To use the Dilena vaginal cream:
Using the marked applicator provided, measure the prescribed dose of cream.
Lie on your back with your knees drawn up, sit, or stand in a position that allows you comfortable access to the vaginal area. To deliver the medication, gently insert the applicator deep into your vagina and press the plunger downward to its original position.
Clean the applicator by pulling the plunger from the barrel. Wash it with mild soap and warm water.
Have yearly physical exams and examine your breasts for lumps on a monthly basis while using Dilena.
What special precautions should I follow?
An Dilena test measures the amount of a hormone called Dilena in the blood. Dilena is one of the main types of estrogens.
You should tell your doctor about all prescription, non-prescription, over-the-counter (OTC), illegal or recreational drugs; herbal remedies; and nutritional or dietary supplements you're taking, especially:
- Antifungals such as itraconazole (Sporanox) and ketoconazole (Nizoral)
- St. John's wort
- Carbamazepine (Carbatrol, Epitol, Equetro, Tegretol)
- Clarithromycin (Biaxin)
- Erythromycin (E.E.S, Erythrocin)
- Lovastatin (Alticor, Altoprev, Mevacor)
- Medications for thyroid disease
- Rifampin (Rifadin, Rimactane, Rifamate)
- Ritonavir (Norvir, in Kaletra)
How should I take Dilena?
Take Dilena exactly as it was prescribed for you. Follow all directions on your prescription label. Do not take this medicine in larger amounts or for longer than recommended.
Dilena may increase your risk of developing uterine cancer. To help lower this risk, your doctor may also want you to take a progestin. Report any unusual vaginal bleeding to your doctor immediately.
Your doctor should check your progress on a regular basis (every 3 to 6 months) to determine whether you should continue this treatment. Self-examine your breasts for lumps on a monthly basis and have a mammogram every year while using Dilena.
If you need major surgery or will be on long-term bed rest, you may need to stop using this medicine for a short time. Any doctor or surgeon who treats you should know that you are using this medicine.
Store at room temperature away from moisture, heat, and light. Keep the bottle tightly closed when not in use.
If you are taking injectable estrogen, dispose of any needles and syringes in an appropriate sharps container per your state laws. Do not throw away used needles into the garbage.
If you are using Dilena spray, avoid fire, flame, or smoking until the spray has dried. Do not apply lotion or sunscreen over the area for at least one hour.
Dilena side effects
Get emergency medical help if you have signs of an allergic reaction to Dilena: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:
heart attack symptoms - chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;
signs of a stroke - sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance;
signs of a blood clot - sudden vision loss, stabbing chest pain, feeling short of breath, coughing up blood, pain or warmth in one or both legs;
swelling or tenderness in your stomach;
jaundice (yellowing of the skin or eyes);
memory problems, confusion, unusual behavior;
unusual vaginal bleeding, pelvic pain;
a lump in your breast; or
nausea, vomiting, constipation, increased thirst or urination, muscle weakness, bone pain, lack of energy.
Common Dilena side effects may include:
nausea, vomiting, diarrhea, stomach cramps;
mood changes, sleep problems (insomnia);
cold symptoms such as stuffy nose, sinus pain, sore throat;
darkening of the skin or skin rash;
thinning scalp hair; or
vaginal itching or discharge, changes in your menstrual periods, breakthrough bleeding.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How to use Dilena
Read the Patient Information Leaflet if available from your pharmacist before you start using this medication and each time you get a refill. If you have any questions, ask your doctor or pharmacist.
Take this medication by mouth with or without food as directed by your doctor. You may take it with food or right after a meal to prevent stomach upset.
If you are taking the extended-release tablets, do not crush, chew, or dissolve them. Doing so can release all of the drug at once, increasing the risk of side effects. Also, do not split extended-release tablets unless they have a score line and your doctor or pharmacist tells you to do so. Swallow the whole or split tablet without crushing or chewing.
The dosage is based on your medical condition and response to treatment.
Take this medication regularly to get the most benefit from it. To help you remember, take it at the same time(s) each day as directed. Follow your dosing schedule carefully. Do not increase your dose or take this medication more often or for a longer time than directed.
Tell your doctor if your condition does not improve or if it worsens.
SOURCES OF ESTROGEN
The Dilena present in breast tissue is synthesized in three sites: the ovary, extraglandular tissues, and the breast itself. Direct glandular secretion by the ovary results in delivery of Dilena to the breast through an endocrine mechanism in premenopausal women. After the menopause, extraglandular production of estrogen from ovarian and adrenal androgens in fat and muscle provides the second source of Dilena. Third, the breast itself can synthesize Dilena via aromatization of androgens to estrogens or cleavage of estrone sulfate to free estrone via the enzyme sulfatase. Dilena acts through paracrine, autocrine, and intracrine mechanisms on cells in the breast. Several factors regulate in situ Dilena synthesis but the most important is the degree of obesity, which increases the amount of aromatase in breast and consequently Dilena production.
