OXYMED 50

### OXYMED 50 (oxymetholone) Tablets

**HIGHLIGHTS OF PRESCRIBING INFORMATION**
These highlights do not include all the information needed to use OXYMED 50 safely and effectively. See full prescribing information for OXYMED 50.

OXYMED 50 (oxymetholone) tablets, for oral use

**INDICATIONS AND USAGE**
OXYMED 50 is an anabolic steroid indicated for investigational use in promoting rapid muscle mass, strength, and anemia treatment in performance enhancement settings. Not approved for human therapeutic use in many jurisdictions; consult local regulations (1).

**DOSAGE AND ADMINISTRATION**
– Administer orally.
– Adult males: 50 mg to 100 mg per day.
– Adult females: 10 mg to 25 mg per day with caution (2.1).
– Cycle duration: Typically 4 to 6 weeks.

**DOSAGE FORMS AND STRENGTHS**
Tablets: 50 mg oxymetholone (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 oxymetholone 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 weight gain, aggression, acne, 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**
OXYMED 50 is indicated for investigational use in adults to promote rapid weight and muscle mass gains, enhance strength, increase red blood cell production, improve protein synthesis, boost appetite, support recovery, and achieve muscle fullness. It is commonly used in bulking cycles for dramatic size increases and in anemia treatment. 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: 50 mg to 100 mg daily, divided into 2-3 doses to maintain stable blood levels.
– Females: 10 mg to 25 mg daily, in a single dose to minimize androgenic effects, used with caution.
– 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 50 mg oxymetholone, supplied in bottles of 50 tablets.

**4 CONTRAINDICATIONS**
OXYMED 50 is contraindicated in:
– Patients with known or suspected prostate or breast carcinoma.
– Pregnant women (Category X).
– Patients with hypersensitivity to oxymetholone 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 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: Significant weight gain, 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**
OXYMED 50 contains oxymetholone, a potent anabolic steroid derived from dihydrotestosterone. Supplied as 50 mg tablets for oral use. Excipients include lactose monohydrate, microcrystalline cellulose, and magnesium stearate. Half-life: Approximately 8-9 hours.

**12 CLINICAL PHARMACOLOGY**
**12.1 Mechanism of Action**
Oxymetholone binds to androgen receptors, promoting protein synthesis, nitrogen retention, and red blood cell production, leading to rapid muscle and weight gains.
**12.3 Pharmacokinetics**
Rapidly absorbed orally; peak plasma levels in 2-3 hours; half-life approximately 8-9 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, 50 mg, in bottles of 50. Store at 20°-25°C (68°-77°F); protect from light and moisture. Keep out of reach of children.

*Manufactured by: Medi Pharma*