Generic Name: esterified estrogens and methyltestosterone (ess TER if fyed ESS troe jenz and METH il tes TOS te rone)
Brand Names: Covaryx, Covaryx HS, EEMT, Essian H.S., Estratest, Estratest H.S., Syntest DS, Syntest HS

What is Syntest HS (esterified estrogens and methyltestosterone)?

Esterified estrogens are female sex hormones necessary for many processes in the body.

Methyltestosterone is a man-made form of testosterone, a naturally occurring sex hormone that is produced in a man’s testicles. Small amounts of testosterone are also produced in a woman’s ovaries and adrenal system.

The combination of esterified estrogens and methyltestosterone is used to treat symptoms of menopause such as hot flashes, and vaginal dryness, burning, and irritation.

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

What is the most important information I should know about Syntest HS (esterified estrogens and methyltestosterone)?

Do not use this medication if you have any of the following conditions: liver disease, a recent history of heart attack, stroke or circulation problems, a hormone-related cancer such as breast or uterine cancer, abnormal vaginal bleeding, or if you are pregnant or breast-feeding. This medication should not be used to prevent heart disease or stroke. This medication can cause birth defects in an unborn baby. Do not use if you are pregnant. Tell your doctor if you become pregnant during treatment.

Esterified estrogens and methyltestosterone increases your risk of developing endometrial hyperplasia, a condition that may lead to cancer of the uterus. Taking progestins while using esterified estrogens and methyltestosterone may lower this risk. If your uterus has not been removed, your doctor may prescribe a progestin for you to take while you are taking esterified estrogens and methyltestosterone.

Long-term esterified estrogens and methyltestosterone treatment may increase your risk of breast cancer, heart attack, or stroke. Talk with your doctor about your individual risks before using esterified estrogens and methyltestosterone long-term. Your doctor should check your progress on a regular basis (every 3 to 6 months) to determine whether you should continue this treatment.

Have regular physical exams and self-examine your breasts for lumps on a monthly basis while using esterified estrogens and methyltestosterone.

What should I discuss with my health care provider before using Syntest HS (esterified estrogens and methyltestosterone)?

Esterified estrogens and methyltestosterone should not be used to prevent heart disease or stroke.

Do not use esterified estrogens and methyltestosterone if you have:

• liver disease;

• a recent history of heart attack, stroke or circulation problems;

• abnormal vaginal bleeding that a doctor has not checked;

• any type of breast, uterine, or hormone-dependent cancer; or

• if you are pregnant or breast-feeding.

Before taking this medication, tell your doctor if you have:

• high blood pressure, heart disease, or coronary artery disease;

• high cholesterol or triglycerides;

• kidney disease;

• asthma;

• epilepsy or other seizure disorder;

• migraines;

• endometriosis;

• diabetes;

• lupus;

• depression;

• gallbladder disease;

• if you smoke; or

• if you have had your uterus removed (hysterectomy).

If you have any of these conditions, you may need a dose adjustment or special tests to safely take this medication.

Esterified estrogens and methyltestosterone increases your risk of developing endometrial hyperplasia, a condition that may lead to cancer of the uterus. Taking progestins while using esterified estrogens and methyltestosterone may lower this risk. If your uterus has not been removed, your doctor may prescribe a progestin for you to take while you are using esterified estrogens and methyltestosterone.

Long-term esterified estrogens and methyltestosterone treatment may increase your risk of stroke. Talk with your doctor about your individual risks before using esterified estrogens and methyltestosterone long-term. Your doctor should check your progress on a regular basis (every 3 to 6 months) to determine whether you should continue this treatment.

FDA pregnancy category X. This medication can cause birth defects. Do not use esterified estrogens and methyltestosterone if you are pregnant. Tell your doctor right away if you become pregnant during treatment. Esterified estrogens and methyltestosterone can pass into breast milk and may harm a nursing baby. This medication may also slow breast milk production. Do not use if you are breast-feeding a baby.

How should I use Syntest HS (esterified estrogens and methyltestosterone)?

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

This medication is usually taken in a cycle of 3 weeks on and 1 week off. Follow your doctor’s instructions.

Have regular physical exams and self-examine your breasts for lumps on a monthly basis while using esterified estrogens and methyltestosterone.

If you need to have any type of medical tests or surgery, or if you will be on bed rest, you may need to stop using this medication for a short time. Esterified estrogens and methyltestosterone may also cause unusual results with certain medical tests. Tell any doctor who treats you that you are taking this medication.

Store this medication at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the medication as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your medicine at the 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 nausea, vomiting, or vaginal bleeding.

What should I avoid while using Syntest HS (esterified estrogens and methyltestosterone)?

Follow your doctor’s instructions about any restrictions on food, beverages, or activity while you are taking this medication.

Syntest HS (esterified estrogens and methyltestosterone) 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 any of these serious side effects:

• chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;

• sudden numbness or weakness, especially on one side of the body;

• sudden headache, confusion, problems with vision, speech, or balance;

• swelling, rapid weight gain;

• confusion, unusual thoughts or behavior;

• pain, swelling, or tenderness in your stomach;

• nausea, stomach pain, loss of appetite jaundice (yellowing of the skin or eyes);

• breast lump, nipple discharge;

• acne, skin color changes, increased facial hair, male pattern baldness, voice changes; or

• changes in your menstrual periods, break-through bleeding.

Less serious side effects may include:

• mild nausea, stomach upset;

• swollen or painful breasts;

• headache;

• hair loss;

• depression, anxiety; or

• decreased sex drive, impotence, or difficulty having an orgasm.

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 Syntest HS (esterified estrogens and methyltestosterone)?

Many drugs can interact with esterified estrogens and methyltestosterone. Below is just a partial list. Tell your doctor if you are using:

• a blood thinner such as warfarin (Coumadin);

• insulin;

• ketoconazole (Nizoral);

• St. John’s wort;

• rifampin (Rifadin, Rifater, Rifamate, Rimactane);

• an antidepressant;

• seizure medicines such as phenytoin (Dilantin), carbamazepine (Tegretol), topiramate (Topamax), and others;

• an antibiotic such as clarithromycin (Biaxin), erythromycin (E-Mycin, Ery-Tab, Erythrocin), telithromycin (Ketek), and others; or

• HIV/AIDS medicine such as atazanavir (Reyataz), indinavir (Crixivan), nelfinavir (Viracept), saquinavir (Invirase, Fortovase), or ritonavir (Norvir).

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

Where can I get more information?

• Your pharmacist can provide more information about esterified estrogens and methyltestosterone.

• 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: 3.04. Revision Date: 06/11/2009 1:15:10 PM.

Generic Name: conjugated estrogens (vaginal) (KON joo gay ted ES troe jenz)
Brand Names: Premarin Vaginal, Synthetic Conjugated Estrogens, A

What are vaginal conjugated estrogens?

Estrogen is a female sex hormone produced by the ovaries. Estrogen is necessary for many processes in the body.

Vaginal conjugated estrogens are a mixture of estrogen hormones used to treat the vaginal symptoms of menopause such as dryness, burning, irritation, and painful sexual intercourse.

Vaginal conjugated estrogens should not be used to prevent heart disease or dementia, because this medication may actually increase your risk of developing these conditions.

Vaginal conjugated estrogens may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about vaginal conjugated estrogens?

This medication can cause birth defects in an unborn baby. Do not use vaginal conjugated estrogens if you are pregnant. Do not use this medication if you have any of the following conditions: a history of heart attack, stroke, or blood clot (especially in your lung or your lower body), liver disease, abnormal vaginal bleeding, or a hormone-related cancer such as breast or uterine cancer.

Long-term treatment with conjugated estrogens may increase your risk of breast cancer, heart attack, or stroke. Talk with your doctor about your individual risks before using vaginal conjugated estrogens long term, especially if you smoke or are overweight. Your doctor should check your progress on a regular basis (every 3 to 6 months) to determine whether you should continue this treatment.

