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Estra-50
Overview
What is Estra-50?
Estradiol N.F. Pellets contain N.F. 25mg and 50mg for subcutaneous implantation. The pellets are sterile unless vial has been opened or damaged.
Estradiol Pellets are cylindrical, with an approximate diameter of 3.2mm. Pellet therapy has the advantage of high efficiency from the standpoint of the quality of the hormone administered and the further advantage that a single treatment has effect continuously for several months.
What does Estra-50 look like?
What are the available doses of Estra-50?
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What should I talk to my health care provider before I take Estra-50?
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How should I use Estra-50?
Estradiol is indicated in the treatment of:
1. Estrogen deficiency in Hysterectomized Women.
(There is no evidence that estrogens are effective for nervous symptoms or depression which might occur during menopause, and they should not be used to treat these conditions.)
2. Atrophic vaginitis.
3. Kraurosis vulvae.
4. Female hypogonadism.
5. Female castration.
6. Primary ovarian failure.
7. Breast cancer (for palliation only) in approximately selected women and men with metastatic disease.
8. Postpartum breast engorgement- Althoughestrogens have been widely used for the prevention of postpatum breast engorgement, controlled studies hve demonstrated that the incidence of significapainful engorgementin patients not receiving such hormonal therapy is low and usually responsive to appropriate analgesic or other supportive therapy. Consequently, the benefit to be derived from estrogen therapy for this indication must be carefully weighed against the potential increased risk or puerperal thromboembolism associated with the use of large doses of estrogen.
ESTRADIOL HAS NOT BEEN SHOWN TO BE EFFECTIVE FOR ANY PURPOSE DURIG PREGNANCY AND ITS USE MAY CAUSE SEVERE HARM TO THE FETUS (SEE BOXED WARNING).
Menopausal Syndrome:
Hypogenitalism and Sexual Infantilism:
Amenorrhea and Oligomenorrhea Associated with Hypogonadism:
Postpartum Breast Engorgement:
Inoperable Breast Carcinoma in Postmenopausal Women:
Carcinoma of the Prostate:
Senile Vaginitis; Pruritis Vulvae; Kraurosis Vulvae:
The pellets may be implanted conveniently and quickly by means of an injector or they may be administered by making an incision in the skin. Either method, though readily carried out in the physician's office, is a minor surgical procedure, and all aseptic precautions must be observed.
BY INJECTOR:
BY INCISION:
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.
What interacts with Estra-50?
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What are the warnings of Estra-50?
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What are the precautions of Estra-50?
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What are the side effects of Estra-50?
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What should I look out for while using Estra-50?
Estrogens should not be used in women (or men) with any of the following conditions:
1. Known or suspected cancer of the breast except in appropriately selected patients being treated for metastatic disease.
2. Known or suspected estrogen-dependant neoplasia.
3. Known or suspected pregnancy (See Boxed Warning).
4. Undiagnosed abnormal genital bleeding.
5. Active thrombophlebitis or thromboembolic disorders.
6. Apast history of thrombophlebitis, thrombosis, or thromboembolic disorders associated with previous estrogen use (except when used in treatment of breast prostatic malignancy).
1. Induction of malignant neoplasma.
At the present ime there is no satisfactory evidencethat estrogens given to postmenopausal women increase the risk of cancer of the breast,
althogh a recent long-term followup of a single physician's practice has raised this possibility.
Because of the animal data there is a heed for caution, in prescribing estrogens for women with a strong history of breast cancer or who have breast nodules, fibrocystic disease, or abnormal mammograms.
2. Gallbladder disease.
3. Effects similar to those caused by estrogen-progsten
a. Thromboembolic disease.
