Why is estrogen a controlled substance

This information does not take the place of talking to your healthcare provider about your medical condition or your treatment. Esterified Estrogens and Methyltestosterone Full and Half-Strength Tablets are medicines that contain estrogen and androgen hormones. Estrogens should be used at the lowest dose possible for your treatment only as long as needed.

You and your healthcare provider should talk regularly for example, every 3 to 6 months about the dose you are taking and whether you still need treatment with Esterified Estrogens and Methyltestosterone Full and Half-Strength Tablets. Call your healthcare provider right away if you get any of these warning signs, or any other unusual symptom that concerns you.

For more information, ask your healthcare provider or pharmacist. Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not give Esterified Estrogens and Methyltestosterone Full and Half-Strength Tablets to other people, even if they have the same symptoms you have. It may harm them. This leaflet provides a summary of the most important information about Esterified Estrogens and Methyltestosterone Full and Half-Strength Tablets. If you would like more information, talk with your healthcare provider or pharmacist.

You can ask for information about Esterified Estrogens and Methyltestosterone Full and Half-Strength Tablets that is written for health professionals. You can get more information by calling the toll free number DailyMed will deliver notification of updates and additions to Drug Label information currently shown on this site through its RSS feed.

DailyMed will deliver this notification to your desktop, Web browser, or e-mail depending on the RSS Reader you select to use.

Due to inconsistencies between the drug labels on DailyMed and the pill images provided by RxImage , we no longer display the RxImage pill images associated with drug labels. We anticipate reposting the images once we are able identify and filter out images that do not match the information provided in the drug labels. View Package Photos. Drug Label Info. NDC National Drug Code - Each drug product is assigned this unique number which can be found on the drug's outer packaging. Drug Label Information Updated November 27, If you are a consumer or patient please visit this version.

Esterified Estrogens Esterified Estrogens, USP is a mixture of the sodium salts of the sulfate esters of the estrogenic substances, principally estrone, that are of the type excreted by pregnant mares. Methyltestosterone Methyltestosterone, USP is an androgen. Methyltestosterone structural formula:. Estrogens: Endogenous estrogens are largely responsible for the development and maintenance of the female reproductive system and secondary sexual characteristics.

Estrogen Pharmacokinetics Distribution The distribution of exogenous estrogens is similar to that of endogenous estrogens. Androgens: Endogenous androgens are responsible for the normal growth and development of the male sex organs and for maintenance of secondary sex characteristics.

There is no evidence that estrogens are effective for nervous symptoms or depression without associated vasomotor symptoms, and they should not be used to treat such conditions. Esterified Estrogens and Methyltestosterone Full and Half-Strength Tablets should not be used in women with any of the following conditions: 1.

Undiagnosed abnormal genital bleeding. Known, suspected, or history of cancer of the breast. Known or suspected estrogen-dependent neoplasia. Active deep vein thrombosis, pulmonary embolism or history of these conditions. Active or recent e. Liver dysfunction or disease.

Esterified Estrogens and Methyltestosterone Full and Half-Strength Tablets should not be used in patients with known hypersensitivity to its ingredients. Known or suspected pregnancy. There appears to be little or no increased risk of birth defects in children born to women who have used estrogens and progestins from oral contraceptives inadvertently during early pregnancy. Methyltestosterone should not be used in: 1. The presence of severe liver damage. Pregnancy and in breast-feeding mothers because of the possibility of masculinization of the female fetus or breast-fed infant.

Malignant Neoplasms Endometrial Cancer: The use of unopposed estrogens in women with intact uteri has been associated with an increased risk of endometrial cancer. Gallbladder Disease A 2- to 4-fold increase in the risk of gallbladder disease requiring surgery in postmenopausal women receiving estrogens has been reported. Glucose Tolerance A worsening of glucose tolerance has been observed in a significant percentage of patients on estrogen-containing oral contraceptives.

Hypercalcemia Estrogen administration may lead to severe hypercalcemia in patients with breast cancer and bone metastases. Visual Abnormalities Retinal vascular thrombosis has been reported in patients receiving estrogens. Warnings Associated with Methyltestosterone In patients with breast cancer, androgen therapy may cause hypercalcemia by stimulating osteolysis.

General Precautions Associated with Estrogens Addition of a progestin when a woman has not had a hysterectomy : Studies of the addition of a progestin for 10 or more days of a cycle of estrogen administration, or daily with estrogen in a continuous regimen, have reported a lowered incidence of endometrial hyperplasia than would be induced by estrogen treatment alone.

General Precautions Associated with Methyltestosterone 1. Women should be observed for signs of virilization deepening of the voice, hirsutism, acne, clitoromegaly, and menstrual irregularities. Discontinuation of drug therapy at the time of evidence of mild virilism is necessary to prevent irreversible virilization.

Such virilization is usual following androgen use at high doses. Prolonged dosage of androgen may result in sodium and fluid retention. This may present a problem, especially in patients with compromised cardiac reserve or renal disease. Hypersensitivity may occur rarely. Protein-bound iodine PBI may be decreased in patients taking androgens. Hypercalcemia may occur. If this does occur, the drug should be discontinued.

