain hormones in your body. This may result in certain effects such as changes in breast size, breast soreness or tenderness, testicular changes, decreased sexual ability, hot flashes, or night sweats. Discuss any questions or concerns with your doctor.
• Lupron Depot 3.75 mg Suspension may cause your bones to weaken (decreased bone density), especially if you use it for a long time. Contact your doctor if you notice bone pain or if you have questions or concerns.
• A serious pituitary gland problem (pituitary apoplexy) has rarely been reported with the use of Lupron Depot 3.75 mg Suspension. Most cases developed within 2 weeks after the first dose. Contact your doctor immediately if you experience a sudden headache, vomiting, fainting, mental or mood changes, eye weakness, inability to move your eyes, or vision changes.
• Lab tests, including liver function and bone density tests, may be performed while you use Lupron Depot 3.75 mg Suspension. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• Lupron Depot 3.75 mg Suspension may interfere with certain lab tests, including certain hormone tests and pituitary gland function tests. Be sure your doctors and lab personnel know you are using Lupron Depot 3.75 mg Suspension.
• Lupron Depot 3.75 mg Suspension should not be used in ELDERLY patients older than 65 years of age.
• Lupron Depot 3.75 mg Suspension is not recommended for use in CHILDREN younger than 18 years of age; safety and effectiveness in these children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: Lupron Depot 3.75 mg Suspension may cause birth defects/fetal and newborn death if you take it while you are pregnant. If you think you may be pregnant, contact your doctor right away. It is not known if Lupron Depot 3.75 mg Suspension is found in breast milk. Do not breast-feed while using Lupron Depot 3.75 mg Suspension.

Possible side effects of Lupron Depot 3.75 mg Suspension:

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:

Acne; changes in weight; dizziness; general body pain; injection-site irritation (eg, mild burning, itching, pain, stinging, swelling); nausea or vomiting; trouble sleeping; weakness.

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); black, tarry stools; blood in urine; chest pain; confusion; decreased hearing; fainting; mood or mental changes (eg, anxiety, delusions, depression, memory problems, nervousness); numbness or tingling of the arms or legs; seizures; severe dizziness or lightheadedness; severe drowsiness; severe headache; shortness of breath; slow, fast, or irregular heartbeat; symptoms of infection (eg, chills, fever); trouble urinating (eg, loss of bladder control, unable to urinate, painful urination); unusual or one-sided weakness; vision changes or blurred vision; vomit that looks like coffee grounds.

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. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately.

Proper storage of Lupron Depot 3.75 mg Suspension:

Store Lupron Depot 3.75 mg Suspension between 68 and 77 degrees F (20 and 25 degrees C). Brief excursions at temperatures between 59 and 86 degrees F (15 and 30 degrees C) are permitted. Keep Lupron Depot 3.75 mg Suspension out of the reach of children and away from pets.

General information:

• If you have any questions about Lupron Depot 3.75 mg Suspension, please talk with your doctor, pharmacist, or other health care provider.
• Lupron Depot 3.75 mg Suspension is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Lupron Depot 3.75 mg Suspension. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Generic Name: leuprolide (LOO proe lide)
Brand Names: Eligard, Lupron, Lupron Depot, Lupron Depot-Gyn, Lupron Depot-Ped

What is Lupron Depot-Gyn (leuprolide)?

Leuprolide is a man-made form of a hormone that regulates many processes in the body. Leuprolide overstimulates the body’s own production of certain hormones, which causes that production to shut down temporarily. Leuprolide reduces the amount of testosterone in men or estrogen in women.

Leuprolide is used in men to treat the symptoms of prostate cancer. Leuprolide treats only the symptoms of prostate cancer and does not treat the cancer itself. Use any other medications your doctor has prescribed to best treat your condition.

Leuprolide is used in women to treat symptoms of endometriosis (overgrowth of uterine lining outside of the uterus) or uterine fibroids.

Leuprolide is also used to treat precocious (early-onset) puberty in both male and female children.

Leuprolide may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Lupron Depot-Gyn (leuprolide)?

This medication can cause birth defects. Do not use if you are pregnant. Use effective birth control, and tell your doctor if you become pregnant during treatment. You should not use this medication if you are allergic to leuprolide or similar medications such as buserelin (Suprefact, Suprecor), goserelin (Zoladex), histrelin (Supprelin), nafarelin (Synarel), or if you have abnormal vaginal bleeding that has not been diagnosed by a doctor; or if you are breast-feeding a baby.

