Serophene

Serophene

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Product dosage: 100mg
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Product dosage: 25mg
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Product dosage: 50mg
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Synonyms

Serophene: Clinically Proven Ovulation Induction Therapy

Serophene (clomiphene citrate) is a first-line oral fertility medication specifically designed to stimulate ovulation in women experiencing anovulation or oligo-ovulation. As a selective estrogen receptor modulator (SERM), it works by blocking estrogen receptors in the hypothalamus, prompting increased secretion of gonadotropin-releasing hormone (GnRH). This subsequently leads to elevated follicle-stimulating hormone (FSH) and luteinizing hormone (LH) production, facilitating follicular development and maturation. With decades of clinical use and extensive research supporting its efficacy, Serophene remains a cornerstone treatment in reproductive endocrinology for patients with functional hypothalamic-pituitary-ovarian axes.

Features

  • Contains 50 mg clomiphene citrate per tablet
  • Oral administration with high bioavailability
  • Standard packaging: 10 tablets per blister, 3 blisters per box
  • White, round, scored tablets for accurate dosing
  • Manufactured under strict GMP (Good Manufacturing Practice) standards
  • Thermo-stable formulation requiring no refrigeration
  • Prescription-only medication with lot tracking
  • Compatible with most assisted reproductive technologies (ART)

Benefits

  • Effectively induces mono-ovulatory cycles in approximately 80% of appropriately selected patients
  • Restores regular ovulatory patterns in women with polycystic ovary syndrome (PCOS)
  • Non-invasive oral administration compared to injectable alternatives
  • Cost-effective first-line intervention for ovulatory disorders
  • Enables timed intercourse or intrauterine insemination (IUI) cycles
  • Established safety profile with over 60 years of clinical use

Common use

Serophene is primarily indicated for the treatment of ovulatory dysfunction in women desiring pregnancy. The most common applications include management of polycystic ovary syndrome (PCOS)-related anovulation, unexplained infertility with ovulatory factors, and luteal phase defects. Physicians may also prescribe Serophene as part of controlled ovarian stimulation protocols before assisted reproductive procedures. Importantly, candidates for Serophene therapy must demonstrate adequate estrogen production and patent fallopian tubes, with thorough evaluation excluding male factor infertility and other contraindications before initiation.

Dosage and direction

The recommended initial dosage is 50 mg (one tablet) daily for five days, beginning on day 3, 4, or 5 of the menstrual cycle following spontaneous or progestin-induced withdrawal bleeding. Treatment should be initiated at the lowest effective dose to minimize side effects and multifetal gestation risk. If ovulation does not occur at the initial dose, the dosage may be increased to 100 mg daily for five days in subsequent cycles. Doses exceeding 100 mg daily are not recommended due to diminished efficacy and increased adverse effects. Maximum recommended duration of continuous therapy is six cycles. Administration should occur at approximately the same time each day, with or without food, though consistency is advised. Patients should be monitored via transvaginal ultrasonography and serum progesterone measurements to assess response and adjust treatment accordingly.

Precautions

Before initiating Serophene therapy, complete gynecologic and endocrine evaluation is mandatory, including assessment of thyroid function, prolactin levels, and androgen excess. Liver function tests should be performed due to hepatic metabolism. Patients must be informed about the increased risk of multiple gestation (approximately 8% risk, predominantly twins) and ovarian hyperstimulation syndrome (OHSS). Visual symptoms such as blurring, scotomas, or photophobia require immediate discontinuation and ophthalmologic evaluation. Long-term use (θΆ…θΏ‡ 12 cycles) may be associated with increased risk of borderline ovarian tumors, though causal relationship remains uncertain. Careful monitoring of ovarian response through ultrasound follicular tracking is essential to minimize complications.

Contraindications

Serophene is contraindicated in patients with: pregnancy; liver disease or history of hepatic dysfunction; abnormal uterine bleeding of undetermined origin; ovarian cysts not related to polycystic ovarian syndrome; uncontrolled thyroid or adrenal dysfunction; organic intracranial lesions such as pituitary tumors; hypersensitivity to clomiphene citrate or any component of the formulation. Additionally, it should not be used in patients with endometrial carcinoma or other estrogen-dependent neoplasms. The medication is strictly contraindicated in cases where the male partner has confirmed infertility not addressed by assisted reproductive techniques.

