Generic name: Estradiol
Brand names: EstroGel

Why is EstroGel prescribed?

EstroGel is used to ease some symptoms of menopause, such as moderate to severe hot flashes (feelings of warmth in the face, neck, and chest, or sudden strong feelings of heat and sweating) and burning and itching around the vagina.

Most important fact about EstroGel

Estrogens, such as EstroGel, increase the chances of getting cancer of the uterus. Do not use estrogens with or without progestins to prevent heart disease, heart attacks, or strokes. Using estrogens with or without progestins may increase your chances of getting heart attack, strokes, breast cancer, and blood clots.

How should you take EstroGel?

EstroGel’s pump must be primed the first time it is being used only; complete depress the pump twice, and throw away and medicine that came out. Apply EstroGel at the same time each day. Apply the gel to one arm using your hand. Spread the gel as thinly as possible over the entire area on the inside and outside of your arm from wrist to shoulder. Never apply EstroGel to your breast. You should apply your daily dose of gel to clean, dry, unbroken skin.

If you take a bath or shower or use a sauna, apply your EstroGel dose afterwards. If you go swimming, try to leave as much time as possible between applying your EstroGel dose and going swimming.

• If you miss a dose…
  If you miss a dose, do not double the dose on the next day to catch up. If your next dose is less than 12 hours away, it is best just to wait and apply your normal dose the next day. If it is more than 12 hours until the next dose, apply the dose you missed and resume your normal dosing the next day.

• Storage instructions…
  Store at room temperature.

What side effects may occur?

Side effects cannot be anticipated. If any develop or change in intensity, inform your doctor as soon as possible. Only your doctor can determine if it is safe for you to continue taking EstroGel.

• Common side effects may include:
  Bloating, breast pain, hair loss, headache, irregular vaginal bleeding or spotting, nausea, stomach cramps, vomiting

• Serious side effects may include:
  Breast lumps, changes in speech and vision, chest pain, dizziness, faintness, pains in your legs, severe headache, shortness of breath, unusual vaginal bleeding, vomiting

Why should EstroGel not be prescribed?

Do not begin therapy with EstroGel if you have unusual vaginal bleeding, have a history of estrogen-dependent cancers (such as breast or uterine), have had a stroke or heart attack in the past year, have a history of blood clots, or if you are pregnant or breastfeeding. Also, do not take EstroGel if you are allergic to any of its ingredients.

Special warnings about EstroGel

It is important that you do not spread the medicine to others, especially men and children. Be sure to wash your hands after applying EstroGel. Do not allow others to make contact with the area of skin where you applied the gel for at least one hour after application. Alcohol based gels are flammable. Avoid fire, flame or smoking until the gel has dried.

Tell your doctor about all prescription, over-the-counter, and herbal medications you are taking before beginning treatment with EstroGel. Also, talk to your doctor about your complete medical history, especially if you have asthma (wheezing), epilepsy (seizures), migraine, endometriosis, lupus, or problems with your heart, liver, thyroid, or kidneys. Your doctor should know if you are scheduled for surgery or need to be on bed rest.

Special information if you are pregnant or breastfeeding

The effects of EstroGel during pregnancy and breastfeeding are unknown. Talk with your doctor before taking EstroGel if you are pregnant, plan to become pregnant, or are breastfeeding.

Recommended dosage for EstroGel

ADULTS

The usual dosage of EstroGel is 1.25 grams (g), or 1 pump, applied to the arm once per day.

Overdosage

Any medication taken in excess can have serious consequences. If you suspect an overdose, seek medical attention immediately.

• Symptoms of EstroGel may overdose include:
  Nausea, vomiting, withdrawal bleeding

Generic Name: Estradiol (ES-tra-DYE-ol)
Brand Name: EstroGel

EstroGel Gel is used for:

Treating moderate to severe symptoms of menopause (eg, hot flashes; vaginal itching, burning, or dryness).

EstroGel Gel is an estrogen hormone. It works by replacing estrogen in the body when it no longer produces enough on its own.

Do NOT use EstroGel Gel if:

• you are allergic to any ingredient in EstroGel Gel
• you are pregnant or suspect you may be pregnant
• you have undiagnosed abnormal vaginal bleeding
• you have a history of blood clots (eg, in the lungs, legs, eyes); endometrial, cervical, or vaginal cancer; estrogen-dependent growths; breast cancer; or liver problems
• you have had a heart attack or stroke within the past 12 months

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

Before using EstroGel Gel:

Some medical conditions may interact with EstroGel Gel. 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 a history of endometriosis, growths in the uterus, abnormal mammogram, abnormal vaginal bleeding, a lump in the breast, or fibrocystic breast disease, or if a family member has had breast cancer
• if you have dementia or other memory problems, or abnormal blood calcium levels
• if you have a history of asthma, cancer, high blood cholesterol or lipid levels, diabetes, heart problems, high blood pressure, heart attack or stroke, kidney problems, liver tumor, mental or mood problems (eg, depression), underactive thyroid, migraine headaches, gallbladder or pancreas problems, seizures (eg, epilepsy), lupus, chorea, or the blood disease porphyria
• if you smoke, are very overweight, or will be having surgery
• if you have a history of yellowing of the eyes or skin during pregnancy or with past estrogen use
• if a member of your family has a history of blood clots (eg, in the legs, lungs, eyes), diabetes, lupus, or obesity
• if you have had your uterus removed (hysterectomy)

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

• Azole antifungals (eg, ketoconazole), HIV protease inhibitors (eg, ritonavir), or macrolide antibiotics (eg, erythromycin) because they may increase the risk of EstroGel Gel’s side effects
• Barbiturates (eg, phenobarbital), carbamazepine, hydantoins (eg, phenytoin), rifampin, or St. John’s wort because they may decrease EstroGel Gel’s effectiveness
• Thyroid hormones (eg, levothyroxine) because their effectiveness may be decreased by EstroGel Gel

