Generic Serophene ( Clomiphene )

Buy Generic Serophene (Clomiphene) without prescription in Canada

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Serophene (clomiphene citrate) is a non‑steroidal, ovulatory stimulant used to treat infertility in women who do not ovulate regularly or at all (anovulation). It works by binding to estrogen receptors in the hypothalamus, which tricks the brain into sensing low estrogen levels. This causes the pituitary gland to release more follicle‑stimulating hormone (FSH) and luteinizing hormone (LH), which stimulate the growth and release of one or more mature eggs from the ovaries.

Usual adult dose: The usual starting dose is 50 mg (one tablet) taken orally once daily for 5 consecutive days, beginning on the fifth day of the menstrual cycle. If ovulation does not occur, a second course of 100 mg once daily for 5 days may be given as early as 30 days after the first course. A third course of 100 mg daily for 5 days may be considered after another 30 days if needed. Doses above 100 mg per day or treatment beyond three cycles are generally not recommended. For women who do not have a spontaneous period, a progestin‑induced withdrawal bleed should be triggered before starting clomiphene. The 25 mg tablet is available to allow half‑dose administration for those who experience ovarian hyperstimulation at 50 mg or require lower doses due to polycystic ovary syndrome.

Dosage form: Oral tablets: 25 mg, 50 mg, and 100 mg (as clomiphene citrate). The 50 mg tablet is the standard starting dose; the 25 mg tablet is scored to allow flexible dosing.

Onset of action: Ovulation usually occurs 5–10 days after the last dose of a 5‑day treatment course. The mid‑cycle luteinizing hormone (LH) surge typically occurs 5–12 days after clomiphene is stopped. If ovulation occurs, a menstrual period will follow approximately 14 days later. Conception, if it is to happen, occurs during the ovulatory window.

Duration of action: Clomiphene has a long biological half‑life (approximately 5–7 days). Its active metabolite, zuclomiphene, has a half‑life of several weeks and may accumulate with repeated cycles. The pharmacodynamic effect on ovulation occurs only during the treatment cycle; the drug must be taken each cycle in which ovulation induction is desired.

Alcohol recommendation: Alcohol consumption should be limited during treatment with Serophene. Heavy alcohol intake can reduce fertility and may interfere with the hormonal response to the medication. While there is no direct drug interaction, avoiding alcohol or limiting intake to an occasional drink is recommended to optimise the chances of conception.

Most common side effects: Hot flushes (11%), abdominal bloating or discomfort (5–7%), breast tenderness, nausea, headache, and mood swings. Ovarian enlargement occurs in about 14% of cycles and is usually mild and reversible. Visual disturbances (blurred vision, spots, flashes) are rare but require immediate discontinuation. The most serious risk is ovarian hyperstimulation syndrome (OHSS), characterized by marked ovarian enlargement, ascites, pleural effusion, and oliguria; this is more common with doses above 100 mg/day and in women with polycystic ovary syndrome (PCOS). Multiple pregnancy (twins) occurs in approximately 5–10% of clomiphene‑induced pregnancies; higher‑order multiples are rare.

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General Information about Serophene (Clomiphene)

• INN (International Nonproprietary Name): Clomiphene (as clomiphene citrate).
• Brand names available in Canada: Serophene® is not a marketed brand in Canada. Clomiphene citrate is available in Canada under the brand name Clomid® (Sanofi‑Aventis Canada Inc.) and as generic clomiphene citrate tablets (50 mg) from several manufacturers, including Teva, Apotex, and Pharmascience. The 25 mg and 100 mg tablet strengths are not routinely stocked in Canadian pharmacies but are available through the international supply chain for personal importation; Serophene is an internationally recognised brand name for clomiphene citrate.
• ATC code: G03GB02 (ovulation stimulants, synthetic).
• Dosage forms and strengths: Oral tablets: 25 mg, 50 mg, and 100 mg of clomiphene citrate. The 50 mg tablet is the most commonly prescribed strength.
• Manufacturers in Canada: Sanofi‑Aventis Canada Inc. (Clomid), Apotex Inc., Teva Canada Limited, Pharmascience Inc., and other generic manufacturers produce the 50 mg tablet. The 25 mg and 100 mg strengths are manufactured internationally and imported for personal use.
• Registration status in Canada: Approved by Health Canada for the 50 mg tablet (DIN 02006506 for Clomid, various DINs for generics). The 25 mg and 100 mg tablets are not currently approved for marketing in Canada but are available internationally.
• OTC / Rx classification: Prescription only (Rx). Schedule I drug under the Controlled Drugs and Substances Act. A valid prescription from a licensed Canadian healthcare professional is required.

