GENERIC NAME: NAFARELIN ACETATE SPRAY - NASAL (NAF-a-REL-in AS-e-tate)
BRAND NAME(S): Synarel
USES: Nafarelin is used in women to treat a condition in which the tissue that normally lines the inside of the uterus grows in the wrong place (endometriosis). This medication helps to decrease the abnormal tissue and also the symptoms of endometriosis (e.g., pelvic pain, painful menstrual cramps, and pain during/after sex).This medication is also used in children to treat a certain type of early puberty (central precocious puberty, gonadotropin-dependent). It helps to slow the bone aging and height growth rate so that it is near normal and to stop or reverse signs of early puberty (e.g., breast growth in girls, growth of sexual organs in boys).Nafarelin is a man-made hormone that is similar to a natural hormone made by the body (gonadotropin-releasing hormone-GnRH). It works by decreasing the testosterone hormones in boys and estrogen hormones in women and girls.
HOW TO USE: Read the Patient Information Leaflet, which contains instructions for proper use of this medication. Learn all preparation and usage instructions. Consult your doctor or pharmacist if you have any questions.Follow the instructions on how to properly prime the bottle if you are using it for the first time.Gently blow your nose before using this drug. For very young children, it may be necessary to clear the nose with a bulb syringe.Use this medication usually twice daily (about every 12 hours) as directed by your doctor. If you are using more than 1 spray at a time, wait 30 seconds between each spray. Avoid spraying this medication in your eyes. Also, avoid sneezing during or immediately after using this medication because this may decrease the amount of medication absorbed. Follow the detailed instructions for using the spray and cleaning the spray tip. It is important to clean the spray tip after each use.Dosage is based on your medical condition and response to therapy. The length of therapy for women taking this medication for endometriosis is 6 months unless otherwise directed by your doctor. The length of therapy for children taking this medication for early puberty depends on when the doctor decides it is appropriate for puberty to resume.Use this medication regularly to get the most benefit from it. It is important not to miss any doses of this medication, or else this medication may not be effective. To help you remember, use it at the same times each day.Consult your doctor or pharmacist to find out how long each bottle of the nasal spray should last. Do not use the nasal spray bottle longer, even though there might be some medication left over, because this may result in getting too low a dose. Make sure to get your medication refills a few days early so that you will not run out of your medication.Do not increase your dose or take this medication more often than prescribed. Your condition will not improve any faster, and the risk of serious side effects may be increased. Also, do not stop this medication without your doctor's approval.If you need to use a nasal decongestant spray while using this medication, wait at least 2 hours after using this medication before using the decongestant.When you first start this medication, worsening of symptoms may occur (e.g., increased vaginal bleeding in endometriosis, or vaginal bleeding/period, increase in breast size/pubic hair, oily skin, or body odor in early puberty). Such symptoms should get better after the first month of treatment. Inform your doctor if your symptoms worsen or persist after 2 months.
SIDE EFFECTS: Nasal irritation, hot flashes, vaginal discharge, or mood swings may occur in children. Nasal irritation, hot flashes, headaches, mood swings, decreased sexual interest, muscle pain, vaginal dryness, acne, or decrease in breast size may occur in women. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.For women taking this medication, tell your doctor immediately if any of these unlikely but serious side effects occur: abdominal/lower back pain, bone pain, depression.For women taking this medication, tell your doctor immediately if any of these rare but very serious side effects occur: fast/pounding heartbeat, numbness/tingling of arms/legs, eye pain.Rarely, a very serious problem with your pituitary gland (pituitary apoplexy) may occur, usually in the first hour to 2 weeks after your first dose of this medication. Seek immediate medical attention if any of these very serious side effects occur: sudden severe headache, mental/mood changes (e.g., confusion), vision changes, vomiting.A very serious allergic reaction to this drug is rare. However, seek immediate medical attention 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 your 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 nafarelin, tell your doctor or pharmacist if you are allergic to it; or to GnRH or other GnRH-like hormones (e.g., leuprolide); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: unexplained abnormal vaginal bleeding.Before using this medication, tell your doctor or pharmacist your medical history, especially of: smoking, daily alcohol use, bone loss (osteoporosis) or family history of osteoporosis, polycystic ovarian disease, high cholesterol/triglyceride levels.This medication must not be used during pregnancy. It may harm an unborn baby. Consult your doctor for more details and to discuss reliable forms of birth control. Women should start this medication between days 2 and 4 of their period. Although periods and the release of eggs (ovulation) may stop while you are taking this drug, this should not be considered a reliable form of birth control. It is recommended that men and women using this medication use two effective non-hormonal forms of birth control (e.g., condoms and diaphragm with spermicide) while taking this medication. Consult your doctor.It is not known if this medication passes into breast milk. Because of the potential risk to the infant, breast-feeding is not recommended while using this drug. Consult your doctor before breast-feeding.
DRUG INTERACTIONS: See also How to Use section.Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first.Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: estrogens, birth control pills, medications that can cause bone loss (e.g., corticosteroids such as prednisone).This medication may interfere with certain laboratory tests (including tests for pituitary gonadotropic and gonadal functions), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.
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 (e.g., growth/bone age velocity in children) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.
MISSED DOSE: It is important that you do not miss any doses of this medication. If you do miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.Vaginal bleeding may occur in girls/women who miss doses of this medication.
STORAGE: Store the bottle upright at room temperature at 77 degrees F (25 degrees C) away from light. Do not store at temperatures above 86 degrees F (30 degrees C). Do not freeze. Keep all medicines 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 for more details about how to safely discard your product.
Information last revised March 2014. Copyright(c) 2014 First Databank, Inc.
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Endometriosis implants are most commonly found on the ovaries, the Fallopian tubes, outer surfaces of the uterus or intestines, and on the surface lining of the pelvic cavity. They also can be found in the vagina, cervix, and bladder. Endometriosis may not produce any symptoms, but when it does the most common symptom is pelvic pain that worsens just prior to menstruation and improves at the end of the menstrual period. Other symptoms of endometriosis include pain during sex, pain with pelvic examinations, cramping or pain during bowel movements or urination, and infertility.
Treatment of endometriosis can be with medication or surgery.
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