Patient Information Androgens The physician should instruct patients to report any of the following side effects of androgens: Women: Hoarseness, acne, changes in menstrual periods, or more hair on the face.

Laboratory Tests Estrogens Estrogen administration should be initiated at the lowest dose approved for the indication and then guided by clinical response rather than by serum hormone levels e. Laboratory Tests Androgens 1. Women with disseminated breast carcinoma should have frequent determination of urine and serum calcium levels during the course of androgen therapy. Because of the hepatotoxicity associated with the use of alpha-alkylated androgens, liver function tests should be obtained periodically.

Hemoglobin and hematocrit should be checked periodically for polycythemia in patients who are receiving high doses of androgens. Increased thyroid-binding globulin TBG levels leading to increased circulating total thyroid hormone levels as measured by protein-bound iodine PBI , T4 levels by column or by radioimmunoassay or T3 levels by radioimmunoassay.

T3 resin uptake is decreased, reflecting the elevated TBG. Free T4 and free T3 concentrations are unaltered. Patients on thyroid replacement therapy may require higher doses of thyroid hormone.

Other binding proteins may be elevated in serum i. Free hormone concentrations may be decreased. Impaired glucose tolerance. Reduced response to metyrapone test. Drug Interactions Androgens Anticoagulants: C substituted derivatives of testosterone, such as methandrostenolone, have been reported to decrease the anticoagulant requirements of patients receiving oral anticoagulants. Carcinogenesis, Mutagenesis, Impairment of Fertility Estrogens Long-term continuous administration of estrogen, with and without progestin, in women with and without a uterus, has shown an increased risk of endometrial cancer, breast cancer, and ovarian cancer.

Carcinogenesis Androgens Animal Data: Testosterone has been tested by subcutaneous injection and implantation in mice and rats. Nursing Mothers Estrogens Estrogen administration to nursing mothers has been shown to decrease the quantity and quality of the milk. Nursing Mothers Androgens It is not known whether androgens are excreted in human milk.

Geriatric Use Clinical studies of Esterified Estrogens and Methyltestosterone Full and Half-Strength Tablets did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

Associated with Estrogens See WARNINGS regarding induction of neoplasia, adverse effects on the fetus, increased incidence of gallbladder disease, and adverse effects similar to those of oral contraceptives, including thromboembolism. Associated with Methyltestosterone Endocrine and Urogenital Female: The most common side effects of androgen therapy are amenorrhea and other menstrual irregularities, inhibition of gonadotropin secretion, and virilization, including deepening of the voice and clitoral enlargement.

Skin and Appendages: Hirsutism, male pattern of baldness, and acne. Metabolic: Increased serum cholesterol. There have been no reports of acute overdosage with the androgens.

Given cyclically for short-term use only: For treatment of moderate to severe vasomotor symptoms associated with the menopause in patients not improved by estrogen alone. Administration should be cyclic e.

Attempts to discontinue or taper medication should be made at three- to six-month intervals. Usual Dosage Range: 1 tablet of Esterified Estrogens and Methyltestosterone or 1 to 2 tablets of Esterified Estrogens and Methyltestosterone Half-Strength daily as recommended by the physician.

NDC Esterified Estrogens and Methyltestosterone Tablets dark green, capsule shaped, sugar-coated oral tablets contain: 1. Report any unusual vaginal bleeding right away while you are taking estrogens. Vaginal bleeding after menopause may be a warning sign of cancer of the uterus womb.

Your healthcare provider should check any unusual vaginal bleeding to find out the cause. Using estrogens with or without progestins may increase your chances of getting heart attacks, strokes, breast cancer, and blood clots. Using estrogens with progestins may increase your risk of dementia.

You and your healthcare provider should talk regularly about whether you still need treatment with Esterified Estrogens and Methyltestosterone Full and Half-Strength Tablets.

Estrogens are hormones made by a woman's ovaries. The ovaries normally stop making estrogens when a woman is between 45 to 55 years old. This drop in body estrogen levels causes the "change of life" or menopause the end of monthly menstrual periods. Sometimes, both ovaries are removed during an operation before natural menopause takes place. The sudden drop in estrogen levels causes "surgical menopause. In some women, the symptoms are mild, and they will not need estrogens.

In other women, symptoms can be more severe. You and your healthcare provider should talk regularly about whether you still need treatment with Esterified Estrogens and Methyltestosterone Full and Half-Strength Tablets to control these problems. If you use Esterified Estrogens and Methyltestosterone Full and Half-Strength Tablets only to treat your dryness, itching, and burning in and around your vagina, talk with your healthcare provider about whether a topical vaginal product would be better for you.

Estrogens may increase the chances of getting certain types of cancers, including cancer of the breast or uterus. If you have or had cancer, talk with your healthcare provider about whether you should take Esterified Estrogens and Methyltestosterone Full and Half-Strength Tablets.

