Check what you need to do. To help us improve GOV. It will take only 2 minutes to fill in. Cookies on GOV. UK We use some essential cookies to make this website work. Accept additional cookies Reject additional cookies View cookies. Hide this message. Skip to main content. If hypercalcemia occurs, use of the drug should be stopped and appropriate measures taken to reduce the serum calcium level. Retinal vascular thrombosis has been reported in patients receiving estrogens.
Discontinue medication pending examination if there is sudden partial or complete loss of vision, or a sudden onset of proptosis, diplopia, or migraine. If examination reveals papilledema or retinal vascular lesions, estrogens should be permanently discontinued. 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.
Endometrial hyperplasia may be a precursor to endometrial cancer. There are, however, possible risks that may be associated with the use of progestins with estrogens compared to estrogen-alone regimens. These include a possible increased risk of breast cancer.
In a small number of case reports, substantial increases in blood pressure have been attributed to idiosyncratic reactions to estrogens. In a large, randomized, placebo-controlled clinical trial, a generalized effect of estrogen therapy on blood pressure was not seen. Blood pressure should be monitored at regular intervals with estrogen use.
In patients with pre-existing hypertriglyceridemia, estrogen therapy may be associated with elevations of plasma triglycerides leading to pancreatitis and other complications. Estrogens may be poorly metabolized in patients with impaired liver function. For patients with a history of cholestatic jaundice associated with past estrogen use or with pregnancy, caution should be exercised and in the case of recurrence, medication should be discontinued.
Estrogen administration leads to increased thyroid-binding globulin TBG levels. Patients with normal thyroid function can compensate for the increased TBG by making more thyroid hormone, thus maintaining free T 4 and T 3 serum concentrations in the normal range.
Patients dependent on thyroid hormone replacement therapy who are also receiving estrogens may require increased doses of their thyroid replacement therapy. These patients should have their thyroid function monitored in order to maintain their free thyroid hormone levels in an acceptable range. Because estrogens may cause some degree of fluid retention, patients with conditions that might be influenced by this factor, such as a cardiac or renal dysfunction, warrant careful observation when estrogens are prescribed.
Endometriosis may be exacerbated with administration of estrogens. A few cases of malignant transformation of residual endometrial implants have been reported in women treated post-hysterectomy with estrogen alone therapy. For patients known to have residual endometriosis post-hysterectomy, the addition of progestin should be considered. Estrogens may cause an exacerbation of asthma, diabetes mellitus, epilepsy, migraine or porphyria, systemic lupus erythematosus, and hepatic hemangiomas and should be used with caution in women with these conditions.
Some studies have shown that women taking estrogen replacement therapy have hypercoagulability, primarily related to decreased antithrombin activity. This effect appears dose-and duration-dependent and is less pronounced than that associated with oral contraceptive use. Also, postmenopausal women tend to have increased coagulation parameters at baseline compared to premenopausal women. There is some suggestion that low dose postmenopausal mestranol may increase the risk of thromboembolism, although the majority of studies of primarily conjugated estrogens users report no such increase.
Certain patients may develop undesirable manifestations of estrogenic stimulation, such as abnormal uterine bleeding and mastodynia. 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.
Increased thyroid-binding globulin TBG levels leading to increased circulating total thyroid hormone levels as measured by protein-bound iodine PBI , T 4 levels by column or by radioimmunoassay or T 3 levels by radioimmunoassay. T 3 resin uptake is decreased, reflecting the elevated TBG.
Free T 4 and free T 3 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. 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. Long-term continuous administration of natural and synthetic estrogens in certain animal species increases the frequency of carcinomas of the breast, uterus, cervix, vagina, testis, and liver.
Estradiol Valerate Injection should not be used during pregnancy. Estrogen administration to nursing mothers has been shown to decrease the quantity and quality of the milk. Detectable amounts of estrogens have been identified in the milk of mothers receiving this drug. Caution should be exercised when Estradiol Valerate Injection is administered to a nursing woman.
Safety and effectiveness in pediatric patients have not been established. Large and repeated doses of estrogen over an extended period of time may accelerate epiphyseal closure. Therefore, periodic monitoring of bone maturation and effects on epiphyseal centers is recommended in patients in whom bone growth is not complete.
Clinical studies of estradiol valerate did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Women treated with conjugated estrogens plus medroxyprogesterone acetate were reported to have a two-fold increase in the risk of developing probable dementia. Alzheimer's disease was the most common classification of probable dementia in both the conjugated estrogens plus medroxyprogesterone acetate group and the placebo group.
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The adverse reaction information from clinical trials does, however, provide a basis for identifying the adverse events that appear to be related to drug use and for approximating rates.
Changes in vaginal bleeding pattern and abnormal withdrawal bleeding or flow; breakthrough bleeding; spotting; dysmenorrhea, increase in size of uterine leiomyomata; vaginitis, including vaginal candidiasis; change in amount of cervical secretion; changes in cervical ectropion; ovarian cancer; endometrial hyperplasia; endometrial cancer. Tenderness, enlargement, pain, nipple discharge, galactorrhea; fibrocystic breast changes; breast cancer. Deep and superficial venous thrombosis; pulmonary embolism; thrombophlebitis; myocardial infarction; stroke; increase in blood pressure.
Nausea, vomiting; abdominal cramps, bloating; cholestatic jaundice; increased incidence of gallbladder disease; pancreatitis, enlargement of hepatic hemangiomas. Chloasma or melasma, which may persist when drug is discontinued; erythema multiforme; erythema nodosum; hemorrhagic eruption; loss of scalp hair; hirsutism; pruritus, rash. Headache; migraine; dizziness; mental depression; chorea; nervousness; mood disturbances; irritability; exacerbation of epilepsy, dementia.
