TAMOXMED 20

### TAMOXMED 20 (tamoxifen) Tablets

**HIGHLIGHTS OF PRESCRIBING INFORMATION**
These highlights do not include all the information needed to use TAMOXMED 20 safely and effectively. See full prescribing information for TAMOXMED 20.

TAMOXMED 20 (tamoxifen) tablets, for oral use

**INDICATIONS AND USAGE**
TAMOXMED 20 is a selective estrogen receptor modulator (SERM) indicated for investigational use in controlling estrogen levels, preventing gynecomastia, and supporting post-cycle therapy in performance enhancement settings. Not approved for all indications in many jurisdictions; consult local regulations (1).

**DOSAGE AND ADMINISTRATION**
– Administer orally.
– Adult males: 10 mg to 20 mg per day.
– Adult females: Not typically used (2.1).
– Cycle duration: Typically 4 to 6 weeks for post-cycle therapy.

**DOSAGE FORMS AND STRENGTHS**
Tablets: 20 mg tamoxifen (3).

**CONTRAINDICATIONS**
– History of thromboembolism (4).
– Hypersensitivity to tamoxifen or any component of the formulation (4).
– Pregnancy (4).

**WARNINGS AND PRECAUTIONS**
– Thromboembolism: Increased risk; monitor for symptoms (5.1).
– Hepatotoxicity: Monitor liver function tests (5.2).
– Visual disturbances: May cause cataracts; monitor vision (5.3).

**ADVERSE REACTIONS**
Common adverse reactions include hot flashes, nausea, and fatigue (6).

**DRUG INTERACTIONS**
– Anticoagulants: May enhance effects; monitor prothrombin time (7.1).
– CYP2D6 inhibitors: May reduce efficacy; use cautiously (7.2).

**USE IN SPECIFIC POPULATIONS**
– Pregnancy: Contraindicated (8.1).
– Lactation: Not recommended (8.2).
– Pediatric use: Safety not established (8.4).
– Geriatric use: Monitor for organ dysfunction (8.5).

Revised: 08/2025

**FULL PRESCRIBING INFORMATION**

**1 INDICATIONS AND USAGE**
TAMOXMED 20 is indicated for investigational use in adults to control estrogen levels, prevent gynecomastia, stimulate LH/FSH production for testosterone recovery, improve cholesterol profiles, reduce water retention, and support bone health during post-cycle therapy. It is commonly used after anabolic steroid cycles to restore hormonal balance. This product is not approved for all indications and should be used under medical supervision.

**2 DOSAGE AND ADMINISTRATION**
**2.1 Recommended Dosage**
Administer orally, with or without food.
– Males: 10 mg to 20 mg daily, typically for 4-6 weeks during post-cycle therapy.
– Females: Not typically used due to hormonal effects; consult a healthcare provider for specific indications.
Adjust dosage based on response and tolerance. 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 20 mg tamoxifen, supplied in bottles of 30 tablets.

**4 CONTRAINDICATIONS**
TAMOXMED 20 is contraindicated in:
– Patients with a history of thromboembolism (e.g., deep vein thrombosis, pulmonary embolism).
– Patients with hypersensitivity to tamoxifen or excipients (e.g., lactose monohydrate).
– Pregnant women (Category X).

**5 WARNINGS AND PRECAUTIONS**
**5.1 Thromboembolism**
Increased risk of deep vein thrombosis, pulmonary embolism, or stroke. Monitor for symptoms like leg swelling or chest pain and discontinue if suspected.
**5.2 Hepatotoxicity**
May cause elevated liver enzymes or, rarely, hepatic neoplasms. Perform liver function tests before and during therapy; discontinue if jaundice or abnormal tests occur.
**5.3 Visual Disturbances**
May cause cataracts or retinopathy; monitor vision and discontinue if significant changes occur.

**6 ADVERSE REACTIONS**
Reported adverse reactions include:
– General: Hot flashes, nausea, fatigue.
– Nervous System: Headache, dizziness.
– Cardiovascular: Increased risk of thromboembolism.
– Hepatic: Elevated AST/ALT, jaundice (rare).
– Ophthalmic: Visual disturbances, cataracts (rare).

**7 DRUG INTERACTIONS**
**7.1 Anticoagulants**
May increase bleeding risk with warfarin or other anticoagulants; monitor INR or prothrombin time closely.
**7.2 CYP2D6 Inhibitors**
Strong CYP2D6 inhibitors (e.g., paroxetine) may reduce tamoxifen’s efficacy by inhibiting its active metabolite. Use cautiously and monitor response.

**8 USE IN SPECIFIC POPULATIONS**
**8.1 Pregnancy**
Category X: May cause fetal harm. 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**
Safety and efficacy not established in pediatric patients; use is not recommended.
**8.5 Geriatric Use**
Increased risk of thromboembolism; monitor closely for cardiovascular and hepatic function.

**9 DRUG ABUSE AND DEPENDENCE**
No evidence of abuse or dependence potential with tamoxifen, but misuse in performance enhancement may occur. Monitor for inappropriate use.

**10 OVERDOSAGE**
Symptoms of overdose may include nausea, hot flashes, or thromboembolism. No specific antidote exists; treat symptomatically and discontinue use immediately.

**11 DESCRIPTION**
TAMOXMED 20 contains tamoxifen, a selective estrogen receptor modulator. Supplied as 20 mg tablets for oral use. Excipients include lactose monohydrate, microcrystalline cellulose, and magnesium stearate. Half-life: Approximately 5-7 days.

**12 CLINICAL PHARMACOLOGY**
**12.1 Mechanism of Action**
Tamoxifen acts as an estrogen receptor antagonist in some tissues and an agonist in others, reducing estrogenic effects like gynecomastia and stimulating LH/FSH for testosterone production.
**12.3 Pharmacokinetics**
Absorbed orally; peak plasma levels in 4-7 hours; half-life approximately 5-7 days; metabolized in the liver via CYP2D6; excreted primarily in feces.

**13 NONCLINICAL TOXICOLOGY**
Animal studies suggest increased risk of endometrial cancer and thromboembolism; no human carcinogenicity data available.

**16 HOW SUPPLIED/STORAGE AND HANDLING**
Tablets, 20 mg, in bottles of 30. Store at 20°-25°C (68°-77°F); protect from light and moisture. Keep out of reach of children.

*Manufactured by: Medi Pharma*