clomiphene (Rx)

Brand and Other Names:Clomid, Serophene
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

tablet

  • 50mg

Treatment of Ovulatory Failure

50 mg PO qDay initially for 5 days

If no ovulation, treatment can be repeated as early as 30 days after previous therapy

Dosage can be increased to 100 mg only in patients who do not respond to first course

Monitor

Reassess diagnosis after 3 courses if ovulation has not occurred or if menses does not occur following ovulatory response

Not used in children

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Interactions

Interaction Checker

and clomiphene

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    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            Ovarian enlargement (14%)

            Vasomotor flushing (10%)

            1-10%

            Abdominal discomfort (6%)

            Blurred vision (1.5%)

            Breast discomfort (2%)

            Nausea/vomiting (2%)

            Postmarketing Reports

            Body as a whole: Fever, tinnitus, weakness

            Cardiovascular: Arrhythmia, chest pain, edema, hypertension, palpitation, phlebitis, pulmonary embolism, shortness of breath, tachycardia, thrombophlebitis

            Central nervous system: Migraine headache, paresthesia, seizure, stroke, syncope

            Dermatologic: Acne, allergic reaction, erythema, erythema multiforme, erythema nodosum, hypertrichosis, pruritus, urticaria

            Genitourinary: Endometriosis, ovarian cyst (ovarian enlargement or cysts could, as such, be complicated by adnexal torsion), ovarian hemorrhage, tubal pregnancy, uterine hemorrhage; reduced endometrial thickness

            Hepatic: Transaminases increased, hepatitis, pancreatitis

            Musculoskeletal: Arthralgia, back pain, myalgia

            Neoplasms: Liver (hepatic hemangiosarcoma, liver cell adenoma, hepatocellular carcinoma); breast (fibrocystic disease, breast carcinoma); endometrium (endometrial carcinoma); nervous system (astrocytoma, pituitary tumor, prolactinoma, neurofibromatosis, glioblastoma multiforme, brain abscess); ovary (luteoma of pregnancy, dermoid cyst of the ovary, ovarian carcinoma); trophoblastic (hydatiform mole, choriocarcinoma); miscellaneous (melanoma, myeloma, perianal cysts, renal cell carcinoma, Hodgkin’s lymphoma, tongue carcinoma, bladder carcinoma)

            Psychiatric: Anxiety, irritability, mood changes, psychosis

            Visual disorders: Abnormal accommodation, cataract, eye pain, macular edema, optic neuritis, photopsia, posterior vitreous detachment, retinal hemorrhage, retinal thrombosis, retinal vascular spasm, temporary or prolonged loss of vision, possibly irreversible

            Metabolism disorders: Hypertriglyceridemia

            Other: Leukocytosis, thyroid disorder

            Fetal/neonatal anomalies

            • Abnormal bone development: skeletal malformations of the skull, face, nasal passages, jaw, hand, limb (ectromelia including amelia, hemimelia, and phocomelia), foot (clubfoot), spine, and joints
            • Cardiac abnormalities: septal heart defects, muscular ventricular septal defect, patent ductus arteriosus, tetralogy of Fallot, and coarctation of the aorta
            • Chromosomal disorders: Downs syndrome
            • Ear abnormalities and deafness
            • Gastrointestinal tract abnormalities: cleft lip and palate, imperforate anus, tracheoesophageal fistula, diaphragmatic hernia, omphalocele
            • Genitalia abnormalities: hypospadias, cloacal exstrophy
            • Lung tissue malformations
            • Malformations of the eye and lens (cataract)
            • Neoplasms: neuroectodermal tumor, thyroid tumor, hepatoblastoma, lymphocytic leukemia
            • Nervous system abnormalities: neural tube defects (anencephaly, meningomyelocele), microcephaly, and hydrocephalus
            • Renal abnormalities: renal agenesis and renal dysgenesis
            • Others: dwarfism, mental retardation
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            Warnings

            Contraindications

            Pregnancy

            Liver disease

            Undiagnosed abnormal uterine bleeding

            Uncontrolled thyroid or adrenal dysfunction

            Endometrial cancer

            Ovarian cysts not due to PCOS

            Cautions

            Careful attention should be given to selection of candidates for therapy; pelvic examination is necessary prior to treatment and before each subsequent course

            Uterine fibroids, pituitary or ovarian failure may occur

            Risk of ovarian enlargement & ovarian hyperstimulation syndrome (OHSS); transient liver function test abnormalities suggestive of hepatic dysfunction, which may be accompanied by morphologic changes on liver biopsy, reported in association with OHSS, which is a medical event distinct from uncomplicated ovarian enlargement; death due to hypovolemic shock, hemoconcentration, or thromboembolism has occurred; if enlargement of ovary occurs, additional therapy should not be given until ovaries have returned to pretreatment size, and dosage or duration of next course should be reduced; ovarian enlargement and cyst formation associated with therapy usually regresses spontaneously within a few days or weeks after discontinuing treatment; potential benefit of subsequent therapy in these cases should exceed risk

            Potential for multiple births, especially at 100 mg dosage

            Risk of visual disturbance (like scotoma & photopsia); patients should be warned that visual symptoms may render activities such as driving a car or operating machinery more hazardous than usual, particularly under conditions of variable lighting; while etiology of visual symptoms is not yet understood, patients with any visual symptoms should discontinue treatment and have complete ophthalmological evaluation carried out promptly

            Cases of hypertriglyceridemia reported; preexisting or family history of hyperlipidemia and use of higher than recommended dose and/or longer duration of treatment are associated with risk of hypertriglyceridemia; periodic monitoring of plasma triglycerides is recommended in patients with preexisting or family history of hyperlipidemia; pretreatment screening of triglyceride levels is recommended in patients initiating therapy

            Cases of pancreatitis reported

            Prolonged use of clomiphene citrate tablets USP may increase risk of a borderline or invasive ovarian tumor

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            Pregnancy & Lactation

            Pregnancy

            Use in pregnant women is contraindicated, as treatment does not offer benefit in this population; to avoid inadvertent administration during early pregnancy, appropriate tests should be utilized during each treatment cycle to determine whether ovulation and/or pregnancy occurs; patients should be evaluated carefully to exclude ovarian enlargement or ovarian cyst formation between each treatment cycle; the next course of therapy should be delayed until these conditions have been excluded

            Available human data from epidemiologic studies do not show apparent cause and effect relationship between clomiphene citrate periconceptual exposure and an increased risk of overall birth defects, or any specific anomaly

            Lactation

            It is not known whether drug is excreted in human milk; because many drugs are excreted in human milk, caution should be exercised if drug is administered to a nursing woman; in some patients, therapy may reduce lactation

            Pregnancy Categories

            A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA: Information not available.

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            Pharmacology

            Mechanism of Action

            Binds to estrogen receptors, induces ovulation by increase output of pituitary gonadotropins

            Pharmacokinetics

            Half-Life elimination: 5-7 days

            Onset: Within 5-10 days

            Peak plasma time 6.5 hours

            Bioavailability: Readily absorbed from GI tract

            Metabolism: Enterohepatically circulated

            Excretion: feces 37-51%; small amount in urine

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            Formulary

            FormularyPatient Discounts

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            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
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            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
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            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.