PREMARIN TABS
WYETH
Congugated estrogen 0.3mg/ 0.625mg tablets,
Strength | Rate | Packing Style |
---|---|---|
0.3mg | 731.43 | 28s tablets |
0.625mg | 1038.25 | 28s tablets |
List of Related Indications:
- Estrogen replacm thearpy
List Of Drugs:
- Estrogens - conjugated ( *** ) @- ( FDC- List ) (Nov 2006)
Indication Type Description:
Drug Interaction
Indication
Adverse Reaction
Contra-Indications
Dosages/ Overdosage Etc
Patient Information
Pharmacology/ Pharmacokinetics
Pregnancy and lactation
Drug Interaction:
Indication:
Female hypogonadism
Primary ovarian failure
Post menopausal symptoms
Prevention of post menopausal osteoporosis
Adverse Reaction:
GU- breakthrough bleeding, spotting, change in menstrual flow, dysmennorrhea, premenstrual -like syndrome, amenorrhea during and after treatment, vaginal candidiasis, change in cervical eversion and degree of cervical secretion, cystitis-like syndrome, hemolytic uremic syndrome , endometrial cystic hyperplasia
GI- nausea, vomiting, abdominal cramps, bloating,cholestatic jaundice,colitis , acute pancreatitis.
Dermatologic- cholasma or melasma (may persist when drug is discontinued ) erythema,
nodusum/multiforme, hemorrhagic eruption, urticaria, dermatitis
Ophthalmic- steepening of corneal curvature, intolerance to contactlens
CNS- headache, migraine, dizziness, mental depression,chorea, convulsions
Local- pain at injectin site, sterile abcess, ostinjectin flare, redness and irritation at appilcation site with estradiol transdermal system, rash (rare)
Miscellaneous- aggravaton of prorphria, edema, changes in libido, breast tenderness,, enlargement or secretion..
Unopposed replacement therapy in postmenopausal women associated with increase risk of endometrial cancer and cancer breast. Abnormal bleedng, vomiting, nausea, tender breasts, weight gain fluid retension, headache and depression.
Males: Gynaecomastia,impotence.
Topical vaginal appln: Prolonged use causes endometrial hyperplasia.
Contra-Indications:
Patients with markedly impaired liver function,personal/family H/O malignancy(breast and
genital). Thromboemboloic disorders, cardiovascular disease, undiagnosed vaginal
bleeding. Estrogen dependent neoplasia, hypersens,pregnancy.
Special precautions:
Asthma, epilepsy, migraine, heart/kidney dysfunction, diabetes, lactation, hypercalcemia, gall bladder disease.
History/Medical examination- before initiating estrogens take complete medical and family history.
Pretreatment and and periodic history and physical exams every 12 months should include blood pressure, breast, abdomen, pelvic organs, and a papanicolaou . Generally do not prescribe for > 1 year between physical examinations.
Estropipate vaginal cream- rule out gonorrhea or neoplasia before prescribing estrogen vaginal cream. Treat trichomonal , monilial or bacterial infection with appropriate anti-microbial therapy.
Excessive estrogenic stimulation- certain patients may develop undesirable manifestatons of excessive estrogenic stimulation( eg. abnormal or excessiveuterine bleeding, mastodynia ) Advice pathologist of estrogen therapy when relevant specimens are submitted.
Fluid retention- estrogens may cause some degree of fluid retention, conditions which might be influenced by this factor (eg. epilepsy, migraine, and cardiac or renal dysfunction)require careful observation.
Calcium and phosphorus metabolism- is influenced by estrogens. Use caution in patients with metabolic bone diseases asociated with hypercalcemia or inrenal insufficiency.
Endometrial hyperplasia- prolonged unopposed estrogen therapy may increase the risk of
endometrial hyperplasia.
Acute intermittant hyperplasia - may be precipitated by estrogens.
Photosentivity- may occur.Caution patients to protect against undue expoure to ultaviolet or sunlight.
Warnings
Induction of malignant neoplasms- estrogern may increase the risk of endometrial carconoma. Closely monitor patients with an intract uterus for signs of endometrial cancer, and take appropiate measures to rule out malignancy.
Gall bladder disease- there is a 2-fold to 3 fold increae in risk of gallbladder disease in women receiving menopausal estrogens. This may be related to large doses.
Effects of similar to those caused by estrogen-progestin oral contraceptives- three is an increased risk of thrombosis in men receiving estrogens for prostatic cancer and in women receiving estrogens for postpatum breast engorgement because lage doses are used in therapy
Elevated blood pressure- is common but is less frequent with estrogen replacement than with OCs use.
Thromboembolic disease- OCs user have an increased risk of thromboembolic and thrombotic vascular diseases, including thromboplebitis, pulmonary embolism, stroke, and myocardial infarction.
Hypercalemia- estrogens may leadto severe hypercalcemia in patients with breast cancer and bone metastases.If this occurs, discontinue the drug.
Glucose tolerance- usual replacement doses of estrogen improve insulin sensitivity.
