Archive for the ‘estrogens’ Category

Tace

Tace

Generic Name: chlorotrianisene (klor oh trye AN i seen)

What is Tace (chlorotrianisene)?

Chlorotrianisene is a form of estrogen. Estrogen is a female sex hormone necessary for many processes in the body.

Chlorotrianisene is used to treat symptoms of menopause, deficiencies in ovary function (including underdevelopment of female sexual characteristics and some types of infertility), and prostate cancer.

Chlorotrianisene may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about Tace (chlorotrianisene)?

Have yearly physical exams and examine your breasts for lumps on a monthly basis while taking chlorotrianisene.

Take chlorotrianisene with food or milk to lessen stomach upset. Do not take chlorotrianisene if you are pregnant.

Who should not take Tace (chlorotrianisene)?

Do not take chlorotrianisene if you

have breast cancer. Tell your doctor if you have (or have ever had) breast cancer.

have vaginal bleeding that has not been diagnosed. It will be necessary to determine if any abnormal bleeding has a hormonal cause.

have a bleeding or blood-clotting disorder. Chlorotrianisene may increase the risk that a blood clot will form.

Before taking this medication, tell your doctor if you

are diabetic,

have epilepsy or seizures,

have heart disease, or

have kidney disease.

You may need a lower dose or special monitoring during treatment if you have any of the conditions listed above.

Chlorotrianisene is in the FDA pregnancy category X. This means that chlortrianisene will cause birth defects in an unborn baby. Do not take this medication if you are pregnant or are planning a pregnancy. Chlorotrianisene may decrease milk flow and have other effects on milk composition. Do not use this medication without first talking to your doctor if you are breast-feeding a baby.

How should I take Tace (chlorotrianisene)?

Take this medication exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

Take each dose with a full glass of water. Take chlorotrianisene with food or milk to lessen stomach upset.

Try to take each dose at the same time each day, preferably in the morning. You may be taking it every day, or you may be taking it every day for 3 weeks with 1 week off each month to mimic your body’s natural cycle. Follow the directions on your prescription label.

If you are taking chlorotrianisene to treat cancer, you may be taking it several times a day in very large doses.

Store chlorotrianisene at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Do not take a double dose of this medication unless otherwise directed by your doctor.

What happens if I overdose?

An overdose of this medication is unlikely to threaten life. Consult an emergency room or poison control center for advice.

Symptoms of an estrogen overdose include nausea and vomiting.

What should I avoid while taking Tace (chlorotrianisene)?

Avoid prolonged exposure to sunlight. Chlorotrianisene may increase the sensitivity of your skin to sunlight. Use a sunscreen and wear protective clothing when exposure to the sun is unavoidable.

Tace (chlorotrianisene) side effects

If you experience any of the following serious side effects, stop taking chlorotrianisene and seek emergency medical attention:

an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives);

a blood clot (pain, redness, and swelling in an arm or leg, shortness of breath, chest pain, headache, blurred vision, or confusion);

a lump in a breast; or

liver damage (yellowing of the skin or eyes, nausea, abdominal pain or discomfort, unusual bleeding or bruising, severe fatigue).

Other, less serious side effects may be more likely to occur. Continue to take chlorotrianisene and talk to your doctor if you experience

decreased appetite, nausea, or vomiting;

swollen breasts;

acné or skin color changes;

decreased sex drive;

migraine headaches or dizziness;

water retention (swollen hands, feet, or ankles);

depression; or

changes in your menstrual cycle or breakthrough bleeding.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

What other drugs will affect Tace (chlorotrianisene)?

Chlorotrianisene may decrease the effects of the following drugs:

anticoagulants (blood thinners) such as warfarin (Coumadin). This could lead to blood clots. Your doctor will want to monitor your anticoagulant therapy.

thyroid medications. A larger dose of thyroid medication may be needed.

insulin. Monitor your blood sugar levels and discuss any unusual changes with your doctor.

tamoxifen. Chlorotrianisene should not be taken during therapy with tamoxifen.

Chlorotrianisene may also increase the effects of some medications. The following drugs may have increased or dangerous side effects if taken with chlorotrianisene:

didanosine (Videx).

Before taking this medication, tell your doctor if you are taking any of the medicines listed above.

Other drugs may also affect chlorotrianisene. The effects of chlorotrianisene are decreased by

phenytoin (Dilantin) and ethotoin (Peganone),

carbamazepine (Tegretol),

phenobarbital (Solfoton, Luminal),

primidone (Mysoline), and

rifampin (Rifadin).

You may need larger doses of chlorotrianisene if you are taking any of the medicines listed above.

Drugs other than those listed here may also interact with chlorotrianisene. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines.

