TESTOMED COMBO 400

### TESTOMED COMBO 400 (testosterone blend high-dose) Injection

**HIGHLIGHTS OF PRESCRIBING INFORMATION**
These highlights do not include all the information needed to use TESTOMED COMBO 400 safely and effectively. See full prescribing information for TESTOMED COMBO 400.

TESTOMED COMBO 400 injection, for intramuscular use

**INDICATIONS AND USAGE**
TESTOMED COMBO 400 is a high-dose testosterone ester blend indicated for investigational use in promoting massive muscle gains, strength, and performance in advanced bulking cycles. Not approved for human therapeutic use in many jurisdictions; consult local regulations (1).

**DOSAGE AND ADMINISTRATION**
– Administer by deep intramuscular injection.
– Adult males: 400 mg to 800 mg per week, divided into two or three doses.
– Adult females: Not recommended due to high androgenic potency (2.1).
– Cycle duration: Typically 8 to 12 weeks.

**DOSAGE FORMS AND STRENGTHS**
Injection: 400 mg/mL blend (188 mg testosterone enanthate, 187 mg testosterone cypionate, 25 mg testosterone propionate) in multi-dose vials (3).

**CONTRAINDICATIONS**
– Known or suspected carcinoma of the prostate or breast in males.
– Pregnancy (4).
– Hypersensitivity to any component of the formulation, including ethyl oleate or ricinus oil (4).

**WARNINGS AND PRECAUTIONS**
– Cardiovascular risk: May alter lipid profiles; monitor cholesterol (5.1).
– Hepatotoxicity: Monitor liver function tests (5.2).
– Androgenic effects: High risk; not recommended for females (5.3).
– Suppression of endogenous testosterone: Use post-cycle therapy (5.4).
– Local reactions: Ethyl oleate or ricinus oil may cause injection site irritation (5.5).

**ADVERSE REACTIONS**
Common adverse reactions include aggression, acne, and injection site pain (6).

**DRUG INTERACTIONS**
– Anticoagulants: May enhance effects; monitor prothrombin time (7.1).
– Insulin or oral hypoglycemics: May alter glucose levels; adjust doses (7.2).

**USE IN SPECIFIC POPULATIONS**
– Pregnancy: Contraindicated (8.1).
– Lactation: Not recommended (8.2).
– Pediatric use: Not recommended; risk of premature epiphyseal closure (8.4).
– Geriatric use: Increased risk of prostate issues (8.5).

Revised: 08/2025

**FULL PRESCRIBING INFORMATION**

**1 INDICATIONS AND USAGE**
TESTOMED COMBO 400 is indicated for investigational use in adults to promote massive muscle and strength gains, enhance energy and mood, boost libido, improve performance, increase endurance, support recovery, and provide hormonal stability. It is commonly used in advanced bulking cycles for significant anabolic effects. This product is not approved for any medical condition and should be used under medical supervision.

**2 DOSAGE AND ADMINISTRATION**
**2.1 Recommended Dosage**
Administer TESTOMED COMBO 400 by deep intramuscular injection into the gluteal muscle or other large muscle groups. Rotate injection sites to minimize irritation.
– Males: 400 mg to 800 mg weekly, divided into two or three doses (e.g., every 3-4 days).
– Females: Not recommended due to high risk of virilization.
Adjust dosage based on response and tolerance. Discontinue if adverse effects occur.

**2.2 Preparation and Handling**
Inspect vial for particulate matter or discoloration before use. Use sterile technique for administration.

**3 DOSAGE FORMS AND STRENGTHS**
TESTOMED COMBO 400 is supplied as a sterile solution containing 400 mg/mL blend (188 mg testosterone enanthate, 187 mg testosterone cypionate, 25 mg testosterone propionate) in 10 mL multi-dose vials.

**4 CONTRAINDICATIONS**
TESTOMED COMBO 400 is contraindicated in:
– Patients with known or suspected prostate or breast carcinoma.
– Pregnant women (Category X).
– Patients with hypersensitivity to testosterone esters, ethyl oleate, ricinus oil, or other excipients.
– Patients with severe cardiac, hepatic, or renal insufficiency.

