Follow your doctor's instructions. You will need to have a pelvic examination before each treatment cycle. You must remain under the care of a doctor while you are using this medicine. You will most likely ovulate within 5 to 10 days after you take clomiphene.
To improve your chance of becoming pregnant, you should have sexual intercourse while you are ovulating. Your doctor may have you take your temperature each morning and record your daily readings on a chart. This will help you determine when you can expect ovulation to occur. In most cases, clomiphene should not be used for more than 3 treatment cycles.
If ovulation occurs but you do not get pregnant after 3 treatment cycles, your doctor may stop treatment and evaluate your infertility further. Store at room temperature away from moisture, heat, and light. What happens if I miss a dose? Call your doctor for instructions if you miss a dose of clomiphene. What happens if I overdose? Seek emergency medical attention or call the Poison Help line at What should I avoid? This medication may cause blurred vision.
Be careful if you drive or do anything that requires you to be alert and able to see clearly. Clomiphene side effects Get emergency medical help if you have any signs of an allergic reaction to clomiphene: Some women using this medicine develop a condition called ovarian hyperstimulation syndrome OHSS , especially after the first treatment.
OHSS can be a life threatening condition. Call your doctor right away if you have any of the following symptoms of OHSS: Stop using clomiphene and call your doctor at once if you have: Common clomiphene side effects may include: This is not a complete list of side effects and others may occur.
Call your doctor for medical advice about side effects. Therapy should be initiated on or near the 5th day of the menstrual cycle, but may be started at any time in patients without recent uterine bleeding. If ovulation occurs and pregnancy is not achieved, up to 2 additional courses of clomiphene 50 mg orally once a day for 5 days may be administered.
Each subsequent course may be started as early as 30 days after the previous course and after pregnancy has been excluded. Most patients ovulate following the first course of therapy. Usual Adult Dose for Lactation Suppression: Generally, one course of therapy is sufficient.
Usual Adult Dose for Oligospermia: 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. Caution should be exercised when using Clomid 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 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. 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. Contraindications Hypersensitivity Clomid is contraindicated in patients with a known hypersensitivity or allergy to clomiphene citrate or to any of its ingredients.
Pregnancy Pregnancy Category X Clomid use in pregnant women is contraindicated, as Clomid 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.
Warnings Visual Symptoms Patients should be advised that blurring or other visual symptoms such as spots or flashes scintillating scotomata may occasionally occur during therapy with Clomid.
These visual symptoms increase in incidence with increasing total dose or therapy duration. These visual disturbances are usually reversible; however, cases of prolonged visual disturbance have been reported with some occurring after Clomid discontinuation.
The visual disturbances may be irreversible, especially with increased dosage or duration of therapy. Patients should be warned that these visual symptoms may render such activities as driving a car or operating machinery more hazardous than usual, particularly under conditions of variable lighting. These visual symptoms appear to be due to intensification and prolongation of afterimages. Symptoms often first appear or are accentuated with exposure to a brightly lit environment.
While measured visual acuity usually has not been affected, a study patient taking mg Clomid daily developed visual blurring on the 7th day of treatment, which progressed to severe diminution of visual acuity by the 10th day. No other abnormality was found, and the visual acuity returned to normal on the 3rd day after treatment was stopped.
Ophthalmologically definable scotomata and retinal cell function electroretinographic changes have also been reported. A patient treated during clinical studies developed phosphenes and scotomata during prolonged Clomid administration, which disappeared by the 32nd day after stopping therapy. While the etiology of these visual symptoms is not yet understood, patients with any visual symptoms should discontinue treatment and have a complete ophthalmological evaluation carried out promptly.
Ovarian Hyperstimulation Syndrome The ovarian hyperstimulation syndrome OHSS has been reported to occur in patients receiving clomiphene citrate therapy for ovulation induction. OHSS may progress rapidly within 24 hours to several days and become a serious medical disorder. In some cases, OHSS occurred following cyclic use of clomiphene citrate therapy or when clomiphene citrate was used in combination with gonadotropins.
Transient liver function test abnormalities suggestive of hepatic dysfunction, which may be accompanied by morphologic changes on liver biopsy, have been reported in association with OHSS. OHSS is a medical event distinct from uncomplicated ovarian enlargement.
The clinical signs of this syndrome in severe cases can include gross ovarian enlargement, gastrointestinal symptoms, ascites, dyspnea, oliguria, and pleural effusion. In addition, the following symptoms have been reported in association with this syndrome: The early warning signs of OHSS are abdominal pain and distention, nausea, vomiting, diarrhea, and weight gain.
Elevated urinary steroid levels, varying degrees of electrolyte imbalance, hypovolemia, hemoconcentration, and hypoproteinemia may occur. Death due to hypovolemic shock, hemoconcentration, or thromboembolism has occurred. Due to fragility of enlarged ovaries in severe cases, abdominal and pelvic examination should be performed very cautiously. If conception results, rapid progression to the severe form of the syndrome may occur. To minimize the hazard associated with occasional abnormal ovarian enlargement associated with Clomid therapy, the lowest dose consistent with expected clinical results should be used.
Maximal enlargement of the ovary, whether physiologic or abnormal, may not occur until several days after discontinuation of the recommended dose of Clomid.
Some patients with polycystic ovary syndrome who are unusually sensitive to gonadotropin may have an exaggerated response to usual doses of Clomid. If enlargement of the ovary occurs, additional Clomid therapy should not be given until the ovaries have returned to pretreatment size, and the dosage or duration of the next course should be reduced.
Ovarian enlargement and cyst formation associated with Clomid therapy usually regresses spontaneously within a few days or weeks after discontinuing treatment. The potential benefit of subsequent Clomid therapy in these cases should exceed the risk. Unless surgical indication for laparotomy exists, such cystic enlargement should always be managed conservatively. A causal relationship between ovarian hyperstimulation and ovarian cancer has not been determined. However, because a correlation between ovarian cancer and nulliparity, infertility, and age has been suggested, if ovarian cysts do not regress spontaneously, a thorough evaluation should be performed to rule out the presence of ovarian neoplasia.
Precautions General Careful attention should be given to the selection of candidates for Clomid therapy. Information for Patients The purpose and risks of Clomid therapy should be presented to the patient before starting treatment. It should be emphasized that the goal of Clomid therapy is ovulation for subsequent pregnancy. The physician should counsel the patient with special regard to the following potential risks:
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