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

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

• An extra patient leaflet is available with EstroGel Gel. Talk to your pharmacist if you have questions about this information.
• EstroGel Gel is applied to the area between the wrist and shoulder. Apply EstroGel Gel to clean, intact skin only. Be sure the area is completely dry before applying EstroGel Gel.
• Do not apply EstroGel Gel to skin that is irritated or broken. Do not apply it to your face, in or around the vagina, or to your breasts.
• If you take a bath or shower, or use a sauna around the time of your dose, apply EstroGel Gel afterwards. Be sure the area is completely dry before applying the medicine.
• You must prime the pump before using it for the first time. To do this, remove the cap, unlock the pump, and press down on the spout 2 times. Discard any medicine that comes out by rinsing it down the sink or placing it in the trash can, out of the reach of children and pets. The pump is now ready for use.
• Press the pump firmly and fully to dispense the medicine into the palm of your hand. Apply the medicine to one arm only. Spread it as thinly as possible over the inside and outside of your entire arm from wrist to shoulder. You do not need to rub it in. Replace the cap after each use.
• Wash your hands with soap and water after using EstroGel Gel.
• Allow the medicine to dry for at least 5 minutes before dressing.
• Do not allow others to apply EstroGel Gel for you. Do not allow others to come into contact with the application site for at least 1 hour after you apply EstroGel Gel. If someone else comes into contact with EstroGel Gel, have them wash the area with soap and water right away.
• This pump contains 64 doses. Throw away the pump after 64 doses have been used, even if there is still medicine left in the pump. It may no longer give the correct amount of medicine with each dose.
• Use EstroGel Gel at the same time each day.
• If you miss a dose of EstroGel Gel, use it as soon as possible. If your next dose is less than 12 hours away, 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 EstroGel Gel.

Important safety information:

• EstroGel Gel is for external use only. Do not get it in your eyes, nose, vagina, or mouth. If you get it in any of these areas, rinse right away with warm clean water.
• Check with your doctor before you apply sunscreen to the application site while using EstroGel Gel.
• If you will be swimming, wait for as long as possible before going into the water after applying EstroGel Gel.
• EstroGel Gel is flammable. Avoid fire, flame, or smoking until the medicine has dried on your skin.
• Eating grapefruit or drinking grapefruit juice may increase the risk of EstroGel Gel’s side effects. Talk to your doctor before including grapefruit or grapefruit juice in your diet while you are taking EstroGel Gel.
• Tell your doctor or dentist that you take EstroGel Gel before you receive any medical or dental care, emergency care, or surgery. If possible, EstroGel Gel should be stopped at least 4 to 6 weeks before surgery or any time you might be confined to a bed or chair for a long period of time (such as a long plane flight, car ride, bedrest, or illness).
• EstroGel Gel may cause dark skin patches on your face. Exposure to the sun may make these patches darker. If patches develop, use a sunscreen or wear protective clothing when exposed to the sun, sunlamps, or tanning booths.
• If you wear contact lenses and you develop problems with them, contact your doctor.
• Diabetes patients – EstroGel Gel may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
• EstroGel Gel may interfere with certain lab tests. Be sure your doctor and lab personnel know you are using EstroGel Gel.
• Lab tests and medical exams, including breast exams, mammograms, Pap tests, physicals, and blood pressure, may be performed while you use EstroGel Gel. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• Examine your breasts monthly as directed by your doctor. Report any lumps right away.
• EstroGel Gel should not be used in CHILDREN; safety and effectiveness in children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: Do not use EstroGel Gel if you are pregnant. If you think you may be pregnant, contact your doctor right away. EstroGel Gel is found in breast milk. If you are or will be breast-feeding while you use EstroGel Gel, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of EstroGel Gel:

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:

Breast pain or tenderness; headache; mild hair loss; mild nausea or vomiting; spotting or breakthrough bleeding; stomach cramps or bloating.

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; unusual hoarseness); blurred or double vision, vision loss, or other vision changes; breast lump or discharge; calf or leg pain or swelling; chest pain; confusion; coughing up blood; fainting; memory problems; mental or mood changes (eg, depression); migraine headache; numbness of an arm or leg; one-sided weakness; persistent or recurring abnormal vaginal bleeding; severe or persistent headache or dizziness; severe or persistent stomach pain, nausea, or vomiting; shortness of breath; slurred speech; swelling of the hands, legs, or feet; vaginal discharge, itching, or odor; 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 abnormal vaginal bleeding; or severe or persistent nausea or vomiting.

Proper storage of EstroGel Gel:

Store EstroGel Gel at room temperature, between 68 and 77 degrees F (20 and 25 degrees C) with the cap secured. 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 EstroGel Gel out of the reach of children and away from pets.

General information:

• If you have any questions about EstroGel Gel, please talk with your doctor, pharmacist, or other health care provider.
• EstroGel Gel 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 EstroGel Gel. 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.

Pronunciation: (ESS-truh-muss-TEEN)
Class: Nitrogen mustard

Trade Names:
Emcyt
- Capsules for oral use 140 mg estramustine phosphate.

Pharmacology

Estramustine appears to act as a relatively weak alkylating agent and imparts a weak estrogenic activity. The estrogenic portion of the molecule acts as a carrier to facilitate selective uptake of the drug into estrogen receptor-positive cells. Because of the selective steroidal uptake, the alkylating effect of the nitrogen mustard is enhanced in these cells. Estramustine phosphate is readily dephosphorylated during absorption, and the major metabolites in plasma are estramustine, the estrone analog, estradiol, and estrone. Terminal half-life of estramustine phosphate is approximately 20 h and mainly excreted in the stool.

Pharmacokinetics

Metabolism

Readily dephosphorylated during absorption; major metabolites in plasma are estramustine, the estrone analog, estradiol, and estrone.

Elimination

The t _1/2 is approximately 20 h. Majority excreted in the feces.

Special Populations

Hepatic Function Impairment

May be poorly metabolized in these patients.

Indications and Usage

Palliative therapy of metastatic or progressive prostate cancer.

Unlabeled Uses

Metastatic renal cell carcinoma.