Have regular physical exams and self-examine your breasts for lumps on a monthly basis while using vaginal conjugated estrogens.

Vaginal conjugated estrogens should not be used to prevent heart disease or dementia, because this medication may actually increase your risk of developing these conditions.

What should I discuss with my healthcare provider before using vaginal conjugated estrogens?

Do not use vaginal conjugated estrogens if you are pregnant, or if you have:

• a history of heart attack, stroke, or blood clot (especially in your lung or your lower body);

• abnormal vaginal bleeding that a doctor has not checked;

• liver disease; or

• any type of breast, uterine, or hormone-dependent cancer.

Before using vaginal conjugated estrogens, tell your doctor if you are allergic to any drugs, or if you have:

• high blood pressure, heart disease, or circulation problems;

• a personal or family history of stroke;

• endometriosis;

• liver or kidney disease;

• asthma;

• epilepsy or other seizure disorder;

• migraines;

• diabetes;

• underactive thyroid;

• high cholesterol or triglycerides;

• high or low levels of calcium in your blood;

• porphyria;

• systemic lupus erythematosus (SLE);

• gallbladder disease; or

• if you have had your uterus removed (hysterectomy).

Vaginal conjugated estrogens increase your risk of developing endometrial hyperplasia, a condition that may lead to cancer of the uterus. Taking progestins while using conjugated estrogens may lower this risk. If your uterus has not been removed, your doctor may prescribe a progestin for you to take while you are using vaginal conjugated estrogens.

Long-term conjugated estrogens treatment may increase your risk of stroke or blood clots. Talk with your doctor about your individual risks before using vaginal conjugated estrogens long term, especially if you smoke or are overweight. Your doctor should check your progress on a regular basis (every 3 to 6 months) to determine whether you should continue this treatment.

FDA pregnancy category X. This medication can cause birth defects. Do not use vaginal conjugated estrogens if you are pregnant. Tell your doctor right away if you become pregnant during treatment. Use an effective form of birth control while you are using this medication. You should know that conjugated estrogens vaginal cream can weaken the latex of a condom, diaphragm, or cervical cap. Talk to your doctor about the best contraceptive methods to use. Conjugated estrogens can pass into breast milk and may harm a nursing baby. This medication may also slow breast milk production. Do not use if you are breast-feeding a baby. Do not use this medication in anyone under 18 years old without the advice of a doctor.

How should I use vaginal conjugated estrogens?

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

Vaginal conjugated estrogens are usually prescribed for only a short time and are most often used in a cycle, such as 3 weeks on followed by 1 week off. Some conditions require daily use and others require use only twice a week during the treatment period. Follow the directions on your prescription label.

To apply this medication, use only the vaginal applicator provided. After each use, take the applicator apart and clean it with mild soap and warm water. Do not use hot or boiling water.

Have regular physical exams and self-examine your breasts for lumps on a monthly basis if you are using vaginal conjugated estrogens long term.

If you need to have any type of surgery, tell the surgeon ahead of time that you are using conjugated estrogens. You may need to stop using the medicine for a short time.

This medication can affect the results of certain medical tests. Tell any doctor who treats you that you are using conjugated estrogens.

Store this medication at room temperature away from moisture and heat.

What happens if I miss a dose?

Use the medication as soon as you remember. If it is almost time for the next dose, skip the missed dose and use your medicine at the next regularly scheduled time. Do not use 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, or vaginal bleeding.

What should I avoid while using vaginal conjugated estrogens?

Do not smoke while using this medication. Smoking can increase your risk of blood clots, stroke, or heart attack caused by vaginal conjugated estrogens.

Vaginal conjugated estrogens 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 this medication and call your doctor at once if you have any of these serious side effects:

• chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;

• sudden numbness or weakness, especially on one side of the body;

• sudden headache, confusion, problems with vision, speech, or balance;

• pain or swelling in your lower leg;

• abnormal vaginal bleeding;

• migraine headache;

• pain, swelling, or tenderness in your stomach;

• confusion, problems with memory or concentration;

• jaundice (yellowing of the skin or eyes);

• swelling in your hands, ankles, or feet; or

• a breast lump.

Less serious side effects may include:

• mild nausea, vomiting, bloating, stomach cramps;

• breast pain, tenderness, or swelling;

• freckles or darkening of facial skin;

• increased hair growth, loss of scalp hair;

• changes in weight or appetite;

• problems with contact lenses;

• vaginal itching or discharge;

• changes in your menstrual periods, decreased sex drive; or

• headache, nervousness, dizziness, tired feeling.

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 vaginal conjugated estrogens?

Before using conjugated estrogens, tell your doctor if you are using any of the following medicines:

• a blood thinner such as warfarin (Coumadin);

• a thyroid medication such as levothyroxine (Synthroid);

• insulin or diabetes medicine taken by mouth;

• rifampin (Rifadin, Rifater, Rifamate, Rimactane);

• ketoconazole (Nizoral) or itraconazole (Sporanox);

• seizure medicines such as phenytoin (Dilantin), carbamazepine (Tegretol), felbamate (Felbatol), oxcarbazepine (Trileptal), or primidone (Mysoline);

• a barbiturate such as amobarbital (Amytal), butabarbital (Butisol), mephobarbital (Mebaral), secobarbital (Seconal), or phenobarbital (Luminal, Solfoton); or

• antidepressants such as amitriptyline (Elavil, Etrafon), amoxapine (Asendin), clomipramine (Anafranil), desipramine (Norpramin), doxepin (Sinequan), imipramine (Janimine, Tofranil), nortriptyline (Pamelor), protriptyline (Vivactil), or trimipramine (Surmontil).

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

Where can I get more information?

• Your pharmacist can provide more information about vaginal conjugated estrogens.

• 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: 5.03. Revision Date: 09/02/2009 12:39:51 PM.

Generic Name: Synthetic Conjugated Estrogens, A (sin-THE-tik KON-joo-GAY-ted ES-troe-jens)
Brand Name: SCE-A

Synthetic Conjugated Estrogens, A Cream is used for:

Treating certain menopausal changes of the vagina (eg, vaginal dryness) and other vaginal conditions. It is also used to treat painful intercourse due to these vaginal changes. It may also be used for other conditions as determined by your doctor.

Synthetic Conjugated Estrogens, A Cream is a mixture of female estrogen hormones. It works by replacing natural estrogens in a woman who can no longer produce enough estrogen.

Do NOT use Synthetic Conjugated Estrogens, A Cream if:

• you are allergic to any ingredient in Synthetic Conjugated Estrogens, A Cream
• you are pregnant or suspect you may be pregnant
• you have known or suspected breast cancer, or a history of breast cancer
• you have or suspect you have other tumors that are estrogen-dependent or abnormal vaginal bleeding of unknown cause
• you have liver problems
• you have a history of stroke or heart attack
• you have a history of blood clots (eg, in the legs or lungs) or circulation disorders

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

Before using Synthetic Conjugated Estrogens, A Cream:

Some medical conditions may interact with Synthetic Conjugated Estrogens, A Cream. 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 had an abnormal mammogram
• if you have asthma (wheezing), a benign breast nodule, blood problems (eg, porphyria), bone cancer, depression, diabetes, endometriosis or endometrial (uterine) cancer, epilepsy (seizures), gallbladder disease, heart problems, high blood pressure, kidney problems, a history of liver problems or a history of yellowing of the skin or eyes, lupus, migraines, obesity, uterine fibroids, pancreatitis, or thyroid problems, or you have high calcium levels in your blood
• if you use tobacco, you are going to have surgery, or you will be on bed rest
• if you have a personal or family history of high cholesterol, lipid, calcium, or triglyceride levels; or breast cancer

