Serophene (clomiphene citrate)
Last reviewed · Source: First Databank (FDB) drug data
Overview
Clomiphene citrate is a nonsteroidal compound with both estrogenic and anti-estrogenic properties that is used to induce ovulation in anovulatory women.
USES: This medication is used to treat infertility in women. It works by stimulating an increase in the amount of hormones that support the growth and release of a mature egg (ovulation). This medication is not recommended for women whose ovaries no longer make eggs properly (primary pituitary or ovarian failure).
Generic name: clomiphene citrate
Pronunciation: (KLOE-mi-feen)
Reference product & biosimilars
No reference, biosimilar or interchangeable associated with this drug.
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Indications
The following indications are listed for Serophene:
- Infertility Associated With Anovulation
Also known as: Infertility Associated With Ovulation Failure.
Dosing
The usual initial dosage of clomiphene citrate used to induce ovulation is 50 mg daily for 5 days. It is important to carefully time the dosage schedule. Therapy may be started at any time in patients who have had no recent uterine bleeding. If progestin-induced bleeding is planned, or if spontaneous uterine bleeding occurs prior to therapy, the regimen should be started on the fifth day of the cycle. Once ovulation has been established, each subsequent course of therapy should be started on the fifth day of the cycle. Although ovulation is slightly more likely to occur with a dosage of 100 mg daily for 5 days, the adverse effects and incidence of multiple ovulations with resulting plural gestations may be expected to increase at this higher dosage.
The majority of the patients who are going to respond to clomiphene citrate will ovulate after the first course of therapy, generally within 5-14 days. If ovulation has not occurred at this time, 100 mg of clomiphene citrate may be administered daily for 5 days, starting as early as 30 days after previous therapy. Dosage should be increased only in those patients who do not respond to the first course of therapy, and dosage should never be increased or extended beyond 100 mg daily for 5 days. Prolonged amenorrhea may be less responsive to clomiphene and may require 2 or more cycles of therapy. Three courses of clomiphene should constitute an adequate therapeutic trial; if ovulatory menses or pregnancy has not occurred at this time, the diagnosis should be reevaluated. The likelihood of conception decreases with each succeeding course of therapy.
Since the relative safety of long-term cyclic therapy with clomiphene has not been conclusively demonstrated, and since the majority of patients will ovulate after 3 courses of therapy, long-term cyclic therapy is not recommended.
Clomiphene citrate is administered orally.
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Drug interactions
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There are no contraindication interactions for this drug.
There are no severe interactions for this drug.
There are no moderate interactions for this drug.
Contraindications
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There are no contraindication contraindications for this drug.
There are no severe contraindications for this drug.
There are no moderate contraindications for this drug.
Adverse reactions
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There are no severe adverse reactions for this drug.
There are no less severe adverse reactions for this drug.
Precautions
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The incidence of multiple ovulations with resulting plural gestations (mostly twins) is increased when conception occurs during a cycle in which clomiphene citrate is administered. Prior to clomiphene citrate therapy, the patient and her male sexual partner should be informed of the possibility and potential risks associated with plural gestation. Simultaneous bilateral tubal pregnancy, an extremely rare form of twin pregnancy, has been reported following combined therapy with clomiphene citrate and chorionic gonadotropin.
Clomiphene citrate is contraindicated during pregnancy. The drug has been shown to be teratogenic in rats and rabbits. Congenital abnormalities (e.g., Down's syndrome, exstrophy, club foot, tibial torsion, blocked tear duct, hemangioma, neural tube defects) have been reported in infants conceived following clomiphene citrate therapy. These effects have not been directly attributed to the drug and the manufacturers state that the cumulative rate of congenital abnormalities does not exceed that reported in the general population. To avoid inadvertent clomiphene citrate administration during early pregnancy, the patient should be carefully observed to determine if ovulation occurs. The basal body temperature should be recorded throughout all treatment cycles, and clomiphene therapy should be discontinued if pregnancy is suspected. If the basal body temperature is biphasic and not followed by menses, the possibility of an ovarian cyst and/or pregnancy should be excluded and subsequent clomiphene therapy should be delayed until a correct diagnosis has been made.
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ICD codes
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Formulary status
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Last reviewed · Source: First Databank (FDB) drug data
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