Synthetic Conjugated Estrogens A

Synthetic Conjugated Estrogens-A

Generic Name: conjugated estrogens (vaginal) (KON joo gay ted ES troe jenz)

What is Synthetic Conjugated Estrogens-A?

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

Synthetic Conjugated Estrogens-A is a mixture of estrogen hormones used to treat the vaginal symptoms of menopause such as dryness, burning, irritation, and painful sexual intercourse.

Synthetic Conjugated Estrogens-A should not be used to prevent heart disease or dementia, because this medication may actually increase your risk of developing these conditions.

Synthetic Conjugated Estrogens-A may also be used for other purposes not listed in this medication guide.

Important information Synthetic Conjugated Estrogens-A

Synthetic Conjugated Estrogens-A can cause birth defects in an unborn baby. Do not use Synthetic Conjugated Estrogens-A 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 Synthetic Conjugated Estrogens-A 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 Synthetic Conjugated Estrogens-A.

Synthetic Conjugated Estrogens-A should not be used to prevent heart disease or dementia, because this medication may actually increase your risk of developing these conditions.

Before using Synthetic Conjugated Estrogens-A

Do not use Synthetic Conjugated Estrogens-A 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 Synthetic Conjugated Estrogens-A, 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;

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).

Synthetic Conjugated Estrogens-A 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 Synthetic Conjugated Estrogens-A.

Long-term conjugated estrogens treatment may increase your risk of stroke or blood clots. Talk with your doctor about your individual risks before using Synthetic Conjugated Estrogens-A 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 Synthetic Conjugated Estrogens-A 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 Synthetic Conjugated Estrogens-A 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 Synthetic Conjugated Estrogens-A in anyone under 18 years old without the advice of a doctor.

How should I use Synthetic Conjugated Estrogens-A?

Use Synthetic Conjugated Estrogens-A 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.

Synthetic Conjugated Estrogens-A 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 Synthetic Conjugated Estrogens-A, 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 Synthetic Conjugated Estrogens-A 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.

Synthetic Conjugated Estrogens-A 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 Synthetic Conjugated Estrogens-A?

Do not smoke while using Synthetic Conjugated Estrogens-A. Smoking can increase your risk of blood clots, stroke, or heart attack caused by Synthetic Conjugated Estrogens-A.

Synthetic Conjugated Estrogens-A side effects

Get emergency medical help if you have any of these signs of an allergic reaction to Synthetic Conjugated Estrogens-A: 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 Synthetic Conjugated Estrogens-A vaginal cream 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.

Conjugated estrogens Dosing Information

Treatment of Atrophic Vaginitis and Kraurosis Vulvae:

What other drugs will affect Synthetic Conjugated Estrogens-A?

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 Synthetic Conjugated Estrogens-A. 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.

Ortho-Est

Ortho-Est

Estrogens have been reported to increase the chance of womb (endometrial) cancer in women who have been through menopause, especially in women with a uterus who receive estrogen-only hormone therapy. Estrogens may also increase the risk of cancer of the ovary or breast. Estrogen-containing products should not be used to prevent heart disease. Estrogen given with another hormone (progestin) for replacement therapy can infrequently cause heart disease (eg, heart attacks), stroke, serious blood clots in the legs or lungs (pulmonary embolism/deep vein thrombosis), dementia, and cancer of the breast. These risks appear to depend on the length of time Ortho-Est is used and the amount of estrogen per dose. Therefore, Ortho-Est should be used for the shortest possible length of time at the lowest effective dose, so that you obtain the benefits and minimize the chance of serious side effects from long-term treatment. Consult your doctor or pharmacist for details. If using Ortho-Est for an extended period, you should be evaluated at least once a year. Ortho-Est is not effective in preventing or treating a tendency toward miscarriage, nor the threat of miscarriage. Ortho-Est should not be used during pregnancy because its use may result in birth defects or cancer later in the child’s life.

Ortho-Est is used for:

Treating conditions due to menopause (eg, hot flashes; vaginal itching, burning, dryness) and vulval or vaginal atrophy, and preventing osteoporosis (brittle bones). It is also used for estrogen replacement therapy after failure of the ovaries and relief of the symptoms of breast cancer.

Ortho-Est is used for relief of the symptoms of breast cancer in selected men.

Ortho-Est is a female hormone. It works by replacing natural estrogens in a woman who can no longer produce enough estrogen.

Do NOT use Ortho-Est if:

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

Before using Ortho-Est :

Some medical conditions may interact with Ortho-Est . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

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

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

Use Ortho-Est as directed by your doctor. Check the label on the medicine for exact dosing instructions. Check the label on the medicine for exact dosing instructions.

Ask your health care provider any questions you may have about how to use Ortho-Est .

Important safety information:

Possible side effects of Ortho-Est :

All medicines may cause side effects, but many people have no, or minor side effects.