Mechanism of Action and Pharmacology

Clomiphene citrate is a racemic mixture of two geometric isomers: enclomiphene (the trans‑isomer, approximately 62%) and zuclomiphene (the cis‑isomer, approximately 38%). Both isomers bind to estrogen receptors in the hypothalamus, but they act as competitive antagonists. By occupying these receptors, clomiphene blocks the normal negative feedback of circulating estrogens. The hypothalamus perceives a state of estrogen deficiency and increases the secretion of gonadotropin‑releasing hormone (GnRH). This, in turn, stimulates the anterior pituitary gland to release follicle‑stimulating hormone (FSH) and luteinizing hormone (LH). The elevated FSH drives the recruitment and maturation of ovarian follicles, while the mid‑cycle LH surge triggers ovulation. Enclomiphene has a shorter half‑life and is cleared rapidly, while zuclomiphene has a very long half‑life (up to several weeks) and can accumulate over multiple cycles, contributing to a prolonged estrogen‑blocking effect. Because clomiphene requires a functioning hypothalamic‑pituitary‑ovarian axis, it is effective only in women who have adequate endogenous estrogen production (as evidenced by a withdrawal bleed after progestin administration) and who do not have primary ovarian failure.

After oral administration, clomiphene is readily absorbed, with peak plasma concentrations of the parent drug occurring approximately 6 hours after a single dose. The drug is highly protein‑bound and undergoes extensive hepatic metabolism, primarily via CYP2D6 and CYP3A4, to active and inactive metabolites. The elimination half‑life of clomiphene is about 5–7 days. Excretion is mainly via the faeces, with a small fraction eliminated in the urine. Because of the slow elimination, steady‑state levels may not be reached before the next cycle, and the drug’s effects can persist into the next menstrual cycle.

Indications

• Treatment of ovulatory dysfunction in women desiring pregnancy. Serophene is indicated for the induction of ovulation in anovulatory and oligo‑ovulatory women who have adequate endogenous estrogen production (e.g., women with polycystic ovary syndrome [PCOS], hypothalamic amenorrhoea with normal estrogen, and luteal phase insufficiency). It is also used in controlled ovarian hyperstimulation for intrauterine insemination (IUI) and in vitro fertilisation (IVF) protocols (off‑label).
• Serophene is not effective in women with primary pituitary or ovarian failure. It is not indicated for the treatment of male infertility, though off‑label use in men with hypogonadotropic hypogonadism has been reported.
• Not recommended for use in children or postmenopausal women.

