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Drug overview for MILOPHENE (clomiphene citrate):
Generic name: CLOMIPHENE CITRATE (KLOE-mi-feen)
Drug class: Fertility Stimulating Preparations, Non-FSH
Therapeutic class: Endocrine
Clomiphene citrate is a nonsteroidal compound with both estrogenic and anti-estrogenic properties that is used to induce ovulation in anovulatory women.
No enhanced Uses information available for this drug.
Generic name: CLOMIPHENE CITRATE (KLOE-mi-feen)
Drug class: Fertility Stimulating Preparations, Non-FSH
Therapeutic class: Endocrine
Clomiphene citrate is a nonsteroidal compound with both estrogenic and anti-estrogenic properties that is used to induce ovulation in anovulatory women.
No enhanced Uses information available for this drug.
DRUG IMAGES
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The following indications for MILOPHENE (clomiphene citrate) have been approved by the FDA:
Indications:
Infertility associated with anovulation
Professional Synonyms:
Infertility associated with ovulation failure
Indications:
Infertility associated with anovulation
Professional Synonyms:
Infertility associated with ovulation failure
The following dosing information is available for MILOPHENE (clomiphene citrate):
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.
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.
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| MILOPHENE 50 MG TAB | Maintenance | Adults take 1 tablet (50 mg) by oral route once daily |
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| CLOMIPHENE CITRATE 50 MG TAB | Maintenance | Adults take 1 tablet (50 mg) by oral route once daily |
The following drug interaction information is available for MILOPHENE (clomiphene citrate):
There are 0 contraindications.
There are 1 severe interactions.
These drug interactions can produce serious consequences in most patients. Actions required for severe interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration scheduling, and providing additional patient monitoring. Review the full interaction monograph for more information.
| Drug Interaction | Drug Names |
|---|---|
| Fluoroestradiol F-18/Estrogen Receptor Blockers (ERBs) SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Drugs that bind to the estrogen receptor (ER) may compete with the binding of radioactive diagnostic agent fluoroestradiol F-18.(1) CLINICAL EFFECTS: Concurrent use of estrogen receptor blockers such as selective estrogen receptor modulators (SERMs) and selective estrogen receptor down-regulators (SERDs) may reduce the detection of ER-positive lesions with fluoroestradiol F-18.(1) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: Before administering fluoroestradiol F-18, discontinue drugs that bind to the ER, such as SERMs and SERDs, for at least 5 biological half-lives.(1) The following washout periods apply when discontinuing ERBs, prior to fluoroestradiol F-18 administration: - Bazedoxifene = 7 days - Clomiphene = 25 days - Elacestrant = 11 days - Enclomiphene = 25 days - Fulvestrant = 28 weeks - Imlunestrant = 7 days - Ospemifene = 5 days - Raloxifene = 7 days - Tamoxifen = 8 weeks - Toremifene = 5 weeks DISCUSSION: The following ERBs are linked to this monograph: SERDs: elacestrant, imlunestrant, and fulvestrant. SERMs: bazedoxifene, clomiphene, enclomiphene, ospemifene, raloxifene, tamoxifen and toremifene. |
CERIANNA |
There are 0 moderate interactions.
The following contraindication information is available for MILOPHENE (clomiphene citrate):
Drug contraindication overview.
No enhanced Contraindications information available for this drug.
No enhanced Contraindications information available for this drug.
There are 6 contraindications.
Absolute contraindication.
| Contraindication List |
|---|
| Abnormal uterine bleeding |
| Disease of liver |
| Ovarian cyst |
| Pituitary neoplasm |
| Thyrotoxicosis |
| Untreated hypothyroidism |
There are 2 severe contraindications.
Adequate patient monitoring is recommended for safer drug use.
| Severe List |
|---|
| Endometriosis |
| Ovarian hyperstimulation syndrome |
There are 4 moderate contraindications.
Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.
| Moderate List |
|---|
| Endometrial carcinoma |
| Hypertriglyceridemia |
| Reduced visual acuity |
| Scotomata |
The following adverse reaction information is available for MILOPHENE (clomiphene citrate):
Adverse reaction overview.
No enhanced Common Adverse Effects information available for this drug.
No enhanced Common Adverse Effects information available for this drug.
There are 35 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Ovarian cyst Ovarian enlargement |
None. |
| Rare/Very Rare |
|---|
|
After image Carcinoma of breast Cardiac arrhythmia Cataracts Cerebrovascular accident Drug-induced psychosis Endometrial carcinoma Endometriosis Erythema multiforme Erythema nodosum Fibrocystic breast disease Hepatitis Hypertension Hypertriglyceridemia Leukocytosis Macular retinal edema Neoplasm Neoplasm of liver Optic neuritis Ovarian hemorrhage Ovarian hyperstimulation syndrome Pancreatitis Photophobia Pulmonary thromboembolism Retinal hemorrhage Retinal thrombosis Scotomata Seizure disorder Sudden visual loss Thromboembolic disorder Thrombophlebitis Vision impairment Vitreous detachment |
There are 57 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Flushing |
Abdominal distension Nausea Vomiting |
| Rare/Very Rare |
|---|
|
Abnormal hair texture Abnormal vaginal bleeding Accommodation disorder Acne vulgaris Alopecia Arthralgia Back pain Blurred vision Chest pain Constipation Depression Diarrhea Diplopia Disorder of thyroid gland Dizziness Dyspnea Edema Endometrial hypoplasia Erythema Fatigue Fever General weakness Gynecomastia Hirsutism Increased appetite Increased urinary frequency Insomnia Irritability Mastalgia Menorrhagia Migraine Mood changes Multiple pregnancy Myalgia Nervousness Ocular pain Palpitations Paresthesia Phlebitis Phosphene Photopsia Pruritus of skin Skin rash Symptoms of anxiety Syncope Tachycardia Tinnitus Urticaria Vaginal dryness Vertigo Vitreous floater Weight gain Weight loss |
The following precautions are available for MILOPHENE (clomiphene citrate):
No enhanced Pediatric Use information available for this drug.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
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.
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.
No enhanced Lactation information available for this drug.
No enhanced Geriatric Use information available for this drug.
The following prioritized warning is available for MILOPHENE (clomiphene citrate):
No warning message for this drug.
No warning message for this drug.
The following icd codes are available for MILOPHENE (clomiphene citrate)'s list of indications:
| Infertility associated with anovulation | |
| N97.0 | Female infertility associated with anovulation |
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