Possible side effect

Common adverse reactions (occurring in >10% of patients) include vasomotor flushes (similar to menopausal hot flashes), abdominal discomfort, bloating, and breast tenderness. Ovarian enlargement occurs in approximately 14% of patients, typically resolving spontaneously after treatment cessation. Visual disturbances (blurred vision, photophobia, diplopia) affect 1-2% of patients and usually resolve after discontinuation. Less frequent side effects include nausea, vomiting, nervousness, insomnia, headache, and hair loss. Rare but serious adverse events include ovarian hyperstimulation syndrome (OHSS), which may present with rapid weight gain, abdominal pain, nausea, and decreased urine output. Thrombboembolic events have been reported in association with fertility medications including clomiphene citrate.

Drug interaction

Serophene may interact with several medications: concomitant use with gonadotropins may increase the risk of ovarian hyperstimulation syndrome. Estrogen-containing medications may antagonize the therapeutic effect of clomiphene. Drugs that induce hepatic enzymes (e.g., rifampin, phenytoin, carbamazepine) may increase clomiphene metabolism, reducing its efficacy. Conversely, drugs that inhibit CYP2D6 (such as fluoxetine, paroxetine, quinidine) may increase clomiphene levels. Tamoxifen and other SERMs may have additive effects. Warfarin efficacy may be altered, requiring more frequent INR monitoring. Healthcare providers should review all medications, including over-the-counter products and herbal supplements, before initiating therapy.

Missed dose

If a dose is missed, the patient should take it as soon as remembered unless it is nearly time for the next scheduled dose. In that case, the missed dose should be skipped, and the regular dosing schedule resumed. Patients should not double the dose to make up for a missed tablet. Given the five-day treatment course, consistency in administration timing is important for optimal follicular development. If multiple doses are missed, the patient should contact their healthcare provider for guidance, as the treatment cycle may need to be restarted or monitored more closely.

Overdose

Symptoms of acute overdose may include nausea, vomiting, vasomotor flushes, abdominal pain, and ovarian enlargement. In cases of massive overdose, visual disturbances, nervousness, and tachycardia may occur. There is no specific antidote for clomiphene citrate overdose. Treatment should be supportive and symptomatic, with particular attention to hydration and monitoring for signs of ovarian hyperstimulation. Gastric lavage may be considered if ingestion occurred within one hour. Dialysis is unlikely to be effective due to high protein binding and extensive tissue distribution. Patients should seek immediate medical attention if overdose is suspected.

Storage

Store at controlled room temperature (20-25Β°C or 68-77Β°F) in the original packaging to protect from light and moisture. Excursions permitted to 15-30Β°C (59-86Β°F). Keep the medication in a secure location out of reach of children and pets. Do not transfer tablets to other containers, as the original packaging provides protection from moisture and light. Discard any medication that shows signs of deterioration or has passed the expiration date printed on the packaging. Do not flush medications down the toilet or pour down a drain unless instructed to do so.

Disclaimer

This information is provided for educational purposes only and does not constitute medical advice. Serophene is a prescription medication that should be used only under the supervision of a qualified healthcare provider specializing in reproductive medicine. Individual response to therapy may vary, and treatment should be tailored based on comprehensive medical evaluation. The patient information leaflet provided with the medication contains the most current and complete information. Always consult with your healthcare provider regarding any questions about medical conditions or medications.

Reviews

Clinical studies demonstrate that approximately 80% of appropriately selected anovulatory women will ovulate in response to clomiphene citrate, with cumulative pregnancy rates of approximately 35-40% after three cycles and 45-50% after six cycles of treatment. In randomized controlled trials comparing clomiphene citrate to letrozole for ovulation induction in PCOS patients, both agents show similar ovulation and pregnancy rates, though some meta-analyses suggest slightly higher live birth rates with letrozole. Patient satisfaction surveys indicate high acceptability of oral administration compared to injectable alternatives, though vasomotor symptoms are frequently cited as bothersome side effects. Long-term follow-up studies have not demonstrated significant increased cancer risk with limited-duration use, though ongoing monitoring is recommended.