Before using leuprolide, tell your doctor if you have epilepsy, asthma, migraines, heart or kidney disease, a history of depression, bone cancer affecting your spine, blood in your urine, or if you are unable to urinate.

Tell your doctor if you have a personal or family history of osteoporosis, or if you have any risk factors for bone loss such as smoking, alcohol use, or taking steroid or seizure medications long term. Long-term use of this medication may decrease bone density, possibly leading to osteoporosis.

Certain brands or strengths of leuprolide are used to treat only men and should not be used in women or children. Always check your medication to make sure you have received the correct brand and strength prescribed by your doctor.

What should I discuss with my healthcare provider before using Lupron Depot-Gyn (leuprolide)?

Certain brands or strengths of leuprolide are used to treat only men and should not be used in women or children. Always check your medication to make sure you have received the correct brand and strength prescribed by your doctor. Ask the pharmacist if you have any questions about the medicine you receive at the pharmacy. You should not use this medication if you are allergic to leuprolide or similar medications such as buserelin (Suprefact, Suprecor), goserelin (Zoladex), histrelin (Supprelin), nafarelin (Synarel), or if you have:

• abnormal vaginal bleeding that has not been diagnosed by a doctor; or

• if you are pregnant or breast-feeding.

If you have any of these other conditions, you may need a dose adjustment or special tests to safely use leuprolide:

• a personal or family history of osteoporosis;

• risk factors for bone loss such as smoking, alcohol use, or taking steroid or seizure medications long term;

• epilepsy;

• asthma;

• migraines;

• heart disease;

• kidney disease;

• a history of depression;

• bone cancer affecting your spine;

• blood in your urine; or

• if you are unable to urinate.

FDA pregnancy category X. This medication can cause birth defects. Do not use leuprolide if you are pregnant. Tell your doctor right away if you become pregnant during treatment. Leuprolide usually causes women to stop ovulating or having menstrual periods. However, you may still be able to get pregnant. Use an effective barrier form of birth control (such as a condom or diaphragm with spermicide gel or inserts). Hormonal forms of contraception (such as birth control pills, injections, implants, skin patches, and vaginal rings) may not be effective in preventing pregnancy while you are using leuprolide. Because leuprolide is expected to cause your menstrual periods to stop, contact your doctor if your periods continue while you are being treated with this medication. Do not breast-feed a baby while using leuprolide.

Long-term use of this medication may decrease bone density, possibly leading to osteoporosis. Talk with your doctor about your possible risk for osteoporosis. You may need to receive a bone scan if you ever need to be re-treated with leuprolide in the future.

How should I use Lupron Depot-Gyn (leuprolide)?

Leuprolide is given as an injection under the skin or into a muscle. Your doctor, nurse, or other healthcare provider will give you this injection. You may be shown how to inject your medicine at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles and syringes.

This medication comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Leuprolide may be given once every month or once every 3 to 6 months. How often you receive this medication will depend on the condition being treated. Follow your doctor’s instructions.

Because different brands or strengths of leuprolide are used to treat different conditions, it is very important that you receive exactly the brand and strength your doctor has prescribed. If you self-inject this medication at home, always check your medication to make sure you have received the correct brand and type prescribed by your doctor.

Your symptoms may become temporarily worse as your hormones adjust when you first start using this medication. For best results, keep using the medication as instructed by your doctor. Your condition should eventually improve with continued use of leuprolide.

To be sure this medication is helping your condition, your blood may need to be tested often. This will help your doctor determine how long to treat you with leuprolide. You may still need blood tests for up to 3 months after you stop using leuprolide to check your hormone levels and pituitary gland function. Do not miss any scheduled appointments.

Store Lupron in the original carton at room temperature, away from moisture and heat. Store Eligard in the refrigerator. Do not freeze. You may take the medicine out and allow it to reach room temperature before mixing and injecting your dose. After the dose is mixed, you must use the injection within 30 minutes.

Use each disposable needle only one time. Throw away used needles in a puncture-proof container (ask your pharmacist where you can get one and how to dispose of it). Keep this container out of the reach of children and pets.

What happens if I miss a dose?

Call your doctor for instructions if you miss a dose.

Women who miss more than one leuprolide dose may have breakthrough bleeding. Children who miss more than one dose may have a return of pubertal symptoms such as breast development, growth in the testicles, or menstrual periods.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include weakness, or irritation where the leuprolide shot was given.

What should I avoid while using Lupron Depot-Gyn (leuprolide)?

