Drug Facts

Type of Drug:

Female hormones; estrogens.

How the Drug Works:

Estrogens represent a group of several female hormones. The ovary produces and releases several natural estrogens until menopaUse occurs. All estrogens produce similar effects. They playa key role in the development and normal function of the reproductive system (inCluding the vagina, uterus, fallopian tubes, and breasts) and secondary sex characteristics (eg, pubic hair) of women. Estrogens also assist in development and maintenance of strong bones.

Uses:

To treat hot flashes associated with menopause. To treat vulval, vaginal, and lower urinary tract tissue breakdoWn drying and thinning following menopause. Estrogen supplements maY prevent or decrease complications. To treat kraurosis vulvae, a condition involving the breakdown a.nd drying of the external female genitalia (vulval area).

For estrogen replacement therapy after a failure of the ovaries due to menopause, disease, or surgical removal.

To treat advanced androgen-dependent cancer of the prostate gland in men.

To relieve the symptoms of breast cancer in selected men and Women with metastatic disease.

Conjugated estrogens, injection: To treat abnormal uterine bleeding caused by hormone imbalance.

Estradiol tablets and transdermal system (patch): To prevent osteoporosis (brittle bones) related to a lack of estrogen after menopause. Therapy should be accompanied by a balanced diet, adequate daily calCium either through the diet or calcium supplements, adequate vitamin D, and weight-bearing exercises.

Unlabeled Uses: Ethinyl estradiol has been used for treating Turner syndrome.

Precautions:

Blood Clots.’ There is an increased risk of blood clots in men receiving estrogens for prostate cancer, in women using estrogens for postpartum breast engorgement, and in those taking oral contraceptives in general.

Cancer Risk: Estrogens may increase the risk of endometrial (lining of the uterus) cancer in postmenopausal women. Have regular physical examinations and contact your doctor if you experience persistent or recur­rent abnormal vaginal bleeding.

Concurrent progestin therapy: A progestin agent is frequently added to long-term estrogen regimens in women who have a uterus. The addition of a progestin reduces the risk of estrogen-induced cancer of the uterus.

History/physical exam: Before beginning estrogen therapy, a complete medical and family history should be performed. Examinations every 12 months should include blood pressure tests, abdomen and pelvic organ examinations, and a Pap test (once a year). Patients should examine their breasts for lumps on a monthly basis. Women older than 40 years of age who take estrogens should have regular mammogram’s.

Pregnancy: Do not use during pregnancy. The risk of use in a pregnant woman clearly outweighs any possible benefit. Urinary system problems and testicular cancer have occurred in sons of women given diethyl­stilbestrol (DES) (not available in the US) during pregnancy. Daughters of women given DES during their pregnancy have shown an increased risk of developing vaginal or cervical cancer.

Breastfeeding: It is not known if estrogens appear in breast milk. Consult your doctor before you begin breastfeeding.

Children: Safety and effectiveness in children have not been established.

Use with extreme caution in young patients who are still growing. Estrogens may interfere with normal bone development.

Tartrazine: Some of these products may contain the dye tartrazine (FD&C Yellow No.5), which can cause allergic reactions in certain individuals. Check package label when available or consult your doctor or pharmacist.

Drug Interactions:

Tell your doctor or pharmacist if you are taking or if you are planning to take any over-the-counter or prescription medications or dietary supplements while taking this medicine. Doses of one or both drugs may need to be modified or a different drug may need to be prescribed. The following drugs and drug classes interact with this medicine:

Side Effects:

Every drug is capable of producing side effects. Many patients experience no, or minor, side effects. The frequency and severity of side effects depend on many factors including dose, duration of therapy, and individual susceptibility. Possible side effects include:

Urinary and Reproductive Tract: Change in menstrual flow; abnormal vaginal bleeding; vaginal discomfort or pain; vaginal infection; unusual vaginal secretions; painful menstruation; absence of menstruation during or after treatment; premenstrual-like syndrome; increased size of uterine fibroids; urinary tract infection symptoms.

Digestive Tract: Nausea; vomiting; stomach pain or cramps; bloating; pancreatitis; diarrhea; gas; enlarged stomach; constipation; indigestion.

Nervous System: Headache; migraine; dizziness; depression; weakness; unusual, jerky body movements; sleeplessness; emotional instability; anxiety; nervousness.

Skin: Rash; hives; itching; skin discoloration, particularly on the face; scalp hair loss; excessive growth of body or facial hair.

Local: Pain at the injection site; redness; irritation or itching at patch application site.

