Clomid 50 mg Tablets

Brand Name

The medication is marketed under the brand name Clomid, a well-established name in the field of reproductive endocrinology and fertility treatment.

International Nonproprietary Name (INN)

The active substance in this product is known internationally as clomiphene citrate, a designation standardized for use across global pharmacological contexts.

Form of Release

Clomid is available as oral tablets, designed for easy administration. Each tablet contains 50 mg of the active ingredient and is typically supplied in blister packs or bottles, depending on regional packaging practices.

Composition

Each tablet of Clomid contains 50 mg of clomiphene citrate as its primary active component. The formulation includes several inactive ingredients, such as lactose monohydrate, which serves as a filler, and corn starch, contributing to tablet structure. Additional excipients like magnesium stearate act as lubricants to aid in manufacturing, while sucrose provides a slight binding effect. Trace amounts of other stabilizers may be included to ensure the drug retains its potency and quality over time, offering a reliable option for patients undergoing treatment.

Pharmacologic Properties

Pharmacodynamics

Clomid operates as a selective estrogen receptor modulator (SERM), exerting its effects by interacting with estrogen receptors in various tissues. Its primary action occurs in the hypothalamus, where it binds to estrogen receptors and blocks the negative feedback of circulating estradiol. This disruption stimulates the release of gonadotropin-releasing hormone (GnRH), which in turn increases secretion of follicle-stimulating hormone (FSH) and luteinizing hormone (LH) from the pituitary gland. The surge in FSH and LH promotes follicular development and ovulation in women with ovulatory dysfunction, making it a cornerstone in infertility treatment.

The medication’s anti-estrogenic effects are also evident in peripheral tissues like the endometrium and cervical mucus, where it may reduce mucus production or endometrial thickness, though these changes are typically outweighed by its ovulatory benefits. Its dual agonist-antagonist properties depend on tissue-specific estrogen levels, offering a nuanced approach to hormonal regulation. Clinical studies demonstrate its ability to induce ovulation in 70–80% of appropriately selected patients, with pregnancy rates varying based on underlying conditions. This targeted mechanism supports its role in restoring reproductive function without directly mimicking sex hormones.

Pharmacokinetics

Following oral administration, Clomid is absorbed efficiently from the gastrointestinal tract, reaching peak plasma concentrations within 4 to 7 hours. Food intake does not significantly alter its absorption, allowing flexibility in dosing timing. The drug exhibits extensive plasma protein binding, approximately 99%, primarily to albumin, directing its distribution to the bloodstream and reproductive tissues.

Metabolism occurs predominantly in the liver, where it is processed into active and inactive metabolites, though the exact enzymatic pathways, including cytochrome P450 involvement, are not fully elucidated. The half-life is approximately 5 days, reflecting slow clearance and supporting short-course regimens. Elimination is primarily fecal, with about 85% of the dose excreted via bile over several weeks, and a smaller fraction appearing in urine. This prolonged excretion profile means detectable levels may persist long after discontinuation, influencing treatment planning.

Indications for Use

Clomid is primarily indicated for the treatment of ovulatory dysfunction in women desiring pregnancy. It is most effective in cases of anovulation or oligo-ovulation, such as in polycystic ovary syndrome (PCOS), where it stimulates follicle development and ovulation. The medication is suitable for women with intact hypothalamic-pituitary-ovarian axes but impaired ovulatory signals, offering a non-invasive fertility option.

In some clinical settings, it may be used off-label to evaluate ovarian reserve or treat unexplained infertility, though such applications depend on physician discretion and patient profile. It is also occasionally employed in men with hypogonadotropic hypogonadism to boost testosterone production by enhancing LH release, though this is less common. Its primary role in female fertility underscores its value in assisting conception for couples facing ovulatory challenges.

Contraindications

Clomid is contraindicated in women with known hypersensitivity to clomiphene citrate or any tablet component, such as lactose, where reactions could range from mild rashes to severe allergic responses. It is also prohibited in those with liver disease or a history of hepatic dysfunction, given its extensive metabolism and potential for toxicity in compromised livers.

Pregnancy is an absolute contraindication, as the drug is intended to induce ovulation, not support gestation, and may pose risks to a developing fetus if taken inadvertently. Patients with ovarian cysts (unrelated to PCOS), endometrial cancer, or abnormal uterine bleeding of unknown cause should avoid it, as it could exacerbate these conditions. Visual disturbances or pituitary tumors also preclude its use, due to potential worsening of symptoms or interference with hormonal regulation.