Follow your doctor’s instructions about any restrictions on food, beverages, or activity.

Lupron Depot-Gyn (leuprolide) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have a serious side effect such as:

• bone pain;

• swelling, rapid weight gain;

• pain, burning, stinging, bruising, or redness where the medication was injected;

• feeling like you might pass out;

• painful or difficult urination;

• urinating more often than usual; or

• sudden headache with vision problems, vomiting, confusion, slow heart rate, weak pulse, fainting, or slow breathing.

Rare but serious side effects may include:

• pain or unusual sensations in your back;

• numbness, weakness, or tingly feeling in your legs or feet;

• muscle weakness or loss of use; and

• loss of bowel or bladder control.

Less serious side effects may include:

• acne, increased growth of facial hair;

• breakthrough bleeding in a female child during the first 2 months of leuprolide treatment;

• dizziness, weakness, tired feeling;

• hot flashes, night sweats, chills, clammy skin;

• nausea, diarrhea, constipation, stomach pain;

• skin redness, itching, or scaling;

• joint or muscle pain;

• vaginal itching or discharge

• breast swelling or tenderness;

• testicle pain;

• impotence, loss of interest in sex;

• depression, sleep problems (insomnia), memory problems; or

• redness, burning, itching, or swelling where the shot was given.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Lupron Depot-Gyn (leuprolide)?

There may be other drugs that can interact with leuprolide. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

Where can I get more information?

• Your pharmacist can provide more information about leuprolide.

• Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
• Every effort has been made to ensure that the information provided by Cerner Multum, Inc. (‘Multum’) is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum’s drug information does not endorse drugs, diagnose patients or recommend therapy. Multum’s drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2006 Cerner Multum, Inc. Version: 7.01. Revision Date: 07/01/2009 8:09:19 PM.

Generic Name: leuprolide (LOO proe lide)
Brand Names: Eligard, Lupron, Lupron Depot, Lupron Depot-Gyn, Lupron Depot-Ped

What is Lupron Depot-Ped (leuprolide)?

Leuprolide is a man-made form of a hormone that regulates many processes in the body. Leuprolide overstimulates the body’s own production of certain hormones, which causes that production to shut down temporarily. Leuprolide reduces the amount of testosterone in men or estrogen in women.

Leuprolide is used in men to treat the symptoms of prostate cancer. Leuprolide treats only the symptoms of prostate cancer and does not treat the cancer itself. Use any other medications your doctor has prescribed to best treat your condition.

Leuprolide is used in women to treat symptoms of endometriosis (overgrowth of uterine lining outside of the uterus) or uterine fibroids.

Leuprolide is also used to treat precocious (early-onset) puberty in both male and female children.

Leuprolide may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Lupron Depot-Ped (leuprolide)?

This medication can cause birth defects. Do not use if you are pregnant. Use effective birth control, and tell your doctor if you become pregnant during treatment. You should not use this medication if you are allergic to leuprolide or similar medications such as buserelin (Suprefact, Suprecor), goserelin (Zoladex), histrelin (Supprelin), nafarelin (Synarel), or if you have abnormal vaginal bleeding that has not been diagnosed by a doctor; or if you are breast-feeding a baby.

Before using leuprolide, tell your doctor if you have epilepsy, asthma, migraines, heart or kidney disease, a history of depression, bone cancer affecting your spine, blood in your urine, or if you are unable to urinate.

Tell your doctor if you have a personal or family history of osteoporosis, or if you have any risk factors for bone loss such as smoking, alcohol use, or taking steroid or seizure medications long term. Long-term use of this medication may decrease bone density, possibly leading to osteoporosis.

Certain brands or strengths of leuprolide are used to treat only men and should not be used in women or children. Always check your medication to make sure you have received the correct brand and strength prescribed by your doctor.

What should I discuss with my healthcare provider before using Lupron Depot-Ped (leuprolide)?

Certain brands or strengths of leuprolide are used to treat only men and should not be used in women or children. Always check your medication to make sure you have received the correct brand and strength prescribed by your doctor. Ask the pharmacist if you have any questions about the medicine you receive at the pharmacy. You should not use this medication if you are allergic to leuprolide or similar medications such as buserelin (Suprefact, Suprecor), goserelin (Zoladex), histrelin (Supprelin), nafarelin (Synarel), or if you have:

• abnormal vaginal bleeding that has not been diagnosed by a doctor; or

• if you are pregnant or breast-feeding.

