Essian H.S.

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.

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. 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 medical tests or surgery, or if you will be on bed rest, you may need to stop using this medication for a short time. Any doctor or surgeon who treats you should know that you are taking esterified estrogens and methyltestosterone.

Store at room temperature away from moisture and heat.

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

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, Kaletra).

This list is not complete and other drugs may interact with esterified estrogens and methyltestosterone. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Applies to esterified estrogens / methyltestosterone: oral tablet

Cardiovascular

Cardiovascular side effects have included increased risks of myocardial infarction, pulmonary embolism, deep and superficial venous thrombosis, stroke, and increased blood pressure.[Ref]

Oncologic

Oncologic side effects have included increase risk of breast cancer[Ref]

Genitourinary

Genitourinary side effects have included changes in vaginal bleeding pattern and abnormal withdrawal bleeding or flow, breakthrough bleeding, spotting, dysmenorrhea, increase in size of uterine leiomyomata, vaginitis, including vaginal candidiasis, change in amount of cervical secretion, changes in cervical ectropion, ovarian cancer, endometrial hyperplasia, endometrial cancer, and cystitis-like syndrome. Side effects involving the breasts have included tenderness, enlargement, pain, nipple discharge, galactorrhea, and fibrocystic breast changes. Side effects of androgen therapy are amenorrhea and other menstrual irregularities, and virilization, including deepening of the voice and clitoral enlargement. The latter usually is not reversible after androgens are discontinued.[Ref]

Gastrointestinal

Gastrointestinal side effects have included nausea, vomiting, abdominal cramps, bloating, cholestatic jaundice, increased incidence of gallbladder disease, pancreatitis, and enlargement of hepatic hemangiomas. Additional side effects have included alterations in liver function test, rarely hepatocellular neoplasms, and peliosis hepatis.[Ref]

Dermatologic

Dermatologic side effects have included chloasma or melasma that may persist when drug is discontinued, erythema multiforme, erythema nodosum, hemorrhagic eruption, loss of scalp hair, hirsutism, pruritus, acne, and rash.[Ref]

Ocular

Ocular side effects have included retinal vascular thrombosis, steepening of corneal curvature, and intolerance to contact lenses.[Ref]

Nervous system

Nervous system side effects have included headache, migraine, dizziness, mental depression, chorea, nervousness, mood disturbances, irritability, exacerbation of epilepsy, and dementia. Additional side effects have included increased or decreased libido, headache, anxiety, depression, and generalized paresthesia.[Ref]

Hematologic

Hematologic side effects have included suppression of clotting factors II, V, VII, and X, bleeding in patients on concomitant anticoagulant therapy, polycythemia, and aggravation of porphyria.[Ref]

Hypersensitivity

Hypersensitivity side effects have included urticaria, angioedema, and anaphylactoid/anaphylactic reactions.[Ref]

Respiratory

Respiratory side effects have included exacerbation of asthma.[Ref]

General

General side effects have included increase or decrease in weight, edema, arthralgias, and leg cramps.[Ref]

Metabolic

Metabolic side effects have included reduced carbohydrate tolerance, increased serum cholesterol, retention of sodium, chloride, water, potassium, calcium, and inorganic phosphates.[Ref]

Some side effects of Essian H.S. may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.