CLOMIPHENE (CLOMIPHENE)

Clomiphene is a brand-name medication for a generic drug called Clomiphene Citrate. It is an FDA-approved prescription drug given by a primary care physician, fertility specialist, or OB/GYN for treating ovulatory dysfunction or to cause ovulation in PCOS (Polycystic Ovarian Syndrome) affected women who desire a biological child.

Clomiphene contains Clomiphene Citrate as the active ingredient and following inactive ingredients sucrose, corn starch, magnesium stearate, lactose, and pregelatinized cornstarch. Clomiphene citrate is a white to pale yellow, odorless crystalline powder that is a mixture of two geometric isomers- cis (Zuclomiphene) and trans (Enclomiphene), having between 30-50% of the cis isomer. It is chemically designated as 2-[p-(2-chloro-1,2-diphenylvinyl) phenoxy] triethylamine citrate (1:1).

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Clomiphene belongs to the pharmacological class of Synthetic Non-Steroidal Ovulatory Stimulants. Ovulatory stimulants like Clomiphene are used to treat infertility in anovulatory women. It stimulates ovulation or releases the ovum (egg) from the ovaries. This class of drugs has another name Selective Estrogen Receptor Modulator (SERM) as its structure is similar to estrogen hormone. It goes and binds to the estrogen receptors and the brain perceives that there is a low estrogen level in the body.

Estrogen cannot deliver negative feedback to the brain's hypothalamus region so there is a release of gonadotropin-releasing hormone (GnRH). GnRH further activates the pituitary gland to secrete two other hormones: Follicle Stimulating Hormone (FSH) and Luteinising Hormone (LH). This leads to stimulation of the growth of ovarian follicles and subsequently ovulation- the release of the mature ovum.

• Clomiphene tablets come in only a single 50mg strength.
• These tablets are white, round, scored, and debossed “Clomiphene 50”.

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Clomiphene use is FDA-approved for treating ovulatory dysfunction in women wanting pregnancy. Ovulatory dysfunction is a condition where a woman has infrequent, irregular menses or no ovulation at all, meaning no release of egg from the ovary every month. This happens either as a result of the problem with a part of the brain that regulates Gonadotropin-releasing hormone release and the glands that control ovulation or else due to problems with ovaries.

Clomiphene is only for patients who have demonstrated ovulatory dysfunction and meet the following criteria:

• Not able to get pregnant.
• Have no ovarian cysts (except for women with PCOS who are experiencing anovulation).
• Have no unusual vaginal bleeding.
• Have sufficient levels of endogenous estrogen.
• Have a normal functioning liver.

• The usual initial dose for ovulation induction is one tablet of 50 mg of Clomiphene daily for 5 days. The dose should be started on or near the 5th day of the menstrual cycle.
• The suggested second dose is 50 mg twice daily for 5 days. It should be initiated if the patient fails to get pregnant, not before 30 days after the earlier course.
• The third recommended dose is 50 mg twice daily for 5 days following 30 days, if necessary.
• The maximum suggested dosage for ovulation induction is 100 mg daily for 5 days duration.

Clomiphene is available in the form of tablets meant for oral administration. These tablets must be swallowed whole with some water after a meal at about the same time daily. The starting dose is one tablet per day for five days. One must make a note that the doctor may adjust the dosage based on one’s response to the treatment.

Commonly reported side effects of Clomiphene include:

• Breast pain, tenderness, or discomfort.
• Warmth, tingly feeling, or redness.
• Headache
• Nausea
• Vomiting
• Vaginal spotting or breakthrough bleeding.
• Diarrhea
• Increased risk of multiple births.

Serious side effects of Clomiphene include:

• Ovarian hyperstimulation syndrome (OHSS).
• Severe allergic reactions.
• Visual disturbances or blurred vision.
• Enlarged pelvic region or pelvic pain/pressure/swelling/tenderness.

Some of the drugs known to interact with Clomiphene include:

• Fedratinib
• Abrocitinib
• Bexarotene
• Baricitinib
• Ruxolitinib Topical
• Momelotinib
• Ospemifene
• Fluoro-Estradiol F 18
• Upadacitinib
• Pacritinib
• Tofacitinib
• Ritlecitinib
• Ruxolitinib

Talk to your doctor and pharmacist about your current intake of medications as they have better knowledge on what medications to avoid or take while taking Clomiphene.

Clomiphene is not safe to be taken by:

• Anyone having an allergy to any of the contents of Clomiphene.
• Patients suffering from liver disease/hepatic dysfunction, a pituitary tumor, an ovarian cyst unrelated to PCOS, abnormal vaginal bleeding, hyperlipidemia, endometriosis or uterine fibroids, or/and untreated/uncontrolled issue with adrenal gland or thyroid gland.
• Pregnant women.
• Women who are nursing babies.
• Small children.

When taking Clomiphene, it is important to watch for the following:

• Before initiating Clomiphene therapy, inform your doctor of any existing allergies or medical conditions, current intake of medications/supplements, whether pregnant or breastfeeding and other significant health-related facts.
• Do not make up for missed doses by doubling the dose.
• Do not reduce or stop taking Clomiphene, until the doctor advises to do so.
• Do not take Clomiphene if it is out of date, the tablets show signs of deterioration, or the package is torn.
• Limit alcohol intake while taking any medication, including Clomiphene, to avoid potential interactions and side effects.
• Clomiphene is contraindicated in pregnancy. Women should ensure they are not pregnant before starting Clomiphene and avoid becoming pregnant while taking it.
• Do not breastfeed while taking Clomiphene as its active ingredient may pass to the baby through breast milk and may cause harm.
• Be careful while operating machinery, driving, or doing anything that requires clear vision and alertness as Clomiphene can cause visual disturbances.

• Store Clomiphene tablets in their blistered pack at room temperature, preferably 15-30°C.
• Keep away from light, moisture, heat, and small children.

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