If you have any of these other conditions, you may need a dose adjustment or special tests to safely use leuprolide:

• a personal or family history of osteoporosis;

• risk factors for bone loss such as smoking, alcohol use, or taking steroid or seizure medications long term;

• epilepsy;

• asthma;

• migraines;

• heart disease;

• kidney disease;

• a history of depression;

• bone cancer affecting your spine;

• blood in your urine; or

• if you are unable to urinate.

FDA pregnancy category X. This medication can cause birth defects. Do not use leuprolide if you are pregnant. Tell your doctor right away if you become pregnant during treatment. Leuprolide usually causes women to stop ovulating or having menstrual periods. However, you may still be able to get pregnant. Use an effective barrier form of birth control (such as a condom or diaphragm with spermicide gel or inserts). Hormonal forms of contraception (such as birth control pills, injections, implants, skin patches, and vaginal rings) may not be effective in preventing pregnancy while you are using leuprolide. Because leuprolide is expected to cause your menstrual periods to stop, contact your doctor if your periods continue while you are being treated with this medication. Do not breast-feed a baby while using leuprolide.

Long-term use of this medication may decrease bone density, possibly leading to osteoporosis. Talk with your doctor about your possible risk for osteoporosis. You may need to receive a bone scan if you ever need to be re-treated with leuprolide in the future.

How should I use Lupron Depot-Ped (leuprolide)?

Leuprolide is given as an injection under the skin or into a muscle. Your doctor, nurse, or other healthcare provider will give you this injection. You may be shown how to inject your medicine at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles and syringes.

This medication comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Leuprolide may be given once every month or once every 3 to 6 months. How often you receive this medication will depend on the condition being treated. Follow your doctor’s instructions.

Because different brands or strengths of leuprolide are used to treat different conditions, it is very important that you receive exactly the brand and strength your doctor has prescribed. If you self-inject this medication at home, always check your medication to make sure you have received the correct brand and type prescribed by your doctor.

Your symptoms may become temporarily worse as your hormones adjust when you first start using this medication. For best results, keep using the medication as instructed by your doctor. Your condition should eventually improve with continued use of leuprolide.

To be sure this medication is helping your condition, your blood may need to be tested often. This will help your doctor determine how long to treat you with leuprolide. You may still need blood tests for up to 3 months after you stop using leuprolide to check your hormone levels and pituitary gland function. Do not miss any scheduled appointments.

Store Lupron in the original carton at room temperature, away from moisture and heat. Store Eligard in the refrigerator. Do not freeze. You may take the medicine out and allow it to reach room temperature before mixing and injecting your dose. After the dose is mixed, you must use the injection within 30 minutes.

Use each disposable needle only one time. Throw away used needles in a puncture-proof container (ask your pharmacist where you can get one and how to dispose of it). Keep this container out of the reach of children and pets.

What happens if I miss a dose?

Call your doctor for instructions if you miss a dose.

Women who miss more than one leuprolide dose may have breakthrough bleeding. Children who miss more than one dose may have a return of pubertal symptoms such as breast development, growth in the testicles, or menstrual periods.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include weakness, or irritation where the leuprolide shot was given.

What should I avoid while using Lupron Depot-Ped (leuprolide)?

Follow your doctor’s instructions about any restrictions on food, beverages, or activity.

Lupron Depot-Ped (leuprolide) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have a serious side effect such as:

• bone pain;

• swelling, rapid weight gain;

• pain, burning, stinging, bruising, or redness where the medication was injected;

• feeling like you might pass out;

• painful or difficult urination;

• urinating more often than usual; or

• sudden headache with vision problems, vomiting, confusion, slow heart rate, weak pulse, fainting, or slow breathing.

Rare but serious side effects may include:

• pain or unusual sensations in your back;

• numbness, weakness, or tingly feeling in your legs or feet;

• muscle weakness or loss of use; and

• loss of bowel or bladder control.

Less serious side effects may include:

• acne, increased growth of facial hair;

• breakthrough bleeding in a female child during the first 2 months of leuprolide treatment;

• dizziness, weakness, tired feeling;

• hot flashes, night sweats, chills, clammy skin;

• nausea, diarrhea, constipation, stomach pain;

• skin redness, itching, or scaling;

• joint or muscle pain;

• vaginal itching or discharge

• breast swelling or tenderness;

• testicle pain;

• impotence, loss of interest in sex;

• depression, sleep problems (insomnia), memory problems; or

• redness, burning, itching, or swelling where the shot was given.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Lupron Depot-Ped (leuprolide)?

