CLOMID 50/MG TAB 10/TAB

Indications

Approved Uses

Ovulation induction in women with ovulatory dysfunction (e.g., anovulation/oligo-ovulation) who desire pregnancy.

Off-Label Uses

Off-label: male infertility/secondary hypogonadism (to increase endogenous gonadotropins/testosterone and potentially improve spermatogenesis).

Dosage & Administration

Dosing by Condition

Ovulation induction (ovulatory dysfunction): 50 mg orally once daily for 5 days, typically starting on cycle day 3-5 (per clinician protocol); if no ovulation, 100 mg once daily for 5 days in the next cycle; generally limit to ~3-6 cycles total.

Initial Dose

50mg orally once daily for 5 days.

Maintenance Dose

The lowest dose required to induce ovulation, typically 50mg or 100mg daily for 5 days per cycle.

Maximum Dose

100mg once daily for 5 days per cycle; maximum 6 treatment cycles

Children's Dosage

Not approved for children.

Dose Adjustment Notes

If ovulation does not occur after 50 mg once daily for 5 days, increase to 100 mg once daily for 5 days in the next cycle; do not exceed 100 mg/day and discontinue if ovarian enlargement, severe pelvic pain, or visual symptoms occur; treatment should be supervised with appropriate pelvic assessment/ultrasound.

How to Take

Oral: take 50 mg tablet by mouth with water once daily for 5 consecutive days, starting on the cycle day specified by the prescriber; may be taken with or without food and preferably at the same time each day.

Side Effects

Common Side Effects

Hot flushes, abdominal discomfort and bloating, nausea, vomiting, breast tenderness, headache, visual disturbances (blurring, spots, flashes), ovarian enlargement, mood changes, intermenstrual spotting

Side Effect Frequency

Very common/common adverse effects include hot flushes, abdominal/pelvic discomfort or bloating, nausea, breast tenderness, headache, and visual disturbances; ovarian enlargement/cysts can occur, and multiple pregnancy is a known risk; serious events (e.g., thromboembolism) are rare.

Safety & Warnings

Contraindications

Pregnancy; liver disease or history of hepatic dysfunction; abnormal uterine bleeding of undetermined origin; ovarian cyst/enlargement not due to PCOS; uncontrolled thyroid or adrenal dysfunction; organic intracranial lesion (e.g., pituitary tumor); hypersensitivity to clomiphene/clomiphene citrate or excipients.

Warnings & Precautions

Exclude pregnancy before each cycle; pelvic exam/ultrasound before each course to rule out ovarian cyst/enlargement; counsel on multiple gestation risk; discontinue and evaluate urgently for visual symptoms; monitor for OHSS (pain, distension, rapid weight gain, dyspnea); use the lowest effective dose and generally avoid >6 cycles; ensure normal liver function before initiation and use extra caution in PCOS due to higher OHSS risk.

Age Restriction

Not indicated for pediatric/prepubertal patients; intended for use in adult women of reproductive age with ovulatory dysfunction.

Driving Warning

Use caution when driving or operating machinery; may cause dizziness or visual disturbances.

Special Populations

Pregnancy

Contraindicated

Breastfeeding

Contraindicated

Children

Not approved for children.

Elderly

Not applicable - indicated for women of reproductive age only

Kidney Impairment

No specific renal dose adjustment is recommended; use caution due to limited data in severe renal impairment.

Liver Impairment

Contraindicated in patients with hepatic disease or history of hepatic dysfunction

Storage & Patient Advice

Stopping the Medicine

Complete only the prescribed short course per cycle (commonly 5 days) and do not extend without prescriber direction; stop and seek urgent medical review if visual disturbances or severe pelvic/abdominal pain/OHSS symptoms occur; discontinue if pregnancy is suspected/confirmed; overall therapy should generally not exceed ~6 cycles.

Overdose

Symptoms may include nausea/vomiting, vasomotor flushing, visual disturbances, and ovarian enlargement with pelvic/abdominal pain; management is supportive (consider GI decontamination if very recent ingestion per toxicology practice), monitor for OHSS; no specific antidote-seek immediate medical attention.

Patient Counseling

Take exactly as prescribed for the 5-day course; ovulation usually occurs ~5-10 days after the last tablet and intercourse/insemination timing should follow clinician advice; increased chance of multiple pregnancy; do not use if pregnant and pregnancy testing is typically done before each cycle; seek urgent care for visual disturbances, severe abdominal/pelvic pain, marked bloating, rapid weight gain, or shortness of breath (possible ovarian enlargement/OHSS).

Monitoring Requirements

Before and during therapy: confirm not pregnant; baseline and periodic pelvic assessment (often ultrasound) to evaluate ovaries/follicular response and exclude ovarian cysts; monitor for ovulation (e.g., mid-luteal progesterone, ovulation predictor kits, or BBT) and for adverse effects (visual symptoms, pelvic pain/ovarian enlargement).

Pharmacology

Mechanism of Action

Selective estrogen receptor modulator (SERM) that blocks estrogen negative feedback at the hypothalamus/pituitary, increasing GnRH-driven FSH and LH release to stimulate follicular development and ovulation.

Onset of Action

Ovulation typically occurs about 5-10 days after the last tablet of the 5-day course.

Duration of Effect

Cycle-specific: each 5-day course is intended to induce ovulation in that treatment cycle; effects do not persist beyond the cycle.

Metabolism

Hepatic metabolism with enterohepatic recirculation; clomiphene is a mixture of stereoisomers (enclomiphene and zuclomiphene) and is not a prodrug requiring CYP2D6 bioactivation.

Product Information

Available Dosage Forms

Tablet (oral).

Composition per Dose

Each tablet: 50mg clomifene citrate (equivalent to approximately 30mg clomifene base)

Generic Availability

Yes

OTC Alternatives

No OTC alternative.

Hormone Type

Non-hormonal

Method

Oral

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