Abnormal hair growth; breast tenderness; changes in sex drive; cramps; depression; dizziness; flushing; hair loss; headache; intolerance to contact lenses; lightheadedness; nausea; reduced tolerance to carbohydrates; stomach bloating and upset; swelling; vaginal infection, bleeding, or spotting; weight changes.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); abnormal vaginal bleeding; breast lumps; changes in vaginal bleeding (eg, spotting, breakthrough bleeding, or prolonged bleeding); changes in vision or speech (eg, change in contact lens fit, loss of vision); chest pain; coughing up blood; dizziness; fainting; mental/mood changes (eg, severe depression, memory loss); pain in calves or chest; pain, swelling, or tenderness in the stomach; severe headache or vomiting; sudden shortness of breath; swelling of hands or feet; unusual vaginal discharge, itching, or odor; 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

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (

Store Ortho-Est at room temperature 59 to 86 degrees F (15 to 30 degrees C) in a tight, light-resistant container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Ortho-Est out of the reach of children and away from pets.

General information:

This information is a summary only. It does not contain all information about Ortho-Est . 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.

More Ortho-Est resources

Compare Ortho-Est with other medications for the treatment of:

Ogen 2.5

Ogen 2.5

Generic Name: estropipate (ES troe PIP ate)

What is Ogen 2.5 (estropipate)?

Estropipate is a form of estrogen. Estrogen is a female sex hormone necessary for many processes in the body.

Estropipate is used to treat symptoms of menopause such as hot flashes, and vaginal dryness, burning, and irritation. It is also used to prevent osteoporosis.

Estropipate may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about Ogen 2.5 (estropipate)?

Do not use this medication if you have any of the following conditions: a history of stroke or blood clot, circulation problems, a hormone-related cancer such as breast or uterine cancer, or abnormal vaginal bleeding. This medication can cause birth defects in an unborn baby. Do not use if you are pregnant. Use an effective form of birth control, and tell your doctor if you become pregnant during treatment.

Estropipate increases your risk of developing endometrial hyperplasia, a condition that may lead to cancer of the uterus. Taking progestins while using estropipate 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 estropipate.

Long-term estropipate treatment may increase your risk of breast cancer, heart attack, or stroke. Talk with your doctor about your individual risks before using estropipate 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 estropipate.

What should I discuss with my health care provider before using Ogen 2.5 (estropipate)?

Do not use estropipate if you have:

a bleeding or blood-clotting disorder;

a history of stroke or circulation problems;

abnormal vaginal bleeding that a doctor has not checked; or

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

Before using estropipate, tell your doctor if you have:

high blood pressure, angina, or heart disease;

high cholesterol or triglycerides;

asthma;

epilepsy or other seizure disorder;

migraines;

diabetes;

depression;

gallbladder disease; or

if you have had your uterus removed (hysterectomy).

If you have any of these conditions, you may not be able to use estropipate, or you may need a dosage adjustment or special tests during treatment.

Estropipate increases your risk of developing endometrial hyperplasia, a condition that may lead to cancer of the uterus. Taking progestins while using estropipate 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 estropipate.

Long-term estropipate treatment may increase your risk of stroke. Talk with your doctor about your individual risks before using estropipate 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 estropipate 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. Estropipate 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 Ogen 2.5 (estropipate)?

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.

Take this medication with a full glass of water. You may take estropipate with food or after a meal to reduce stomach upset.

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

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. Symptoms of an estropipate overdose may include nausea, vomiting, or vaginal bleeding.

What should I avoid while using Ogen 2.5 (estropipate)?

There are no restrictions on food, beverages, or activity while using estropipate unless your doctor has told you otherwise.

Ogen 2.5 (estropipate) 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;

pain or swelling in your lower leg;

abnormal vaginal bleeding;

pain, swelling, or tenderness in your stomach;

jaundice (yellowing of the skin or eyes); or

a lump in your breast.

Other less serious side effects are more likely to occur, such as:

nausea, vomiting, loss of appetite;

swollen breasts;

acne or skin color changes;

decreased sex drive, impotence, or difficulty having an orgasm;

migraine headaches or dizziness;

vaginal pain, dryness, or discomfort;

swelling of your ankles or feet;

depression; or

changes in your menstrual periods, break-through bleeding.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Ogen 2.5 (estropipate)?

Before using estropipate, tell your doctor if you are using any of the following drugs:

St. John’s wort;

phenobarbital (Luminal, Solfoton);

phenytoin (Dilantin);

a blood thinner such as warfarin (Coumadin);

ritonavir (Norvir);

cimetidine (Tagamet);

carbamazepine (Carbatrol, Tegretol);

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

antibiotics such as clarithromycin (Biaxin), erythromycin (E-Mycin, E.E.S., Erythrocin, Ery-Tab), ketoconazole (Nizoral), or itraconazole (Sporanox);

If you are using any of these drugs, you may not be able to use estropipate or you may need dosage adjustments or special tests during treatment.