Some MEDICINES MAY INTERACT with Synthetic Conjugated Estrogens, A Cream. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Erythromycin, clarithromycin, ketoconazole, itraconazole, or ritonavir because they may increase the risk of Synthetic Conjugated Estrogens, A Cream’s side effects
• Carbamazepine, hydantoins (eg, phenytoin), phenobarbital, rifampin, or St. John’s wort because they may decrease Synthetic Conjugated Estrogens, A Cream’s effectiveness

This may not be a complete list of all interactions that may occur. Ask your health care provider if Synthetic Conjugated Estrogens, A Cream 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 Synthetic Conjugated Estrogens, A Cream:

Use Synthetic Conjugated Estrogens, A Cream as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• An extra patient leaflet is available with Synthetic Conjugated Estrogens, A Cream. Talk to your pharmacist if you have questions about this information.
• Closely follow the dosing schedule provided by your doctor.
• Wash your hands before and after using Synthetic Conjugated Estrogens, A Cream.
• Fill the applicator with Synthetic Conjugated Estrogens, A Cream according to the directions provided. Lie on your back with your knees drawn up, insert the applicator high into the vagina, and press the plunger to release the medicine.
• To clean the applicator, pull the plunger to remove it from the barrel. Wash with mild soap and warm water and rinse well. Do not boil or use hot water.
• Talk with your doctor about stopping Synthetic Conjugated Estrogens, A Cream 4 to 6 weeks before surgery.
• Eating grapefruit or drinking grapefruit juice may increase the risk of side effects. Check with your doctor before including grapefruit or grapefruit juice in your diet.
• If you miss a dose of Synthetic Conjugated Estrogens, A Cream, take it as soon as possible. If it is almost time for the 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 Synthetic Conjugated Estrogens, A Cream.

Important safety information:

• Synthetic Conjugated Estrogens, A Cream may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Synthetic Conjugated Estrogens, A Cream with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Synthetic Conjugated Estrogens, A Cream may increase the risk of stroke, blood clots, high blood pressure, or similar problems. The risk may be greater if you smoke (especially in women more than 35 years old).
• Before using Synthetic Conjugated Estrogens, A Cream, you will need to have a complete medical and family history exam, which will include blood pressure, breast, stomach, and pelvic organ exams and a Pap smear.
• You should have periodic mammograms as determined by your doctor. Follow your doctor’s instructions for examining your own breasts, and report any lumps immediately.
• Your doctor should reevaluate you every 3 to 6 months to determine whether or not you need to continue taking Synthetic Conjugated Estrogens, A Cream.
• If you are only being treated for vaginal menopause symptoms, products applied locally such as vaginal creams, tablets, or rings should be considered before products taken by mouth or absorbed through the skin. If you have other medical conditions and are prescribed estrogens for more than one condition, consult your doctor about your treatment plan and its options.
• Synthetic Conjugated Estrogens, A Cream may weaken and increase the failure of condoms, diaphragms, or cervical caps made of latex or rubber. If you may become pregnant, use another form of birth control.
• Diabetes patients – Synthetic Conjugated Estrogens, A Cream may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
• Synthetic Conjugated Estrogens, A Cream may cause dark skin patches on your face (melasma). Exposure to the sun may make these patches darker, and you may need to avoid prolonged sun exposure and sunlamps. Consult your doctor regarding the use of sunscreens and protective clothing.
• If you wear contact lenses and you develop problems with them, contact your doctor.
• If you will be having surgery or will be on bed rest, notify your doctor beforehand. Special precautions may need to be taken in these circumstances while you are taking Synthetic Conjugated Estrogens, A Cream.
• Synthetic Conjugated Estrogens, A Cream may interfere with certain lab tests. Be sure your doctor and lab personnel know you are using Synthetic Conjugated Estrogens, A Cream.
• Lab tests, including a lipid profile and thyroid function, may be performed while you use Synthetic Conjugated Estrogens, A Cream. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• Use Synthetic Conjugated Estrogens, A Cream with caution in the ELDERLY; they may be more sensitive to its effects.
• Synthetic Conjugated Estrogens, A Cream should not be used in CHILDREN; safety and effectiveness in children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: Do not use Synthetic Conjugated Estrogens, A Cream if you are pregnant. Avoid becoming pregnant while you are taking it. If you think you may be pregnant, contact your doctor right away. Synthetic Conjugated Estrogens, A Cream is found in breast milk. If you are or will be breast-feeding while you use Synthetic Conjugated Estrogens, A Cream, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Synthetic Conjugated Estrogens, A Cream:

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:

Back pain; bloating; breast pain or tenderness; diarrhea; dizziness; headache; increased cough; increased or decreased interest in sex; irregular vaginal bleeding or spotting; lightheadedness; mild hair loss; mild vaginal burning, itching, or irritation; muscle aches or cramps; nausea; sore throat; stomach pain or cramping; trouble sleeping; vomiting; weakness; weight changes.

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); breast lumps; changes in vision or speech; chest pain; confusion; dark urine; depression; fainting; fever, chills or persistent sore throat; mental or mood changes; one-sided weakness; pain or tenderness in the calves; persistent pain or tenderness in the upper abdomen; severe or persistent dizziness or headache; severe or persistent stomach or back pain with nausea or vomiting; sudden shortness of breath; swelling of the hands or feet; unusual vaginal bleeding or discharge, itching, odor; vision loss; weakness or numbness of an arm or leg; yellowing of the skin or eyes.

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 excessive vaginal bleeding 2 to 7 days following overdose; severe nausea and vomiting.

Proper storage of Synthetic Conjugated Estrogens, A Cream:

Store Synthetic Conjugated Estrogens, A Cream at 68 to 77 degrees F (20 to 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 Synthetic Conjugated Estrogens, A Cream out of the reach of children and away from pets.

General information:

• If you have any questions about Synthetic Conjugated Estrogens, A Cream, please talk with your doctor, pharmacist, or other health care provider.
• Synthetic Conjugated Estrogens, A Cream 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 Synthetic Conjugated Estrogens, A Cream. Additionally, your doctor may have prescribed Synthetic Conjugated Estrogens, A Cream for a use not mentioned above. 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: dalfopristin and quinupristin (dal FOE pris tin and kwi NYOO pris tin)
Brand Names: Synercid

What is Synercid (dalfopristin and quinupristin)?

Dalfopristin and quinupristin is a combination antibiotic that fights severe or life-threatening infection caused by bacteria.

Dalfopristin and quinupristin is used to treat severe infections in the blood and other body systems.

Dalfopristin and quinupristin may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Synercid (dalfopristin and quinupristin)?

You should not receive this medication if you are allergic to dalfopristin and quinupristin.

Before receiving dalfopristin and quinupristin, tell your doctor if you have liver or kidney disease, or a history of any type of allergy.

Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or has blood in it, call your doctor. Do not use any medicine to stop the diarrhea unless your doctor has told you to.

What should I discuss with my health care provider before receiving Synercid (dalfopristin and quinupristin)?

You should not receive this medication if you are allergic to dalfopristin and quinupristin.

If you have certain conditions, you may need a dose adjustment or special tests to safely receive this medication. Before you receive dalfopristin and quinupristin, tell your doctor if you are allergic to any drugs, or if you have:

• liver disease;

• kidney disease; or

• a history of any type of allergy.

FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether dalfopristin and quinupristin passes into breast milk or if it could harm a nursing baby. Do not receive this medication without telling your doctor if you are breast-feeding a baby.

How is dalfopristin and quinupristin given?

Dalfopristin and quinupristin is given as an injection through a needle placed into a vein. Your doctor, nurse, or other healthcare provider will give you this injection.

Dalfopristin and quinupristin is most often given in a hospital setting. The medicine must be given slowly through an IV infusion, and can take up to 1 hour or longer to complete.

Dalfopristin and quinupristin is usually given for at least 7 days, or longer for more severe infections.

What happens if I miss a dose?

Since this medicine is usually given in a hospital, it is not likely that you will miss a dose.

What happens if I overdose?

