LEUPROLIDE 3 MONTH PEDIATRIC - INJECTION

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LEUPROLIDE 3 MONTH PEDIATRIC - INJECTION

PHONETIC PRONUNCIATION: (LOO-proe-lide)

COMMON BRAND NAME(S): Lupron Depot-Ped

GENERIC NAME(S): leuprolide acetate

Uses

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).


How to use LEUPROLIDE 3 MONTH PEDIATRIC - INJECTION

HOW TO USE: Read the Medication Guide provided by your pharmacist before you start using leuprolide and each time you get a refill. If you have any questions, ask your doctor or pharmacist. 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 using this medication at home, learn all preparation and usage instructions from the health care professional and the product package. Learn how to store and discard medical supplies safely. Wash your hands and properly mix the medication. Before injecting each dose, clean the injection site with rubbing alcohol. Change the injection site each time to lessen injury under the skin. Inject each dose within 2 hours of mixing. If more than 2 hours have passed since mixing, throw out the product and prepare another syringe/dose. Use this medication regularly to get the most benefit from it. To help you remember, mark your calendar to keep track of when your child should receive the next dose. During the first few weeks of treatment, hormone levels will actually go up before they go down. This is a normal response to this medication. 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 starting treatment.

Side Effects

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, or increased weight may occur. If any of these effects last or get worse, tell the doctor or pharmacist promptly. 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 your doctor right away if you have any serious side effects, including: mental/mood changes (such as depression, thoughts of suicide, mood swings, aggression). 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 any of these very serious side effects occur: sudden severe headache, sudden severe mental/mood changes (such as severe confusion, difficulty concentrating), vision changes, severe vomiting, 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 or at www.fda.gov/medwatch. 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

PRECAUTIONS: Before using leuprolide, tell the doctor or pharmacist if your child is allergic to it; or if your child has any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to the pharmacist for more details. Before using this medication, tell the doctor or pharmacist the child's medical history, especially of: mental/mood problems (such as depression), seizures. Before having surgery, tell the doctor or dentist about all the products being used (including prescription drugs, nonprescription drugs, and herbal products). This medication must not be used during pregnancy. It may harm an unborn baby. Consult your doctor for more details and to discuss using reliable forms of non-hormonal birth control (such as condoms, diaphragm with spermicide) while using this medication. If you become pregnant or think you may be pregnant, tell your doctor right away. It is unknown if leuprolide passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.

Interactions

DRUG 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 your child uses (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. This medication may interfere with certain lab tests possibly causing false test results. Make sure lab personnel and all the doctors know your child uses this drug.

Overdose

OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

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Faq for LEUPROLIDE 3 MONTH PEDIATRIC - INJECTION

Leuprolide 3 Month Pediatric Injection is used in the treatment of central precocious puberty in children.

Leuprolide 3 Month Pediatric Injection suppresses the production of hormones that cause early puberty by decreasing the release of luteinizing hormone and follicle-stimulating hormone from the pituitary gland.

The recommended dosage for Leuprolide 3 Month Pediatric Injection is determined by the child's weight. It is administered as a subcutaneous injection every 3 months.

Common side effects of Leuprolide 3 Month Pediatric Injection include injection site reactions, hot flashes, mood swings, headache, and decreased appetite.

The effects of Leuprolide 3 Month Pediatric Injection may be seen within a few weeks of starting the treatment. However, it may take a few months to fully suppress puberty.

Leuprolide 3 Month Pediatric Injection may cause a decrease in bone mineral density, so regular monitoring is advised. It should not be used in children with hypersensitivity to GnRH agonists or with undiagnosed abnormal vaginal bleeding.

Leuprolide 3 Month Pediatric Injection is not recommended for use during pregnancy or while breastfeeding. It is essential to consult a healthcare provider for guidance in such cases.

If a dose is missed, it should be administered as soon as possible. However, if it is close to the next scheduled dose, the missed dose should be skipped and the regular dosing schedule should be followed.

Leuprolide 3 Month Pediatric Injection may interact with certain medications, such as hormonal contraceptives, antiandrogens, or medications that affect liver enzymes. It is important to inform the healthcare provider about all current medications before starting Leuprolide 3 Month Pediatric Injection.

Leuprolide is administered as an injection under the skin (subcutaneously) every three months by a healthcare professional.

If you miss a dose, contact your healthcare provider to reschedule the injection.

Certain medications, including hormonal contraceptives, may interact with Leuprolide. It is important to inform your healthcare provider about all the medications you are taking.

Leuprolide 3 Month Pediatric Injection is specifically formulated for use in children and is not recommended for use in adults.

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Disclaimer

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.