Ovophene is a non-steroidal fertility medicine. It causes the pituitary gland to release hormones needed to stimulate ovulation (the release of an egg from the ovary).
Ovophene is used to cause ovulation in women with certain medical conditions (such as polycystic ovary syndrome) that prevent naturally occurring ovulation.
Ovophene may also be used for purposes not listed in this medication guide.
An indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, acetaminophen or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.
Ovophene tablets USP is indicated for the treatment of ovulatory dysfunction in women desiring pregnancy. Impediments to achieving pregnancy must be excluded or adequately treated before beginning Ovophene tablets USP therapy. Those patients most likely to achieve success with Ovophene therapy include patients with polycystic ovary syndrome, amenorrhea-galactorrhea syndrome, psychogenic amenorrhea, post-oral-contraceptive amenorrhea, and certain cases of secondary amenorrhea of undetermined etiology.
Properly timed coitus in relationship to ovulation is important. A basal body temperature graph or other appropriate tests may help the patient and her physician determine if ovulation occurred. Once ovulation has been established, each course of Ovophene tablets USP should be started on or about the 5th day of the cycle. Long-term cyclic therapy is not recommended beyond a total of about six cycles (including three ovulatory cycles).
Ovophene tablets USP is indicated only in patients with demonstrated ovulatory dysfunction who meet the conditions described below:
Patients who are not pregnant.
Patients without ovarian cysts. Ovophene tablets USP should not be used in patients with ovarian enlargement except those with polycystic ovary syndrome. Pelvic examination is necessary prior to the first and each subsequent course of Ovophene tablets USP treatment.
Patients without abnormal vaginal bleeding. If abnormal vaginal bleeding is present, the patient should be carefully evaluated to ensure that neoplastic lesions are not present.
Patients with normal liver function.
In addition, patients selected for Ovophene tablets USP therapy should be evaluated in regard to the following:
Estrogen Levels. Patients should have adequate levels of endogenous estrogen (as estimated from vaginal smears, endometrial biopsy, assay of urinary estrogen, or from bleeding in response to progesterone). Reduced estrogen levels, while less favorable, do not preclude successful therapy.
Primary Pituitary or Ovarian Failure. Ovophene tablets USP therapy cannot be expected to substitute for specific treatment of other causes of ovulatory failure.
Endometriosis and Endometrial Carcinoma. The incidence of endometriosis and endometrial carcinoma increases with age as does the incidence of ovulatory disorders. Endometrial biopsy should always be performed prior to Ovophene tablets USP therapy in this population.
Other Impediments to Pregnancy. Impediments to pregnancy can include thyroid disorders, adrenal disorders, hyperprolactinemia, and male factor infertility.
Uterine Fibroids. Caution should be exercised when using Ovophene tablets USP in patients with uterine fibroids due to the potential for further enlargement of the fibroids.
There are no adequate or well-controlled studies that demonstrate the effectiveness of Ovophene tablets USP in the treatment of male infertility. In addition, testicular tumors and gynecomastia have been reported in males using Ovophene. The cause and effect relationship between reports of testicular tumors and the administration of Ovophene tablets USP is not known.
Although the medical literature suggests various methods, there is no universally accepted standard regimen for combined therapy (ie, Ovophene tablets USP in conjunction with other ovulation-inducing drugs). Similarly, there is no standard Ovophene tablets USP regimen for ovulation induction in in vitro fertilization programs to produce ova for fertilization and reintroduction. Therefore, Ovophene tablets USP is not recommended for these uses.
How should I use Ovophene?
Use Ovophene as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Take Ovophene by mouth with or without food.
Properly timed sexual intercourse is important for good results. Ovulation usually occurs 5 to 10 days after a course of Ovophene.
If you do not ovulate or become pregnant after 3 courses of treatment, further treatment is not recommended. Long-term use of Ovophene is not recommended.
If you miss a dose of Ovophene, contact your doctor right away.
Ask your health care provider any questions you may have about how to use Ovophene.
Uses of Ovophene in details
There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.
Use: Labeled Indications
Treatment of ovulatory dysfunction: Treatment of ovulatory dysfunction in women desiring pregnancy
Ovophene is 2-[ρ-(2-chloro-1,2-diphenylvinyl)phenoxy] triethylamine dihydrogen citrate.
Ovophene is a chemical analog of other triarylethylene compounds eg, chlorotrianisene and the cholesterol inhibitor, triparanol.
The workup and treatment of candidates for Ovophene tablets USP therapy should be supervised by physicians experienced in management of gynecologic or endocrine disorders. Patients should be chosen for therapy with Ovophene tablets USP only after careful diagnostic evaluation. The plan of therapy should be outlined in advance. Impediments to achieving the goal of therapy must be excluded or adequately treated before beginning Ovophene tablets USP. The therapeutic objective should be balanced with potential risks and discussed with the patient and others involved in the achievement of a pregnancy.