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

Overdose can cause vomiting, trouble breathing, tremors, shaking, and loss of balance or coordination.

What should I avoid while taking Synercid (dalfopristin and quinupristin)?

Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or has blood in it, call your doctor. Do not use any medicine to stop the diarrhea unless your doctor has told you to.

Synercid (dalfopristin and quinupristin) 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 any of these serious side effects:

• diarrhea that is watery or bloody;

• jaundice (yellowing of the skin or eyes);

• fever, sore throat, and headache with a severe blistering, peeling, and red skin rash;

• confusion, seizure (convulsions);

• feeling light-headed, fainting;

• pale skin, easy bruising or bleeding, unusual weakness; or

• fever, chills, body aches, flu symptoms.

Less serious side effects may include:

• joint or muscle pain;

• mild skin rash or itching;

• nausea, vomiting, constipation;

• headache, dizziness;

• sleep problems (insomnia);

• vaginal itching or discharge; or

• pain, swelling, or irritation where the IV needle is placed.

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 Synercid (dalfopristin and quinupristin)?

Before receiving dalfopristin and quinupristin, tell your doctor if you are using any of the following drugs:

• cisapride (Propulsid);

• digoxin (digitalis, Lanoxin);

• diazepam (Valium) or midazolam (Versed);

• methylprednisolone (Medrol, Duralone, Medipred, and others);

• cyclosporine (Gengraf, Neoral, Sandimmune), tacrolimus (Prograf);

• cancer medications such as vinblastine (Velban), vincristine (Oncovin), vinorelbine (Navelbine), docetaxel (Taxotere), paclitaxel (Taxol);

• a calcium channel blocker such as diltiazem (Cartia, Cardizem), felodipine (Plendil), nifedipine (Nifedical, Procardia), verapamil (Calan, Covera, Isoptin, Verelan), and others;

• HIV or AIDS medications such as delavirdine (Rescriptor), indinavir (Crixivan), nevirapine (Viramune), or ritonavir (Norvir); or

• heart rhythm medications such as disopyramide (Norpace), lidocaine, or quinidine (Quinaglute, Quinidex).

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

Where can I get more information?

• Your doctor or pharmacist can provide more information about dalfopristin and quinupristin.

• 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: 3.03. Revision Date: 08/21/2009 1:36:27 PM.

Generic Name: esterified estrogens and methyltestosterone (Oral route)

es-TER-i-fide ES-troe-jenz, meth-il-tes-TOS-ter-one

Commonly used brand name(s):

In the U.S.

• Covaryx
• Covaryx HS
• Essian
• Estratest
• Menogen
• Syntest D.S.
• Syntest H.S.

Available Dosage Forms:

• Tablet

Therapeutic Class: Estrogen/Androgen Combination

Pharmacologic Class: Estrogen

Uses For Syntest D.S.

Esterified estrogens and methyltestosterone combination is used to treat the symptoms of menopause in patients who did not get relief after being treated with estrogens alone. These symptoms may include a feeling of heat, sweating, and warmth in the face, neck, or chest (“hot flashes”); and dryness, burning, and itching in the vagina.

Esterified estrogens are a man-made mixture of estrogens. Estrogen is a hormone that is produced by the body in greater amounts in females. It is necessary for normal sexual development of the female and for regulation of the menstrual cycle during the childbearing years. Methyltestosterone is a man-made form of testosterone, a hormone that is produced by the body in greater amounts in males and small amounts in females. Menopause symptoms occur when the hormone balance changes in the female body. This combination of hormones will relieve the symptoms of menopause by adding more hormones to the body.

This medicine is available only with your doctor’s prescription.

Before Using Syntest D.S.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

The use of esterified estrogens and methyltestosterone combination is not recommended in children.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of esterified estrogens and methyltestosterone combination in the elderly. However, elderly patients are more likely to develop dementia and age-related kidney, liver, or heart problems, which may require caution and an adjustment in the dose for patients receiving this medicine.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	X	Studies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities. This drug should not be used in women who are or may become pregnant because the risk clearly outweighs any possible benefit.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Anisindione
• Bupropion
• Dicumarol
• Phenprocoumon

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Clarithromycin
• Ginseng
• Itraconazole
• Ketoconazole
• Levothyroxine
• Licorice
• Tipranavir
• Warfarin

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Grapefruit Juice

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Abnormal vaginal bleeding, undiagnosed or
• Blood clotting problems (e.g., deep vein thrombosis, pulmonary embolism), history of or
• Breast cancer, or history of or
• Heart attack, recent or history of or
• Liver disease, severe or
• Stroke, recent or history of—Should not be used in patients with these conditions.

• Asthma or
• Cancer (e.g., breast, cervix, liver, vagina) or
• Depression, history of or
• Diabetes or
• Edema (fluid retention) or
• Endometriosis (problem with the lining of the uterus) or
• Epilepsy or
• Eye or vision problems (e.g., retinal vascular thrombosis) or
• Gallbladder disease or
• Hepatitis (including cholestatic jaundice), history of or
• Hypercalcemia (high calcium in the blood) or
• Hypocalcemia (high calcium in the blood) or
• Hypothyroidism (underactive thyroid) or
• Migraine headaches, history of or
• Porphyria (enzyme problem) or
• Systemic lupus erythematosus—Use with caution. May make these conditions worse.

• Heart or blood vessel disease or
• Hypercholesterolemia (high cholesterol in the blood) or
• Hypertension (high blood pressure) or
• Hypertriglyceridemia (high triglycerides or fat in the blood) or
• Venous thromboembolism (clot in the veins), history of—May increase risk for more serious side effects.

Proper Use of esterified estrogens and methyltestosterone

This section provides information on the proper use of a number of products that contain esterified estrogens and methyltestosterone. It may not be specific to Syntest D.S.. Please read with care.

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

This medicine comes with a patient information insert. Read and follow the instructions in the insert carefully. Ask your doctor if you have any questions.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor’s orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):
  • For treatment of menopause symptoms:
    • Adults—One to two tablets once a day.
    • Children—Use is not recommended.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using Syntest D.S.

It is very important that your doctor check your progress at regular visits to make sure the medicine is working properly and to decide if you should continue to take it. These visits should be every 6 to 12 months or as otherwise directed by your doctor.

It is unlikely that a postmenopausal woman may become pregnant. But, you should know that using this medicine while you are pregnant could harm your unborn baby. If you think you have become pregnant while using the medicine, tell your doctor right away.

Very rarely, this medicine can cause serious side effects such as a heart attack or stroke. You are much more likely to have these side effects if you smoke cigarettes or are overweight, or if you have diabetes, high blood pressure, or a high blood cholesterol. Talk with your doctor if you think you might be at risk.

Using large doses of estrogen alone over a long period of time may increase the risk of some kinds of cancer (e.g., endometrial cancer). Talk with your doctor about this risk. If you have vaginal bleeding with this medicine, call your doctor right away.

This medicine may increase the risk of getting breast cancer. It is very important that you check your breasts on a regular basis for any unusual lumps or discharge, and that you have breast x-rays every year as directed by your doctor. These exams are very important if you have a family member with a history of breast cancer. Talk with your doctor about this risk.

This medicine may increase the risk of getting dementia in elderly women (above 65 years of age). Talk with your doctor if this concerns you.

Check with your doctor right away if blurred vision, difficulty with reading, or any other change in vision occurs during or after treatment. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).

Using large doses of methyltestosterone over a long period of time may increase the risk of serious liver problems (e.g., peliosis hepatis or liver cancer). Talk with your doctor about this risk.