**5 WARNINGS AND PRECAUTIONS**
**5.1 Cardiovascular Effects**
May alter serum lipid profiles, increasing LDL and decreasing HDL, raising the risk of atherosclerosis. Monitor cholesterol levels periodically during treatment.
**5.2 Hepatotoxicity**
May cause elevated liver enzymes or, rarely, peliosis hepatis. Perform liver function tests before and during therapy; discontinue if jaundice or abnormal tests occur.
**5.3 Androgenic Effects**
High risk of virilization, including deepening of voice, hirsutism, or clitoromegaly, making it unsuitable for females. Discontinue immediately if signs appear in accidental use.
**5.4 Endocrine Effects**
Suppresses hypothalamic-pituitary-gonadal axis, reducing natural testosterone production. Implement post-cycle therapy to restore hormonal balance.
**5.5 Injection Site Reactions**
Ethyl oleate and ricinus oil may cause localized pain, redness, or swelling at the injection site. Rotate injection sites and monitor for signs of infection or abscess.

**6 ADVERSE REACTIONS**
Reported adverse reactions include:
– Psychiatric: Aggression, irritability, mood swings.
– Dermatologic: Acne, oily skin, male pattern baldness in predisposed individuals.
– Endocrine: Gynecomastia, testicular atrophy, reduced fertility.
– Cardiovascular: Hypertension, altered lipid profiles.
– Hepatic: Elevated AST/ALT, jaundice (rare).
– Local: Injection site pain, erythema, or abscess (rare).

**7 DRUG INTERACTIONS**
**7.1 Anticoagulants**
May increase bleeding risk with warfarin or other anticoagulants; monitor INR or prothrombin time closely.
**7.2 Hypoglycemic Agents**
May alter blood glucose levels, potentially requiring adjustment of insulin or oral antidiabetic doses; monitor closely.
**7.3 Corticosteroids**
Concurrent use may increase risk of edema, particularly in patients with cardiac or renal conditions.

**8 USE IN SPECIFIC POPULATIONS**
**8.1 Pregnancy**
Category X: May cause fetal harm, including virilization of a female fetus. 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**
Not recommended; may cause premature epiphyseal closure, leading to stunted growth.
**8.5 Geriatric Use**
Increased risk of prostatic hypertrophy or carcinoma; monitor prostate health closely during use.

**9 DRUG ABUSE AND DEPENDENCE**
Controlled substance in some jurisdictions. High potential for misuse leading to physical or psychological dependence due to potent anabolic effects.

**10 OVERDOSAGE**
Symptoms of overdose may include severe androgenic effects, such as aggression, acne exacerbation, or hypertension. No specific antidote exists; treat symptomatically and discontinue use immediately.

**11 DESCRIPTION**
TESTOMED COMBO 400 is a high-dose blend of testosterone esters (188 mg enanthate, 187 mg cypionate, 25 mg propionate) for potent anabolic effects. It is a clear oily solution for intramuscular injection, with benzyl alcohol (1.5% v/v) as preservative, ethyl oleate, and ricinus oil (castor oil) as carrier oils. Half-life: Approximately 7-10 days (blended).

**12 CLINICAL PHARMACOLOGY**
**12.1 Mechanism of Action**
The testosterone blend binds to androgen receptors, promoting protein synthesis, nitrogen retention, and red blood cell production for massive muscle growth and strength.
**12.3 Pharmacokinetics**
Absorbed after intramuscular injection; half-life approximately 7-10 days due to mixed esters; metabolized in the liver; excreted primarily in urine.

**13 NONCLINICAL TOXICOLOGY**
Animal studies indicate potential carcinogenicity, including hepatic and prostate tumors; no human data available.

**16 HOW SUPPLIED/STORAGE AND HANDLING**
10 mL multi-dose vial, 400 mg/mL. Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F). Protect from light. Keep out of reach of children.

*Manufactured by: Medi Pharma*