Synarel

Synarel is a prescription medication used to treat symptoms of endometriosis in women including severe menstrual cramps, pain during sexual intercourse, low back pain, and painful bowel movements. It is also used to treat abnormally early sexual development in children, known medically as central precocious puberty (CPP). 

Synarel belongs to a group of drugs called synthetic hormones, which work by helping to control natural hormone levels in the body.

This medication comes in the form of a nasal spray. In treating endometriosis, one spray is administered into one nostril in the morning, and one spray is administered into the other nostril in the evening. In treating CPP, two sprays are administered into each nostril each morning and evening.

Common side effects of Synarel include acne, breast enlargement, and hot flashes.

Synarel is a prescription medication used to treat the symptoms of endometriosis in women and also to treat abnormally early sexual development in children, a condition known medically as central precocious puberty (CPP).

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• GD Searle LLC

Serious side effects have been reported with Synarel. See the “Synarel Precautions” section.

Common side effects of Synarel include the following:

• acne
• breast enlargement
• vaginal bleeding (menstruation should stop with this medication)
• mood swings
• increase in pubic hair
• body odor
• seborrhea (skin irritation)
• nasal irritation
• headache
• hot flashes
• insomnia
• change in weight
• vaginal dryness or vaginal discharge
• change in sex drive
• oily skin
• muscle aches
• rhinitis (runny nose)

This is not a complete list of Synarel side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

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

No drug interactions have been reported by the manufacturer. However, you should tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Not all drug interactions are known or reported and new drug interactions are continually being reported.

Serious side effects have been reported with Synarel including the following:

• Suppression of natural hormone production. Consult your physician if you experience abnormal tiredness and/or weakness.
• Abnormal natural hormone release causing ovarian cysts. Consult your physician if you experience abnormal abdominal pain not related to menstruation.
• Blockage of blood flow to parts of the brain. Get medical attention immediately if you experience sudden headache, vomiting, visual changes, eye pain, and/or altered thinking or speech.

Do not use Synarel if:

• you are pregnant
• you are breastfeeding
• you have abnormal vaginal bleeding that has not been checked into by your doctor
• you are allergic to any ingredient of this medication.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Synarel, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Synarel, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Synarel, gonadotropin-releasing hormones, or any other medicines
• have or ever have had osteoporosis, ovarian cysts, ovarian tumors, ovarian cancer, chronic runny nose (rhinitis), a history of depression
• are pregnant, plan to become pregnant, or are breastfeeding
• you have abnormal vaginal bleeding that has not been checked into by your doctor

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Synarel falls into category X. In animal studies, pregnant animals were given this medication and had some babies born with problems. Synarel may cause fetal harm when administered to a pregnant woman. There are no situations where the benefits of the medication for the mother outweigh the risks of harm to the baby. These medicines should never be used by pregnant women.

It is important to use a non-hormonal means of contraception (birth control) while using Synarel (e.g., condom or diaphragm). If you become pregnant while using Synarel, consult with your doctor immediately.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Synarel crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Synarel.

Take Synarel exactly as prescribed.

Synarel comes in nasal spray form and is typically taken twice per day.

General proper use of Synarel

• You should avoid sneezing during or immediately after using Synarel, if possible, as sneezing can impair drug absorption.
• Before you use Synarel nasal spray for the first time, you will need to prime it. This will ensure that you get the right dose of medicine each time you use it.

Proper use of Synarel for Treatment of Endometriosis

• The length of treatment is usually about 6 months, unless your doctor has given you special instructions.
• A bottle of Synarel will typically not be used for longer than 30 days (60 sprays). Each bottle contains sufficient quantity of nasal solution for initial priming of the pump and 30 days (60 sprays) of treatment. At the end of 30 days, a small amount of liquid will be left in the bottle. Do not try to use up that leftover amount because you might get too low a dose, which could interfere with the effectiveness of your treatment. Dispose of the bottle and do not reuse.

Proper Use of Synarel for Treatment of Central Precocious Puberty

• The head should be tilted slightly back, and you should wait about 30 seconds between sprays into the same nostril.
• Treatment for central precocious puberty should continue until you and your child's doctor decide that it is appropriate for puberty to resume.
• A bottle of Synarel for central precocious puberty patients will typically not be used for longer than 7 days, unless your child's doctor specifically tells you it may be used for a longer time. If the doctor tells you to use a bottle only for 7 days, then a small amount of liquid will be left in the bottle. Do not try to use up the leftover amount because your child might get too low a dose, which could interfere with the effectiveness of the treatment. Dispose of the used bottle properly and do not reuse.

If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of Synarel at the same time. 

If you miss 1 or more doses of Synarel, vaginal bleeding (often called breakthrough bleeding) may occur. If you miss successive doses of Synarel and have not been using contraception as described above, release of an egg from the ovary (ovulation) may occur, with the possibility of pregnancy. Under these circumstances you must see your physician to make sure you are not pregnant. If you should become pregnant while using Synarel, you must discuss the possible risks to the fetus and the choices available to you with your physician.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your weight
• your height
• your age
• your gender

The recommended dose of Synarel for the treatment of endometriosis is one spray in one nostril in the morning and one spray in the other nostril in the evening. Synarel should be started between the second and fourth days of your menstrual period. Synarel should not be used for longer than 6 months to treat endometriosis.

The recommended dose of Synarel for the treatment of precocious puberty is two sprays in each nostril each morning and each evening, for a total of eight sprays each day.

If you take too much Synarel, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

• Store Synarel at 59°F to 86°F (15°C to 30°C).
• Store the Synarel bottle upright.
• Keep Synarel out of the light.
• Do not freeze Synarel.
• Keep out of the reach of children and use carefully as directed.