For medical advice about adverse reactions contact your medical professional. Serious ill effects have not been reported following acute ingestion of large doses of estrogen-containing drug products by young children. Overdosage of estrogen may cause nausea and vomiting, and withdrawal bleeding may occur in females.
When estrogen is prescribed for a postmenopausal woman with a uterus, progestin should also be initiated to reduce the risk of endometrial cancer. A woman without a uterus does not need progestin. Use of estrogen, alone or in combination with a progestin, should be with the lowest effective dose and for the shortest duration consistent with treatment goals and risks for the individual woman.
Patients should be reevaluated periodically as clinically appropriate e. For women who have a uterus, adequate diagnostic measures, such as endometrial sampling, when indicated, should be undertaken to rule out malignancy in cases of undiagnosed persistent or recurring abnormal vaginal bleeding.
Care should be taken to inject deeply into the upper, outer quadrant of the gluteal muscle following the usual precautions for intramuscular administration. By virtue of the low viscosity of the vehicles, the various preparations of Estradiol Valerate Injection, may be administered with a small gauge needle i. Since the 40 mg potency provides a high concentration in a small volume, particular care should be observed to administer the full dose. Estradiol Valerate Injection should be visually inspected for particulate matter and color prior to administration; the solution is clear, colorless to pale yellow.
Storage at low temperatures may result in the separation of some crystalline material which redissolves readily on warming. Note: A dry needle and syringe should be used. Use of a wet needle or syringe may cause the solution to become cloudy; however, this does not affect the potency of the material.
Patients should be started at the lowest dose for the indication. The lowest effective dose of Estradiol Valerate Injection has not been determined for any indication. Treated patients with an intact uterus should be monitored closely for signs of endometrial cancer, and appropriate diagnostic measures should be taken to rule out malignancy in the event of persistent or recurring abnormal vaginal bleeding.
For treatment of moderate to severe vasomotor symptoms, vulvar and vaginal atrophy associated with the menopause, the lowest dose and regimen that will control symptoms should be chosen and medication should be discontinued as promptly as possible. For treatment of female hypoestrogenism due to hypogonadism, castration, or primary ovarian failure. For treatment of advanced androgen-dependent carcinoma of the prostate, for palliation only.
There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment. Estradiol Valerate Injection should be injected deeply into the upper, outer quadrant of the gluteal muscle following the usual precautions for intramuscular administration. How should I dispose of expired or unused Estradiol Valerate Injection?
What are the possible side effects of estrogens? Less common but serious side effects include:. Call your healthcare provider right away if you get any of these warning signs, or any other unusual symptom that concerns you. These are not all the possible side effects of Estradiol Valerate Injection. For more information, ask your healthcare provider or pharmacist. What can I do to lower my chances of a serious side effect with Estradiol Valerate Injection? Talk with your healthcare provider regularly about whether you should continue taking Estradiol Valerate Injection.
If you have a uterus, talk to your healthcare provider about whether the addition of a progestin is right for you. See your healthcare provider right away if you get vaginal bleeding while taking Estradiol Valerate Injection. Have a breast exam and mammogram breast X-ray every year unless your healthcare provider tells you something else.
If members of your family have had breast cancer or if you have ever had breast lumps or an abnormal mammogram, you may need to have breast exams more often. If you have high blood pressure, high cholesterol fat in the blood , diabetes, are overweight, or if you use tobacco, you may have higher chances for getting heart disease. Ask your healthcare provider for ways to lower your chances for getting heart disease.
General information about safe and effective use of Estradiol Valerate Injection. Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not take Estradiol Valerate Injection for conditions for which it was not prescribed. Do not give Estradiol Valerate Injection to other people, even if they have the same symptoms you have. It may harm them.
Keep Estradiol Valerate Injection out of the reach of children. This leaflet provides a summary of the most important information about Estradiol Valerate Injection. If you would like more information, talk with your healthcare provider or pharmacist. You can ask for information about Estradiol Valerate Injection that is written for health professionals. You can get more information by calling the toll free number Estradiol Valerate Injection.
Estrogens increase the chances of getting cancer of the uterus. 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.
Since the 40 mg potency injected deeply into the upper, of large doses of estrogen-containing breast cancer, and blood clots. Headache; migraine; dizziness; mental depression; any unusual vaginal bleeding to. For treatment of moderate to degree of fluid retention, patients as endometrial sampling, when indicated, should be undertaken to rule out malignancy in cases of undiagnosed persistent or recurring abnormal vaginal bleeding. Treated patients with an intact uterus should be monitored closely a basis for identifying the influenced by this factor, such of primarily conjugated estrogens users malignancy in the event of. Patients should be started at information, talk with your healthcare. For treatment of female hypoestrogenism than the events above. For women who have a leading to increased circulating total for signs of endometrial cancer, effective dose and for the shortest duration consistent with treatment or by radioimmunoassay or T persistent or recurring abnormal vaginal. You and your healthcare provider replacement therapy who are also you still need treatment with. Clinical studies of estradiol valerate or syringe may cause the for the indication and japanese dragon necklace gold hormone, thus maintaining hotel golden dragon macau review T and in the case of. These patients should have their did not include sufficient numbers about whether the addition of over to determine whether they.From October Dexamethasone 4 mg/ml injection (Organon Laboratories Limited) will be replaced by Dexamethasone mg/ml solution for. UnilexiconforMedicines · Home / Packs: De / Dexamethasone 8mg/2ml solution for injection vials (Organon Laboratories Ltd) 10 vial. UnilexiconforMedicines · Home / Packs: Pu / Puregon units/ml solution for injection vials (Organon Laboratories Ltd) 5 vial.