There may be other drugs not listed that can affect estropipate. 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.

Ogen 1.25

Ogen 1.25

Generic Name: estropipate (ES troe PIP ate)

What is Ogen 1.25 (estropipate)?

Estropipate is a form of estrogen. Estrogen is a female sex hormone necessary for many processes in the body.

Estropipate is used to treat symptoms of menopause such as hot flashes, and vaginal dryness, burning, and irritation. It is also used to prevent osteoporosis.

Estropipate may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about Ogen 1.25 (estropipate)?

Do not use this medication if you have any of the following conditions: a history of stroke or blood clot, circulation problems, a hormone-related cancer such as breast or uterine cancer, or abnormal vaginal bleeding. This medication can cause birth defects in an unborn baby. Do not use if you are pregnant. Use an effective form of birth control, and tell your doctor if you become pregnant during treatment.

Estropipate increases your risk of developing endometrial hyperplasia, a condition that may lead to cancer of the uterus. Taking progestins while using estropipate 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 estropipate.

Long-term estropipate treatment may increase your risk of breast cancer, heart attack, or stroke. Talk with your doctor about your individual risks before using estropipate 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 estropipate.

What should I discuss with my health care provider before using Ogen 1.25 (estropipate)?

Do not use estropipate if you have:

a bleeding or blood-clotting disorder;

a history of stroke or circulation problems;

abnormal vaginal bleeding that a doctor has not checked; or

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

Before using estropipate, tell your doctor if you have:

high blood pressure, angina, or heart disease;

high cholesterol or triglycerides;

asthma;

epilepsy or other seizure disorder;

migraines;

diabetes;

depression;

gallbladder disease; or

if you have had your uterus removed (hysterectomy).

If you have any of these conditions, you may not be able to use estropipate, or you may need a dosage adjustment or special tests during treatment.

Estropipate increases your risk of developing endometrial hyperplasia, a condition that may lead to cancer of the uterus. Taking progestins while using estropipate 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 estropipate.

Long-term estropipate treatment may increase your risk of stroke. Talk with your doctor about your individual risks before using estropipate 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 estropipate 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. Estropipate 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 Ogen 1.25 (estropipate)?

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.

Take this medication with a full glass of water. You may take estropipate with food or after a meal to reduce stomach upset.

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

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. Symptoms of an estropipate overdose may include nausea, vomiting, or vaginal bleeding.

What should I avoid while using Ogen 1.25 (estropipate)?

There are no restrictions on food, beverages, or activity while using estropipate unless your doctor has told you otherwise.

Ogen 1.25 (estropipate) 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;

pain or swelling in your lower leg;

abnormal vaginal bleeding;

pain, swelling, or tenderness in your stomach;

jaundice (yellowing of the skin or eyes); or

a lump in your breast.

Other less serious side effects are more likely to occur, such as:

nausea, vomiting, loss of appetite;

swollen breasts;

acne or skin color changes;

decreased sex drive, impotence, or difficulty having an orgasm;

migraine headaches or dizziness;

vaginal pain, dryness, or discomfort;

swelling of your ankles or feet;

depression; or

changes in your menstrual periods, break-through bleeding.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Ogen 1.25 (estropipate)?

Before using estropipate, tell your doctor if you are using any of the following drugs:

St. John’s wort;

phenobarbital (Luminal, Solfoton);

phenytoin (Dilantin);

a blood thinner such as warfarin (Coumadin);

ritonavir (Norvir);

cimetidine (Tagamet);

carbamazepine (Carbatrol, Tegretol);

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

antibiotics such as clarithromycin (Biaxin), erythromycin (E-Mycin, E.E.S., Erythrocin, Ery-Tab), ketoconazole (Nizoral), or itraconazole (Sporanox);

If you are using any of these drugs, you may not be able to use estropipate or you may need dosage adjustments or special tests during treatment.

There may be other drugs not listed that can affect estropipate. 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.

Ogen 0.625

Ogen 0.625

Generic Name: estropipate (ES troe PIP ate)

What is Ogen 0.625 (estropipate)?

Estropipate is a form of estrogen. Estrogen is a female sex hormone necessary for many processes in the body.

Estropipate is used to treat symptoms of menopause such as hot flashes, and vaginal dryness, burning, and irritation. It is also used to prevent osteoporosis.

Estropipate may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about Ogen 0.625 (estropipate)?