Contraindications

Hypersensitivity to estradiol or nitrogen mustard; active thrombophlebitis or thromboembolic disorders, except where the actual tumor mass is the cause of the thromboembolic phenomenon and the benefits of therapy outweigh the risks.

Dosage and Administration

Prostate Cancer
Adults

PO 14 mg/kg/day (range, 10 to 16 mg/kg/day) in 3 to 4 divided doses for 30 to 90 days before assessing for continuation of therapy. Continue therapy as long as response is favorable.

General Advice

Administer PO with water 1 h or more before or 2 h after meals.

Storage/Stability

Refrigerate. Capsules may be stored at room temperature for 24 to 48 h without affecting potency. Protect from light.

Drug Interactions

Food

Milk, milk products, and calcium-rich foods or antacids may impair the absorption of estramustine.

Laboratory Test Interactions

Abnormalities of hepatic enzymes and of bilirubin have occurred but have seldom required cessation of therapy. Perform such tests at appropriate intervals during therapy and repeat after the drug has been withdrawn for 2 mo.

Adverse Reactions

Cardiovascular

Hypertension; CHF; edema; increased risk of cerebrovascular accident; MI, thrombosis.

CNS

Lethargy; emotional lability; insomnia.

Dermatologic

Rash; pruritus; dry skin; easy bruising.

Endocrine

Decreased glucose tolerance; breast tenderness or enlargement.

GI

Nausea; vomiting; diarrhea; anorexia; flatulence; elevated LFTs.

Genitourinary

Decreased glucose tolerance; gonadal suppression; breast tenderness; breast enlargement.

Hematologic

Leukopenia and thrombocytopenia have been reported in a small number of patients.

Musculoskeletal

Leg cramps.

Respiratory

Dyspnea.

Precautions

Children

Safety and efficacy not established.

Hepatic Function

Estramustine may be poorly metabolized in patients with impaired liver function.

Mutagenesis

Both estradiol and nitrogen mustard are mutagenic. Advise use of contraceptive measures.

Thrombosis

The risk of thrombosis including nonfatal MI, increases in men receiving estrogens for prostate cancer. Use with caution in patients with a history of thrombophlebitis, thrombosis, or thromboembolic disorders, especially if associated with estrogen therapy. Use with caution in patients with cerebral vascular or coronary artery disease.

Glucose tolerance

Tolerance to glucose may be decreased. Monitor blood sugar in diabetic patient when therapy is started. Report significant changes to health care provider.

Elevated BP

BP elevation may occur. Monitor BP periodically while on estramustine.

Fluid retention

Exacerbation of preexisting or incipient peripheral edema or CHD may occur.

Calcium/Phosphorus metabolism

Calcium/phosphorus metabolism may be influenced. Use with caution in patients with metabolic bone disease associated with hypercalcemia or in patients with renal function impairment.

Patient Information

• Use contraceptive measures during therapy because of the possibility of mutagenic effects.
• Milk, milk products, and calcium-rich foods or antacids may impair the absorption of estramustine.
• Take with water at least 1 h before or 2 h after meals.

Copyright © 2009 Wolters Kluwer Health.

Generic name: Estradiol topical lotion Brand names: Estrasorb Why is Estrasorb prescribed? Estrasorb is a topical lotion that contains the hormone estrogen. It’s used to reduce the symptoms of moderate to severe hot flashes associated with menopause. The most common symptoms during a hot flash include sudden sweating, intense feelings of body heat, and sudden feelings of warmth spreading to the face, neck, and chest. Most important fact about Estrasorb Because estrogens have been linked with an increased risk of endometrial cancer (cancer in the lining of the uterus), it is essential to have regular checkups and to report any unusual vaginal bleeding to your doctor immediately. How should you take Estrasorb? Estrasorb lotion is packaged in foil pouches. Do not open the pouches until just before you’re ready to use Estrasorb. Apply Estrasorb in the morning. Be sure your skin is dry before applying the lotion, and do not rub it on skin that is red or irritated. Cut or tear open one pouch and apply the contents to your left thigh. Rub the lotion into your entire left thigh and calf for 3 minutes until Estrasorb is absorbed. You can rub any excess lotion remaining on your hands onto your buttocks. When you’re done with the left leg, cut or tear open a second pouch and follow the same procedure on your right thigh and calf. Be sure to use all of the lotion in each pouch. Wash your hands with soap and water when you’re finished. Allow the application sites to dry completely before putting on clothes. The legs are the only application sites recommended by the drug’s manufacturer. It is not known if Estrasorb will be absorbed as well if it’s applied to other parts of the body. Do not apply Estrasorb and sunscreen at the same time, since sunscreen may affect how much of Estrasorb you absorb. –If you miss a dose… If you forget to apply Estrasorb in the morning, do it as soon as you remember. Do not apply Estrasorb more than once a day. –Storage instructions… Store the pouches at room temperature. Estrasorb side effects Side effects cannot be anticipated. If any develop or change in intensity, tell your doctor as soon as possible. Only your doctor can determine if it is safe to continue using Estrasorb. Side effects may include: Abdominal cramps, bloating, breast pain, hair loss, headache, infection, irregular vaginal bleeding or spotting, itchy spots, nausea and vomiting, problems with the lining of the uterus (endometrium), sinus inflammation, skin irritation at the application site This side effects list is not complete. If you have any questions about side effects you should consult your doctor. Report any new or continuing symptoms to your doctor right away. Why should Estrasorb not be prescribed? You should not use estrogen products, including Estrasorb, if you have any of the following: Unexplained genital bleeding A history of breast cancer or any other cancer stimulated by estrogen (or a possibility that you have this type of cancer) A history of blood clots, especially in the legs or lungs Active or recent (within the past year) blood-vessel disease such as stroke or heart attack Liver disease or poor liver function Known or suspected pregnancy Allergic reaction to Estrasorb or any of its ingredients Special warnings about Estrasorb Estrogen therapy may increase the risk of heart disease, stroke, and blood clots. It could also increase the risk of certain cancers, including breast, uterine, and ovarian cancer. (Combination products that also contain progestin pose less risk of uterine cancer, but increase the risk of breast cancer.) If you are in danger of developing any of these, your doctor should take a complete medical and family history–and do a complete physical exam–before prescribing Estrasorb. As a general rule, you should have an examination at least once a year while using this product. Estrogen therapy may also increase the risk of gallbladder disease and high calcium levels (hypercalcemia). Serious eye problems, including blood clots in the retina, have been reported during estrogen therapy. Contact your doctor immediately if you suddenly lose all or part of your vision or you develop any eye problems. Also tell your doctor if you suddenly develop migraines, which could be related to eye problems. Use Estrasorb with caution if you have a history of high blood pressure, endometriosis, liver problems, jaundice, or low calcium levels (hypocalcemia). Also be cautious if you have cholesterol problems, since using estrogen could trigger a spike in your triglyceride levels and possibly damage the pancreas. While taking estrogen, get in touch with your doctor right away if you notice any of the following: Abdominal pain, tenderness, or swelling Abnormal bleeding from the vagina Breast lumps Coughing up blood Difficulty with speech Dizziness or fainting Pain in your chest or calves Severe headache or vomiting Sudden shortness of breath Vision changes Weakness or numbness of an arm or leg Yellowing of the skin or eyes Because estrogen can affect the ability to handle blood sugar, diabetic women should use this product with caution. Be alert, too, for signs of fluid retention, which can be especially harmful for people with a heart condition or kidney problems. Estrogen can also worsen the symptoms of asthma, epilepsy, migraine, lupus, and the genetic disorder porphyria. Estrogen could interfere with thyroid hormone metabolism. Tell your doctor if you have thyroid problems or are taking thyroid hormone, since you may need your dosage increased. If you’re having surgery or need long periods of bed rest, you should stop taking Estrasorb at least 4 to 6 weeks beforehand to avoid the risk of blood clots. Possible food and drug interactions when using Estrasorb If you take certain other drugs while using estrogen, the effects of either could be increased, decreased, or altered. It is especially important to check with your doctor before taking the following: Carbamazepine (Tegretol) Clarithromycin (Biaxin) Erythromycin (E-Mycin, Ery-Tab, Erythrocin) Grapefruit juice Itraconazole (Sporanox) Ketoconazole (Nizoral) Phenobarbital Rifampin (Rifadin) Ritonavir (Norvir) St. John’s wort Special information if you are pregnant or breastfeeding Estrasorb must not be used during pregnancy. Estrasorb does appear in breast milk. If Estrasorb is essential to your health, you may have to quit breastfeeding until your treatment is finished. Recommended dosage for Estrasorb The recommended daily dose is two lotion-filled pouches, one applied to each leg every morning. Two pouches deliver 3.48 grams of estrogen. Overdosage No serious side effects have been reported after oral overdoses of estrogen-containing products. An oral overdose of estrogen could be expected to cause nausea, vomiting, or vaginal bleeding.

