OXAMED 10

### OXAMED 10 (oxandrolone) Tablets

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

OXAMED 10 (oxandrolone) tablets, for oral use

**INDICATIONS AND USAGE**
OXAMED 10 is an anabolic steroid indicated for investigational use in promoting lean muscle gains, fat loss, and strength, particularly in beginners and females, in performance enhancement settings. Not approved for human therapeutic use in many jurisdictions; consult local regulations (1).

**DOSAGE AND ADMINISTRATION**
– Administer orally.
– Adult males: 20 mg to 80 mg per day.
– Adult females: 5 mg to 20 mg per day (2.1).
– Cycle duration: Typically 6 to 8 weeks.

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

**WARNINGS AND PRECAUTIONS**
– Hepatotoxicity: 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).
– Suppression of endogenous testosterone: Use post-cycle therapy (5.4).

**ADVERSE REACTIONS**
Common adverse reactions include mild acne, hair loss, and libido changes (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**
OXAMED 10 is indicated for investigational use in adults to promote lean muscle retention, enhance fat loss, increase strength and endurance, improve vascularity, support recovery, and aid wound healing with minimal side effects. It is commonly used in cutting cycles and by beginners or females due to its mild profile. 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 80 mg daily, divided into 2-3 doses to maintain stable blood levels.
– Females: 5 mg to 20 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 oxandrolone, supplied in bottles of 100 tablets.

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

**5 WARNINGS AND PRECAUTIONS**
**5.1 Hepatotoxicity**
May cause elevated liver 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 Endocrine Effects**
Suppresses hypothalamic-pituitary-gonadal axis, reducing natural testosterone production. Implement post-cycle therapy to restore hormonal balance.

**6 ADVERSE REACTIONS**
Reported adverse reactions include:
– Dermatologic: Mild acne, oily skin, male pattern baldness in predisposed individuals.
– Endocrine: Libido changes, testicular atrophy, reduced fertility in males.
– Hepatic: Elevated AST/ALT, jaundice (rare).
– Cardiovascular: Hypertension, altered lipid profiles.
– General: Mild 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. 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, acne exacerbation, or hormonal imbalances. No specific antidote exists; treat symptomatically and discontinue use immediately.

**11 DESCRIPTION**
OXAMED 10 contains oxandrolone, a mild anabolic steroid derived from dihydrotestosterone. 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**
Oxandrolone binds to androgen receptors, promoting protein synthesis and nitrogen retention with minimal androgenic effects, ideal for lean muscle and fat loss.
**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 potential carcinogenicity, including hepatic tumors; no human data available. Use caution due to hepatotoxicity risk.

**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*