Important Warnings and Precautions

At‑risk groups

• Pregnancy: Serophene is contraindicated during pregnancy. A pregnancy test should be performed before each treatment cycle to ensure that the patient is not pregnant. If pregnancy occurs during therapy, the medication must be discontinued immediately, and the patient should be informed of the potential hazard to the fetus. No specific pattern of congenital malformations has been established, but clomiphene should not be used in pregnant women.
• Breastfeeding: It is not known whether clomiphene is excreted in human breast milk. Because it may suppress lactation and could cause adverse effects in the nursing infant, clomiphene is not recommended during breastfeeding.
• Paediatrics (< 18 years): Safety and efficacy have not been established in children. Serophene is not indicated for paediatric use.
• Elderly: Not indicated for use in postmenopausal women.
• Ovarian hyperstimulation syndrome (OHSS): Clomiphene can cause ovarian enlargement and, in susceptible women, the development of OHSS, a potentially life‑threatening condition characterized by marked ovarian enlargement, ascites, pleural effusion, haemoconcentration, oliguria, and electrolyte imbalances. The risk is higher at doses above 100 mg/day, in women with PCOS, and when clomiphene is combined with exogenous gonadotropins. Ovarian size should be monitored by palpation before each treatment cycle, and if ovaries are enlarged or cystic, treatment should be withheld until they return to normal. In cases of severe OHSS, hospitalisation is required.
• Visual disturbances: Blurred vision, diplopia, scotomas, and photopsia (flashes of light) have been reported in approximately 1–2% of patients. These effects are usually reversible upon discontinuation, but there have been rare reports of persistent visual impairment. All patients should be warned that visual symptoms may occur, and they should report any changes immediately. If visual disturbances develop, clomiphene should be discontinued, and a full ophthalmologic evaluation should be performed.
• Multiple pregnancy: The incidence of multiple gestations with clomiphene is approximately 5–10%, predominantly twins. Higher‑order multiples (triplets or more) occur in less than 1% of pregnancies. Patients should be counselled about this risk before starting therapy.
• Ovarian cysts: Clomiphene can cause follicular cysts and luteal cysts. Pelvic examination should be performed before each treatment cycle; if ovarian enlargement or cysts are present, therapy should be withheld until resolution.
• Liver disease: Clomiphene is metabolised by the liver. Use with caution in patients with hepatic impairment, and liver function should be assessed before starting therapy. Contraindicated in severe liver disease.
• Thromboembolic disease: There is a rare association between clomiphene use and thromboembolic events, particularly in the setting of OHSS. Clomiphene should be used with caution in women with a history of venous thromboembolism or thrombophilia.
• Allergy: Do not take Serophene if you have a known hypersensitivity to clomiphene citrate or any excipient in the formulation.

Driving and alcohol

Serophene is not known to impair the ability to drive or operate machinery. However, patients should be warned about the rare possibility of visual disturbances, which could impair driving. If visual symptoms occur, stop taking clomiphene immediately and do not drive until evaluated by an ophthalmologist. Alcohol consumption should be limited during treatment. While there is no direct pharmacokinetic interaction, heavy alcohol intake can reduce fertility and may exacerbate the gastrointestinal side effects of clomiphene. Alcohol should be avoided when trying to conceive.

Dosage Instructions

• Standard ovulation induction regimen: 50 mg orally once daily for 5 days, starting on day 5 of the menstrual cycle. If ovulation does not occur (confirmed by basal body temperature chart, serum progesterone, or urinary LH surge), a second course of 100 mg daily for 5 days may be started as early as 30 days after the previous course. A third course of 100 mg daily for 5 days may be given after another 30 days if needed. Most pregnancies occur within the first three ovulatory cycles. If ovulation does not occur after three courses, the diagnosis should be re‑evaluated. Long‑term cyclic therapy beyond 6 cycles is not recommended due to insufficient data on long‑term ovarian cancer risk.
• For women with PCOS or sensitivity to clomiphene: Lower doses (e.g., 25 mg daily for 5 days) may be used to reduce the risk of OHSS and multiple follicular development. The 25 mg tablet is useful for this purpose.
• Administration: Swallow the tablet whole with a glass of water, with or without food. Doses are typically taken at the same time each day to maintain consistent blood levels. The 5‑day course should be completed; do not skip doses.
• Missed dose: If a dose is missed, take it as soon as remembered on the same day. If it is close to the time of the next dose, skip the missed dose and continue with the regular schedule. Do not double the dose. If an entire treatment cycle is missed, a new cycle should be started at the usual starting dose after ensuring that the patient is not pregnant.
• Monitoring: Ovulation should be confirmed by basal body temperature, urinary LH kits, or mid‑luteal serum progesterone. Ovarian size should be assessed by palpation or transvaginal ultrasound before each treatment cycle. If ovaries are enlarged or a functional cyst is present, withhold treatment until they return to pre‑treatment size. A pregnancy test should be performed before each new cycle.