Do not use this medication if you have any of the following conditions: a history of stroke or blood clot, circulation problems, a hormone-related cancer such as breast or uterine cancer, or abnormal vaginal bleeding. This medication can cause birth defects in an unborn baby. Do not use if you are pregnant. Use an effective form of birth control, and tell your doctor if you become pregnant during treatment.

Estropipate increases your risk of developing endometrial hyperplasia, a condition that may lead to cancer of the uterus. Taking progestins while using estropipate 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 estropipate.

Long-term estropipate treatment may increase your risk of breast cancer, heart attack, or stroke. Talk with your doctor about your individual risks before using estropipate 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 estropipate.

What should I discuss with my health care provider before using Ogen 0.625 (estropipate)?

Do not use estropipate if you have:

a bleeding or blood-clotting disorder;

a history of stroke or circulation problems;

abnormal vaginal bleeding that a doctor has not checked; or

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

Before using estropipate, tell your doctor if you have:

high blood pressure, angina, or heart disease;

high cholesterol or triglycerides;

asthma;

epilepsy or other seizure disorder;

migraines;

diabetes;

depression;

gallbladder disease; or

if you have had your uterus removed (hysterectomy).

If you have any of these conditions, you may not be able to use estropipate, or you may need a dosage adjustment or special tests during treatment.

Estropipate increases your risk of developing endometrial hyperplasia, a condition that may lead to cancer of the uterus. Taking progestins while using estropipate 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 estropipate.

Long-term estropipate treatment may increase your risk of stroke. Talk with your doctor about your individual risks before using estropipate 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 estropipate 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. Estropipate 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 Ogen 0.625 (estropipate)?

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.

Take this medication with a full glass of water. You may take estropipate with food or after a meal to reduce stomach upset.

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

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. Symptoms of an estropipate overdose may include nausea, vomiting, or vaginal bleeding.

What should I avoid while using Ogen 0.625 (estropipate)?

There are no restrictions on food, beverages, or activity while using estropipate unless your doctor has told you otherwise.

Ogen 0.625 (estropipate) 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;

pain or swelling in your lower leg;

abnormal vaginal bleeding;

pain, swelling, or tenderness in your stomach;

jaundice (yellowing of the skin or eyes); or

a lump in your breast.

Other less serious side effects are more likely to occur, such as:

nausea, vomiting, loss of appetite;

swollen breasts;

acne or skin color changes;

decreased sex drive, impotence, or difficulty having an orgasm;

migraine headaches or dizziness;

vaginal pain, dryness, or discomfort;

swelling of your ankles or feet;

depression; or

changes in your menstrual periods, break-through bleeding.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Ogen 0.625 (estropipate)?

Before using estropipate, tell your doctor if you are using any of the following drugs:

St. John’s wort;

phenobarbital (Luminal, Solfoton);

phenytoin (Dilantin);

a blood thinner such as warfarin (Coumadin);

ritonavir (Norvir);

cimetidine (Tagamet);

carbamazepine (Carbatrol, Tegretol);

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

antibiotics such as clarithromycin (Biaxin), erythromycin (E-Mycin, E.E.S., Erythrocin, Ery-Tab), ketoconazole (Nizoral), or itraconazole (Sporanox);

If you are using any of these drugs, you may not be able to use estropipate or you may need dosage adjustments or special tests during treatment.

There may be other drugs not listed that can affect estropipate. 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.

Ogen

Ogen

Estrogens have been reported to increase the chance of womb (endometrial) cancer in women who have been through menopause, especially in women with a uterus who receive estrogen-only hormone therapy. Estrogens may also increase the risk of cancer of the ovary or breast. Estrogen-containing products should not be used to prevent heart disease. Estrogen given with another hormone (progestin) for replacement therapy can infrequently cause heart disease (eg, heart attacks), stroke, serious blood clots in the legs or lungs (pulmonary embolism/deep vein thrombosis), dementia, and cancer of the breast. These risks appear to depend on the length of time Ogen is used and the amount of estrogen per dose. Therefore, Ogen should be used for the shortest possible length of time at the lowest effective dose, so that you obtain the benefits and minimize the chance of serious side effects from long-term treatment. Consult your doctor or pharmacist for details. If using Ogen for an extended period, you should be evaluated at least once a year. Ogen is not effective in preventing or treating a tendency toward miscarriage, nor the threat of miscarriage. Ogen should not be used during pregnancy because its use may result in birth defects or cancer later in the child’s life.

Ogen is used for:

Treating conditions due to menopause (eg, hot flashes; vaginal itching, burning, dryness) and vulval or vaginal atrophy, and preventing osteoporosis (brittle bones). It is also used for estrogen replacement therapy after failure of the ovaries and relief of the symptoms of breast cancer.

Ogen is used for relief of the symptoms of breast cancer in selected men.