Generic Name: Estradiol (ES-tra-DYE-ol)
Brand Name: Estrasorb

Estrasorb Emulsion is used for:

Treating conditions due to menopause (eg, hot flashes; vaginal itching, burning, or dryness).

Estrasorb Emulsion is an estrogen hormone used to provide the female hormone when the body no longer produces enough.

Do NOT use Estrasorb Emulsion if:

• you are allergic to any ingredient in Estrasorb Emulsion
• you are pregnant or suspect you may be pregnant, have recently given birth or are breast-feeding, have vaginal bleeding of abnormal or unknown cause, or have cancer of the uterus
• you have known or suspected breast cancer (unless directed by your doctor) or you have cancers that are estrogen-dependent
• you have blood clots, circulation disorders, or liver problems
• you have had a recent heart attack or stroke

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

Before using Estrasorb Emulsion:

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

• if you are planning to become pregnant
• 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 a family history of breast cancer, or you have breast lumps or disease, or an abnormal mammogram
• if you have yellowing of the whites of the eyes or skin during pregnancy or with past estrogen use, or high blood pressure during pregnancy (toxemia)
• if you have a vaginal infection or womb problems (eg, uterine fibroids/endometriosis, abnormal vaginal bleeding, other uterine problems)
• if you have abnormal calcium levels in the blood, asthma, cancer, certain blood disorder (porphyria), cholesterol or lipid problems, depression, diabetes, epilepsy, excessive weight gain, gallbladder disease, heart disease or other heart problems, high blood pressure, kidney or liver disease, low thyroid hormone levels, lupus, migraine headaches, pancreas disease, seizures, or yellowing of the skin or eyes
• if you smoke or will be having surgery

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

• Anticoagulants (eg, warfarin), corticosteroids (eg, prednisone), succinylcholine, or tacrine because their actions and the risk of their side effects may be increased by Estrasorb Emulsion
• Anticoagulants (eg, warfarin) because their effectiveness may be decreased by Estrasorb Emulsion
• Barbiturates (eg, phenobarbital), hydantoins (eg, phenytoin), or rifampin because they may decrease Estrasorb Emulsion’s effectiveness

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

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

• An extra patient leaflet is available with Estrasorb Emulsion. Talk to your pharmacist if you have questions about this information.
• If you are switching from oral estrogen to Estrasorb Emulsion, stop taking the oral estrogen and wait 1 week before using Estrasorb Emulsion. However, if symptoms return, you may start using Estrasorb Emulsion sooner.
• Wash your hands with soap and water both before and after using Estrasorb Emulsion.
• Sit in a comfortable sitting position and apply Estrasorb Emulsion to clean, dry skin of the leg. Cut or tear the pouch of medicine and empty the entire contents of the pouch onto the top of the thigh. Rub the medicine in well into the thigh and calf of the leg for 3 minutes until it is completely absorbed. Rub any medicine remaining on the hands onto the buttocks. If you are using two pouches of Estrasorb Emulsion, apply the second pouch of medicine to the opposite leg in the same way.
• Grapefruit and grapefruit juice may increase the risk of Estrasorb Emulsion’s side effects. Talk to your doctor before including grapefruit or grapefruit juice in your diet while you are taking Estrasorb Emulsion.
• If you miss a dose of Estrasorb Emulsion, 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 Estrasorb Emulsion.