While an increased rate of thromboembolic and thrombotic disease in postmenopausal users of estrogen has not been found,
this does not rule out that such an increase maymay be present or that sugroups of women having underlyingrisk factors or who are receiving relatively large doses of estrogen may have an increased risk. Therefore estrogens should not be used in persons with active thrombophlebitis or thromboembolic disorders and they should not be used (except in treatent of malignancy) in persons with a history of such disorders in association with estrogen use. They should be used with caution in patients with cerebral vascular or coronary artery disease and only for those in whom estrogens are clearly needed.
Large doses of estrogens (5mg conjugated estrogens per day), comparable to those used to treat cancer of the prostat and breast, have been shown in a large prospectiveclinical trial in men
to increase the risk of nonfatal myocardial infarction, pulmonary embolism, and thrombophlebitis. When estrogen doses of this size are used, any of th thromboembolicand thrombotic adverse effects associated with oral contraceptive use should be considered a clear risk.
b. Hepatic adenoma.
c. Elevated blood pressure.
d. Glucose tolerance.
4. Hypercalcemia.
†
®
What might happen if I take too much Estra-50?
Numerous reports of ingestion of large doses of estrogen-containing oral contraceptives by young children indicate that serious ill effects do not occur. Overdosage of estrogen may cause nausea, and withdrawl bleeding may occur in females.
How should I store and handle Estra-50?
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Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Estradiol is one of the more potent of the known estrogenic compounds, identical with the primary estrogenic hormone produced by the human ovary. Estradiol exerts a developmental action on the female generative tract, has an inhibitory effect upon the pituitary in large doses, and produces a marked constitutional effect with an increase in muscular strength, body vigor, and mental acumen. It supplies follicular hormone in cases where estrogenic activity is depressed, insufficient, or absent.
Non-Clinical Toxicology
Estrogens should not be used in women (or men) with any of the following conditions:1. Known or suspected cancer of the breast except in appropriately selected patients being treated for metastatic disease.
2. Known or suspected estrogen-dependant neoplasia.
3. Known or suspected pregnancy (See Boxed Warning).
4. Undiagnosed abnormal genital bleeding.
5. Active thrombophlebitis or thromboembolic disorders.
6. Apast history of thrombophlebitis, thrombosis, or thromboembolic disorders associated with previous estrogen use (except when used in treatment of breast prostatic malignancy).
1. Induction of malignant neoplasma.
At the present ime there is no satisfactory evidencethat estrogens given to postmenopausal women increase the risk of cancer of the breast, althogh a recent long-term followup of a single physician's practice has raised this possibility. Because of the animal data there is a heed for caution, in prescribing estrogens for women with a strong history of breast cancer or who have breast nodules, fibrocystic disease, or abnormal mammograms.
2. Gallbladder disease.
3. Effects similar to those caused by estrogen-progsten
a. Thromboembolic disease.
While an increased rate of thromboembolic and thrombotic disease in postmenopausal users of estrogen has not been found, this does not rule out that such an increase maymay be present or that sugroups of women having underlyingrisk factors or who are receiving relatively large doses of estrogen may have an increased risk. Therefore estrogens should not be used in persons with active thrombophlebitis or thromboembolic disorders and they should not be used (except in treatent of malignancy) in persons with a history of such disorders in association with estrogen use. They should be used with caution in patients with cerebral vascular or coronary artery disease and only for those in whom estrogens are clearly needed.
Large doses of estrogens (5mg conjugated estrogens per day), comparable to those used to treat cancer of the prostat and breast, have been shown in a large prospectiveclinical trial in men to increase the risk of nonfatal myocardial infarction, pulmonary embolism, and thrombophlebitis. When estrogen doses of this size are used, any of th thromboembolicand thrombotic adverse effects associated with oral contraceptive use should be considered a clear risk.
b. Hepatic adenoma.
c. Elevated blood pressure.
d. Glucose tolerance.