Before you have any medical tests, tell the medical doctor in charge that you are taking this medicine. The results of some tests may be affected by this medicine. Also, you may need to stop using this medicine for a few weeks before and after having surgery, or if you are inactive for a long period of time.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Syntest D.S. Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

• Absent, missed, or irregular menstrual periods
• acne or oily skin
• decreased breast size
• enlarging clitoris
• hoarseness or deepening of the voice
• menstrual changes
• stopping of menstrual bleeding
• unnatural hair growth or loss

Rare

• Continuing nausea
• cough
• dark-colored urine
• difficulty with swallowing
• dizziness
• fast heartbeat
• fever
• hives
• itching
• light-colored stools
• loss of appetite
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• purple or red-colored spots on the body or inside the mouth or nose
• shortness of breath
• skin rash
• sore throat
• tightness in the chest
• unusual tiredness or weakness
• vomiting
• wheezing

Incidence not known

• Abdominal or stomach bloating, cramps, or pain
• anxiety
• bleeding from gums or nose
• blistering, peeling, or loosening of the skin
• bloating
• bloody or cloudy urine
• burning, crawling, itching, numbness, prickling, “pins and needles”, or tingling feelings
• change in vaginal discharge
• changes in skin color, pain, or tenderness
• chest pain or discomfort
• chills
• clay-colored stools
• clear or bloody discharge from nipple
• confusion
• constipation
• convulsions
• darkening of urine
• decrease in amount of urine
• diarrhea
• difficult, burning, or painful urination
• difficulty with breathing
• difficulty with moving
• difficulty with speaking
• dimpling of the breast skin
• dizziness or lightheadedness
• double vision
• eye pain
• fainting
• fever
• fluid-filled skin blisters
• frequent urge to urinate
• headache
• heavy bleeding
• inability to move the arms, legs, or facial muscles
• inability to speak
• indigestion
• inverted nipple
• irregular heartbeats
• itching of the vagina or genital area
• joint or muscle pain
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• light-colored stools
• loss of appetite
• lump in the breast or under the arm
• mood or mental changes
• muscle cramps in the hands, arms, feet, legs, or face
• muscle pain or stiffness
• nausea
• noisy, rattling breathing
• numbness and tingling around the mouth, fingertips, or feet
• pain
• pain during sexual intercourse
• pain in the ankles or knees
• pain or discomfort in the arms, jaw, back, or neck
• pain or feeling of pressure in pelvis
• painful, red lumps under the skin, mostly on the legs
• pains in the stomach, side, or abdomen, possibly radiating to the back
• pelvic pain
• persistent crusting or scaling of the nipple
• pinpoint red or purple spots on the skin
• poor insight and judgment problems with memory or speech
• red, irritated eyes
• redness or swelling of the breast
• ringing in the ears
• sensitivity to the sun
• shortness of breath
• skin thinness
• slow speech
• sore on the skin of the breast that does not heal
• sore throat
• sores, ulcers, or white spots in the mouth or on the lips
• stomach pain
• sudden shortness of breath or troubled breathing
• sweating
• swelling
• swelling of the fingers, hands, feet, or lower legs
• tenderness of the breast
• thick, white curd-like vaginal discharge without odor or with mild odor
• tiredness
• tremor
• trouble recognizing objects
• trouble thinking and planning
• trouble walking
• troubled breathing at rest
• unexpected or excess milk flow from breasts
• unpleasant breath odor
• vaginal bleeding
• vision changes
• vomiting of blood
• weakness
• weight gain
• yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Incidence not known

• Blemishes on the skin
• brown, blotchy spots on the exposed skin
• decreased interest in sexual intercourse
• depression
• headache, severe and throbbing
• inability to have or keep an erection
• increase or decrease in weight
• increased hair growth, especially on the face
• increased in sexual ability, desire, drive, or performance
• increased interest in sexual intercourse
• irritability
• leg cramps
• loss in sexual ability, desire, drive, or performance
• loss of hair
• mental depression
• pimples
• redness of the skin
• swelling or inflammation of the mouth
• twitching, uncontrolled movements of the tongue, lips, face, arms, or legs

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided “AS IS” and “as available” for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

Generic Name: lidocaine and tetracaine (Topical application route)

LYE-doe-kane, TE-tra-kane

Commonly used brand name(s):

In the U.S.

• Synera

Available Dosage Forms:

• Patch, Extended Release

Therapeutic Class: Anesthetic Combination

Chemical Class: Amino Amide

Uses For Synera

Lidocaine and tetracaine combination is used on the skin to cause numbness or loss of feeling for patients having certain medical or skin procedures.

Lidocaine and tetracaine combination belongs to a group of medicines known as topical local anesthetics. It deadens the nerve endings in the skin. This medicine does not cause unconsciousness as general anesthetics do when used for surgery.

This medicine is available only with your doctor’s prescription.

Before Using Synera

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of lidocaine and tetracaine combination in children. However, safety and efficacy have not been established in children below 3 years of age.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of lidocaine and tetracaine combination in the elderly.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Infection at or near the place of application or
• Large sores, broken skin, or severe injury at the area of application—Use with caution. The chance of side effects may be increased.

• Liver disease, severe or
• Pseudocholinesterase deficiency (enzyme problem)—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of Synera

A nurse or other trained health care professional will apply this medicine before your medical procedure.

The patch is applied to your skin about 20 to 30 minutes before your procedure. Tell your doctor if you still have feeling in the skin after 30 minutes have passed.

Be careful not to get any of this medicine in your eyes, because it can cause severe eye irritation. If any of the medicine does get in your eyes, wash the eyes with water and check with your doctor right away.

Precautions While Using Synera

It is very important that your doctor check you closely for any problems or unwanted effects that may be caused by this medicine.

This medicine may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have itching; hives; hoarseness; trouble with breathing; trouble with swallowing; or any swelling of your hands, face, or mouth while you are using this medicine.

Check with your doctor right away if you have a skin rash, burning, stinging, swelling, or irritation of your skin.

Lidocaine and tetracaine combination cause numbness or loss of feeling in the skin. Be careful not to injure the treated skin by rubbing, scratching, or exposing the skin to extreme cold or heat.

Synera Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

• Flushing or redness of the skin
• swelling
• unusually warm skin

Less common

• Blistering, burning, crusting, dryness, or flaking of the skin
• change in the color of treated skin
• itching, scaling, severe redness, soreness, or swelling of the skin
• rash

Rare

• Burning, crawling, itching, numbness, prickling, “pins and needles”, or tingling feelings
• cough or hoarseness
• fainting or loss of consciousness
• fast or irregular breathing
• fever or chills
• hives or welts
• lower back or side pain
• painful or difficult urination
• swelling of the eyes or eyelids
• tightness in the chest or wheezing
• trouble with breathing

Incidence not known

• Blurred vision
• chest pain or discomfort
• cold, clammy, or pale skin
• confusion
• difficulty with breathing
• difficulty with swallowing
• dizziness
• dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly
• fast, slow, or irregular heartbeat
• feelings of coldness, heat, or numbness
• irregular, fast or slow, or shallow breathing
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• no breathing
• noisy breathing
• pale or blue lips, fingernails, or skin
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• seizures
• shakiness in the legs, arms, hands, or feet
• shortness of breath
• slow heart rate
• sweating
• trembling or shaking of the hands or feet
• twitching
• unconsciousness
• unusual tiredness or weakness

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

• Change in consciousness
• fast, pounding, or irregular heartbeat or pulse
• no blood pressure or pulse
• stopping of heart

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Rare

• Headache
• nausea
• sleepiness or unusual drowsiness
• vomiting

Incidence not known

• Continuing ringing or buzzing or other unexplained noise in the ears
• depression
• double vision
• drowsiness
• false or unusual sense of well-being
• fear
• hearing loss
• nervousness

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided “AS IS” and “as available” for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

Generic Name: Lidocaine/Tetracaine (LYE-doe-kane/TE-tra-kane)
Brand Name: Synera

Synera Patch is used for:

Numbing the skin before certain medical procedures. It may also be used for other conditions as determined by your doctor.

Synera Patch is a local anesthetic. It works by blocking nerves from sending pain signals to the brain.