Ogen is a female hormone. It works by replacing natural estrogens in a woman who can no longer produce enough estrogen.

Do NOT use Ogen if:

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

Before using Ogen :

Some medical conditions may interact with Ogen . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

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

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

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

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

Important safety information:

Possible side effects of Ogen :

All medicines may cause side effects, but many people have no, or minor side effects.

Abnormal hair growth; breast tenderness; changes in sex drive; cramps; depression; dizziness; flushing; hair loss; headache; intolerance to contact lenses; lightheadedness; nausea; reduced tolerance to carbohydrates; stomach bloating and upset; swelling; vaginal infection, bleeding, or spotting; weight changes.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); abnormal vaginal bleeding; breast lumps; changes in vaginal bleeding (eg, spotting, breakthrough bleeding, or prolonged bleeding); changes in vision or speech (eg, change in contact lens fit, loss of vision); chest pain; coughing up blood; dizziness; fainting; mental/mood changes (eg, severe depression, memory loss); pain in calves or chest; pain, swelling, or tenderness in the stomach; severe headache or vomiting; sudden shortness of breath; swelling of hands or feet; unusual vaginal discharge, itching, or odor; 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

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (

Store Ogen at room temperature 59 to 86 degrees F (15 to 30 degrees C) in a tight, light-resistant container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Ogen out of the reach of children and away from pets.

General information:

This information is a summary only. It does not contain all information about Ogen . 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.

More Ogen resources

Menostar

Menostar

Generic Name: estradiol transdermal (ess tra DYE ol tranz DERM al)

What is Menostar?

Estradiol is a form of estrogen, a female sex hormone the regulates many processes in the body.

Menostar skin patches are used to prevent postmenopausal osteoporosis. Menostar skin patches release estradiol slowly, and it is absorbed through your skin. They are used to provide the female hormone when the body no longer produces enough.

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

What is the most important information I should know about Menostar?

Do not use Menostar if you have any of the following conditions: a history of stroke or blood clot, circulation problems, a bleeding disorder, a hormone-related cancer such as breast or uterine cancer, or abnormal vaginal bleeding. Menostar can cause birth defects in an unborn baby. Do not use if you are pregnant. Use an effective form of birth control, and tell your doctor if you become pregnant during treatment.

Estradiol increases your risk of developing endometrial hyperplasia, a condition that may lead to cancer of the uterus. Taking progestins while using estradiol 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 Menostar.

Long-term Menostar treatment may increase your risk of breast cancer, heart attack, or stroke. Talk with your doctor about your individual risks before using Menostar 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 Menostar.

What should I discuss with my healthcare provider before using Menostar?

Do not use Menostar if you have:

a bleeding or blood-clotting disorder;

a history of stroke or circulation problems;

abnormal vaginal bleeding that a doctor has not checked; or

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

Before using Menostar, tell your doctor if you have:

high blood pressure, angina, or heart disease;

high cholesterol or triglycerides;

asthma;

epilepsy or other seizure disorder;

migraines;

diabetes;

depression;

gallbladder disease; 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 use Menostar.

Menostar increases your risk of developing endometrial hyperplasia, a condition that may lead to cancer of the uterus. Taking progestins while using Menostar 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 Menostar.

Long-term Menostar treatment may increase your risk of stroke. Talk with your doctor about your individual risks before using Menostar 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. Menostar can cause birth defects. Do not use Menostar 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 Menostar. Estradiol can pass into breast milk and may harm a nursing baby. Menostar may also slow breast milk production. Do not use if you are breast-feeding a baby.

How should I use Menostar?

Use Menostar 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 instructions on your prescription label.

Apply the skin patch to clean, dry skin on your stomach, lower back, or buttocks. Choose a different spot within these skin areas each time you apply a new patch. Avoid skin that is oily, irritated, or damaged.

Press the patch in place firmly for about 10 seconds, especially around the edges.

Do not apply a skin patch to your breasts. Do not apply a patch where it might be rubbed off by tight clothing, such as under an elastic waistband.

If a patch falls off, try putting it back on to a different skin area, pressing the patch into place for 10 seconds. If the patch will not stick you may apply a new one.

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

Store Menostar at room temperature away from moisture and heat.

What happens if I miss a dose?

Apply a skin patch as soon as you remember. If it is almost time to apply your next patch, skip the missed dose and apply a patch at the next regularly scheduled time. Do not use extra patches 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, and vaginal bleeding.

What should I avoid while using Menostar?

Avoid using other estrogen products without your doctor’s advice.

Menostar 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;

pain or swelling in your lower leg;

abnormal vaginal bleeding;

pain, swelling, or tenderness in your stomach;

jaundice (yellowing of the skin or eyes); or

a lump in your breast.

