Before Using This Medicine

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

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to androgens, anabolic steroids, or estrogens. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Estrogens (contained in this combination medicine) are not recommended for use during pregnancy, since some estrogens have been shown to cause serious birth defects in humans. Some daughters of women who took diethylstilbestrol (DES) during pregnancy have developed reproductive (genital) tract problems and, rarely, cancer of the vagina and/or uterine cervix when they reached childbearing age. Some sons of women who took DES during pregnancy have developed urinary-genital tract problems.

Androgens (contained in this combination medicine) should not be used during pregnancy because they may cause male-like changes in a female baby.

Breast-feeding—Use of this medicine is not recommended in nursing mothers. Estrogens pass into the breast milk and their possible effect on the baby is not known. It is not known if androgens pass into breast milk. However, androgens may cause unwanted effects in nursing babies such as too early sexual development in males or male-like changes in females.

Older adults—This medicine has been tested and has not been shown to cause different side effects or problems in older women than it does in younger females.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking an androgen and estrogen combination product, it is especially important that your health care professional know if you are taking any of the following:

• Acetaminophen (e.g., Tylenol) (with long-term, high-dose use) or
• Amiodarone (e.g., Cordarone) or
• Anabolic steroids (nandrolone [e.g., Anabolin], oxandrolone [e.g., Anavar], oxymetholone [e.g., Anadrol], stanozolol [e.g., Winstrol]) or
• Anti-infectives by mouth or by injection (medicine for infection) or
• Antithyroid agents (medicine for overactive thyroid) or
• Carbamazepine (e.g., Tegretol) or
• Carmustine (e.g., BiCNU) or
• Chloroquine (e.g., Aralen) or
• Dantrolene (e.g., Dantrium) or
• Daunorubicin (e.g., Cerubidine) or
• Disulfiram (e.g., Antabuse) or
• Divalproex (e.g., Depakote) or
• Etretinate (e.g., Tegison) or
• Gold salts (medicine for arthritis) or
• Hydroxychloroquine (e.g., Plaquenil) or
• Mercaptopurine (e.g., Purinethol) or
• Methotrexate (e.g., Mexate) or
• Methyldopa (e.g., Aldomet) or
• Naltrexone (e.g., Trexan) (with long-term, high-dose use) or
• Phenothiazines (acetophenazine [e.g., Tindal], chlorpromazine [e.g., Thorazine], fluphenazine [e.g., Prolixin], mesoridazine [e.g., Serentil], perphenazine [e.g., Trilafon], prochlorperazine [e.g., Compazine], promazine [e.g., Sparine], promethazine [e.g., Phenergan], thioridazine [e.g., Mellaril], trifluoperazine [e.g., Stelazine], triflupromazine [e.g., Vesprin], trimeprazine [e.g., Temaril]) or
• Phenytoin (e.g., Dilantin) or
• Plicamycin (e.g., Mithracin) or
• Valproic acid (e.g., Depakene)—Androgens, estrogens, and all of these medicines can cause liver damage. Your doctor may want you to have extra blood tests that tell about your liver, while you are taking any of these medicines with an androgen and estrogen combination product.

• Anticoagulants (blood thinners)—Androgens can cause an increased effect of blood thinners, which could lead to uncontrolled or excessive bleeding

• Cyclosporine (e.g., Sandimmune)—Estrogens can increase the chances of toxic effects to the kidney or liver from cyclosporine because estrogens can interfere with the body's ability to get the cyclosporine out of the bloodstream as it normally would

Other medical problems—The presence of other medical problems may affect the use of androgen and estrogen combination products. Make sure you tell your doctor if you have any other medical problems, especially:

• Blood clots (or history of during previous estrogen therapy)—Estrogens may worsen blood clots or cause new clots to form

• Breast cancer (active or suspected)—Estrogens may cause growth of the tumor

• Changes in vaginal bleeding of unknown causes—Some irregular vaginal bleeding is a sign that the lining of the uterus is growing too much or is a sign of cancer of the uterus lining; estrogens may make these conditions worse

• Diabetes mellitus (sugar diabetes)—Androgens can decrease blood sugar levels

• Edema (swelling of feet or lower legs caused by retaining [keeping] too much body water) or
• Heart or circulation disease or
• Kidney disease or
• Liver disease—Androgens can worsen these conditions because androgens cause the body to retain extra fluid (keep too much body water). Also, heart or circulation disease can be worsened by androgens because androgens may increase blood cholesterol levels

• Endometriosis—Estrogens may worsen endometriosis by causing growth of endometriosis implants

• Fibroid tumors of the uterus—Estrogens may cause fibroid tumors to increase in size

• Gallbladder disease or gallstones (or history of)—There is no clear evidence as to whether estrogens increase the risk of gallbladder disease or gallstones

• Jaundice (or history of during pregnancy)—Estrogens use may worsen or cause jaundice in these patients

• Liver disease—Toxic drug effects may occur in patients with liver disease because the body is not able to get this medicine out of the bloodstream as it normally would

• Porphyria—Estrogens can worsen porphyria