There may be other drugs that can interact with leuprolide. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

Where can I get more information?

• Your pharmacist can provide more information about leuprolide.

• Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
• Every effort has been made to ensure that the information provided by Cerner Multum, Inc. (‘Multum’) is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum’s drug information does not endorse drugs, diagnose patients or recommend therapy. Multum’s drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2006 Cerner Multum, Inc. Version: 7.01. Revision Date: 07/01/2009 8:09:19 PM.

Generic Name: Leuprolide Depot (loo-PRO-lide)
Brand Name: Lupron Depot

Lupron Depot Suspension is used for:

Treating symptoms of advanced prostate cancer and certain conditions as determined by your doctor.

Lupron Depot Suspension is a gonadotropin-releasing hormone agonist. It works by decreasing levels of certain hormones produced by the testes and ovaries. It prevents the growth of certain tumors which need these hormones to grow.

Do NOT use Lupron Depot Suspension if:

• you are allergic to any ingredient in Lupron Depot Suspension
• you are pregnant, may become pregnant, or are breast-feeding

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

Before using Lupron Depot Suspension:

Some medical conditions may interact with Lupron Depot Suspension. 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 or other substances
• if you have bone problems, urinary problems (eg, blockage of the bladder or ureters), spinal cord problems, or abnormal growths on or near the spinal cord
• if you have vaginal bleeding

Some MEDICINES MAY INTERACT with Lupron Depot Suspension. However, no specific interactions with Lupron Depot Suspension are known at this time.

Ask your health care provider if Lupron Depot Suspension 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.

How to use Lupron Depot Suspension:

Use Lupron Depot Suspension as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• An extra patient leaflet is available with Lupron Depot Suspension. Talk to your pharmacist if you have questions about this information.
• Lupron Depot Suspension is usually given as an injection at your doctor’s office, hospital, or clinic. If you will be using Lupron Depot Suspension at home, a health care provider will teach you how to use it. Be sure you understand how to use Lupron Depot Suspension. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
• 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.
• Do not miss any doses of Lupron Depot Suspension. If you miss a dose of Lupron Depot Suspension, contact your doctor immediately.

Ask your health care provider any questions you may have about how to use Lupron Depot Suspension.

Important safety information:

• Certain hormone levels may increase during the first few weeks of treatment with Lupron Depot Suspension. You may notice an increase in symptoms or onset of new symptoms during this time. Tell your doctor if any new symptoms occur or if you have worsened symptoms that last longer than a few weeks after your start to use Lupron Depot Suspension.
• Lupron Depot Suspension lowers the amount of certain hormones in the body. This may result in certain effects, such as changes in breast size, breast soreness or tenderness, testicular changes, decreased sexual ability, hot flashes, or night sweats. Discuss any questions or concerns with your doctor.
• Lupron Depot Suspension may cause your bones to weaken (decreased bone density), especially if you use it for a long time. Contact your doctor if you notice bone pain or if you have questions or concerns.
• A serious pituitary gland problem (pituitary apoplexy) has rarely been reported with the use of Lupron Depot Suspension. Most cases developed within 2 weeks after the first dose. Contact your doctor right away if you experience a sudden headache, vomiting, fainting, mental or mood changes, eye weakness, inability to move your eyes, or vision changes.
• Lupron Depot Suspension may interfere with certain lab tests, including certain hormone tests and pituitary gland function tests. Be sure your doctors and lab personnel know you are using Lupron Depot Suspension.
• Lab tests, including blood testosterone levels, prostate-specific antigen (PSA), and bone density tests, may be performed while you use Lupron Depot Suspension. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• Lupron Depot Suspension is not recommended for use in CHILDREN; safety and effectiveness in children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: Lupron Depot Suspension is not approved for use in women. Lupron Depot Suspension may cause birth defects/fetal and newborn death if you take it while you are pregnant. If you think you may be pregnant, contact your doctor right away. It is not known if Lupron Depot Suspension is found in breast milk. Do not breast-feed while using Lupron Depot Suspension.

Possible side effects of Lupron Depot Suspension:

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:

Dizziness; general body pain; injection site irritation (eg, mild burning, itching, pain, stinging, swelling); tiredness; trouble sleeping; weakness.

