Clomifene


Concise Prescribing Info
Indications/Uses
Anovulatory infertility.
Dosage/Direction for Use
Adult : PO 50 mg/day for 5 days, starting at any time if there is no uterine bleeding or on the 5th day of the menstrual cycle. If ovulation does not occur, 100 mg/day for 5 days may be given as early as 30 days after the previous course. Max: 3 courses.
Dosage Details
Oral
Anovulatory infertility
Adult: 50 mg once daily for 5 days, starting at any time if there is no uterine bleeding or on the 5th day of the menstrual cycle. If ovulation does not occur w/in 5-10 days, a 2nd course of 100 mg once daily for 5 days may be given, starting as early as 30 days after the previous course. Max: 3 courses.
Hepatic Impairment
Contraindicated.
Administration
May be taken with or without food.
Contraindications
Abnormal uterine bleeding of unknown origin, ovarian cyst or enlargement not due to polycystic ovarian syndrome, organic intracranial lesion (e.g. pituitary tumour), uncontrolled thyroid or adrenal dysfunction. Active liver disease or history of hepatic impairment. Pregnancy.
Special Precautions
Patient w/ uterine fibroids, polycystic ovarian syndrome (PCOS). Lactation.
Adverse Reactions
Significant: Mild to moderate OHSS, visual disturbance (e.g. blurring, scotomata, diplopia, photophobia), endometriosis, ovarian enlargement and cyst formation, risk of multiple or ectopic pregnancy. Rarely, risk of borderline or invasive ovarian cancer.
Nervous: Headache, convulsion, restlessness, insomnia, dizziness, vertigo, lightheadedness, depression, nervous tension, fatigue, insomnia.
GI: Nausea, vomiting, constipation, diarrhoea, increased appetite.
Genitourinary: Increased urinary frequency and volume, vag dryness, menorrhagia, uterine haemorrhage, endometriosis.
Endocrine: Vasomotor flushes, hypertriglyceridemia, wt gain.
Dermatologic: Urticaria, rash, dermatitis, hair loss and dryness.
Others: Breast discomfort.
Potentially Fatal: Severe OHSS manifesting as gross ovarian enlargement, pericardial effusion, severe abdominal pain, ascites, dyspnoea, acute resp distress syndrome, hypotension, tachycardia, thromboembolism, hypovolemic shock, and haemoconcentration.
Patient Counseling Information
This drug may cause visual disturbances, dizziness, and lightheadedness, if affected, do not drive or operate machinery.
MonitoringParameters
Monitor serum oestrogen prior to therapy. Perform pelvic exam and endometrial biopsy before each course and pregnancy test prior to repeat courses. Monitor for ovulation through basal body temp, ultrasound, serum progesterone, oestradiol, and urinary LH. Assess signs and symptoms of ovarian hyperstimulation syndrome (OHSS).
Overdosage
Symptoms: Nausea, vomiting, vasomotor flashes, blurring of vision, scotomata, ovarian enlargement w/ pelvic or abdominal pain. Management: Supportive treatment. Perform GI decontamination.
Drug Interactions
May enhance adverse effect of ospemifene.
Action
Description: Clomifene is a nonsteroidal compound that has both oestrogenic and anti-oestrogenic effects. It stimulates ovulation by inhibiting the negative feedback effect of oestrogens at receptor sites in the hypothalamus and pituitary, thereby increasing hypothalamic GnRH secretion w/ subsequent release of pituitary FSH and LH.
Onset: 5-10 days.
Pharmacokinetics:
Absorption: Readily absorbed from the GI tract. Time to peak plasma concentration: Approx 6 hr.
Metabolism: Metabolised in the liver; undergoes enterohepatic recirculation.
Excretion: Via faeces (42%) and urine (8%). Elimination half-life: Approx 5 days.
Chemical Structure

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Storage
Store below 25°C. Protect from light, heat, and excessive humidity.
Use appropriate personal protective equipment (e.g. gloves) for receiving, handling, admin and disposal.
ATC Classification
G03GB02 - clomifene ; Belongs to the class of synthetic agents used as ovulation stimulants.
Disclaimer: This information is independently developed by MIMS based on Clomifene from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2020 MIMS. All rights reserved. Powered by MIMS.com
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