Important safety information:

• Estrasorb Emulsion may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Estrasorb Emulsion with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Limit alcoholic beverages while you are using Estrasorb Emulsion.
• Estrasorb Emulsion 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.
• Estrasorb Emulsion may increase the risk of blood clots. The risk may be greater if you smoke (especially in women older than 35 years of age).
• Contact your doctor if vaginal bleeding of unknown cause occurs. This could be a sign of a serious condition requiring immediate medical attention.
• Contact your doctor if vaginal discomfort occurs or if you suspect you have developed an infection while taking Estrasorb Emulsion.
• Follow your doctor’s instructions for examining your breasts, and report any lumps immediately.
• If you wear contact lenses and you develop problems with them, contact your doctor.
• If you will be having surgery or will be confined to a chair or bed for a long period of time (eg, a long plane flight), notify your doctor beforehand. Special precautions may need to be taken in these circumstances while you are taking Estrasorb Emulsion.
• Nonprescription therapy to help prevent bone loss includes a weight-bearing exercise plan, as well as adequate daily calcium and vitamin D intake. Consult your doctor or pharmacist for more details.
• Estrasorb Emulsion may increase the risk of breast and endometrial cancer.
• Diabetes patients – Estrasorb Emulsion may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
• Estrasorb Emulsion may interfere with certain lab tests. Be sure your doctor and lab personnel know you are using Estrasorb Emulsion.
• Lab tests, including physical exams and blood pressure, may be performed while you use Estrasorb Emulsion. You should have breast and pelvic exams, and a Pap test at least once a year. You should also have periodic mammograms as determined by your doctor. Be sure to keep all doctor and lab appointments.
• Estrasorb Emulsion should not be used in CHILDREN; safety and effectiveness in children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: Do not use Estrasorb Emulsion if you are pregnant. Avoid becoming pregnant while you are taking it. If you think you may be pregnant, contact your doctor right away. Estrasorb Emulsion may be found in breast milk. If you are or will be breast-feeding while you use Estrasorb Emulsion, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Estrasorb Emulsion:

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:

Breast pain or tenderness; headache; hair loss; mild nausea or vomiting; spotting or breakthrough bleeding; stomach cramps or bloating.

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); back pain;breast discharge or lump in the breast; calf or leg pain or swelling; chest pain; coughing up blood; dark urine; depression; dizziness; fainting; fever; memory problems; mental or mood changes; muscle pain; one-sided weakness; painful or difficult urination; persistent or severe breast pain or tenderness; persistent or severe headache, nausea, or vomiting; severe stomach pain or swelling; slurred speech; sudden shortness of breath; sunburn-like rash; swelling of hands, legs, or feet; unusual vaginal bleeding, discharge, itching, or odor; vision changes; vomiting; 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; severe nausea; vomiting.

Proper storage of Estrasorb Emulsion:

Store Estrasorb Emulsion at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store in original packaging until just before use. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Estrasorb Emulsion out of the reach of children and away from pets.

General information:

• If you have any questions about Estrasorb Emulsion, please talk with your doctor, pharmacist, or other health care provider.
• Estrasorb Emulsion 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 Estrasorb Emulsion. 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: esterified estrogens (ess TER ih fied ESS troe jenz)
Brand Names: Estratab, Menest

What are Estratab (esterified estrogens)?

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

Esterified estrogens are naturally occurring female sex hormones that are used to treat symptoms of menopause; deficiency in ovary function (including underdevelopment of female sexual characteristics and some types of infertility); some types of breast cancer in men and in postmenopausal women; degeneration of the vagina; and urethra and prostate cancer. In addition, esterified estrogens are used to prevent osteoporosis.

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

What is the most important information I should know about Estratab (esterified estrogens)?

Esterified estrogens increase the risk of developing a condition (endometrial hyperplasia) that may lead to cancer of the lining of the uterus. Taking progestins, another hormone drug, with esterified estrogens lowers the risk of developing this condition. Therefore, if your uterus has not been removed, your doctor may prescribe a progestin for you to take together with the estrogen. Visit your doctor regularly and report any unusual vaginal bleeding right away.

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

Do not take esterified estrogens if you are pregnant.

Who should not take Estratab (esterified estrogens)?

Do not take esterified estrogens without first talking to your doctor if you have

• a circulation, bleeding, or blood-clotting disorder;

• undiagnosed, abnormal vaginal bleeding; or

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

Taking esterified estrogens may be dangerous in some cases if you have any of the conditions listed above.

Before taking esterified estrogens, tell your doctor if you have

• high blood pressure, angina, or heart disease;

• high levels of cholesterol or triglycerides in your blood;

• liver disease;
• kidney disease;

• asthma;

• epilepsy;

• migraines;

• diabetes;

• depression;

• gallbladder disease;

• uterine fibroids; or

• had a hysterectomy (uterus removed).

You may not be able to take esterified estrogens, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.

Esterified estrogens are in the FDA pregnancy category X. This means that esterified estrogens will cause birth defects in an unborn baby. Do not take this medication if you are pregnant or are planning a pregnancy. Esterified estrogens 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 Estratab (esterified estrogens)?

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 esterified estrogens with food or milk to lessen stomach upset.

Try to take every dose at the same time each day. 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 esterified estrogens to treat cancer, you may be taking it several times a day in very large doses.

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

Store esterified estrogens 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 overdose of esterified estrogens include nausea, vomiting, and breakthrough bleeding in females.

What should I avoid while taking Estratab (esterified estrogens)?

There are no restrictions on food, beverages, or activity while taking esterified estrogens unless your doctor directs otherwise.

Estratab (esterified estrogens) side effects

If you experience any of the following serious side effects, stop taking esterified estrogens 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 esterified estrogens and talk to your doctor if you experience

• decreased appetite, nausea, or vomiting;

• swollen or tender breasts;

• acne or skin color changes;

• decreased sex drive;

• migraine headaches or dizziness;

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

• problems with wearing contact lenses;

• depression; or

• changes in your menstrual cycle or breakthrough bleeding.