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

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black, tarry stools; blood in urine; chest pain; decreased hearing; fainting; mood or mental changes (eg, anxiety, delusions, depression, nervousness); numbness or tingling of the arms or legs; seizures; severe dizziness or lightheadedness; severe drowsiness; severe headache; shortness of breath; slow, fast, or irregular heartbeat; symptoms of infection (eg, chills, fever); trouble urinating (eg, loss of bladder control, inability to urinate, painful urination); unusual bruising or bleeding; unusual or one-sided weakness; vision changes or blurred vision; vomit that looks like coffee grounds.

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. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately.

Proper storage of Lupron Depot Suspension:

Store Lupron Depot Suspension at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Because the product does not contain a preservative, once mixed, the suspension should be discarded if not used immediately. Keep Lupron Depot Suspension out of the reach of children and away from pets.

General information:

• If you have any questions about Lupron Depot Suspension, please talk with your doctor, pharmacist, or other health care provider.
• Lupron Depot Suspension is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Lupron Depot Suspension. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Generic Name: Leuprolide (loo-PRO-lide)
Brand Name: Lupron Depot

Lupron Depot Depot Suspension is used for:

Treating symptoms of advanced prostate cancer. It may also be used for other conditions as determined by your doctor.

Lupron Depot Depot Suspension is a gonadotropin-releasing hormone agonist. It works by decreasing levels of certain hormones produced by the testes and ovaries. It prevents the growth of certain tumors that need these hormones to grow.

Do NOT use Lupron Depot Depot Suspension if:

• you are allergic to any ingredient in Lupron Depot Depot Suspension
• you are pregnant, may become pregnant, or are breast-feeding

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

Before using Lupron Depot Depot Suspension:

Some medical conditions may interact with Lupron Depot Depot Suspension. 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 or other substances
• if you have bone problems, urinary problems (eg, blockage of the bladder or ureters), spinal cord problems, or abnormal growths on or near the spinal cord
• if you have vaginal bleeding

Some MEDICINES MAY INTERACT with Lupron Depot Depot Suspension. However, no specific interactions with Lupron Depot Depot Suspension are known at this time.

Ask your health care provider if Lupron Depot Depot Suspension 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.

How to use Lupron Depot Depot Suspension:

Use Lupron Depot Depot Suspension as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• An extra patient leaflet is available with Lupron Depot Depot Suspension. Talk to your pharmacist if you have questions about this information.
• Lupron Depot Depot Suspension is usually given as an injection at your doctor’s office, hospital, or clinic. If you will be using Lupron Depot Depot Suspension at home, a health care provider will teach you how to use it. Be sure you understand how to use Lupron Depot Depot Suspension. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
• 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.
• Do not miss any doses of Lupron Depot Depot Suspension. If you miss a dose of Lupron Depot Depot Suspension, contact your doctor immediately.

Ask your health care provider any questions you may have about how to use Lupron Depot Depot Suspension.

Important safety information:

• Certain hormone levels may increase during the first few weeks of treatment with Lupron Depot Depot Suspension. You may notice an increase in symptoms or onset of new symptoms during this time. Tell your doctor if any new symptoms occur or if you have worsened symptoms that last longer than a few weeks after your start to use Lupron Depot Depot Suspension.
• Lupron Depot Depot Suspension lowers the amount of certain hormones in the body. This may result in certain effects, such as changes in breast size, breast soreness or tenderness, testicular changes, decreased sexual ability, hot flashes, or night sweats. Discuss any questions or concerns with your doctor.
• Lupron Depot Depot Suspension may cause your bones to weaken (decreased bone density), especially if you use it for a long time. Contact your doctor if you notice bone pain or if you have questions or concerns.
• A serious pituitary gland problem (pituitary apoplexy) has rarely been reported with the use of Lupron Depot Depot Suspension. Most cases developed within 2 weeks after the first dose. Contact your doctor right away if you experience a sudden headache, vomiting, fainting, mental or mood changes, eye weakness, inability to move your eyes, or vision changes.
• Lupron Depot Depot Suspension may interfere with certain lab tests, including certain hormone tests and pituitary gland function tests. Be sure your doctors and lab personnel know you are using Lupron Depot Depot Suspension.
• Lab tests, including blood testosterone levels, , prostate-specific antigen (PSA), and bone density tests, may be performed while you use Lupron Depot Depot Suspension. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• Lupron Depot Depot Suspension is not recommended for use in CHILDREN; safety and effectiveness in children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: Lupron Depot Depot Suspension is not approved for use in women. Lupron Depot Depot Suspension may cause birth defects/fetal and newborn death if you take it while you are pregnant. If you think you may be pregnant, contact your doctor right away. It is not known if Lupron Depot Depot Suspension is found in breast milk. Do not breast-feed while using Lupron Depot Depot Suspension.

