STANOMED 10

### STANOMED 10 (stanozolol) Tablets

**HIGHLIGHTS OF PRESCRIBING INFORMATION**
These highlights do not include all the information needed to use STANOMED 10 safely and effectively. See full prescribing information for STANOMED 10.

STANOMED 10 (stanozolol) tablets, for oral use

**INDICATIONS AND USAGE**
STANOMED 10 is an anabolic steroid indicated for investigational use in promoting muscle hardness, strength, and fat loss in cutting and athletic performance settings. Not approved for human therapeutic use in many jurisdictions; consult local regulations (1).

**DOSAGE AND ADMINISTRATION**
– Administer orally.
– Adult males: 20 mg to 50 mg per day.
– Adult females: 5 mg to 10 mg per day (2.1).
– Cycle duration: Typically 6 to 8 weeks.

**DOSAGE FORMS AND STRENGTHS**
Tablets: 10 mg stanozolol (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 stanozolol or any component of the formulation (4).

**WARNINGS AND PRECAUTIONS**
– Hepatotoxicity: High risk; monitor liver function tests (5.1).
– Cardiovascular risk: May alter lipid profiles; monitor cholesterol (5.2).
– Androgenic effects: Risk of virilization in females; discontinue if occurs (5.3).
– Joint discomfort: May cause dryness; monitor joint health (5.4).

**ADVERSE REACTIONS**
Common adverse reactions include acne, hair loss, and joint 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**
STANOMED 10 is indicated for investigational use in adults to promote muscle hardness, enhance strength and endurance, increase fat loss, improve vascularity, boost red blood cell production, and reduce SHBG to enhance free testosterone. It is commonly used in cutting cycles and by athletes for performance enhancement. 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 orally, preferably with food to reduce gastrointestinal irritation.
– Males: 20 mg to 50 mg daily, divided into 2-3 doses to maintain stable blood levels.
– Females: 5 mg to 10 mg daily, in a single dose to minimize androgenic effects.
– Cycle duration: Typically 6 to 8 weeks to limit hepatotoxicity. 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 10 mg stanozolol, supplied in bottles of 100 tablets.

**4 CONTRAINDICATIONS**
STANOMED 10 is contraindicated in:
– Patients with known or suspected prostate or breast carcinoma.
– Pregnant women (Category X).
– Patients with hypersensitivity to stanozolol or excipients (e.g., lactose monohydrate).
– Patients with severe hepatic insufficiency due to high hepatotoxicity risk.

**5 WARNINGS AND PRECAUTIONS**
**5.1 Hepatotoxicity**
High risk of liver damage, including elevated enzymes, peliosis hepatis, or hepatic neoplasms. Perform liver function tests before and during therapy; discontinue if jaundice or abnormal tests occur.
**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 Androgenic Effects**
Females may experience virilization, including deepening of voice, hirsutism, or clitoromegaly, which may be irreversible. Discontinue immediately if signs of virilization appear.
**5.4 Joint Discomfort**
May cause joint dryness or pain due to reduced water retention. Monitor joint health and use supportive measures if needed.

**6 ADVERSE REACTIONS**
Reported adverse reactions include:
– Hepatic: Elevated AST/ALT, jaundice, liver toxicity.
– Dermatologic: Acne, oily skin, male pattern baldness in predisposed individuals.
– Musculoskeletal: Joint pain, tendon discomfort.
– Cardiovascular: Hypertension, altered lipid profiles.
– Endocrine: Libido changes, testicular atrophy, reduced fertility.

**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 tendon injury or edema.

**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 liver toxicity, joint pain, or acne exacerbation. No specific antidote exists; treat symptomatically and discontinue use immediately.

**11 DESCRIPTION**
STANOMED 10 contains stanozolol, a dihydrotestosterone-derived anabolic steroid. Supplied as 10 mg tablets for oral use. Excipients include lactose monohydrate, microcrystalline cellulose, and magnesium stearate. Half-life: Approximately 9 hours.

**12 CLINICAL PHARMACOLOGY**
**12.1 Mechanism of Action**
Stanozolol binds to androgen receptors, promoting protein synthesis, nitrogen retention, and red blood cell production while reducing SHBG to enhance free testosterone.
**12.3 Pharmacokinetics**
Rapidly absorbed orally; peak plasma levels in 1-2 hours; half-life approximately 9 hours; metabolized in the liver; excreted primarily in urine.

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

**16 HOW SUPPLIED/STORAGE AND HANDLING**
Tablets, 10 mg, in bottles of 100. Store at 20°-25°C (68°-77°F); protect from light and moisture. Keep out of reach of children.

*Manufactured by: Medi Pharma*