Method of Administration and Dosage

Administration Guidelines

The tablets should be taken orally, swallowed whole with water to ensure proper absorption. They can be consumed with or without food, offering convenience in daily scheduling. Taking them at a consistent time each day during the prescribed cycle enhances treatment precision, and splitting or crushing the tablets is not advised unless directed by a healthcare provider.

Dosage for Adults and Children

For adult women seeking ovulation induction, the typical starting dose of Clomid is 50 mg daily (1 tablet) for 5 days, usually beginning on day 3, 4, or 5 of the menstrual cycle. If ovulation does not occur, the dose may increase to 100 mg daily (2 tablets) in subsequent cycles, with a maximum of 150 mg under close monitoring. Treatment is generally limited to 3–6 cycles, depending on response. Children are not candidates for this therapy, as it targets adult reproductive function, and safety in pediatric populations is unestablished.

Dose Adjustment in Specific Conditions

No specific adjustments are needed for renal impairment, as kidney excretion is minimal. In mild to moderate liver dysfunction, caution is advised due to metabolic reliance on the liver, with severe hepatic impairment contraindicating use entirely. Patients with PCOS may require lower or higher doses based on sensitivity, guided by ultrasound and hormonal monitoring. Missed doses should be taken as soon as remembered within the 5-day window, but doubling up is avoided to prevent overstimulation.

Side Effects

Clomid may cause a range of side effects, though many women tolerate it with minimal disruption. Common reactions include hot flashes, reflecting its anti-estrogenic effects on the hypothalamus, and abdominal bloating or pelvic discomfort, often linked to ovarian enlargement during ovulation. Mood swings or irritability are also reported, typically transient as the body adjusts.

Less frequent issues include breast tenderness, headaches, or nausea, which usually resolve post-cycle. Serious but rare effects include ovarian hyperstimulation syndrome (OHSS), characterized by severe pelvic pain or swelling, and visual disturbances like blurred vision, necessitating immediate discontinuation. Multiple pregnancies, particularly twins, occur in 6–8% of cases due to multi-follicular development. Regular monitoring mitigates these risks and ensures safe use.

Overdose

Symptoms of Overdose

Excessive intake of Clomid may amplify typical side effects rather than cause acute toxicity, given its short-course use. Reported symptoms include severe nausea, vomiting, hot flashes, and pelvic pain, with rare instances of visual changes or ovarian overstimulation. Specific overdose thresholds are not well-defined, but effects align with exaggerated pharmacological action.

First Aid Measures

In case of overdose, medical consultation is advised, though emergency measures are seldom required. No specific antidote exists, so treatment focuses on symptom management, such as hydration for nausea or rest for discomfort. Monitoring ovarian response and vital signs is recommended until symptoms subside, typically within days due to the drug’s clearance profile.

Drug Interactions

Effects on Other Medications

Clomid has limited documented interactions with drugs metabolized by cytochrome P450 enzymes, as it does not strongly induce or inhibit these pathways. Co-administration with gonadotropins or other fertility agents may enhance ovarian stimulation, requiring careful dosing adjustments. Its effects on estrogen receptors do not significantly alter the metabolism of unrelated medications like warfarin or antibiotics.

Drugs that affect pituitary function, such as dopamine agonists, could theoretically interfere with its efficacy, though evidence is sparse. Patients should inform their healthcare provider of all medications to assess potential overlaps, particularly in complex fertility regimens.

Compatibility with Alcohol and Food

Moderate alcohol consumption does not impair the drug’s effectiveness, allowing typical use without concern. Food intake has negligible impact on absorption, so tablets can be taken with meals or on an empty stomach, accommodating individual routines seamlessly.

Special Precautions

Use During Pregnancy and Breastfeeding

Clomid is contraindicated in pregnancy, as its purpose is ovulation induction, not gestation support, and it may pose risks to fetal development if taken inadvertently. Women must confirm non-pregnant status before each cycle, typically via testing, and discontinue immediately if pregnancy is suspected. During breastfeeding, it is not recommended, as clomiphene may pass into milk and suppress lactation or affect the infant, though data are limited.

Non-hormonal fertility options or cessation of breastfeeding may be considered if treatment is needed, with decisions guided by medical advice.

Impact on Driving and Operating Machinery

The medication does not typically affect cognitive or motor skills, making it safe for most women to drive or operate machinery. Rare visual disturbances or dizziness suggest caution during use, particularly if these symptoms emerge, until they resolve post-cycle.

Considerations for Elderly and Pediatric Populations

Elderly women rarely use Clomid, as its fertility focus targets reproductive-age individuals, and postmenopausal use is irrelevant. Adolescents with precocious puberty or ovulatory dysfunction are not typically prescribed this therapy, as safety and efficacy in those under 18 are unestablished, limiting its use to adult women.