Esterified estrogens increase the risk of developing a condition (endometrial hyperplasia) that may lead to cancer of the lining of the uterus. Taking progestins, another hormone drug, with esterified estrogens lowers the risk of developing this condition. Therefore, if your uterus has not been removed, your doctor may prescribe a progestin for you to take together with the estrogen. Visit your doctor regularly and report any unusual vaginal bleeding right away.

It is unclear to what extent estrogen treatments may affect the risk of breast cancer.

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 Estratab (esterified estrogens)?

Before taking esterified estrogens, tell your doctor if you are taking any of the following medicines:

• an anticoagulant (blood thinner) such as warfarin (Coumadin);

• a thyroid medication such as Synthroid, Levoxyl, Levothroid, and others;

• insulin or an oral diabetes medicine such as glipizide (Glucotrol) or glyburide (Diabeta, Micronase);

• tamoxifen (Nolvadex);

• didanosine (Videx);

• phenytoin (Dilantin) or ethotoin (Peganone);

• carbamazepine (Tegretol);

• phenobarbital (Solfoton, Luminal);

• primidone (Mysoline); or

• rifampin (Rifadin).

A dosage adjustment or special monitoring may be required during treatment if you are taking any of the medicines listed above.

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

Where can I get more information?

• Your pharmacist has additional information about esterified estrogens written for health professionals that you may read.

• 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: 4/12/2009 4:37:35 PM.

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 Estratest (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 Estratest (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 Estratest (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 Estratest (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 Estratest (esterified estrogens and methyltestosterone)?

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

Estratest (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 Estratest (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: 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 Estratest H.S. (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 Estratest H.S. (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 Estratest H.S. (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 Estratest H.S. (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 Estratest H.S. (esterified estrogens and methyltestosterone)?

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

Estratest H.S. (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 Estratest H.S. (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.

Pronunciation: (ES-tra-dye-ole/droh-SYPE-re-none)
Class: Estrogen and progestin combined

Trade Names:
Angeliq
- Tablets estradiol 1 mg/drospirenone 0.5 mg

Yasmin 21 (Canada)
Yasmin 28 (Canada)

Indications and Usage

Treatment of moderate to severe vasomotor symptoms associated with menopause; treatment of moderate to severe symptoms of vulvar and vaginal atrophy associated with menopause.

Contraindications

Known or suspected pregnancy; undiagnosed abnormal genital bleeding; known, suspected, or history of cancer of the breast; known or suspected estrogen-dependent neoplasm; active deep vein thrombosis, pulmonary embolism, or history of these conditions; active or recent (eg, within past year) arterial thromboembolic disease (eg, MI, stroke); renal insufficiency; liver dysfunction or disease; adrenal insufficiency; hypersensitivity to any component of the product.

Dosage and Administration

Adults

PO 1 tablet daily.

Storage/Stability

Store at 59° to 86°F.

Drug Interactions

Corticosteroids

May result in an increase in the pharmacologic and toxicologic effects of corticosteroids.

Drugs affecting electrolytes (eg, angiotensin-converting enzyme inhibitors, angiotensin receptor blockers, diuretics, NSAIDs)

Potential increase in serum potassium.

Hydantoins (eg, phenytoin)

Possible loss of seizure control.

Inducers of CYP3A4 (eg, carbamazepine, modafinil, NNRT inhibitors [eg, nevirapine], phenobarbital, phenytoin, rifampin, St. John’s wort)

Estrogen plasma concentrations may be reduced, decreasing the therapeutic effects and changing the uterine bleeding profile.

Inhibitors of CYP3A4 (eg, clarithromycin, erythromycin, grapefruit juice, itraconazole, ketoconazole, ritonavir)

Estrogen plasma concentrations may be elevated, increasing the risk of adverse reactions.

Thyroid hormones

Serum-free thyroxine concentration may be decreased, increasing the need for thyroid hormone.

Topiramate

May reduce estrogen concentration, decreasing the efficacy.

Laboratory Test Interactions

Decreased

Decreased antithrombin III activity; decreased levels of anti-factor Xa and antithrombin III; decreased free hormone concentrations; impaired glucose tolerance; reduced LDL; reduced response to metyrapone test; T ₃ resin uptake is decreased.

Increased

Increased activated partial thromboplastin time, platelet aggregation time, and PT; increased platelet count; increased factors II, VII antigen, VIII antigen, VIII coagulation activity, IX, X, XII, VII-X complex, II-VII-X complex, and beta thromboglobulin; increased levels of fibrinogen activity; increased plasminogen antigen and activity; increased thyroid-binding globulin (TBG) leading to increased circulating total thyroid hormone; increased corticosteroid binding globulin; increased sex hormone binding globulin; increased angiotensinogen/rennin substrate, alpha-1-antitrypsin, ceruloplasmin; increased TBG and levels of various other lipids and lipoproteins may be affected.

Adverse Reactions

Cardiovascular

Deep and superficial venous thrombosis; increased BP; MI; pulmonary embolism; stroke; thrombophlebitis.

CNS

Headache (10%); changes in libido; chorea; dementia; dizziness; exacerbation of epilepsy; irritability; mental depression; migraine; mood disturbances; nervousness.

Dermatologic

Chloasma or melasma; erythema multiforme; erythema nodosum; hemorrhagic eruption; hirsutism; loss of scalp hair; pruritus; rash.

EENT

Intolerance to contact lenses; retinal vascular thrombosis.

GI

Abdominal pain (11%); enlarged abdomen (7%); abdominal cramps; bloating; gallbladder disease; nausea; pancreatitis; vomiting.

Genitourinary

Breast pain (19%); vaginal hemorrhage (9%); endometrial disorder (2%); leukorrhea (1%); abnormal withdrawal bleeding or flow; breakthrough bleeding; breast cancer; breast enlargement, pain, and tenderness; changes in amount of cervical secretion, cervical ectropion, or vaginal bleeding pattern; dysmenorrhea; endometrial cancer; endometrial hyperplasia; fibrocystic breast changes; galactorrhea; increased size of uterine leiomyomata; nipple discharge; ovarian cancer; spotting; vaginitis, including vaginal candidiasis.