Your healthcare provider may need to check you more carefully if you have certain conditions, such as asthma wheezing , epilepsy seizures , migraine, endometriosis, lupus, problems with your heart, liver, thyroid, kidneys, or have high calcium levels in your blood. This includes prescription and nonprescription medicines, vitamins, and herbal supplements. Esterified Estrogens and Methyltestosterone Full and Half-Strength Tablets may also affect how your other medicines work.

If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at Before having any laboratory test, tell your doctor and the laboratory personnel that you are taking estrogen.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription. It is important for you to keep a written list of all of the prescription and nonprescription over-the-counter medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements.

You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies. Generic alternatives may be available. Estrogen pronounced as ess' troe jen. Why is this medication prescribed?

How should this medicine be used? Other uses for this medicine What special precautions should I follow? What special dietary instructions should I follow?

What should I do if I forget a dose? What side effects can this medication cause? What should I know about storage and disposal of this medication?

Brand names Brand names of combination products Other names. Talk to your doctor regularly about the risks and benefits of taking estrogen. Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient. Other uses for this medicine. What special precautions should I follow?

Before taking estrogen, tell your doctor and pharmacist if you are allergic to any brand of oral estrogen, any other estrogen products, any other medications, or any of the ingredients in estrogen tablets. Ask your pharmacist or check the manufacturer's patient information for a list of the inactive ingredients in the brand of estrogen tablets you plan to take.

Be sure to mention any of the following: amiodarone Cordarone, Pacerone ; certain antifungals such as itraconazole Sporanox and ketoconazole Nizoral ; aprepitant Emend ; carbamazepine Carbatrol, Epitol, Tegretol ; cimetidine Tagamet ; clarithromycin Biaxin ; cyclosporine Neoral, Sandimmune ; dexamethasone Decadron, Dexpak ; diltiazem Cardizem, Dilacor, Tiazac, others ; erythromycin E.

Your doctor may need to change the doses of your medications or monitor you carefully for side effects. John's wort. If you become pregnant while taking estrogen, call your doctor immediately. Older women should not usually take oral estrogen unless they are also taking other hormones. Oral estrogen taken without other hormones is not as safe or effective as other medications that can be used to treat the same condition.

Estrogen may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away: breast pain or tenderness upset stomach vomiting heartburn constipation diarrhea gas weight gain or loss leg cramps nervousness depression dizziness burning or tingling in the arms or legs tight muscles hair loss unwanted hair growth spotty darkening of the skin on the face difficulty wearing contact lenses swelling, redness, burning, itching, or irritation of the vagina vaginal discharge change in sexual desire cold symptoms Some side effects can be serious.

If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately: bulging eyes sore throat, fever, chills, cough, and other signs of infection pain, swelling, or tenderness in the stomach loss of appetite weakness yellowing of the skin or eyes joint pain movements that are difficult to control rash or blisters hives itching swelling of the eyes, face, tongue, throat, hands, arms, feet, ankles, or lower legs hoarseness difficulty breathing or swallowing Estrogen may increase your risk of developing cancer of the ovaries or gallbladder disease that may need to be treated with surgery.

Symptoms of overdose may include: upset stomach vomiting vaginal bleeding. HHS further noted that ECI's two products contain the same active drug substance in the same amounts and most of the same excipients as eight different products which had previously been exempted from control. HHS thus found that "[f]rom an abuse potential perspective, it is reasonable to conclude that the mixture itself is undesirable," as the mixture contains "estrogen, a hormone that lacks anabolic steroid properties sought by abusers.

Based on "the similarity in formulation, route of administration and dosage strength". Further, after reviewing several law enforcement databases, DEA has found no evidence of significant abuse or trafficking of these types of products.

Based on the evaluation and recommendation of the ASH, as well as DEA having found no evidence of significant abuse or trafficking of these types of products, the Assistant Administrator finds that "because of [their] concentration, preparation, formulation, or delivery system," ECI's Esterified Estrogens and Methyltestosterone 0.

Information on these products is given below. Therefore, the Assistant Administrator, Diversion Control Division, hereby orders that the above products containing anabolic steroids be exempted from application of sections , , , , , , , of the CSA 21 U. These exemptions apply only with respect to the finished products. To the extent ECI handles methyltestosterone in the manufacturing process, because such material remains a controlled anabolic steroid, ECI must comply with all applicable registration, security and recordkeeping requirements set forth in the CSA and DEA regulations.

Pursuant to 21 CFR If any comments or objections raise significant issues regarding any finding of fact or conclusion of law upon which this order is based, the Assistant Administrator, Diversion Control Division, shall immediately suspend the effectiveness of this order until he may reconsider the application in light of the comments and objections filed.

Thereafter, the Assistant Administrator shall reinstate, revoke, or amend his original order as he determines appropriate. The Department of Justice does not endorse the organizations or views represented by this site and takes no responsibility for, and exercises no control over, the accuracy, accessibility, copyright or trademark compliance or legality of the material contained on this site.

Electronic comments: The Drug Enforcement Administration DEA encourages that all comments be submitted electronically through the Federal eRulemaking Portal which provides the ability to type short comments directly into the comment field on the web page or attach a file for lengthier comments.