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Duinum

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Indications:

Treats ovulation problems in women who want to become pregnant.

Contraindications:

hypersensitivity this medicine is contraindicated in patients with a known hypersensitivity or allergy to clomiphene citrate or to any of its ingredients. Pregnancy this medicine should not be administered during pregnancy. this medicine may cause fetal harm in animals (see Animal Fetotoxicity). Although no causative evidence of a deleterious effect of CLOMID therapy on the human fetus has been established, there have been reports of birth anomalies which, during clinical studies, occurred at an incidence within the range reported for the general population (see Fetal/Neonatal Anomalies and Mortality; ADVERSE REACTIONS). To avoid inadvertent this medicine administration during early pregnancy, appropriate tests should be utilized during each treatment cycle to determine whether ovulation occurs. The patient should be evaluated carefully to exclude pregnancy, ovarian enlargement, or ovarian cyst formation between each treatment cycle. The next course of this medicine therapy should be delayed until these conditions have been excluded. Fetal/Neonatal Anomalies and Mortality. The following fetal abnormalities have been reported subsequent to pregnancies following ovulation induction therapy with this medicine during clinical trials. Each of the following fetal abnormalities were reported at a rate of < 1% (experiences are listed in order of decreasing frequency): Congenital heart lesions, Down syndrome, club foot, congenital gut lesions, hypospadias, microcephaly, harelip and cleft palate, congenital hip, hemangioma, undescended testicles, polydactyly, conjoined twins and teratomatous malformation, patent ductus arteriosus, amaurosis, arteriovenous fistula, inguinal hernia, umbilical hernia, syndactyly, pectus excavatum, myopathy, dermoid cyst of scalp, omphalocele, spina bifida occulta, ichthyosis, and persistent lingual frenulum. Neonatal death and fetal death/stillbirth in infants with birth defects have also been reported at a rate of < 1%. The overall incidence of reported birth anomalies from pregnancies associated with maternal CLOMID ingestion during clinical studies was within the range of that reported for the general population. In addition, reports of birth anomalies have been received during postmarketing surveillance of this medicine (see ADVERSE REACTIONS). Animal Fetotoxicity. Oral administration of clomiphene citrate to pregnant rats during organogenesis at doses of 1 to 2 mg/kg/day resulted in hydramnion and weak, edematous fetuses with wavy ribs and other temporary bone changes. Doses of 8 mg/kg/day or more also caused increased resorptions and dead fetuses, dystocia, and delayed parturition, and 40 mg/kg/day resulted in increased maternal mortality. Single doses of 50 mg/kg caused fetal cataracts, while 200 mg/kg caused cleft palate. Following injection of clomiphene citrate 2 mg/kg to mice and rats during pregnancy, the offspring exhibited metaplastic changes of the reproductive tract. Newborn mice and rats injected during the first few days of life also developed metaplastic changes in uterine and vaginal mucosa, as well as premature vaginal opening and anovulatory ovaries. These findings are similar to the abnormal reproductive behavior and sterility described with other estrogens and antiestrogens. In rabbits, some temporary bone alterations were seen in fetuses from dams given oral doses of 20 or 40 mg/kg/day during pregnancy, but not following 8 mg/kg/day. No permanent malformations were observed in those studies. Also, rhesus monkeys given oral doses of 1.5 to 4.5 mg/kg/day for various periods during pregnancy did not have any abnormal offspring. Liver Disease. this medicine therapy is contraindicated in patients with liver disease or a history of liver

Adverse reactions:

Severe lower stomach pain Nausea, vomiting Weight gain. Blurred vision

Interactions:

* 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 clomiphene. This medicine may cause changes in vision such as blurring or trouble focusing. * If this becomes severe, tell your doctor. * Be careful driving or operating machinery.

Warnings:

You should not use this medicine if you have had an allergic reaction to clomiphene, are pregnant (or think you might be pregnant), or if you have liver disease, cysts on the ovaries, enlarged ovaries, or unusual vaginal bleeding.

Form:

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