Hepatic

Cholestatic jaundice; enlargement of hepatic hemangiomas.

Metabolic

Peripheral edema (2%).

Metabolic-Nutritional

Hypocalcemia; increased triglycerides; increased weight; reduced carbohydrate tolerance.

Musculoskeletal

Back pain (7%); arthralgia; leg cramps.

Respiratory

Upper respiratory tract infection (19%); sinusitis (5%).

Miscellaneous

Pain in extremities (8%); decreased weight, flu syndrome (7%); accidental injury (6%); surgery (5%); aggravation of porphyria; anaphylactic/anaphylactoid reactions, including angioedema and urticaria; edema; exacerbation of asthma.

Precautions

Warnings Do not use estrogens for prevention of CV disease or dementia. The Women’s Health Initiative study reported increased risks of MI, stroke, invasive breast cancer, pulmonary emboli, and deep vein thrombosis in postmenopausal women during 5 yr of treatment with oral conjugated estrogens combined with medroxyprogesterone. In addition, increased risk of developing probable dementia in postmenopausal women 65 yr of age and older during 5.2 yr of treatment with conjugated estrogens alone and during 4 yr of treatment with oral conjugated estrogens plus medroxyprogesterone was reported. Although the combination of estradiol/drospirenone was not studied, in the absence of comparable data, assume these risks are similar. Because of these risks, prescribe estrogens with or without progestins at the lowest effective dose and for the shortest duration consistent with treatment goals and risks for the individual woman.

Monitor Monitor BP at regular intervals; monitor blood glucose levels in patients with diabetes. Consider checking potassium levels during the first treatment cycle in patients predisposed to hyperkalemia.

Pregnancy

Category X .

Lactation

Secreted in breast milk.

Children

Not indicated for use in children.

Hepatic Function

Drospirenone Cl may be decreased, and estrogens may be poorly metabolized. Use with caution in patients with history of cholestatic jaundice associated with estrogen use or pregnancy.

Special Risk Patients

Use with caution in patients with asthma, diabetes mellitus, epilepsy, hepatic hemangiomas, migraine, porphyria, and systemic lupus erythematosus.

Elevated BP

Sustained increases in BP have been attributed to idiosyncratic reactions to estrogens.

Endometrial cancer

Use of unopposed estrogens in women with intact uteri has been associated with increased risk of endometrial cancer, which is related to the dose and duration of estrogen therapy.

Endometriosis

May be exacerbated.

Fluid retention

Carefully monitor patients with conditions that might be influenced by fluid retention (eg, cardiac or renal dysfunction) because estrogen and estrogen/progestin therapy may cause fluid retention.

Gallbladder disease

The risk of gallbladder disease requiring surgery is increased 2- to 4-fold.

Hypercalcemia

Estrogen administration may lead to severe hypercalcemia in patients with breast cancer and bone metastases.

Hyperkalemia

Do not use in patients with conditions that predispose them to hyperkalemia (eg, adrenal insufficiency, hepatic or renal function impairment).

Hypertriglyceridemia

In patients with preexisting hypertriglyceridemia, estrogen therapy may be associated with elevations in plasma triglycerides, leading to pancreatitis and other complications.

Hypocalcemia

Use with caution in patients with severe hypocalcemia.

Hyponatremia

Risk may be increased by drospirenone.

Ovarian cancer

The risk may be increased.

Visual abnormalities

Retinal vascular thrombosis may occur, leading to diplopia, loss of vision, migraine, or sudden onset of proptosis.

Overdosage

Symptoms

Altered potassium and sodium plasma concentrations, nausea, withdrawal bleeding in women.

Patient Information

• Advise patients to discuss the patient information leaflet with the health care provider.
• Advise patients to regularly (eg, every 3 to 6 mo) talk with health care provider to assess the need to continue treatment.
• Advise patients who experience breast lumps, changes in speech, changes in vision, chest pain, dizziness, faintness, leg pain, severe headache, shortness of breath, unusual vaginal bleeding, or vomiting to notify health care provider.

Copyright © 2009 Wolters Kluwer Health.

Estradiol/

Levonorgestrel Weekly Patch

Generic Name: Estradiol/Levonorgestrel (ESS-truh-DIE-ole/LEE-voe-nor-jes-trel)
Brand Name: Climara Pro

Estradiol/Levonorgestrel Weekly Patch is used for:

Treating certain symptoms of menopause (eg, hot flashes). It is used to prevent osteoporosis (weak bones) after menopause in certain patients. It may also be used for other conditions as determined by your doctor.

Estradiol/Levonorgestrel Weekly Patch is an estrogen hormone used to provide the female hormone when the body no longer produces enough.

Do NOT use Estradiol/Levonorgestrel Weekly Patch if:

• you are allergic to any ingredient in Estradiol/Levonorgestrel Weekly Patch
• you are pregnant or suspect you may be pregnant, have recently given birth or are breast-feeding, have vaginal bleeding of abnormal or unknown cause, or have cancer of the uterus
• you have known or suspected breast cancer (unless directed by your doctor) or other cancer that is estrogen-dependent
• you have blood clots, circulation disorders, liver problems, or the blood disease porphyria
• you have had a recent heart attack or stroke

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

Before using Estradiol/Levonorgestrel Weekly Patch:

Some medical conditions may interact with Estradiol/Levonorgestrel Weekly 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 substances
• you have breast lumps or disease, an abnormal mammogram, or a family history of breast cancer
• if you have yellowing of the whites of the eyes or skin during pregnancy or with past estrogen use, or high blood pressure during pregnancy (toxemia)
• if you have a vaginal infection or womb problems (eg, uterine fibroids/endometriosis, abnormal vaginal bleeding, other uterine problems)
• if you have abnormal calcium levels in the blood, asthma, cancer, cholesterol or lipid problems, depression, diabetes, epilepsy, excessive weight gain, gallbladder disease, heart disease or other heart problems, high blood pressure, kidney or liver disease, low thyroid hormone levels, lupus, migraine headaches, pancreas disease, seizures, or yellowing of the skin or eyes
• if you smoke or will be having surgery

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

• Anticoagulants (eg, warfarin), corticosteroids (eg, prednisone), tacrine, or succinylcholine because their actions and side effects may be increased by Estradiol/Levonorgestrel Weekly Patch
• Anticoagulants (eg, warfarin) because their effectiveness may be decreased by Estradiol/Levonorgestrel Weekly Patch
• Hydantoins (eg, phenytoin), barbiturates (eg, phenobarbital), or rifampin because they may decrease Estradiol/Levonorgestrel Weekly Patch’s effectiveness

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

Use Estradiol/Levonorgestrel Weekly Patch 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.