Do NOT use Synera Patch if:

• you are allergic to any ingredient in Synera Patch, to other local anesthetics, or to paraaminobenzoic acid (PABA)

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

Before using Synera Patch:

Some medical conditions may interact with Synera Patch. 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 substance
• if you have liver problems or pseudocholinesterase deficiency
• if you have been very ill or have very poor health

Some MEDICINES MAY INTERACT with Synera Patch. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Antiarrhythmics (eg, amiodarone, dofetilide, mexiletine, tocainide), beta-blockers (eg, propranolol), cimetidine, other local anesthetics (eg, benzocaine), or other medicines containing lidocaine or tetracaine because of the risk of side effects or toxic effects, including heart or nerve problems, may be increased
• Succinylcholine because the risk of its side effects may be increased by Synera Patch

This may not be a complete list of all interactions that may occur. Ask your health care provider if Synera Patch 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 Synera Patch:

Use Synera Patch as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Synera Patch is usually applied at your doctor’s office, hospital, or clinic. It is usually applied for 20 to 30 minutes before certain medical procedures.
• Apply the patch right away after opening the pouch.
• Do not cut the patch, remove the top cover, or damage the patch in any way. This could cause the patch to overheat and damage the skin.
• Do not cover the holes on the top side of the patch. This way prevent the patch from working properly.
• Synera Patch should only be used on normal, unbroken skin. Do not apply to damaged or inflamed skin.
• Apply the patch as directed. Press firmly around the edges of the patch to be sure it sticks.
• Wash your hands right away after using Synera Patch.
• After removing the used patch, fold it in half with the sticky sides together. Discard the patch out of the reach of children and away from pets.
• If you miss a dose of Synera Patch, use 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 use 2 doses at once.

Ask your health care provider any questions you may have about how to use Synera Patch.

Important safety information:

• Synera Patch is for external use only. Do not get it in your eyes, nose, or mouth. If you get Synera Patch in any of these areas, rinse with plenty of water or saline. Protect the eye until feeling returns.
• Synera Patch may infrequently cause drowsiness or dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Synera Patch with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Synera Patch blocks pain and feeling in the skin. Be careful not to injure the treated skin by scratching, rubbing, or coming into contact with extreme cold or heat.
• Do NOT use more than the recommended dose or use for longer than prescribed without checking with your doctor.
• Check with your doctor before you receive any vaccines while you are using Synera Patch.
• Tell your doctor or dentist that you use Synera Patch before you receive any medical or dental care, emergency care, or surgery.
• If you will be having a magnetic resonance imaging (MRI) scan, be sure your doctor and lab personnel know you are using Synera Patch. You will need to remove this patch before an MRI.
• Synera Patch may cause harm if swallowed. If you may have taken it by mouth, contact your poison control center or emergency room right away.
• If the patient is a young child, be sure to watch the child closely to prevent the accidental swallowing of Synera Patch.
• Use Synera Patch with caution in the ELDERLY; they may be more sensitive to its effects.
• Synera Patch should be used with extreme caution in CHILDREN younger than 3 years old; effectiveness in these children has not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Synera Patch while you are pregnant. Synera Patch is found in breast milk. If you are or will be breast-feeding while you use Synera Patch, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Synera Patch:

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:

Abnormal skin sensations; pale skin, redness, or swelling at the application site.

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

Severe allergic reactions (rash; hives; itching; difficulty breathing or swallowing; tightness in the chest; swelling of the mouth, face, lips, or tongue; hoarseness); burning, irritation, or severe redness or swelling at the application site.

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 blurred or double vision; chest pain; confusion; dizziness; mental or mood changes; ringing in the ears; seizures; slow or irregular breathing; slow or irregular heartbeat; tremors; unusual sensations (eg, feeling of being unusually hot or cold); unusual or severe drowsiness; vomiting. Synera Patch may be harmful if swallowed.

Proper storage of Synera Patch:

Store Synera Patch at room temperature, at 77 degrees F (25 degrees C), in a tightly closed container. 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 Synera Patch out of the reach of children and away from pets.

General information:

• If you have any questions about Synera Patch, please talk with your doctor, pharmacist, or other health care provider.
• Synera Patch 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 Synera Patch. 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: fluocinolone (Topical application route)

floo-oh-SIN-oh-lone a-SEET-oh-nide

Commonly used brand name(s):

In the U.S.

• Capex
• Derma-Smoothe/FS
• Synalar

In Canada

• Fluoderm Mild Cream
• Fluoderm Mild Ointment
• Fluoderm Regular Cream
• Fluoderm Regular Ointment
• Fluolar Mild
• Fluolar Regular
• Fluonide Mild-Cream
• Synalar Mild
• Synalar Regular
• Synamol

Available Dosage Forms:

• Cream
• Solution
• Shampoo
• Oil
• Ointment
• Lotion
• Gel/Jelly
• Kit

Therapeutic Class: Corticosteroid, Intermediate

Pharmacologic Class: Fluocinolone

Uses For Synamol

Fluocinolone topical is used to relieve redness, itching, swelling, or other discomfort caused by skin conditions. Fluocinolone scalp oil is used to treat psoriasis of the scalp, and fluocinolone shampoo for seborrheic dermatitis of the scalp. This medicine is a corticosteroid (cortisone-like medicine or steroid).

This medicine is available only with your doctor’s prescription.

Before Using Synamol

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of fluocinolone topical in the pediatric population. However, because of this medicine’s toxicity, it should be used with caution. Children may absorb large amounts through the skin, which can cause serious side effects. If your child is using this medicine, follow your doctor’s instructions very carefully. For the body oil form, safety and efficacy in children 3 months of age and younger have not been established.

Geriatric

No information is available on the relationship of age to the effects of fluocinolone topical in geriatric patients.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Cushing’s syndrome (adrenal gland disorder) or
• Diabetes or
• Hyperglycemia (high blood sugar) or
• Intracranial hypertension (increased pressure in the head)—Use with caution. May make these conditions worse.

• Infection of the skin at or near the place of application or
• Large sores, broken skin, or severe skin injury at the place of application—The chance of side effects may be increased.

Proper Use of fluocinolone

This section provides information on the proper use of a number of products that contain fluocinolone. It may not be specific to Synamol. Please read with care.

It is very important that you use this medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. To do so may cause unwanted side effects or skin irritation.

This medicine is for use on the skin only. Do not get it in your eyes. Do not use it on skin areas that have cuts, scrapes, or burns. If it does get on these areas, rinse it off right away with water.

This medicine should only be used for skin conditions that your doctor is treating. Check with your doctor before using it for other conditions, especially if you think that a skin infection may be present. This medicine should not be used to treat certain kinds of skin infections or conditions, such as severe burns.

To use cream, ointment, solution, and body oil:

• Wash your hands with soap and water before and after using this medicine.
• Apply a thin layer of this medicine to the affected area of the skin or scalp. Rub it in gently.
• Do not bandage or otherwise wrap the skin being treated unless directed to do so by your doctor.
• If the medicine is applied to the diaper area of an infant, do not use tight-fitting diapers or plastic pants unless directed to do so by your doctor.
• If your doctor ordered an occlusive dressing or airtight covering to be applied over the medicine, make sure you know how to apply it. Occlusive dressings increase the amount of medicine absorbed through your skin, so use them only as directed. If you have any questions about this, check with your doctor.

To use shampoo:

• Wash your hands with soap and water before and after using this medicine.
• Wet hair and scalp thoroughly.
• Shake the container well, and apply about an ounce of the shampoo to the scalp area.
• Work the shampoo into a lather, and leave on the scalp for 5 minutes.
• Wash hair and scalp thoroughly with water.

