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leuprolide (4-month) intramuscular

LEUPROLIDE 3 MONTH PEDIATRIC - INJECTION

GENERIC NAME(S): LEUPROLIDE ACETATE

Uses

Leuprolide is used to stop early puberty (precocious puberty) in children. It helps to delay sexual development (such as growth of the breasts/testicles) and the start of menstrual periods. It also helps slow down early bone growth to increase the likelihood of reaching normal adult height. Leuprolide works by decreasing the amount of sex hormones that a child's body makes (estrogen in girls, testosterone in boys).

OTHER USES: This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.

Other leuprolide products may also be used to treat prostate cancer in men and disorders of the uterus (including endometriosis, fibroids) in women.

How to use leuprolide (4-month) intramuscular

This medication is given by injection into a muscle by a health care professional as directed by the doctor, usually every 3 months. This product slowly releases the medication into the blood over a 3-month period.

In children, the dosage is based on weight and response to treatment. The doctor should consider stopping treatment before age 11 for girls and age 12 for boys. Consult the doctor for details.

If you are directed to use this medication at home, learn all preparation and usage instructions in the product package. Learn how to store and discard needles and medical supplies safely. If any of the information is unclear, consult the doctor or pharmacist.

Before injecting each dose, clean the injection site with rubbing alcohol. Change the injection site each time to lessen injury under the skin.

Use this medication regularly to get the most benefit from it. To help you remember, mark your calendar to keep track of when to receive the next dose.

You may notice worsening symptoms of early puberty (such as menstrual periods) at the start of treatment. However, you should see an improvement in symptoms usually within 1 to 2 months. Tell the doctor promptly if new or worsened symptoms develop after beginning treatment.

Side Effects

Mild pain/irritation at the injection site, hot flashes (flushing), increased sweating, night sweats, headache, breast changes, acne/seborrhea, joint/muscle aches, vaginal discomfort/dryness, vaginal bleeding/discharge, increased weight, or mood changes may occur. If any of these effects persist or worsen, tell the doctor or pharmacist promptly.

During the first few weeks of treatment, hormone levels will actually increase before they decrease. This is normal. This may result in a temporary increase in symptoms (for example, menstrual periods in girls) for a few weeks. When this medication is used regularly, it is expected that the menstrual period will stop, or decrease to light bleeding/spotting during the first 2 months. Tell the doctor promptly if regular periods continue after 2 months of treatment with leuprolide.

Remember that the doctor has prescribed this medication because he or she has judged that the benefit is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell the doctor right away if you have any serious side effects, including: mental/mood changes (such as depression, thoughts of suicide, mood swings, aggression in children), bone pain (in adults).

Get medical help right away if you have any very serious side effects, including: seizures.

Rarely, a very serious problem with the pituitary gland (pituitary apoplexy) may occur, usually in the first hour to 2 weeks after the first injection. Get medical help right away if you notice any of the following symptoms: sudden severe headache (often with nausea and vomiting), sudden severe mental/mood changes (such as severe confusion, difficulty concentrating), vision changes (including partial loss of vision, double vision, inability to tolerate bright light), fainting.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact the doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

Before using leuprolide, tell the doctor or pharmacist of allergy to it; or of any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell the doctor or pharmacist the child's medical history.

Before having surgery, tell the doctor or dentist about all the products being used (including prescription drugs, nonprescription drugs, and herbal products).

This form of leuprolide is not usually used in adults. Therefore, it is unlikely to be used during pregnancy or breast-feeding. Consult the doctor if you have any questions about this medication.

Interactions

Drug interactions may change how medications work or increase the risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products being used (including prescription/nonprescription drugs and herbal products) and share it with the doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without the doctor's approval.

Overdose

If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Notes

Do not share this medication with others.

Laboratory and/or medical tests (such as hormone levels, height measurement, bone tests) should be performed periodically to monitor progress or check for side effects. Consult the doctor for more details.

Missed Dose

For the best possible benefit, it is important to receive each scheduled dose of this medication as directed. If a dose is missed, contact the doctor immediately to establish a new dosing schedule.

Storage

Store at room temperature away from light and moisture. After mixing, use the medication immediately. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Information last revised August 2013. Copyright(c) 2013 First Databank, Inc.

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Selected from data included with permission and copyrighted by First Databank, Inc. This copyrighted material has been downloaded from a licensed data provider and is not for distribution, expect as may be authorized by the applicable terms of use.

CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment.

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