**DOSAGE FORMS AND STRENGTHS**
Lyophilized powder: 5000 IU per vial (3).
**CONTRAINDICATIONS**
– Hypersensitivity to human chorionic gonadotropin or any component of the formulation (4).
– Prostate cancer or other androgen-dependent tumors (4).
– Pregnancy (4).
**WARNINGS AND PRECAUTIONS**
– Multiple pregnancies: Increased risk if used for fertility (5.1).
– Ovarian hyperstimulation: Risk in females if used (5.2).
– Hormonal imbalance: Monitor testosterone levels (5.3).
– Injection site reactions: Monitor for irritation (5.4).
**ADVERSE REACTIONS**
Common adverse reactions include injection site pain, headache, and fatigue (6).
**DRUG INTERACTIONS**
– Limited known interactions; monitor with gonadotropins (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**
HCGMED is indicated for investigational use in adults to maintain testicular size and function during anabolic steroid cycles, boost testosterone production, improve fertility and sperm production, aid in weight loss by mobilizing fat, and support hormonal recovery during post-cycle therapy. It is commonly used to mimic luteinizing hormone (LH) in performance enhancement settings. This product is not approved for all indications and should be administered under medical supervision.
**2 DOSAGE AND ADMINISTRATION**
**2.1 Recommended Dosage**
Reconstitute 5000 IU vial with 1-2 mL bacteriostatic water. Administer subcutaneously or intramuscularly.
– Males: 500 IU to 1000 IU weekly on-cycle, divided into 2-3 doses, or 1000 IU to 2000 IU every other day for post-cycle therapy.
– Females: Not typically used; consult a healthcare provider for specific indications.
– Cycle duration: As needed during steroid cycles or 2-4 weeks for PCT. Adjust based on response and tolerance.
**2.2 Preparation and Handling**
Use sterile technique to reconstitute and draw doses. Inspect reconstituted solution for clarity; do not use if discolored or particulate matter is present.
**3 DOSAGE FORMS AND STRENGTHS**
Supplied as lyophilized powder containing 5000 IU human chorionic gonadotropin per single-use vial.
**4 CONTRAINDICATIONS**
HCGMED is contraindicated in:
– Patients with known hypersensitivity to human chorionic gonadotropin or excipients (e.g., mannitol).
– Patients with prostate cancer or other androgen-dependent tumors due to testosterone stimulation.
– Pregnant women (Category X).
**5 WARNINGS AND PRECAUTIONS**
**5.1 Multiple Pregnancies**
If used for fertility in females, may increase the risk of twins or higher-order pregnancies. Counsel patients on this risk before initiating therapy.
**5.2 Ovarian Hyperstimulation**
In females, may cause ovarian enlargement or cyst formation, leading to pelvic pain or discomfort. Monitor and discontinue if severe.
**5.3 Hormonal Imbalance**
May cause excessive testosterone production, leading to side effects like gynecomastia. Monitor testosterone levels and adjust dosing as needed.
**5.4 Injection Site Reactions**
May cause localized pain, redness, or swelling at the injection site. Rotate injection sites and monitor for signs of infection or severe reactions.
**6 ADVERSE REACTIONS**
Reported adverse reactions include:
– General: Headache, fatigue, irritability.
– Local: Injection site pain, erythema, or swelling.
– Endocrine: Gynecomastia, fluid retention.
– Reproductive: Testicular discomfort (rare).
Serious reactions may include hypersensitivity responses or severe hormonal imbalances.
**7 DRUG INTERACTIONS**
**7.1 Gonadotropins**
Concurrent use with other gonadotropins may enhance hormonal effects, increasing the risk of side effects. Monitor closely and adjust doses as needed.
**8 USE IN SPECIFIC POPULATIONS**
**8.1 Pregnancy**
Category X: May cause fetal harm due to hormonal effects. 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 prostate or cardiovascular issues.
**9 DRUG ABUSE AND DEPENDENCE**
No evidence of abuse or dependence potential with HCGMED, but misuse for performance enhancement may occur. Monitor for inappropriate use.
**10 OVERDOSAGE**
Symptoms of overdose may include excessive testosterone effects, such as gynecomastia or fluid retention. No specific antidote exists; treat symptomatically and discontinue use.
**11 DESCRIPTION**
HCGMED contains human chorionic gonadotropin (hCG), a peptide hormone that mimics luteinizing hormone to stimulate testosterone production. It is supplied as a white lyophilized powder, soluble in bacteriostatic water for injection. Each vial contains 5000 IU hCG, with mannitol as a stabilizer. Half-life: Approximately 24-36 hours. Note: Ethyl oleate and ricinus oil are not used in this formulation, as it is water-based.
**12 CLINICAL PHARMACOLOGY**
**12.1 Mechanism of Action**
HCG mimics luteinizing hormone, stimulating Leydig cells in the testes to produce testosterone and supporting spermatogenesis.
**12.3 Pharmacokinetics**
Absorbed after subcutaneous or intramuscular injection; half-life approximately 24-36 hours; metabolized and excreted primarily via urine.
**13 NONCLINICAL TOXICOLOGY**
Limited data available; animal studies suggest potential reproductive toxicity. No human carcinogenicity data available.
**16 HOW SUPPLIED/STORAGE AND HANDLING**
5000 IU lyophilized powder in single-use vials. Store refrigerated at 2°-8°C (36°-46°F). Reconstituted solution stable for up to 30 days refrigerated. Protect from light. Keep out of reach of children.
*Manufactured by: Medi Pharma*