To use scalp oil:

• Wash your hands with soap and water before and after using this medicine.
• Wet hair and scalp thoroughly.
• Apply a thin layer of this medicine to the affected area of the scalp. Rub it in gently.
• Cover the scalp with the supplied shower cap overnight for at least 4 hours.
• Wash hair with regular shampoo and clean well.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor’s orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For redness, itching, and swelling of the skin:
  • For topical dosage form (cream, ointment, and solution):
    • Adults—Apply to the affected areas of the skin three to four times a day.
    • Children—Use and dose must be determined by your doctor.
  • For topical dosage form (body oil):
    • Adults—Apply to the affected areas of the skin three times a day for up to 2 weeks.
    • Children 3 months of age and older—Apply to the affected areas two times a day for up to 4 weeks.

• For seborrheic dermatitis:
  • For topical dosage form (shampoo):
    • Adults—Use on the scalp area once a day.
    • Children—Use and dose must be determined by your doctor.

• For scalp psoriasis:
  • For topical dosage form (scalp oil):
    • Adults—Apply to the affected areas of the scalp and leave overnight.
    • Children 2 years of age and older—Apply to the affected areas 2 times a day for up to 4 weeks.

Missed Dose

If you miss a dose of this medicine, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using Synamol

It is very important that your doctor check the progress of you or your child at regular visits for any unwanted effects that may be caused by this medicine.

If your or your child’s symptoms do not improve within a few days, or if they become worse, check with your doctor.

Using too much of this medicine or using it for a long time may increase your risk of having adrenal gland problems. The risk is greater for children and patients who use large amounts for a long time. Talk to your doctor right away if you or your child have more than one of these symptoms while you are using this medicine: blurred vision; dizziness or fainting; a fast, irregular, or pounding heartbeat; increased thirst or urination; irritability; or unusual tiredness or weakness.

Stop using this medicine and check with your doctor right away if you or your child have a skin rash, burning, stinging, swelling, or irritation on the skin.

Synamol Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

• Body aches or pain
• congestion
• cough
• dryness or soreness of the throat
• fever
• headache
• hoarseness
• lightening of normal skin color
• lightening of treated areas of dark skin
• sore throat
• stuffy or runny nose
• tender, swollen glands in the neck
• trouble swallowing
• unusual tiredness or weakness
• voice changes

Less common

• Acne or pimples
• accumulation of pus
• blistering, crusting, irritation, itching, or reddening of the skin
• burning, itching, and pain in hairy areas, or pus at the root of the hair
• burning and itching of the skin with pinhead-sized red blisters
• change in hearing
• cracked, dry, scaly skin
• diarrhea
• dry skin
• earache or pain in the ear
• ear drainage
• flushing or redness of the skin
• darkening of the skin
• itching, scaling, severe redness, soreness, or swelling of the skin
• itchy, raised, round, smooth, skin-colored bumps found on just one area of the body
• ooze thick white fluid
• raised, dark red, wart-like spots on skin, especially when used on the face
• redness or swelling in the ear
• skin irritation
• skin rash, encrusted, scaly and oozing
• spots on your skin resembling a blister or pimple
• swelling
• swollen, red, tender area of infection
• thickened patches of the skin
• vomiting

Incidence not known

• Redness and scaling around the mouth
• thinning, weakness, or wasting away of the skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

• Changes in skin color
• shiny skin

Incidence not known

• increased hair growth on the forehead, back, arms, and legs
• reddish purple lines on the arms, face, legs, trunk, or groin
• softening of the skin

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided “AS IS” and “as available” for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

Generic Name: nafarelin nasal (NAF a REL in)
Brand Names: Synarel

What is Synarel (nafarelin nasal)?

Nafarelin nasal is a man-made form of a protein that is like a hormone in the body that helps regulate the menstrual cycle, fertility, and sexual development during puberty.

Nafarelin nasal is used to treat precocious puberty in both male and female children. It is also used to treat endometriosis in women who are 18 years of age or older.

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

What is the most important information I should know about Synarel (nafarelin nasal)?

This medication can cause birth defects in an unborn baby. Do not use if you are pregnant. Use an effective barrier form of birth control, and tell your doctor if you become pregnant during treatment. Do not use nafarelin nasal if you have ever had an allergic reaction to nafarelin or similar medicines such as gonadorelin (Factrel). Do not use nafarelin nasal if you are pregnant or breast-feeding, or if you have undiagnosed, abnormal vaginal bleeding.

To be sure this medication is helping your condition, your doctor will need to check your progress on a regular basis, especially during the first 6 to 8 weeks of treatment. It is important that you not miss any scheduled visits to your doctor.

When you first start using nafarelin nasal to treat precocious puberty, you may notice an increase in signs of puberty, such as enlarged breasts or vaginal bleeding. These are normal side effects of this medication during the first month of use. If such pubertal signs continue for longer than 1 month, contact your doctor.

Get emergency medical help if you have any of these signs of a rare side effect called pituitary apoplexy: sudden headache with vision changes, vomiting, confusion, slow heart rate, chest pain, weakness, fainting, or cardiac arrest.

What should I discuss with my healthcare provider before using Synarel (nafarelin nasal)?

Do not use nafarelin nasal if you have:

• a history of allergic reaction to this medication or to similar medicines such as gonadorelin (Factrel);

• undiagnosed, abnormal vaginal bleeding; or

• if you are pregnant or breast-feeding.

If you have certain conditions, you may need a dose adjustment or special tests to safely use this medication. Before using nafarelin nasal, tell your doctor if you have:

• polycystic ovary disease;

• a personal or family history of osteoporosis;

• a head cold, allergies, or other causes of a stuffy or runny nose; or

• if you smoke or drink large amounts of alcohol.

FDA pregnancy category X. This medication can cause birth defects. Do not use nafarelin nasal if you are pregnant. Tell your doctor right away if you become pregnant during treatment. 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 enough to prevent pregnancy during your treatment. It is not known whether nafarelin nasal passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I use Synarel (nafarelin nasal)?

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

To use the nasal spray:

• Before the first use, prime the spray bottle by pumping it 5 to 10 times until a fine spray appears.

• Gently blow your nose to clear any mucus. Uncap the spray bottle.

• Insert the tip of the spray bottle into your nostril, pointing it straight upward. Block your other nostril with your finger. Quickly and gently pump the spray bottle one time and sniff gently at the same time. Remove the pump from your nose and tilt your head back slightly for a few seconds.

• If using more than one spray per nostril, wait at least 30 seconds between each spray.

• Clean the spray bottle tip with a tissue and recap it.

To be sure this medication is helping your condition, your doctor will need to check your progress on a regular basis, especially during the first 6 to 8 weeks of treatment. It is important that you not miss any scheduled visits to your doctor.

When you first start using nafarelin nasal to treat precocious puberty, you may notice an increase in signs of puberty, such as enlarged breasts or vaginal bleeding. These are normal side effects of this medication during the first month of use. If such pubertal signs continue for longer than 1 month, contact your doctor.

It is important to use nafarelin nasal regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

Store nafarelin nasal at room temperature away from moisture, heat, and light.

What happens if I miss a dose?

Use the medication as soon as you remember. If it is almost time for the next dose, skip the missed dose and use the medicine at the next regularly scheduled time. Do not use 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.

An overdose of nafarelin nasal is not likely to produce life-threatening symptoms.

What should I avoid while taking Synarel (nafarelin nasal)?

Try not to sneeze or blow your nose just after using the spray. This may decrease the amount of medication your body absorbs.

Synarel (nafarelin nasal) side effects

Get emergency medical help if you have any of these signs of a rare side effect called pituitary apoplexy: sudden headache with vision changes, vomiting, confusion, slow heart rate, chest pain, weakness, fainting, or cardiac arrest. 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 any of these serious side effects:

• heavy or continued menstrual bleeding;

• chest pain, shortness of breath;

• fast or irregular heartbeats; or

• pelvic pain or swelling.

Less serious side effects may include:

• mild itching or skin rash;

• oily skin or acne, increased body odor;

• dandruff;

• changes in breast size;

• increase in pubic hair growth;

• nasal irritation or runny nose;

• hot flashes;

• mild headache, muscle pain;

• mood swings;

• white or brownish vaginal discharge;

• light and occasional menstrual bleeding;

• vaginal dryness; or

• changes in sexual desire.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Synarel (nafarelin nasal)?