4. Hypercalcemia.
Cyclobenzaprine HCl may have life-threatening interactions with MAO inhibitors (see ). Postmarketing cases of serotonin syndrome have been reported during combined use of Cyclobenzaprine Hydrochloride and other drugs, such as SSRIs, SNRIs, TCAs, tramadol, bupropion, meperidine, verapamil, or MAO inhibitors. If concomitant treatment with Cyclobenzaprine Hydrochloride and other serotonergic drugs is clinically warranted, careful observation is advised, particularly during treatment initiation or dose increases (see ).
Cyclobenzaprine HCl may enhance the effects of alcohol, barbiturates, and other CNS depressants.
Tricyclic antidepressants may block the antihypertensive action of guanethidine and similarly acting compounds.
Tricyclic antidepressants may enhance the seizure risk in patients taking tramadol.
____________________________________________________________________
† ULTRAM (tramadol HCl tablets, PriCar, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc.)
Array
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A. General Precautions.
1. A complete medical and family history should be taken prior to initiation of any estrogen therapy. The pretreatment and periodic physical examination should include special reference to blood pressure, breasts, abdomen, and pelvic organs, and should include a Papnicolau smear. As a general rule, estrogen should not be prescribed for longer than one year without a physical examinationbeing performed.
2. Fluid retention- Because estrogens may cause some degree of fluid retention, conditions which may be influenced by this factor such as epilepsy, migraine, and cardiac or renal dysfunction, require careful observation.
3. Certain patients may develope undesirable manifestations of excessive estrogenic stimulation, such as abnormal or excessive uterine bleeding, mastodynia, etc.
4.Oral contraceptives appear to be associated with an increased incidence of mental depression. Although it is not clear whether this is due to the estrogenic or progestogenic component of the contraceptive, patients with a history of depression should be carefully observed.
5. Preexisting uterine leiomyomata may increase in size during estrogen use.
6. The pathologist should be advised of estrogen therapy when relevent specimens are submitted.
7. Patients with a history of jaundice during pregnancy have an increased risk of reccuranceof jaundice while receiving estrogen-containing oral contraceptive therapy. If jaundice develops in any patient receiving estrogen, the medication should be discontinued while the cause is investigated.
8. Estrogens may be poorly metabolized in patients with impaired liver function and they should be administered with caution in such patients.
9. Because estrogens influence the metabolism of calcium and phosphorous, they should be used with caution in patients with metabolic bone diseases that are associated with hypercalcemia or in patients with renal insufficiency.
10. Because of the effects of estrogens on epiphyseal closure, they should be used judiciously in young patients in whom bone growth is not complete.
11. Certain endocrine and liver function tests may be affected by estrogen-containing oral contraceptives. The following similar changes may be expected with larger doses of estrogen;
a. Increased sullobromophthalein retention.
b. Increased prothrombin and factors VII, VIII, IX, and X; decreased antithrombin 3; increased norepinephrine-induced platelet aggregability.
c. Increased thyroid binding globulin (TGB) leading to increased circulating total thyroid hormone, as measured by PBI, T4 by column, or T4 by radioimmunoassay. Free T3 resin uptake is decreased, reflecting elevated TBG; free T4 concentration is unaltered.
d. Impaired glucose toerance.
e. Decreased pregnanediol excretion.
f. Reduced response to metyrapone test.
g. Reduced serum folate concentration.
h. Increased serum triglyceride and phospholipid concentration.
B. Pregnancy Category X
(See Contraindications and Boxed Warning).
C. Nursing Mothers.
As a general principal, the administration of any drug to nursing mothers should be done only when clearly necessary since many drugs are excreted in human milk.
(See Warnings regarding induction of neoplasia, adverse effects on the fetus, increased incidence of gall bladder disease, and adverse effects similar to those of oral contraceptives, including thromboembolism.) The following additional adverse reactions have been reported with estrogenic therapy, including oral cantraceptives:
1. Genitourinary System-
2. Breasts-
3. Gastrointestinal-
4. Skin-
5. Eyes-
6. CNS-
7. Miscellaneous-
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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