Less serious side effects may include:

nausea, vomiting, loss of appetite;

swollen breasts;

acne or skin color changes;

decreased sex drive, impotence, or difficulty having an orgasm;

migraine headaches or dizziness;

vaginal pain, dryness, or discomfort;

swelling of your ankles or feet;

depression; or

changes in your menstrual periods, break-through bleeding.

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 Menostar?

Before using Menostar, tell your doctor if you are using any of the following drugs:

St. John’s wort;

phenobarbital (Luminal, Solfoton);

a blood thinner such as warfarin (Coumadin);

ritonavir (Norvir);

carbamazepine (Carbatrol, Tegretol);

an antibiotic such as clarithromycin (Biaxin), erythromycin (E-Mycin, E.E.S., Erythrocin, Ery-Tab) or rifampin (Rifadin, Rifater, Rifamate, Rimactane); or

an antifungal medication such as ketoconazole (Nizoral) or itraconazole (Sporanox).

This list is not complete and there may be other drugs that can interact with Menostar. 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.

Menaval-20

Menaval-20

Generic Name: estradiol injection (ess tra DYE ol)

What is Menaval-20 (estradiol injection)?

Estradiol is a form of estrogen. Estrogen is a female sex hormone necessary for many processes in the body.

Estradiol injection is used to treat symptoms of menopause such as hot flashes, and vaginal dryness, burning, and irritation. It is also used to treat a lack of estrogen that is caused by ovarian failure or a condition called hypogonadism. Some forms of estradiol injection are used in men to treat the symptoms of prostate cancer.

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

What is the most important information I should know about Menaval-20 (estradiol injection)?

Do not use this medication if you have any of the following conditions: a history of stroke or blood clot, circulation problems, a hormone-related cancer such as breast or uterine cancer, or abnormal vaginal bleeding. This medication can cause birth defects in an unborn baby. Do not use if you are pregnant. Use an effective form of birth control, and tell your doctor if you become pregnant during treatment.

Estradiol increases your risk of developing endometrial hyperplasia, a condition that may lead to cancer of the uterus. Taking progestins while using estradiol 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 estradiol injection.

Long-term estradiol treatment may increase your risk of breast cancer, heart attack, or stroke. Talk with your doctor about your individual risks before using estradiol 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 estradiol.

What should I discuss with my health care provider before using Menaval-20 (estradiol injection)?

Do not use estradiol injection if you have:

a bleeding or blood-clotting disorder;

a history of stroke or circulation problems;

abnormal vaginal bleeding that a doctor has not checked; or

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

Before using estradiol injection, tell your doctor if you have:

high blood pressure, angina, or heart disease;

high cholesterol or triglycerides;

asthma;

epilepsy or other seizure disorder;

migraines;

diabetes;

depression;

gallbladder disease; 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 use estradiol injection.

Estradiol increases your risk of developing endometrial hyperplasia, a condition that may lead to cancer of the uterus. Taking progestins while using estradiol 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 estradiol injection.

Long-term estradiol treatment may increase your risk of stroke. Talk with your doctor about your individual risks before using estradiol 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 estradiol injection 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. Estradiol 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 Menaval-20 (estradiol injection)?

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.

Estradiol injection is given as an shot into a muscle. You may be shown how to inject your medicine at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles and syringes.

This medicine is usually given once every 4 weeks. Follow your doctor’s instructions.

Do not draw your estradiol dose into a syringe until you are ready to give yourself an injection. Do not use the medication if it has changed colors or has any particles in it. Call your doctor for a new prescription.

Use each disposable needle only one time. Throw away used needles in a puncture-proof container (ask your pharmacist where you can get one and how to dispose of it). Keep this container out of the reach of children and pets.

Have regular physical exams and self-examine your breasts for lumps on a monthly basis while using estradiol injection.

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 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. Overdose symptoms may include nausea, vomiting, or vaginal bleeding.

What should I avoid while using Menaval-20 (estradiol injection)?

Follow your doctor’s instructions about any restrictions on food, beverages, or activity while you are using estradiol injection.

Menaval-20 (estradiol injection) 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;

pain or swelling in your lower leg;

abnormal vaginal bleeding;

pain, swelling, or tenderness in your stomach;

jaundice (yellowing of the skin or eyes); or

a lump in your breast.

Less serious side effects may include:

nausea, vomiting, loss of appetite;

swollen breasts;

acne or skin color changes;

decreased sex drive, impotence, or difficulty having an orgasm;

migraine headaches or dizziness;

vaginal pain, dryness, or discomfort;

swelling of your ankles or feet;

depression; or

changes in your menstrual periods, break-through bleeding.

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 Menaval-20 (estradiol injection)?