If you have a stuffy nose during your treatment with nafarelin nasal, ask your doctor before using a decongestant. If your doctor recommends a decongestant nasal spray, do not use the decongestant for at least 2 hours after you have used nafarelin nasal.

Before using nafarelin nasal, tell your doctor if you use steroids or medicine to control seizures.

• seizure medication; or

• steroids such as prednisone, fluticasone (Advair), mometasone (Asmanex, Nasonex), dexamethasone (Decadron, Hexadrol) and others.

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

Where can I get more information?

• Your pharmacist can provide more information about nafarelin nasal.

• 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: 2.02. Revision Date: 4/12/2009 4:37:42 PM.

Generic Name: fluocinolone (Topical application route)

floo-oh-SIN-oh-lone a-SEET-oh-nide

Commonly used brand name(s):

In the U.S.

• Capex
• Derma-Smoothe/FS
• Synalar

In Canada

• Fluoderm Mild Cream
• Fluoderm Mild Ointment
• Fluoderm Regular Cream
• Fluoderm Regular Ointment
• Fluolar Mild
• Fluolar Regular
• Fluonide Mild-Cream
• Synalar Mild
• Synalar Regular
• Synamol

Available Dosage Forms:

• Cream
• Solution
• Shampoo
• Oil
• Ointment
• Lotion
• Gel/Jelly
• Kit

Therapeutic Class: Corticosteroid, Intermediate

Pharmacologic Class: Fluocinolone

Uses For Synalar Regular

Fluocinolone topical is used to relieve redness, itching, swelling, or other discomfort caused by skin conditions. Fluocinolone scalp oil is used to treat psoriasis of the scalp, and fluocinolone shampoo for seborrheic dermatitis of the scalp. This medicine is a corticosteroid (cortisone-like medicine or steroid).

This medicine is available only with your doctor’s prescription.

Before Using Synalar Regular

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of fluocinolone topical in the pediatric population. However, because of this medicine’s toxicity, it should be used with caution. Children may absorb large amounts through the skin, which can cause serious side effects. If your child is using this medicine, follow your doctor’s instructions very carefully. For the body oil form, safety and efficacy in children 3 months of age and younger have not been established.

Geriatric

No information is available on the relationship of age to the effects of fluocinolone topical in geriatric patients.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Cushing’s syndrome (adrenal gland disorder) or
• Diabetes or
• Hyperglycemia (high blood sugar) or
• Intracranial hypertension (increased pressure in the head)—Use with caution. May make these conditions worse.

• Infection of the skin at or near the place of application or
• Large sores, broken skin, or severe skin injury at the place of application—The chance of side effects may be increased.

Proper Use of fluocinolone

This section provides information on the proper use of a number of products that contain fluocinolone. It may not be specific to Synalar Regular. Please read with care.

It is very important that you use this medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. To do so may cause unwanted side effects or skin irritation.

This medicine is for use on the skin only. Do not get it in your eyes. Do not use it on skin areas that have cuts, scrapes, or burns. If it does get on these areas, rinse it off right away with water.

This medicine should only be used for skin conditions that your doctor is treating. Check with your doctor before using it for other conditions, especially if you think that a skin infection may be present. This medicine should not be used to treat certain kinds of skin infections or conditions, such as severe burns.

To use cream, ointment, solution, and body oil:

• Wash your hands with soap and water before and after using this medicine.
• Apply a thin layer of this medicine to the affected area of the skin or scalp. Rub it in gently.
• Do not bandage or otherwise wrap the skin being treated unless directed to do so by your doctor.
• If the medicine is applied to the diaper area of an infant, do not use tight-fitting diapers or plastic pants unless directed to do so by your doctor.
• If your doctor ordered an occlusive dressing or airtight covering to be applied over the medicine, make sure you know how to apply it. Occlusive dressings increase the amount of medicine absorbed through your skin, so use them only as directed. If you have any questions about this, check with your doctor.

To use shampoo:

• Wash your hands with soap and water before and after using this medicine.
• Wet hair and scalp thoroughly.
• Shake the container well, and apply about an ounce of the shampoo to the scalp area.
• Work the shampoo into a lather, and leave on the scalp for 5 minutes.
• Wash hair and scalp thoroughly with water.

To use scalp oil:

• Wash your hands with soap and water before and after using this medicine.
• Wet hair and scalp thoroughly.
• Apply a thin layer of this medicine to the affected area of the scalp. Rub it in gently.
• Cover the scalp with the supplied shower cap overnight for at least 4 hours.
• Wash hair with regular shampoo and clean well.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor’s orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For redness, itching, and swelling of the skin:
  • For topical dosage form (cream, ointment, and solution):
    • Adults—Apply to the affected areas of the skin three to four times a day.
    • Children—Use and dose must be determined by your doctor.
  • For topical dosage form (body oil):
    • Adults—Apply to the affected areas of the skin three times a day for up to 2 weeks.
    • Children 3 months of age and older—Apply to the affected areas two times a day for up to 4 weeks.

• For seborrheic dermatitis:
  • For topical dosage form (shampoo):
    • Adults—Use on the scalp area once a day.
    • Children—Use and dose must be determined by your doctor.

• For scalp psoriasis:
  • For topical dosage form (scalp oil):
    • Adults—Apply to the affected areas of the scalp and leave overnight.
    • Children 2 years of age and older—Apply to the affected areas 2 times a day for up to 4 weeks.

Missed Dose

If you miss a dose of this medicine, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using Synalar Regular

It is very important that your doctor check the progress of you or your child at regular visits for any unwanted effects that may be caused by this medicine.

If your or your child’s symptoms do not improve within a few days, or if they become worse, check with your doctor.

Using too much of this medicine or using it for a long time may increase your risk of having adrenal gland problems. The risk is greater for children and patients who use large amounts for a long time. Talk to your doctor right away if you or your child have more than one of these symptoms while you are using this medicine: blurred vision; dizziness or fainting; a fast, irregular, or pounding heartbeat; increased thirst or urination; irritability; or unusual tiredness or weakness.

Stop using this medicine and check with your doctor right away if you or your child have a skin rash, burning, stinging, swelling, or irritation on the skin.

Synalar Regular Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

• Body aches or pain
• congestion
• cough
• dryness or soreness of the throat
• fever
• headache
• hoarseness
• lightening of normal skin color
• lightening of treated areas of dark skin
• sore throat
• stuffy or runny nose
• tender, swollen glands in the neck
• trouble swallowing
• unusual tiredness or weakness
• voice changes

Less common

• Acne or pimples
• accumulation of pus
• blistering, crusting, irritation, itching, or reddening of the skin
• burning, itching, and pain in hairy areas, or pus at the root of the hair
• burning and itching of the skin with pinhead-sized red blisters
• change in hearing
• cracked, dry, scaly skin
• diarrhea
• dry skin
• earache or pain in the ear
• ear drainage
• flushing or redness of the skin
• darkening of the skin
• itching, scaling, severe redness, soreness, or swelling of the skin
• itchy, raised, round, smooth, skin-colored bumps found on just one area of the body
• ooze thick white fluid
• raised, dark red, wart-like spots on skin, especially when used on the face
• redness or swelling in the ear
• skin irritation
• skin rash, encrusted, scaly and oozing
• spots on your skin resembling a blister or pimple
• swelling
• swollen, red, tender area of infection
• thickened patches of the skin
• vomiting

Incidence not known

• Redness and scaling around the mouth
• thinning, weakness, or wasting away of the skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

• Changes in skin color
• shiny skin

Incidence not known

• increased hair growth on the forehead, back, arms, and legs
• reddish purple lines on the arms, face, legs, trunk, or groin
• softening of the skin

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

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