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Clomifene

Clomifene, also known as clomiphene, is a medication used to treat infertility in women who do not ovulate, including those with polycystic ovary syndrome. Use results in a greater chance of twins. It is taken by mouth once a day, with a course of treatment that usually lasts for 5 days.

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Clomid is a prescription medicine used to treat the symptoms of infertility in women who have ovulatory failure. Clomid may be used alone or with other medications. Clomid belongs to a class of drugs called Selective Estrogen Receptor Modulators. It is not known if Clomid is safe and effective in children.

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What are the possible side effects of Clomid? Clomid may cause serious side effects including:
  • stomach pain,
  • bloating,
  • nausea,
  • vomiting,
  • diarrhea,
  • rapid weight gain (especially in your face and midsection),
  • little or no urination,
  • pain when you breathe,
  • rapid heart rate, and
  • shortness of breath
Get medical help right away, if you have any of the symptoms listed above.

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The most common side effects of Clomid include:
  • flushing (warmth, redness, or tingly feeling),
  • nausea,
  • vomiting,
  • bloating,
  • breast pain or tenderness,
  • headache, and
  • breakthrough bleeding or spotting
Tell the doctor if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of Clomid. For more information, ask your doctor or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. Clomiphene citrate is a white to pale yellow, essentially odorless, crystalline powder. It is freely soluble in methanol; soluble in ethanol; slightly soluble in acetone, water, and chloroform; and insoluble in ether. CLOMID is a mixture of two geometric isomers [cis (zuclomiphene) and trans (enclomiphene)] containing between 30% and 50% of the cis-isomer.

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Each white scored tablet contains 50 mg clomiphene citrate USP. The tablet also contains the following inactive ingredients: corn starch, lactose, magnesium stearate, pregelatinized cornstarch, and sucrose. INDICATIONS CLOMID is indicated for the treatment of ovulatory dysfunction in women desiring pregnancy. Impediments to achieving pregnancy must be excluded or adequately treated before beginning CLOMID therapy. Those patients most likely to achieve success with clomiphene therapy include patients with polycystic ovary syndrome (see WARNINGS: Ovarian Hyperstimulation Syndrome), amenorrhea-galactorrhea syndrome, psychogenic amenorrhea, post-oral-contraceptive amenorrhea, and certain cases of secondary amenorrhea of undetermined etiology.

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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 CLOMID 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). (See DOSAGE AND ADMINISTRATION and PRECAUTIONS.)

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CLOMID is indicated only in patients with demonstrated ovulatory dysfunction who meet the conditions described below: Patients who are not pregnant. Patients without ovarian cysts. CLOMID 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 CLOMID 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.

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In addition, patients selected for CLOMID 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. Priary Pituitary or Ovarian Failure. CLOMID 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 CLOMID 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 CLOMID in patients with uterine fibroids due to the potential for further enlargement of the fibroids.

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There are no adequate or well-controlled studies that demonstrate the effectiveness of CLOMID in the treatment of male infertility. In addition, testicular tumors and gynecomastia have been reported in males using clomiphene. The cause and effect relationship between reports of testicular tumors and the administration of CLOMID is not known.

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Although the medical literature suggests various methods, there is no universally accepted standard regimen for combined therapy (ie, CLOMID in conjunction with other ovulation-inducing drugs). Similarly, there is no standard CLOMID regimen for ovulation induction in in vitro fertilization programs to produce ova for fertilization and reintroduction. Therefore, CLOMID is not recommended for these uses.
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