### DROSTAMED 200 (drostanolone enanthate) Injection
**HIGHLIGHTS OF PRESCRIBING INFORMATION**
These highlights do not include all the information needed to use DROSTAMED 200 safely and effectively. See full prescribing information for DROSTAMED 200.
DROSTAMED 200 (drostanolone enanthate) injection, for intramuscular use
**INDICATIONS AND USAGE**
DROSTAMED 200 is an anabolic androgenic steroid indicated for the promotion of muscle hardness, fat loss, and performance enhancement in cutting and pre-competition phases. Not approved for human therapeutic use in many jurisdictions; consult local regulations (1).
**DOSAGE AND ADMINISTRATION**
– Administer by deep intramuscular injection.
– Adult males: 200 mg to 600 mg per week, divided into two or three equal doses.
– Adult females: 50 mg to 100 mg per week, divided into two or three equal doses (2.1).
– Cycle duration: Typically 6 to 10 weeks.
**DOSAGE FORMS AND STRENGTHS**
Injection: 200 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 drostanolone enanthate, ethyl oleate, ricinus oil, or any component of the formulation (4).
**WARNINGS AND PRECAUTIONS**
– Androgenic effects: Risk of virilization in females; discontinue if occurs (5.1).
– Cardiovascular risk: May alter lipid profiles; monitor cholesterol (5.2).
– Hepatotoxicity: Monitor liver function tests (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 acne, hair loss, increased aggression, 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**
DROSTAMED 200 is indicated for use in adults to enhance muscle hardness and density, reduce estrogen levels to prevent water retention, increase strength and aggression, improve fat loss while preserving muscle, and boost libido and overall performance. It is commonly used in cutting cycles and pre-competition preparation for a chiseled, vascular physique. 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 DROSTAMED 200 by deep intramuscular injection into the gluteal muscle or other large muscle groups. Rotate injection sites to minimize irritation.
– Males: 200 mg to 600 mg weekly, administered in divided doses (e.g., every 3-4 days).
– Females: 50 mg to 100 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**
DROSTAMED 200 is supplied as a sterile solution containing 200 mg drostanolone enanthate per mL in 10 mL multi-dose vials.
**4 CONTRAINDICATIONS**
DROSTAMED 200 is contraindicated in:
– Patients with known or suspected prostate or breast carcinoma.
– Pregnant women (Category X).
– Patients with hypersensitivity to drostanolone enanthate, ethyl oleate, ricinus oil, or other excipients.
– Patients with severe cardiac, hepatic, or renal insufficiency.
**5 WARNINGS AND PRECAUTIONS**
**5.1 Androgenic Effects**
Females may experience virilization, including deepening of voice, hirsutism, or clitoromegaly, which may be irreversible. Discontinue immediately if signs of virilization appear.
**5.2 Cardiovascular Effects**
May alter serum lipid profiles, increasing LDL and decreasing HDL, raising the risk of atherosclerosis. Monitor cholesterol levels periodically during treatment.
**5.3 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.
**5.4 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:
– Dermatologic: Acne, oily skin, male pattern baldness in predisposed individuals.
– Psychiatric: Increased aggression, irritability, mood swings.
– Endocrine: Reduced fertility, testicular atrophy, libido changes.
– 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. Potential for misuse leading to physical or psychological dependence, particularly with prolonged use or high doses.
**10 OVERDOSAGE**
Symptoms of overdose may include severe androgenic effects, such as aggression, acne exacerbation, or hypertension. No specific antidote exists; provide supportive care and discontinue use immediately.
**11 DESCRIPTION**
DROSTAMED 200 contains drostanolone enanthate, a long-acting dihydrotestosterone (DHT) derivative with anabolic and anti-estrogenic properties. It is a clear oily solution for intramuscular injection. Each mL contains 200 mg drostanolone enanthate, with benzyl alcohol (1.5% v/v) as preservative, ethyl oleate, and ricinus oil (castor oil) as carrier oils. Half-life: Approximately 8 days.
**12 CLINICAL PHARMACOLOGY**
**12.1 Mechanism of Action**
Drostanolone enanthate binds to androgen receptors, promoting muscle hardness and fat loss while inhibiting estrogen conversion, reducing water retention and gynecomastia risk.
**12.3 Pharmacokinetics**
Absorbed slowly after intramuscular injection; peak plasma levels in 2-3 days; half-life approximately 8 days. Metabolized in the liver; excreted primarily in urine.
**13 NONCLINICAL TOXICOLOGY**
Animal studies indicate potential carcinogenicity, including hepatic tumors; no human data available. Use caution due to androgenic effects.
**16 HOW SUPPLIED/STORAGE AND HANDLING**
10 mL multi-dose vial, 200 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*