Side Effects and Contraindications

• Very common side effects (≥ 10%): Hot flushes (11%), ovarian enlargement (14% — usually mild and transient).
• Common side effects (1–10%): Abdominal bloating, distension, or discomfort (5–7%), breast tenderness, nausea, vomiting, headache, mood swings, dizziness, and visual disturbances (blurred vision, spots — about 1–2%).
• Less common but serious side effects: Ovarian hyperstimulation syndrome (OHSS), which can be severe and require hospitalisation. Thromboembolic events, including deep vein thrombosis and pulmonary embolism, particularly in the context of severe OHSS. Persistent ovarian cysts. Visual disturbances that may, in very rare cases, be irreversible. Multiple pregnancy (twins in 5–10% of conceptions). There have been isolated reports of pancreatitis, hepatitis, and seizures.
• Post‑marketing reports: A possible association between prolonged clomiphene use (beyond 12 cycles) and an increased risk of ovarian cancer has been suggested but not definitively proven. Current guidelines limit treatment to 3–6 cycles.
• Contraindications: Pregnancy. Breastfeeding. Known hypersensitivity to clomiphene citrate or any excipient. Primary ovarian failure (hypogonadotropic hypogonadism not responsive to clomiphene). Ovarian cysts of unknown aetiology (unless part of PCOS). Abnormal uterine bleeding of undetermined cause. Severe liver disease. History of thromboembolic disease (relative contraindication — use with caution). Uncontrolled thyroid or adrenal dysfunction.

Drug Interactions

• No known clinically significant pharmacokinetic interactions: Clomiphene has not been shown to interact with most other medications. However, caution is advised when co‑administered with drugs that induce or inhibit CYP2D6 or CYP3A4, as these could theoretically alter clomiphene metabolism and efficacy.
• Gonadotropins (FSH, LH, hMG): When clomiphene is used in combination with exogenous gonadotropins for controlled ovarian hyperstimulation (e.g., IUI or IVF), there is an additive risk of OHSS and multiple pregnancy. This should only be undertaken under specialist fertility clinic supervision.
• GnRH agonists and antagonists: Used in IVF protocols to prevent premature LH surges; clomiphene may be used in conjunction with these agents in antagonist protocols, but monitoring is essential.
• Alcohol and other substances: Heavy alcohol use may reduce fertility and should be avoided. Recreational drugs and tobacco can also reduce fertility and compromise the response to ovulation induction.
• Food: No specific food interactions have been identified. Clomiphene may be taken with or without meals.

Practical Advice

• Administration: Begin each 5‑day course on day 5 of your menstrual cycle (the first day of full menstrual flow is day 1). If you do not have regular cycles, your doctor may prescribe a progestin (e.g., medroxyprogesterone) to induce a withdrawal bleed before starting clomiphene. Take the tablet at approximately the same time each day. Swallow it whole with water; it may be taken with food to reduce stomach upset.
• Monitoring: Ovulation prediction kits (urinary LH kits) can be used to detect the mid‑cycle LH surge, which usually occurs 5–12 days after the last clomiphene tablet. Basal body temperature charting can confirm ovulation has occurred. Your doctor may perform transvaginal ultrasound to monitor follicle development and endometrial thickness, and a mid‑luteal serum progesterone level (day 21 in a 28‑day cycle) may be checked to document ovulation.
• Storage: Store at room temperature (15‑30 °C) in a dry place, protected from moisture and light. Keep the container tightly closed. Keep out of the reach and sight of children.
• Lifestyle: To optimise your chances of conception, maintain a healthy body weight (both underweight and overweight can impair ovulation), eat a balanced diet rich in folic acid (at least 400 mcg/day), avoid smoking and alcohol, and engage in regular moderate exercise. Have intercourse every 1–2 days during the fertile window (typically days 12–18 of a 28‑day cycle, but this varies). If visual disturbances occur, stop the medication immediately and contact your doctor; do not drive. Report any severe pelvic pain, rapid weight gain, shortness of breath, or decreased urination, which could indicate OHSS.
• Missed dose: If you forget a tablet, take it as soon as you remember on the same day. If you miss an entire day, skip that dose and continue the next day. Do not extend the 5‑day course to 6 days.
• When to seek medical review: Contact your doctor immediately if you experience severe lower abdominal pain (especially if accompanied by nausea, vomiting, or rapid weight gain), blurred vision or visual spots, or signs of an allergic reaction. Seek emergency care for chest pain, shortness of breath, or leg swelling.
• Disposal: Return unused or expired medication to a pharmacy for safe disposal. Do not flush down the toilet or discard in household waste.