Ovulation most often occurs from 5 to 10 days after a course of Ovophene tablets USP. Coitus should be timed to coincide with the expected time of ovulation. Appropriate tests to determine ovulation may be useful during this time.
Treatment of the selected patient should begin with a low dose, 50 mg daily (1 tablet) for 5 days. The dose should be increased only in those patients who do not ovulate in response to cyclic 50 mg Ovophene tablets USP. A low dosage or duration of treatment course is particularly recommended if unusual sensitivity to pituitary gonadotropin is suspected, such as in patients with polycystic ovary syndrome.
The patient should be evaluated carefully to exclude pregnancy, ovarian enlargement, or ovarian cyst formation between each treatment cycle.
If progestin-induced bleeding is planned, or if spontaneous uterine bleeding occurs prior to therapy, the regimen of 50 mg daily for 5 days should be started on or about the 5th day of the cycle. Therapy may be started at any time in the patient who has had no recent uterine bleeding. When ovulation occurs at this dosage, there is no advantage to increasing the dose in subsequent cycles of treatment.
If ovulation does not appear to occur after the first course of therapy, a second course of 100 mg daily (two 50 mg tablets given as a single daily dose) for 5 days should be given. This course may be started as early as 30 days after the previous one after precautions are taken to exclude the presence of pregnancy. Increasing the dosage or duration of therapy beyond 100 mg/day for 5 days is not recommended.
The majority of patients who are going to ovulate will do so after the first course of therapy. If ovulation does not occur after three courses of therapy, further treatment with Ovophene tablets USP is not recommended and the patient should be reevaluated. If three ovulatory responses occur, but pregnancy has not been achieved, further treatment is not recommended. If menses does not occur after an ovulatory response, the patient should be reevaluated. Long-term cyclic therapy is not recommended beyond a total of about 6 cycles.
* If you think you might be pregnant, stop taking this medicine and tell your doctor. Talk to your doctor before taking this medicine if you have thyroid problems. Multiple births (such as twins or triplets) are possible when taking Ovophene. This medicine may cause changes in vision such as blurring or trouble focusing.
Clinical Trial Adverse Events. Ovophene tablets USP, at recommended dosages, is generally well tolerated. Adverse reactions usually have been mild and transient and most have disappeared promptly after treatment has been discontinued. Adverse experiences reported in patients treated with Ovophene during clinical studies are shown in Table 2.
Table 2. Incidence of Adverse Events in Clinical Studies (Events Greater than 1%) (n = 8029*)
* Includes 498 patients whose reports may have been duplicated in the event totals and could not be distinguished as such. Also, excludes 47 patients who did not report symptom data.
The following adverse events have been reported in fewer than 1% of patients in clinical trails: Acute abdomen, appetite increase, constipation, dermatitis or rash, depression, diarrhea, dizziness, fatigue, hair loss/dry hair, increased urinary frequency/volume, insomnia, light-headedness, nervous tension, vaginal dryness, vertigo, weight gain/loss.
Patients on prolonged Ovophene tablets USP therapy may show elevated serum levels of desmosterol. This is most likely due to a direct interference with cholesterol synthesis. However, the serum sterols in patients receiving the recommended dose of Ovophene tablets USP are not significantly altered. Ovarian cancer has been infrequently reported in patients who have received fertility drugs. Infertility is a primary risk factor for ovarian cancer; however, epidemiology data suggest that prolonged use of Ovophene may increase the risk of a borderline or invasive ovarian tumor.
Postmarketing Adverse Events
The following adverse reactions have been identified during post approval use of Ovophene. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Ovophene tablets USP is contraindicated in patients with a known hypersensitivity or allergy to Ovophene or to any of its ingredients.
Pregnancy Category X. Ovophene tablets USP use in pregnant women is contraindicated, as Ovophene does not offer benefit in this population.
Available human data do not suggest an increased risk for congenital anomalies above the background population risk when used as indicated. However, animal reproductive toxicology studies showed increased embryo-fetal loss and structural malformations in offspring. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential risks to the fetus.
Liver Disease. Ovophene tablets USP therapy is contraindicated in patients with liver disease or a history of liver dysfunction.
Abnormal Uterine Bleeding. Ovophene tablets USP is contraindicated in patients with abnormal uterine bleeding of undetermined origin.
Ovarian Cysts. Ovophene tablets USP is contraindicated in patients with ovarian cysts or enlargement not due to polycystic ovarian syndrome.
Other. Ovophene tablets USP is contraindicated in patients with uncontrolled thyroid or adrenal dysfunction or in the presence of an organic intracranial lesion such as pituitary tumor.
The results of a survey conducted on ndrugs.com for Ovophene are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Ovophene. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.
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