Other: Intolerance to contact lenses; weight changes; breast tenderness or enlargement; breast milk secretion; sudden vision problems; abnormal blood glucose levels; swelling; high blood pressure; changes in sex drive; yellowing of skin or eyes; swelling of the arms or legs; vertigo (feeling of whirling motion); cough; abnormal lab tests; gallbladder disease; blood clots; steepening of corneal curvature; reduced carbohydrate tolerance; liver tumor development; runny nose; back, joint, muscle, or bone pain; sore throat; flu-like symptoms; hot flushes; palpitations (pounding in the chest); leg cramps; abnormal skin sensations

• Guidelines for Use:
• Dosage is individualized.
• Carefully read the patient package insert available with your medicines.
• The lowest dose that will control symptoms should be chosen and medication should be discontinued as soon as possible.
• Notify your doctor immediately if you experience pain in the groin, calves, or chest; sudden shortness of breath; abnormal vaginal bleeding; missed menstrual period or suspected pregnancy; lumps in the breast; severe headache; dizziness; fainting; changes in vision or speech; weakness or numbness in an arm or leg; stomach pain, swelling, or tenderness; yellowing of the skin or eyes; severe depression; severe vomiting; or coughing up blood.
• Fluid retention caused by estrogens may aggravate asthma, epilepsy, migraine, heart disease, or kidney disease. Use with caution if you have any of these conditions.
• If a dose is missed, take it as soon as possible. If several hours have passed or if it is nearing time for the next dose, do not double the dose in order to catch up, unless advised to do so by your doctor. If several doses are missed, or it is necessary to establish a new dosage schedule, contact your doctor or pharmacist.
• While taking estrogens, it is important to visit your doctor at least once a year for a check-up. If members of your family have had breast cancer or if you have ever had breast lumps, you may need to have more frequent breast exams.
• Approximately every 6 months, you and your doctor should reevaluate whether or not you need to continue estrogen therapy.
• Diabetic patients - Glucose tolerance may be decreased. Monitor blood sugar closely and report changes to your doctor.
• When using estrogens to treat hot flashes and other symptoms of menopause, the dose may need to be changed occasionally. Discuss your symptoms with your doctor.
• Inform your doctor if you are pregnant, become pregnant, or are planning to become pregnant or if you are breastfeeding.
• Do not share your medicine with anyone else.
• Brand interchange - Do not change from one brand of these drugs to another without consulting your pharmacist or doctor. Products manufactured by different companies may not be equally effective and will require different doses .
• Injections - Visually inspect solutions for particles or discoloration. If you are self-administering, carefully follow the storage, preparation, and administration instructions provided by your health care provider.
• Transdermal system (patch) - Apply immediately after opening the pouch and removing the protective liner. Press firmly in place with the palm of the hand for approximately 10 seconds. Make sure there is good contact, especially around the edges. Avoid touching the sticky side of the patch with your fingers. Place adhesive side of the system on a clean, dry area of the skin on the trunk of the body that is not exposed to sunlight, preferably the buttocks or the abdomen. Do not apply to the. breasts.

• Transdermal system (patch) (cont.) When it is time to change the patch, remove the old patch and discard. Apply a new patch on a different skin site. Rotate the application site with an interval of at least 1 week between applications to a particular site. The area selected should not be oily, damaged, or irritated. Avoid the waistline since tight clothing may rub the system off. Application to areas where sitting would dislodge the system should also be avoided. In the unlikely event that a system should fall off, the same system may be reapplied. If necessary, apply a new system. In either case, continue the original treatment schedule. If a rash or irritation develops at an application site, remove the patch and reapply at a different site. Contact your doctor if rash or irritation continues with each patch application. Contact with water while bathing, swimming, or showering will not affect the patch.
• Vaginal creams - Fill the applicator provided with the prescribed amount of cream. Insert the applicator high into the vagina. After use, clean applicator by removing the plunger from the barrel. Wash with mild soap and warm water. Do not boil or use hot water. Cream exposure has been reported to weaken latex condoms. The potential for creams to weaken and contribute to the failure of condoms, diaphragms, or cervical caps made of latex or rubber should be considered.
• Vaginal ring — Press the ring into an oval shape and insert as deeply as possible into the upper one-third of the vaginal vault. The ring will remain in place continuously for 3 months, after which it is removed and, if appropriate, replaced by a new ring. The exact position of the ring is not critical, although if you feel discomfort, it is probably not far enough inside the vagina. You should not feel the ring when it is in place and it should not interfere with sexual inter­course. Some women have experienced moving or gliding of the ring in the vagina. Instances of the ring being expelled from the vagina in connection with moving the bowels, strain, or constipation have been reported. If this occurs, the ring can be rinsed in lukewarm water and reinserted into the vagina. The ring should be removed if another intra vaginally administered medication is being used. The ring may be removed by hooking a finger through the ring and pulling it out. Contact your doctor if signs of vaginal irritation develop.
• Calcium - If you are taking calcium supplements as part of the treatment to prevent osteoporosis, check with your doctor about the amounts recommended.
• Storage - Before reconstitution, store the conjugated estrogens injection in the refrigerator (36° to 46°F). Use the reconstituted solution within a few hours. Reconstituted solution is stable for 60 days in the refrigerator. All other dose forms can be stored at controlled room temperature (59° to 86°F).

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