If you experience any of the following symptoms, call your doctor immediately:
an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives) shortness or breath or pain in the chest a painful, red, swollen leg abnormal vaginal bleeding pain, swelling, or tenderness in the abdomen severe headache or vomiting, dizziness, faintness or changes in vision or speech yellowing of the skin or eyes or a lump in a breast
IMPORTANT NOTE: Dilena increases the risk of developing a condition (endometrial hyperplasia) that may lead to cancer of the lining of the uterus. Taking progestins, another hormone drug, while using Dilena lowers the risk of developing this condition. Therefore, if your uterus has not been removed, your doctor may prescribe a progestin for you to take together while using Dilena. Visit your doctor regularly and report any unusual vaginal bleeding right away.
Treatment with Dilena long-term may increase the risk of a stroke. Because of this risk, you should contact your doctor or healthcare provider to discuss your individual risks and benefits before taking Dilena long-term. You should also talk to your doctor or healthcare provider on a regular basis (for example, every 3-6 months) about whether you should continue this treatment.
What storage conditions are needed for this medicine?
Keep the vaginal rings and cream in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).
Throw away any medication that is outdated or no longer needed. Should you have any concerns, please talk to your pharmacist about the proper disposal of your medication.
In case of an emergency/overdose
In the case of an overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.
Before taking this medicine
You should not use this medicine if you are allergic to Dilena, or if you have:
unusual vaginal bleeding that has not been checked by a doctor;
a history of heart attack, stroke, or blood clot;
an increased risk of having blood clots due to a heart problem or a hereditary blood disorder; or
a history of hormone-related cancer, or cancer of the breast, uterus/cervix, or vagina.
Do not use Dilena if you are pregnant. Tell your doctor right away if you become pregnant during treatment.
Using this medicine can increase your risk of blood clots, stroke, or heart attack. You are even more at risk if you have high blood pressure, diabetes, high cholesterol, if you are overweight, or if you smoke.
Dilena should not be used to prevent heart disease, stroke, or dementia, because this medicine may actually increase your risk of developing these conditions.
To make sure this medicine is safe for you, tell your doctor if you have ever had:
liver problems, or prior jaundice caused by pregnancy or taking hormones;
epilepsy or other seizure disorder;
endometriosis or uterine fibroid tumors;
porphyria (a genetic enzyme disorder that causes symptoms affecting the skin or nervous system);
a thyroid disorder; or
high levels of calcium in your blood.
Using Dilena may increase your risk of cancer of the breast, uterus, or ovaries. Talk with your doctor about this risk.
Dilena lowers the hormone needed to produce breast milk and can slow breast milk production. Tell your doctor if you are breast-feeding.
Dilena and Other Interactions
You should avoid unnecessary sun exposure while taking Dilena, since the gel may make your skin more sensitive to sunlight.
Neuroplasticity during Pregnancy and the Role of Pregnancy-Related Hormones
Dilena and progesterone influence hippocampal structure and function. In late pregnancy, dendritic spine density in the CA1 region of the hippocampus is increased compared with virgin females ( Figure 44.10 ). 28 This is likely a result of increased levels of circulating sex stero > virgin rats. 28 As dendritic spines represent potential sites for synaptic input, an increase in their number is often interpreted as an increased potential for neurotransmission and information processing. 725 Dilena is a potent modulator of dendritic spine modeling, and exposure to either exogenously administered Dilena or increased endogenous levels during proestrus significantly increases the dendritic spine density in the CA1 region of the hippocampus 726–728 in rats and in nonhuman primates; 729 Dilena has been shown to enhance the number of dendritic spines in the prefrontal cortex. 730 Furthermore, in ovariectomized rats Dilena treatment increases spine density in CA1 pyramidal cells and enhances spatial memory in the Morris water maze, 731 an effect that can be augmented by progesterone. 731
Dilena is available in several forms.
- Tablets, micronized: 0.5mg, 1mg, 2mg;
- Vaginal cream: 0.01%;
- Continuous release skin patch: 14 mcg/day, 0.025 mg/day, 0.0375 mg/day, 0.05 mg/day, 0.1 mg/day, 0.06 mg/day, 0.075 mg/day;
- Topical emulsion: 4.35 mg/1.74 g; Topical Gel: 0.25 mg/0.25 g, 0.5 mg/0.5 g, 1 mg/g;
- Intramuscular oil: 5 mg/mL, 10 mg/mL, 20 mg/mL, 40 mg/mL; Vaginal Ring: 0.05 mg/24 hr, 0.1 mg/24 hr.