Hepatic functin impairment- if jaundice develpos in any patient on estrogen, discontinue medication and investigate the cause.
Pregnancy- if estrogens are used during pregnancy or if the patient becomes pregnant while taking estrogens inform her of the potential risks to the fetus.
Lactation- estrogen have beenshown to decrease the quantity and quality of breast milk and may be excreted in breast milk. Administer only when needed
Children- safety and efficacy are not established
Dosages/ Overdosage Etc:
Indications:
Female hypogonadism
Primary ovarian failure
Post menopausal symptoms
Prevention of post menopausal osteoporosis
Dosage:
Administer cyclically ,3 weeks on and 1 week off. Give 2 or 4g daily vaginally depending on severity of condition.
Overdosage
Serious ill effects have been reported following ingestion of large doses estyrogen-containing OCS by young children.
Overdosage of estrogen may cause nausea, withdrawal bleeding may occur in females.
Missed dose-
If you miss adose of this medicine and your dosing schedule is-
One dose a day-
1. Take, use or apply the missed dose as soon as possible.
2.However, if you do not remember it until the next day, skip the missed dose and go back to your regular dosing
schedule.
3. Do not double doses.
More than one dose a day-
1. Take or use the missed dose as soon as possible.
2.However, ifit is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.
3. Do not double doses
4.If you have question about this check with your doctor.
Patient Information:
1. Diabetic patients- notify physician if any of the following occur.-
pain in groin, or calves, of the leg, sharp chest pain,or sudden shortness of breath, abnormal vaginal bleeding, missed menstrual period, or suspected pregnancy, lumps in the breast, sudden severe headache, dizziness or fainting, vision or speech disturbance, weakness or nunbness in the arm or the leg, severe abdominal pain, yellowing of the skin or eyes, severe depression
2. Allergies- Tell your doctor if you have ever had any unusual or allergic reactions to estrogens or related medicines. Also tell your doctor if your are allergic to any other substances such as foods, preservatives or dyes.
3. Pregnancy- oestrogens are not recommended for use during pregnancy since some have been shown to cause serious birth defects in humans and animals.
4. Breast feeding- use of this medicine not recommended in nursing mothers
5. Elderly- this medicine is not expected to cause different side effects or problems in older people than it does in younger women
6. Other medicines- tell your doctor if you are taking any of the following-
Acetaminophen or
Amiadarone or
Anabolic steroids or
Androgens or
Anti-infectives by mouth or or by injection
Carbamazepine or
Carmustine or
Chloroquine or
Dantrolene or
Daunorubicin or
Disulfram or
Divalproex or
Etretinate or
Gold salts or
Hydroxychloroquine or
Mercaptopurine or
Methotrexate or
Methyldopa or
Naltexone or
Oral contraceptives or
Phenothiazines or
Phenytoin or
Plicamycin or
Valproic acid - estrogens and all these medicines can cause liver damage. Your doctor may want
to have extra blood tests that tell about your liver
Bromocriptine - estrogens may interfere with the effects of bromocriptine
Cyclosporine - estyrogens can increase the chance of toxic effects to the kidney or liver from cyclosporine out of blood stream as it normally would.
7. Other medical problems- presence of other medical problems may afect the use of erythromycin-
Blood clots - estrogens may worsen blood clots or cause new clots to form
Breast cancer- estrogens may cause growth of the tumor in some cases
Changes in vaginal bleeding- some irregular vaginal bleeding is a sign that the lining of the utreus is growing too much or is sign of cancer of the uterus lining
Endometriosis- estrogens may worsen endometriosisby causing growth of endometriosis implants
Fibroid tomors of the uterus - estrogens may cause fibroid tumors to increase in size
Gall bladder disease or gallstones -estrogens may possibly increase te risk of gallbladder disease or gallstones
Jaundice -estrogens may worsen or cause jaunduce in these patients
Liver disease- toxic drug effects may occur in patients with liver disease because the body is not able this medicine out of the bloodstream asit normally would
Porphyria- estrogens can make porphyria worse
8. Missed dose-
If you miss a dose of this medicine take it as soon as possible. However if it is almost time for your next dose go back to your regular dosing schedule.
Do not double doses.
Pharmacology/ Pharmacokinetics:
Pharmacology-
Estrogens induce proliferatin in the epithelium of the fallopian tubes ,endometrium, cervix, vagina, and muscosa of GI tractand increase vacxularity.Estrogens are responsible for the vaginal acidity caused by deposition of glycogen in vaginal epithelum.
Pharmacokinetics-
Absorption of most natural occuring estrogens and their derivatives from the GI tract is complete. Therefore transdermal use produces the therapeutic serumlevels of estrodiol with lower circulating levels of estrone and estrone conjugates and requires smaller total doses.
Pregnancy and lactation:
Pregnancy-
If estrogens are used during pregnancy or if the patient becomes pregnant while taking estrogens
inform her of the potential risks to the fetus.
Lactation-
Estrogen have beenshown to decrease the quantity and quality of breast milk and may be excreted in
breast milk. Administer only when needed
Children-
Safety and efficacy are not established