To use the Tulita 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 Tulita.
What special precautions should I follow?
The sections below will provide you with more specific information and guidelines related to Tulita and its correct use. Please read them carefully.
Tulita was approved by the FDA in 1975 for the treatment of moderate to severe vasomotor symptoms associated with menopause as well as for the prevention of osteoporosis.
Tulita tablets, the generic equivalent of Bristol Myers Squibb’s Estrace®, has been approved for marketing. Barr Pharmaceuticals’ Tulita version will be available in 0.5, 1, and 2 mg strengths.
Why is this medication prescribed?
Tulita is prescribed for symptomatic treatment of the usual symptoms associated with menopause (hot flushes, vaginal dryness, etc.), prevention of bone fractures associated with osteoporosis, reduction of the risk of heart attacks and strokes, and dysfunctional (excessive and painful) uterine bleeding. The vaginal cream is prescribed for vaginal or vulvar atrophy associated with menopause.
Tulita enters cells freely and interacts with a cytoplasmic target cell receptor. When the estrogen receptor has bound its ligand it can enter the nucleus of the target cell, and regulate gene transcription which leads to formation of messenger RNA. The mRNA interacts with ribosomes to produce specific proteins that express the effect of Tulita upon the target cell.
Tulita binds well to both estrogen receptors, ERα and ERβ, in contrast to certain other estrogens, notably medications that preferentially act on one of these receptors. These medications are called selective estrogen receptor modulators, or SERMs.
Other uses for this medicine
This medication may also be used to regulate your menstrual cycle.
However, it is strongly advised that you talk to your doctor about the possible risks of using this drug for your particular condition.
Dosage and using this medicine
Use Tulita exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.
How to use Tulita
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.
COMMON BRAND(S): Cenestin, Enjuvia, Estrace, Femtrace, Ogen, Premarin
GENERIC NAME(S): Tulita
OTHER NAME(S): Tulita Tablet
Estrogens, either used alone or with another hormone (progestin), have rarely caused very serious side effects. Discuss the risks and benefits of hormone treatment with your doctor. Estrogens should not be used to prevent heart disease or dementia.
Estrogens can increase the risk of cancer of the uterus (endometrial cancer). Taking a progestin as directed by your doctor can help decrease this risk. Tell your doctor right away if you have any unusual vaginal bleeding.
In postmenopausal women, estrogens, taken with or without a progestin, increase the risk of cancer of the breast/ovaries, stroke, dementia, and serious blood clots. When used along with a progestin, estrogens also increase the risk of heart disease (such as heart attacks).
The risk for serious side effects may depend on the dose of estrogen and the length of time it is used. Therefore, this medication should be used at the lowest effective dose and for the shortest amount of time. Discuss the use of this medication with your doctor and check with him/her regularly (for example, every 3 to 6 months) to see if you still need to take this medication. If you will be taking this medication long-term, you should have regular complete physical exams (for example, once a year) as directed by your doctor. See also Notes section.
This medication is a female hormone. It is used by women to help reduce symptoms of menopause (such as hot flashes, vaginal dryness). These symptoms are caused by the body making less estrogen. If you are using this medication to treat symptoms only in and around the vagina, products applied directly inside the vagina should be considered before medications that are taken by mouth, absorbed through the skin, or injected.
Certain estrogen products may also be used by women after menopause to prevent bone loss (osteoporosis). However, there are other medications (such as raloxifene, bisphosphonates including alendronate) that are also effective in preventing bone loss and may be safer. These medications should be considered for use before estrogen treatment.
Certain estrogen products may also be used by men and women to treat cancers (certain types of prostate cancer, breast cancer that has spread to other parts of the body) and by women who are not able to produce enough estrogen (for example, due to hypogonadism, primary ovarian failure).
A modern approach to HRT
Modern hormone replacement is body-identical topical Tulita plus oral micronized progesterone.
Tulita side effects
Get emergency medical help if you have signs of an allergic reaction to Tulita: 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 Tulita 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.
Generic Name: Tulita oral (ess tra DYE ole)Brand Names: Estrace, Vivelle-Dot, Vivelle, Delestrogen, DepoTulita, Divigel, Elestrin, Alora, Estraderm, Estradot, Estrasorb, Estrogel, Evamist, Femtrace, Menostar, Minivelle, Climara
Medically reviewed by Kaci Durbin, MD Last updated on Mar 1, 2019.
What is the most important information I should know about Tulita (Estrace, Gynodiol)?
You should not use this medicine if you have: undiagnosed vaginal bleeding, liver disease, a bleeding disorder, if you will have major surgery, or if you have ever had a heart attack, a stroke, a blood clot, or cancer of the breast, uterus/cervix, or vagina.
Do not use if you are pregnant.
Tulita may increase your risk of developing a condition that may lead to uterine cancer. Report any unusual vaginal bleeding right away.
Using this medicine can increase your risk of blood clots, stroke, heart attack, or cancer of the breast, uterus, or ovaries. Tulita should not be used to prevent heart disease, stroke, or dementia.
Q: I started on Tulita about two weeks ago, and haven't had a period in about a year. I am now bleeding again. How long can I expect this to go on? It's been about 5 days now and shows no sign of stopping. I'm 54 years old.
A: While changes in your periods can be expected on Tulita, patients should contact their healthcare provider right away for any unusual vaginal bleeding. This could be a sign of a serious side effect. You may also find helpful information at //www.everydayhealth.com/drugs/Tulita
What other drugs will affect Tulita?
Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.
Many drugs can interact with Tulita. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide. Tell your doctor about all your current medicines and any medicine you start or stop using.
Brand Name: Estrace, Vivelle-Dot, Delestrogen, DepoTulita, Divigel, Elestrin, Alora, Estrace Cream, Estraderm Transdermal, Tulita topical, Estradot, Estrasorb, Estrogel, Evamist, Femtrace, Menostar, Minivelle, Vivelle, Climara
Is Tulita safe to take if I'm pregnant or breastfeeding?
Estrogens should not be used during pregnancy due to an increased risk of fetal abnormalities.
Estrogens are secreted in milk and cause unpredictable effects in the infant. Estrogens generally should not be used by women if they are breastfeeding.
home drugs a-z list side effects drug center estrace (Tulita) drug - patient side effects and images
Find Lowest Prices on