METHAMED 10

### METHAMED 10 (methandienone) Tablets

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

METHAMED 10 (methandienone) tablets, for oral use

**INDICATIONS AND USAGE**
METHAMED 10 is an anabolic steroid indicated for investigational use in promoting rapid muscle mass and strength gains in bulking cycles. 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 4 to 6 weeks.

**DOSAGE FORMS AND STRENGTHS**
Tablets: 10 mg methandienone (3).

**CONTRAINDICATIONS**
– Known or suspected carcinoma of the prostate or breast in males.
– Pregnancy (4).
– Hypersensitivity to methandienone 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).
– Edema: Monitor fluid status (5.4).

**ADVERSE REACTIONS**
Common adverse reactions include acne, aggression, water retention, and gynecomastia (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**
METHAMED 10 is indicated for investigational use in adults to promote explosive muscle growth, enhance strength, improve glycogenolysis, increase protein synthesis, boost nitrogen retention, enhance energy, improve recovery, and elevate mood and motivation. It is commonly used as a kickstarter in bulking cycles for rapid results. 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 4 to 6 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 methandienone, supplied in bottles of 100 tablets.

**4 CONTRAINDICATIONS**
METHAMED 10 is contraindicated in:
– Patients with known or suspected prostate or breast carcinoma.
– Pregnant women (Category X).
– Patients with hypersensitivity to methandienone 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 appear.
**5.4 Edema**
May cause significant fluid retention, potentially exacerbating cardiac or renal conditions. Monitor fluid status and use cautiously in patients with heart, kidney, or liver disease.

**6 ADVERSE REACTIONS**
Reported adverse reactions include:
– Hepatic: Elevated AST/ALT, jaundice, liver toxicity.
– Dermatologic: Acne, oily skin, male pattern baldness in predisposed individuals.
– Psychiatric: Aggression, irritability, mood swings.
– Endocrine: Gynecomastia, testicular atrophy, reduced fertility.
– Cardiovascular: Hypertension, altered lipid profiles.
– General: Water retention, edema.

**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 rapid anabolic effects.

**10 OVERDOSAGE**
Symptoms of overdose may include severe liver toxicity, aggression, or edema. No specific antidote exists; treat symptomatically and discontinue use immediately.

**11 DESCRIPTION**
METHAMED 10 contains methandienone, an oral anabolic steroid derived from testosterone. Supplied as 10 mg tablets for oral use. Excipients include lactose monohydrate, microcrystalline cellulose, and magnesium stearate. Half-life: Approximately 3-5 hours.

**12 CLINICAL PHARMACOLOGY**
**12.1 Mechanism of Action**
Methandienone binds to androgen receptors, promoting protein synthesis, glycogenolysis, and nitrogen retention, leading to rapid muscle and strength gains.
**12.3 Pharmacokinetics**
Rapidly absorbed orally; peak plasma levels in 1-3 hours; half-life approximately 3-5 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*