Important Note

The following information is intended to supplement, not substitute for, the expertise and judgment of your physician, pharmacist or other healthcare professional. It should not be construed to indicate that use of the drug is safe, appropriate, or effective for you. Consult your healthcare professional before using this drug.

DIENESTROL - VAGINAL CREAM

(dye-en-ES-trole)

COMMON BRAND NAME(S): Ortho-Dienestrol

WARNING: Estrogens have been reported to increase the chance of womb (endometrial) cancer in women who have been through menopause, especially in women with a uterus who receive estrogen-only hormone therapy. Estrogens may also increase the risk of cancer of the ovary or breast. Estrogen-containing products should not be used to prevent heart disease. Estrogen given in combination with another hormone (progestin) for replacement therapy can infrequently cause heart disease (e.g., heart attacks), stroke, dementia, serious blood clots (pulmonary embolism and deep venous thrombosis), and cancer of the breast. These risks appear to depend on the length of time this drug is used and the amount of estrogen per dose. Therefore, this medication should be used for the shortest possible length of time at the lowest effective dose so you obtain the benefits and minimize the chance of serious side effects from long-term treatment. Consult your doctor or pharmacist for details. If you use this drug for an extended period, you should be evaluated at least once a year. See Notes section. This medication is not effective in preventing or treating a tendency toward miscarriages (natural habitual abortion), nor the threat of miscarriage. This drug must not be used during pregnancy because its use may result in birth defects or cancer later in the child's life. See Precautions section.

Uses

This medication is a female hormone and is usually given to women who no longer produce the proper amount. It is used to reduce menopause symptoms (e.g., vaginal dryness).

How To Use

Use this medication as prescribed. Follow the instructions and dosing schedule carefully. Fill the applicator with the medication according to directions. Insert the applicator high into the vagina and press the plunger to release the medication. Clean the applicator with warm soapy water and rinse well. Do not boil or use hot water to clean the applicator. Read the Patient Information Leaflet available from your pharmacist. Consult your doctor or pharmacist if you have any questions.

Side Effects

Vaginal irritation, dizziness, lightheadedness, headache, stomach upset, bloating, nausea, weight changes, increased/decreased interest in sex, and breast tenderness may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly. Tell your doctor immediately if any of these unlikely but serious side effects occur: mental/mood changes (e.g., severe depression, memory loss), calf pain/swelling, sudden severe headache, chest pain, trouble breathing, one-sided weakness, slurred speech, vision changes (e.g., change in contact lens fit, loss of vision), breast lumps, swelling of hands or feet, changes in vaginal bleeding (e.g., spotting, breakthrough bleeding or prolonged bleeding), unusual vaginal discharge/itching/odor, yellowing of the eyes or skin. An allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include: rash, itching, swelling, severe dizziness, trouble breathing. If you notice other effects not listed above, contact your doctor or pharmacist.

Precautions

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: undiagnosed abnormal vaginal bleeding, certain cancers (e.g., breast cancer, especially non-metastatic type), blood clots, active/recent stroke or heart attack. Before using this medication, tell your doctor or pharmacist your medical history, especially of: family medical history (especially breast lumps and cancer), asthma, diabetes, seizures, migraine headaches, liver disease, heart disease (e.g., high blood pressure, heart attacks, congestive heart failure), kidney disease, low thyroid hormone (hypothyroidism), abnormal calcium level in the blood, depression, high blood pressure during pregnancy (toxemia), yellowing of eyes and skin (cholestatic jaundice) during pregnancy or with past estrogen use, womb problems (e.g., uterine fibroids, endometriosis), cholesterol or lipid problems, gallbladder disease, excessive weight gain, certain blood disorder (porphyria), any allergies (especially peanut allergy). If you will be having surgery or will be confined to a chair or bed for a long period of time (e.g., a long plane flight), notify your doctor beforehand. Special precautions may need to be taken in these circumstances while you are taking this drug. This drug may make you dizzy; use caution engaging in activities requiring alertness such as driving or using machinery. Limit alcoholic beverages. This drug may cause a patchy darkening of the skin on the face (melasma). Sunlight may intensify this darkening and you may need to avoid prolonged sun exposure and sunlamps. Consult your doctor regarding use of sunscreens and protective clothing. Cigarette smoking can increase the chance of blood clots while taking this medication (especially in women over the age of 35). This medication must not be used during pregnancy. If you become pregnant or think you may be pregnant, inform your doctor immediately. It is unknown if this drug passes into breast milk. Estrogens may have undesirable effects on a nursing infant. Therefore, breast-feeding while using this medication is not recommended.

Drug Interactions

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription products you may use, especially of: other vaginal products. This product can affect the results of certain lab tests. Make sure laboratory personnel and your doctors know you use this drug. Do not start or stop any medicine without doctor or pharmacist approval.

Overdose

If overdose is suspected, contact your local poison control center or emergency room immediately. This medicine may be harmful if swallowed. Symptoms of overdose may include: severe nausea/vomiting or excessive vaginal bleeding.

Notes

Do not share this medication with others. Keep all appointments with your doctor and the laboratory. You should have a complete physical examination, including blood pressure measurements, breast and pelvic examinations, and a PAP test (for vaginal cancer), at least once a year. You should also have periodic mammograms as determined by your doctor. Follow your doctor's instructions for examining your own breasts, and report any lumps immediately.

Missed Dose

If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

Storage

Store at room temperature below 86 degrees F (30 degrees C) away from light and moisture. Do not store in the bathroom. Keep all medicines away from children and pets.