• If you are switching from oral estrogen to Estradiol/Levonorgestrel Weekly Patch, stop taking the oral estrogen and wait 1 week before using Estradiol/Levonorgestrel Weekly Patch. However, if symptoms return, you may start using Estradiol/Levonorgestrel Weekly Patch sooner.
• An extra patient leaflet is available with Estradiol/Levonorgestrel Weekly Patch. Talk to your pharmacist if you have questions about this information.
• One patch is usually applied to the skin and worn for 1 week and then replaced. Follow the dosing schedule carefully.
• Do not open the sealed pouch containing the patch until ready to use. Open the pouch and remove the patch from the protective liner. Apply to an area of clean, dry skin on the lower stomach area below the belly button. Press the patch firmly against the skin for about 10 seconds to be sure the patch stays on. If the system lifts, press down to reapply. Wear only 1 system at any one time.
• Do not place the patch on the breast. Make sure the application site is not oily, damaged, or irritated. Avoid applying to the waistline because tight clothing may rub the patch off. Do not put the patch on areas where sitting may loosen it. Do not apply to a site that is exposed to sunlight. Contact with water while bathing, showering, or swimming will not affect the patch.
• When it is time to change the patch, remove it slowly, fold in half (sticky sides together), and throw it away out of the reach of children and away from pets.
• Apply a new patch to a different area to prevent skin irritation. Use a different site when replacing the patch and do not repeat the same site for at least 1 week. If the area around the patch becomes red, itchy, or irritated, try a new site. If the irritation continues or becomes worse, notify your doctor promptly.
• Do not eat grapefruit or drink grapefruit juice while you use Estradiol/Levonorgestrel Weekly Patch.
• If you forget to change the patch as scheduled, change it as soon as possible 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 Estradiol/Levonorgestrel Weekly Patch.

Important safety information:

• Estradiol/Levonorgestrel Weekly Patch may cause dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Estradiol/Levonorgestrel Weekly Patch with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Talk to your doctor before you take Estradiol/Levonorgestrel Weekly Patch if you drink more than 3 drinks with alcohol per day.
• Estradiol/Levonorgestrel Weekly Patch 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.
• Estradiol/Levonorgestrel Weekly Patch may increase the risk of stroke, heart attack, blood clots, high blood pressure, or similar problems. The risk may be greater if you smoke, especially if you are older than 35 years old.
• Contact your doctor if vaginal bleeding of unknown cause occurs. This could be a sign of a serious condition requiring immediate medical attention.
• Contact your doctor if vaginal discomfort occurs or if you suspect you have developed an infection while taking Estradiol/Levonorgestrel Weekly Patch.
• Follow your doctor’s instructions for examining your breasts and report any lumps immediately.
• If you wear contact lenses and you develop problems with them, contact your doctor.
• If you will be having surgery or will be confined to a chair or bed for a long period of time (eg, a long plane flight), notify your doctor beforehand. Special precautions may need to be taken in these circumstances while you are taking Estradiol/Levonorgestrel Weekly Patch.
• Nonprescription therapy to help prevent bone loss includes a weight-bearing exercise plan, as well as adequate daily calcium and vitamin D intake. Consult your doctor or pharmacist for more details.
• Estradiol/Levonorgestrel Weekly Patch may increase the risk of breast and endometrial cancer.
• Diabetes patients – Estradiol/Levonorgestrel Weekly Patch may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
• Estradiol/Levonorgestrel Weekly Patch may affect certain lab test results. Make sure laboratory personnel and your doctors know you take Estradiol/Levonorgestrel Weekly Patch.
• Lab tests, including complete physical exams, breast and pelvic exams, periodic mammograms, Pap smears, and blood pressure measurements, may be performed while you use Estradiol/Levonorgestrel Weekly Patch. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• Estradiol/Levonorgestrel Weekly Patch should not be used in CHILDREN; safety and effectiveness in children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: Do not use Estradiol/Levonorgestrel Weekly Patch if you are pregnant. If you think you may be pregnant, contact your doctor right away. It is not known if Estradiol/Levonorgestrel Weekly Patch if found in breast milk. If you are or will be breast-feeding while you use Estradiol/Levonorgestrel Weekly Patch, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Estradiol/Levonorgestrel Weekly 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:

Headache; irregular vaginal bleeding or spotting; mild breast pain; mild hair loss; nausea; stomach cramps or bloating; vomiting.

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; breast pain; calf pain or tenderness; changes in vision or speech (eg, change in contact lens fit, loss of vision); chest pain; coughing of blood; dizziness; fainting; mental or mood changes (eg, severe depression, memory loss); pain, swelling, or tenderness in the stomach; severe headache or vomiting; severe, persistent, or unusual vaginal bleeding; slurred speech; 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 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; severe nausea; vomiting.

Proper storage of Estradiol/Levonorgestrel Weekly Patch:

Store Estradiol/Levonorgestrel Weekly Patch at room temperature, between 59 and 86 degrees F (15 and 30 degrees C), in the original sealed pouch. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Estradiol/Levonorgestrel Weekly Patch out of the reach of children and away from pets.

General information:

• If you have any questions about Estradiol/Levonorgestrel Weekly Patch, please talk with your doctor, pharmacist, or other health care provider.
• Estradiol/Levonorgestrel Weekly 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 Estradiol/Levonorgestrel Weekly 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.