Possible side effects of Lupron Depot Depot Suspension:

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:

Dizziness; general body pain; headache; hot flashes; increased sweating; injection-site irritation (eg, mild burning, itching, pain, stinging, swelling); mild joint pain; muscle pain; tiredness; trouble sleeping; weakness.

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

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black, tarry stools; blood in urine; chest pain; decreased hearing; fainting; mood or mental changes (eg, anxiety, delusions, depression, nervousness); numbness or tingling of the arms or legs; seizures; severe dizziness or lightheadedness; severe drowsiness; severe headache; shortness of breath; slow, fast, or irregular heartbeat; symptoms of infection (eg, chills, fever); trouble urinating (eg, loss of bladder control, unable to urinate, painful urination); unusual bruising or bleeding; unusual or one-sided weakness; vision changes or blurred vision; vomit that looks like coffee grounds.

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. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately.

Proper storage of Lupron Depot Depot Suspension:

Store Lupron Depot Depot Suspension at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Because the product does not contain a preservative, once mixed, the suspension should be discarded if not used immediately. Keep Lupron Depot Depot Suspension out of the reach of children and away from pets.

General information:

• If you have any questions about Lupron Depot Depot Suspension, please talk with your doctor, pharmacist, or other health care provider.
• Lupron Depot Depot Suspension is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Lupron Depot Depot Suspension. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Generic Name: leuprolide (LOO proe lide)
Brand Names: Eligard, Lupron, Lupron Depot, Lupron Depot-Gyn, Lupron Depot-Ped

What is Lupron Depot (leuprolide)?

Leuprolide is a man-made form of a hormone that regulates many processes in the body. Leuprolide overstimulates the body’s own production of certain hormones, which causes that production to shut down temporarily. Leuprolide reduces the amount of testosterone in men or estrogen in women.

Leuprolide is used in men to treat the symptoms of prostate cancer. Leuprolide treats only the symptoms of prostate cancer and does not treat the cancer itself. Use any other medications your doctor has prescribed to best treat your condition.

Leuprolide is used in women to treat symptoms of endometriosis (overgrowth of uterine lining outside of the uterus) or uterine fibroids.

Leuprolide is also used to treat precocious (early-onset) puberty in both male and female children.

Leuprolide may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Lupron Depot (leuprolide)?

This medication can cause birth defects. Do not use if you are pregnant. Use effective birth control, and tell your doctor if you become pregnant during treatment. You should not use this medication if you are allergic to leuprolide or similar medications such as buserelin (Suprefact, Suprecor), goserelin (Zoladex), histrelin (Supprelin), nafarelin (Synarel), or if you have abnormal vaginal bleeding that has not been diagnosed by a doctor; or if you are breast-feeding a baby.

Before using leuprolide, tell your doctor if you have epilepsy, asthma, migraines, heart or kidney disease, a history of depression, bone cancer affecting your spine, blood in your urine, or if you are unable to urinate.

Tell your doctor if you have a personal or family history of osteoporosis, or if you have any risk factors for bone loss such as smoking, alcohol use, or taking steroid or seizure medications long term. Long-term use of this medication may decrease bone density, possibly leading to osteoporosis.

Certain brands or strengths of leuprolide are used to treat only men and should not be used in women or children. Always check your medication to make sure you have received the correct brand and strength prescribed by your doctor.

What should I discuss with my healthcare provider before using Lupron Depot (leuprolide)?

Certain brands or strengths of leuprolide are used to treat only men and should not be used in women or children. Always check your medication to make sure you have received the correct brand and strength prescribed by your doctor. Ask the pharmacist if you have any questions about the medicine you receive at the pharmacy. You should not use this medication if you are allergic to leuprolide or similar medications such as buserelin (Suprefact, Suprecor), goserelin (Zoladex), histrelin (Supprelin), nafarelin (Synarel), or if you have:

• abnormal vaginal bleeding that has not been diagnosed by a doctor; or

• if you are pregnant or breast-feeding.

If you have any of these other conditions, you may need a dose adjustment or special tests to safely use leuprolide:

• a personal or family history of osteoporosis;

• risk factors for bone loss such as smoking, alcohol use, or taking steroid or seizure medications long term;

• epilepsy;

• asthma;

• migraines;

• heart disease;

• kidney disease;

• a history of depression;

• bone cancer affecting your spine;

• blood in your urine; or

• if you are unable to urinate.

