### CLOMMED 50 (clomiphene citrate) Tablets
**HIGHLIGHTS OF PRESCRIBING INFORMATION**
These highlights do not include all the information needed to use CLOMMED 50 safely and effectively. See full prescribing information for CLOMMED 50.
CLOMMED 50 (clomiphene citrate) tablets, for oral use
**INDICATIONS AND USAGE**
CLOMMED 50 is a selective estrogen receptor modulator (SERM) indicated for investigational use in restoring testosterone production during post-cycle therapy (PCT) and improving fertility in performance enhancement or fertility settings. Not approved for all indications in many jurisdictions; consult local regulations (1).
**DOSAGE AND ADMINISTRATION**
– Administer orally.
– Adult males: 50 mg to 150 mg per day for PCT.
– Adult females: 25 mg to 50 mg per day for fertility treatment (2.1).
– Cycle duration: Typically 3-4 weeks for PCT; fertility as prescribed.
**DOSAGE FORMS AND STRENGTHS**
Tablets: 50 mg clomiphene citrate (3).
**CONTRAINDICATIONS**
– Hypersensitivity to clomiphene or any component of the formulation (4).
– Liver disease or uncontrolled thyroid/adrenal dysfunction (4).
– Pregnancy (4).
– Abnormal uterine bleeding (4).
**WARNINGS AND PRECAUTIONS**
– Visual disturbances: May cause blurred vision; discontinue if occurs (5.1).
– Ovarian hyperstimulation: Risk in females; monitor for pelvic pain (5.2).
– Multiple pregnancies: Increased risk with fertility use (5.3).
– Mood changes: Monitor for emotional instability (5.4).
**ADVERSE REACTIONS**
Common adverse reactions include hot flashes, headache, nausea, and visual blurring (6).
**DRUG INTERACTIONS**
– Gonadotropins: May enhance ovulation effects; monitor closely (7.1).
**USE IN SPECIFIC POPULATIONS**
– Pregnancy: Contraindicated (8.1).
– Lactation: Not recommended (8.2).
– Pediatric use: Safety not established (8.4).
– Geriatric use: Monitor for organ dysfunction (8.5).
Revised: 08/2025
**FULL PRESCRIBING INFORMATION**
**1 INDICATIONS AND USAGE**
CLOMMED 50 is indicated for investigational use in adults to stimulate endogenous testosterone production, reduce estrogen-related side effects (e.g., gynecomastia), improve fertility, enhance libido, and support endocrine balance in post-cycle therapy or fertility treatment. It is commonly used to prevent hormonal imbalances after anabolic steroid cycles. This product is not approved for all indications and should be administered under medical supervision.
**2 DOSAGE AND ADMINISTRATION**
**2.1 Recommended Dosage**
Administer orally, with or without food.
– Males: 50 mg to 150 mg daily for PCT, typically tapering over 3-4 weeks (e.g., 150 mg for 1 week, 100 mg for 1 week, 50 mg for 2 weeks).
– Females: 25 mg to 50 mg daily for fertility treatment, as prescribed by a healthcare provider.
Adjust dosage based on response and tolerance. Discontinue if adverse effects occur.
**2.2 Preparation and Handling**
Store tablets in original packaging to protect from light and moisture. Do not crush or chew tablets.
**3 DOSAGE FORMS AND STRENGTHS**
Tablets containing 50 mg clomiphene citrate, supplied in bottles of 30 tablets.
**4 CONTRAINDICATIONS**
CLOMMED 50 is contraindicated in:
– Patients with hypersensitivity to clomiphene or excipients (e.g., lactose monohydrate).
– Patients with liver disease, uncontrolled thyroid or adrenal dysfunction, or abnormal uterine bleeding of undetermined origin.
– Pregnant women (Category X).
**5 WARNINGS AND PRECAUTIONS**
**5.1 Visual Disturbances**
May cause blurred vision, scotomata, or photophobia, which may impair activities like driving. Discontinue use and seek medical evaluation if visual symptoms occur.
**5.2 Ovarian Hyperstimulation**
In females, may cause ovarian enlargement or cyst formation, leading to pelvic pain or discomfort. Monitor for signs and discontinue if severe.
**5.3 Multiple Pregnancies**
Increased risk of twins or higher-order pregnancies in fertility treatment; counsel patients on this risk before initiating therapy.
**5.4 Mood Changes**
May cause emotional instability, irritability, or depression in some patients. Monitor mental health and adjust therapy as needed.
**6 ADVERSE REACTIONS**
Reported adverse reactions include:
– General: Hot flashes, nausea, abdominal discomfort.
– Nervous System: Headache, dizziness, visual disturbances (e.g., blurred vision).
– Reproductive: Ovarian enlargement, breast discomfort in females.
– Psychiatric: Mood swings, irritability.
Serious reactions may include thromboembolism or severe ovarian hyperstimulation (rare).
**7 DRUG INTERACTIONS**
**7.1 Gonadotropins**
Concurrent use with gonadotropins (e.g., hCG) may enhance ovulation, increasing the risk of ovarian hyperstimulation. Monitor closely and adjust doses as needed.
**8 USE IN SPECIFIC POPULATIONS**
**8.1 Pregnancy**
Category X: May cause fetal harm. Contraindicated in pregnant women.
**8.2 Lactation**
Excretion in breast milk is unknown; breastfeeding is not recommended due to potential risks to the infant.
**8.4 Pediatric Use**
Safety and efficacy not established in pediatric patients; use is not recommended.
**8.5 Geriatric Use**
Limited data available; monitor for age-related organ dysfunction, particularly liver or cardiovascular issues.
**9 DRUG ABUSE AND DEPENDENCE**
No evidence of abuse or dependence potential with clomiphene, but misuse in performance enhancement settings may occur. Monitor for inappropriate use.
**10 OVERDOSAGE**
Symptoms of overdose may include nausea, hot flashes, visual disturbances, or ovarian hyperstimulation. No specific antidote exists; treat symptomatically and discontinue use.
**11 DESCRIPTION**
CLOMMED 50 contains clomiphene citrate, a non-steroidal selective estrogen receptor modulator that stimulates ovulation and testosterone production. Supplied as 50 mg tablets for oral use. Excipients include lactose monohydrate, corn starch, and magnesium stearate. Half-life: Approximately 5-7 days.
**12 CLINICAL PHARMACOLOGY**
**12.1 Mechanism of Action**
Clomiphene blocks estrogen receptors in the pituitary, increasing luteinizing hormone (LH) and follicle-stimulating hormone (FSH) release, which stimulates testosterone production in males and ovulation in females.
**12.3 Pharmacokinetics**
Absorbed orally; peak plasma levels in 6-8 hours; half-life approximately 5-7 days; metabolized in the liver; excreted primarily in feces and urine.
**13 NONCLINICAL TOXICOLOGY**
Animal studies suggest potential reproductive toxicity, including fetal abnormalities; no human carcinogenicity data available.
**16 HOW SUPPLIED/STORAGE AND HANDLING**
Tablets, 50 mg, in bottles of 30. Store at 20°-25°C (68°-77°F); protect from light and moisture. Keep out of reach of children.
*Manufactured by: Medi Pharma*