Before using estradiol injection, tell your doctor if you are using any of the following drugs:

St. John’s wort;

phenobarbital (Luminal, Solfoton);

a blood thinner such as warfarin (Coumadin);

ritonavir (Norvir);

carbamazepine (Carbatrol, Tegretol);

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

antibiotics such as clarithromycin (Biaxin), erythromycin (E-Mycin, E.E.S., Erythrocin, Ery-Tab), ketoconazole (Nizoral), or itraconazole (Sporanox).

This list is not complete and there may be other drugs that can interact with estradiol injection. 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.

Gynogen LA 20

Gynogen LA 20

Generic Name: estradiol injection (ess tra DYE ol)

What is Gynogen LA 20 (estradiol injection)?

Estradiol is a form of estrogen. Estrogen is a female sex hormone necessary for many processes in the body.

Estradiol injection is used to treat symptoms of menopause such as hot flashes, and vaginal dryness, burning, and irritation. It is also used to treat a lack of estrogen that is caused by ovarian failure or a condition called hypogonadism. Some forms of estradiol injection are used in men to treat the symptoms of prostate cancer.

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

What is the most important information I should know about Gynogen LA 20 (estradiol injection)?

Do not use this medication if you have any of the following conditions: a history of stroke or blood clot, circulation problems, a hormone-related cancer such as breast or uterine cancer, or abnormal vaginal bleeding. This medication can cause birth defects in an unborn baby. Do not use if you are pregnant. Use an effective form of birth control, and tell your doctor if you become pregnant during treatment.

Estradiol increases your risk of developing endometrial hyperplasia, a condition that may lead to cancer of the uterus. Taking progestins while using estradiol 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 estradiol injection.

Long-term estradiol treatment may increase your risk of breast cancer, heart attack, or stroke. Talk with your doctor about your individual risks before using estradiol 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 estradiol.

What should I discuss with my health care provider before using Gynogen LA 20 (estradiol injection)?

Do not use estradiol injection if you have:

a bleeding or blood-clotting disorder;

a history of stroke or circulation problems;

abnormal vaginal bleeding that a doctor has not checked; or

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

Before using estradiol injection, tell your doctor if you have:

high blood pressure, angina, or heart disease;

high cholesterol or triglycerides;

asthma;

epilepsy or other seizure disorder;

migraines;

diabetes;

depression;

gallbladder disease; 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 use estradiol injection.

Estradiol increases your risk of developing endometrial hyperplasia, a condition that may lead to cancer of the uterus. Taking progestins while using estradiol 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 estradiol injection.

Long-term estradiol treatment may increase your risk of stroke. Talk with your doctor about your individual risks before using estradiol 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 estradiol injection 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. Estradiol 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 Gynogen LA 20 (estradiol injection)?

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.

Estradiol injection is given as an shot into a muscle. You may be shown how to inject your medicine at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles and syringes.

This medicine is usually given once every 4 weeks. Follow your doctor’s instructions.

Do not draw your estradiol dose into a syringe until you are ready to give yourself an injection. Do not use the medication if it has changed colors or has any particles in it. Call your doctor for a new prescription.

Use each disposable needle only one time. Throw away used needles in a puncture-proof container (ask your pharmacist where you can get one and how to dispose of it). Keep this container out of the reach of children and pets.

Have regular physical exams and self-examine your breasts for lumps on a monthly basis while using estradiol injection.

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 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. Overdose symptoms may include nausea, vomiting, or vaginal bleeding.

What should I avoid while using Gynogen LA 20 (estradiol injection)?

Follow your doctor’s instructions about any restrictions on food, beverages, or activity while you are using estradiol injection.

Gynogen LA 20 (estradiol injection) 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;

pain or swelling in your lower leg;

abnormal vaginal bleeding;

pain, swelling, or tenderness in your stomach;

jaundice (yellowing of the skin or eyes); or

a lump in your breast.

Less serious side effects may include:

nausea, vomiting, loss of appetite;

swollen breasts;

acne or skin color changes;

decreased sex drive, impotence, or difficulty having an orgasm;

migraine headaches or dizziness;

vaginal pain, dryness, or discomfort;

swelling of your ankles or feet;

depression; or

changes in your menstrual periods, break-through bleeding.

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 Gynogen LA 20 (estradiol injection)?

Before using estradiol injection, tell your doctor if you are using any of the following drugs:

St. John’s wort;

phenobarbital (Luminal, Solfoton);

a blood thinner such as warfarin (Coumadin);

ritonavir (Norvir);

carbamazepine (Carbatrol, Tegretol);

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

antibiotics such as clarithromycin (Biaxin), erythromycin (E-Mycin, E.E.S., Erythrocin, Ery-Tab), ketoconazole (Nizoral), or itraconazole (Sporanox).

This list is not complete and there may be other drugs that can interact with estradiol injection. 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.

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