Alternative Medications

• Letrozole (Femara®): An aromatase inhibitor used off‑label for ovulation induction, particularly in women with PCOS. Letrozole has been shown in several randomised trials to result in higher live‑birth rates and lower multiple‑pregnancy rates compared with clomiphene, and it is now recommended as a first‑line agent for ovulation induction by many fertility societies, including the Canadian Fertility and Andrology Society. It is taken as a 5‑day course starting on day 3 of the cycle, typically at 2.5–7.5 mg/day.
• Gonadotropins (injectable FSH and LH): Used when clomiphene or letrozole fail to induce ovulation, or for controlled ovarian hyperstimulation in IUI and IVF. Gonadotropins are more potent but carry a higher risk of OHSS and multiple pregnancy, and require intensive monitoring with ultrasound and serum estradiol.
• Metformin (Glucophage®): An insulin‑sensitising agent used in women with PCOS to improve ovulatory function, either alone or in combination with clomiphene. Metformin alone is less effective than clomiphene for achieving pregnancy, but it may restore ovulatory cycles in some women.
• Ovarian drilling: A laparoscopic surgical procedure for women with PCOS who have failed medical ovulation induction. It involves making multiple small punctures in the ovarian surface and can restore ovulation for a period of time without the need for daily medication.
• In vitro fertilisation (IVF): For women who do not conceive after 3–6 cycles of ovulation induction, or who have other infertility factors (tubal factor, severe male factor), IVF is the next step. It involves controlled ovarian stimulation, egg retrieval, fertilisation in the laboratory, and embryo transfer.

Clinical Efficacy

Clomiphene has been used for ovulation induction since the 1960s and is one of the most widely prescribed fertility medications worldwide. In properly selected anovulatory women with adequate estrogen production, approximately 80% will ovulate in response to clomiphene, and of those who ovulate, about 40–50% will conceive within six cycles. The per‑cycle fecundability (chance of pregnancy per ovulatory cycle) is approximately 20–25%, which is similar to the natural fecundability of fertile couples. The majority of pregnancies occur within the first three ovulatory cycles. A 2018 systematic review and network meta‑analysis found that letrozole was associated with a higher live‑birth rate than clomiphene in women with PCOS (RR 1.45; 95% CI 1.18–1.78), leading many guidelines to recommend letrozole as the first‑line agent. However, clomiphene remains a second‑line option and is still widely used worldwide, particularly in settings where letrozole is not available or contraindicated. Clomiphene is also used in combination with intrauterine insemination (IUI) for unexplained infertility, where it improves pregnancy rates compared with timed intercourse alone. The risks of ovarian hyperstimulation syndrome and multiple pregnancy are modest when the drug is used at the recommended doses of 50–100 mg/day with appropriate monitoring.

Important:

Serophene (clomiphene) is a prescription medication that should be used only under the supervision of a qualified healthcare professional, typically a fertility specialist or gynaecologist. It must not be taken during pregnancy; a pregnancy test should be performed before each treatment cycle. This medication can cause ovarian hyperstimulation syndrome, which may be life‑threatening, as well as visual disturbances that may impair driving. Multiple pregnancy (twins) occurs in 5–10% of conceptions. Do not use Serophene if you have primary ovarian failure, undiagnosed abnormal uterine bleeding, or liver disease. Alcohol should be avoided while trying to conceive. If you experience severe pelvic pain, rapid weight gain, shortness of breath, visual changes, or signs of a blood clot, stop the medication and seek immediate medical attention. This information is not a substitute for professional medical advice, diagnosis, or treatment.

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