### BOLDSOMED 250 (boldenone undecylenate) Injection
**HIGHLIGHTS OF PRESCRIBING INFORMATION**
These highlights do not include all the information needed to use BOLDSOMED 250 safely and effectively. See full prescribing information for BOLDSOMED 250.
BOLDSOMED 250 (boldenone undecylenate) injection, for intramuscular use
**INDICATIONS AND USAGE**
BOLDSOMED 250 is an anabolic androgenic steroid indicated for the promotion of muscle growth, enhancement of endurance, and support of recovery in performance enhancement settings. Not approved for human therapeutic use in many jurisdictions; consult local regulations (1).
**DOSAGE AND ADMINISTRATION**
– Administer by deep intramuscular injection.
– Adult males: 300 mg to 800 mg per week, divided into two or three equal doses.
– Adult females: 50 mg to 150 mg per week, divided into two or three equal doses (2.1).
– Cycle duration: Typically 8 to 12 weeks.
**DOSAGE FORMS AND STRENGTHS**
Injection: 250 mg/mL in multi-dose vials (3).
**CONTRAINDICATIONS**
– Known or suspected carcinoma of the prostate or breast in males.
– Known or suspected carcinoma of the breast in females with hypercalcemia.
– Pregnancy (4).
– Hypersensitivity to boldenone undecylenate, ethyl oleate, ricinus oil, or any component of the formulation (4).
**WARNINGS AND PRECAUTIONS**
– Cardiovascular risk: May cause lipid changes; monitor cholesterol levels (5.1).
– Hepatotoxicity: Monitor liver function tests (5.2).
– Androgenic effects: Risk of virilization in females; discontinue if occurs (5.3).
– Suppression of endogenous testosterone: Use post-cycle therapy (5.4).
– Edema: May occur with or without congestive heart failure (5.5).
– Local reactions: Ethyl oleate or ricinus oil may cause injection site irritation (5.6).
**ADVERSE REACTIONS**
Common adverse reactions include acne, injection site pain, increased aggression, hair loss, and gynecomastia (6).
**DRUG INTERACTIONS**
– Anticoagulants: May enhance effects; monitor prothrombin time (7.1).
– Insulin or oral hypoglycemics: May decrease blood glucose; 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**
BOLDSOMED 250 is indicated for use in adults for the promotion of lean muscle mass, appetite stimulation, protein synthesis enhancement, nitrogen retention, red blood cell production, and strength increases without significant water retention. It is commonly used in lean bulking cycles to enhance vascularity and support serious training regimens. 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 BOLDSOMED 250 by deep intramuscular injection into the gluteal muscle or other large muscle groups. Rotate injection sites to minimize irritation.
– Males: 300 mg to 800 mg weekly, administered in divided doses (e.g., every 3-4 days).
– Females: 50 mg to 150 mg weekly, in divided doses.
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**
BOLDSOMED 250 is supplied as a sterile solution containing 250 mg boldenone undecylenate per mL in 10 mL multi-dose vials.
**4 CONTRAINDICATIONS**
BOLDSOMED 250 is contraindicated in:
– Patients with known or suspected prostate or breast carcinoma.
– Pregnant women (Category X).
– Patients with hypersensitivity to boldenone undecylenate, ethyl oleate, ricinus oil, or other excipients.
– Patients with severe cardiac, hepatic, or renal insufficiency.
**5 WARNINGS AND PRECAUTIONS**
**5.1 Cardiovascular Effects**
Anabolic steroids may alter serum lipid profiles, increasing LDL and decreasing HDL, raising the risk of atherosclerosis. Monitor cholesterol levels periodically during treatment to assess cardiovascular risk.
**5.2 Hepatotoxicity**
May cause peliosis hepatis, hepatic neoplasms, or elevated liver enzymes. Perform liver function tests before and during therapy; discontinue if jaundice or abnormal liver tests occur.
**5.3 Virilization**
Females may experience deepening of voice, hirsutism, or clitoromegaly, which may be irreversible. Discontinue immediately if signs of virilization appear.
**5.4 Endocrine Effects**
Suppresses hypothalamic-pituitary-gonadal axis, reducing natural testosterone production. Implement post-cycle therapy to restore hormonal balance after cycle completion.
**5.5 Edema**
May cause fluid retention, potentially exacerbating cardiac or renal conditions. Use cautiously in patients with heart, kidney, or liver disease, and monitor for signs of edema.
**5.6 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 formation.
**6 ADVERSE REACTIONS**
Reported adverse reactions include:
– Dermatologic: Acne, oily skin, male pattern baldness in predisposed individuals.
– Cardiovascular: Hypertension, changes in cholesterol levels (increased LDL, decreased HDL).
– Hepatic: Elevated AST/ALT, jaundice (rare).
– Endocrine: Gynecomastia, testicular atrophy, reduced fertility in males.
– Psychiatric: Aggression, mood swings, irritability.
– Local: Injection site pain, erythema, or abscess formation (rare).
**7 DRUG INTERACTIONS**
**7.1 Anticoagulants**
May increase bleeding risk with warfarin or other anticoagulants; monitor INR or prothrombin time closely during concurrent use.
**7.2 Hypoglycemic Agents**
May enhance effects of insulin or oral antidiabetics, leading to hypoglycemia; monitor blood glucose and adjust doses as needed.
**7.3 Corticosteroids**
Concurrent use may increase risk of edema, particularly in patients with underlying cardiac or renal conditions. Monitor fluid status closely.
**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 in children and adolescents.
**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. Potential for misuse leading to physical or psychological dependence, particularly with prolonged use or high doses. Monitor for signs of dependence.
**10 OVERDOSAGE**
Symptoms of overdose may include severe androgenic effects, such as aggression, hypertension, or acne exacerbation. No specific antidote exists; provide supportive care and discontinue use immediately.
**11 DESCRIPTION**
BOLDSOMED 250 contains boldenone undecylenate, a synthetic derivative of testosterone with anabolic and androgenic properties. It is a clear, yellowish oily solution for intramuscular injection. Each mL contains 250 mg boldenone undecylenate, with benzyl alcohol (1.5% v/v) as preservative, ethyl oleate, and ricinus oil (castor oil) as carrier oils. Half-life: Approximately 14 days.
**12 CLINICAL PHARMACOLOGY**
**12.1 Mechanism of Action**
Boldenone undecylenate binds to androgen receptors, promoting protein synthesis, nitrogen retention, and erythropoiesis. It exhibits mild aromatization to estrogen, reducing the risk of estrogenic side effects compared to other anabolic steroids.
**12.3 Pharmacokinetics**
Absorbed slowly after intramuscular injection; peak plasma levels reached in 3-4 days; half-life approximately 14 days. Metabolized in the liver; excreted primarily in urine.
**13 NONCLINICAL TOXICOLOGY**
Animal studies indicate potential carcinogenicity at high doses, including hepatic and mammary tumors; no human data available. Use caution due to long-term risks.
**16 HOW SUPPLIED/STORAGE AND HANDLING**
10 mL multi-dose vial, 250 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*