FDA pregnancy category X. This medication can cause birth defects. Do not use leuprolide if you are pregnant. Tell your doctor right away if you become pregnant during treatment. Leuprolide usually causes women to stop ovulating or having menstrual periods. However, you may still be able to get pregnant. Use an effective barrier form of birth control (such as a condom or diaphragm with spermicide gel or inserts). Hormonal forms of contraception (such as birth control pills, injections, implants, skin patches, and vaginal rings) may not be effective in preventing pregnancy while you are using leuprolide. Because leuprolide is expected to cause your menstrual periods to stop, contact your doctor if your periods continue while you are being treated with this medication. Do not breast-feed a baby while using leuprolide.

Long-term use of this medication may decrease bone density, possibly leading to osteoporosis. Talk with your doctor about your possible risk for osteoporosis. You may need to receive a bone scan if you ever need to be re-treated with leuprolide in the future.

How should I use Lupron Depot (leuprolide)?

Leuprolide is given as an injection under the skin or into a muscle. Your doctor, nurse, or other healthcare provider will give you this injection. You may be shown how to inject your medicine at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles and syringes.

This medication comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Leuprolide may be given once every month or once every 3 to 6 months. How often you receive this medication will depend on the condition being treated. Follow your doctor’s instructions.

Because different brands or strengths of leuprolide are used to treat different conditions, it is very important that you receive exactly the brand and strength your doctor has prescribed. If you self-inject this medication at home, always check your medication to make sure you have received the correct brand and type prescribed by your doctor.

Your symptoms may become temporarily worse as your hormones adjust when you first start using this medication. For best results, keep using the medication as instructed by your doctor. Your condition should eventually improve with continued use of leuprolide.

To be sure this medication is helping your condition, your blood may need to be tested often. This will help your doctor determine how long to treat you with leuprolide. You may still need blood tests for up to 3 months after you stop using leuprolide to check your hormone levels and pituitary gland function. Do not miss any scheduled appointments.

Store Lupron in the original carton at room temperature, away from moisture and heat. Store Eligard in the refrigerator. Do not freeze. You may take the medicine out and allow it to reach room temperature before mixing and injecting your dose. After the dose is mixed, you must use the injection within 30 minutes.

Use each disposable needle only one time. Throw away used needles in a puncture-proof container (ask your pharmacist where you can get one and how to dispose of it). Keep this container out of the reach of children and pets.

What happens if I miss a dose?

Call your doctor for instructions if you miss a dose.

Women who miss more than one leuprolide dose may have breakthrough bleeding. Children who miss more than one dose may have a return of pubertal symptoms such as breast development, growth in the testicles, or menstrual periods.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include weakness, or irritation where the leuprolide shot was given.

What should I avoid while using Lupron Depot (leuprolide)?

Follow your doctor’s instructions about any restrictions on food, beverages, or activity.

Lupron Depot (leuprolide) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have a serious side effect such as:

• bone pain;

• swelling, rapid weight gain;

• pain, burning, stinging, bruising, or redness where the medication was injected;

• feeling like you might pass out;

• painful or difficult urination;

• urinating more often than usual; or

• sudden headache with vision problems, vomiting, confusion, slow heart rate, weak pulse, fainting, or slow breathing.

Rare but serious side effects may include:

• pain or unusual sensations in your back;

• numbness, weakness, or tingly feeling in your legs or feet;

• muscle weakness or loss of use; and

• loss of bowel or bladder control.

Less serious side effects may include:

• acne, increased growth of facial hair;

• breakthrough bleeding in a female child during the first 2 months of leuprolide treatment;

• dizziness, weakness, tired feeling;

• hot flashes, night sweats, chills, clammy skin;

• nausea, diarrhea, constipation, stomach pain;

• skin redness, itching, or scaling;

• joint or muscle pain;

• vaginal itching or discharge

• breast swelling or tenderness;

• testicle pain;

• impotence, loss of interest in sex;

• depression, sleep problems (insomnia), memory problems; or

• redness, burning, itching, or swelling where the shot was given.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Lupron Depot (leuprolide)?

There may be other drugs that can interact with leuprolide. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

Where can I get more information?

• Your pharmacist can provide more information about leuprolide.

• Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
• Every effort has been made to ensure that the information provided by Cerner Multum, Inc. (‘Multum’) is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum’s drug information does not endorse drugs, diagnose patients or recommend therapy. Multum’s drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2006 Cerner Multum, Inc. Version: 7.01. Revision Date: 07/01/2009 8:09:19 PM.