LETROMED 2.5

### LETROMED 2,5 (letrozole) Tablets

**HIGHLIGHTS OF PRESCRIBING INFORMATION**
These highlights do not include all the information needed to use LETROMED 2,5 safely and effectively. See full prescribing information for LETROMED 2,5.

LETROMED 2,5 (letrozole) tablets, for oral use

**INDICATIONS AND USAGE**
LETROMED 2,5 is a potent aromatase inhibitor indicated for investigational use in suppressing estrogen levels, preventing gynecomastia, and enhancing muscle dryness in cutting cycles. Not approved for all indications in many jurisdictions; consult local regulations (1).

**DOSAGE AND ADMINISTRATION**
– Administer orally.
– Adult males: 0.5 mg to 2.5 mg per day.
– Adult females: 0.25 mg to 1 mg per day if applicable for estrogen control (2.1).
– Cycle duration: As needed during cycle or post-cycle therapy.

**DOSAGE FORMS AND STRENGTHS**
Tablets: 2.5 mg letrozole (3).

**CONTRAINDICATIONS**
– Hypersensitivity to letrozole or any component of the formulation (4).
– Premenopausal women (4).
– Pregnancy (4).

**WARNINGS AND PRECAUTIONS**
– Bone density loss: Monitor bone mineral density (5.1).
– Lipid changes: Monitor cholesterol levels (5.2).
– Fatigue and hot flashes: Common side effects; monitor patient comfort (5.3).
– Hepatic effects: Monitor liver function (5.4).

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

**DRUG INTERACTIONS**
– Estrogens: May antagonize effects; avoid concurrent use (7.1).
– CYP3A4 inducers: May reduce efficacy; monitor closely (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**
LETROMED 2,5 is indicated for investigational use in adults to potently suppress estrogen production, prevent gynecomastia and bloating, increase free testosterone levels, aid fat loss, and improve muscle hardness and vascularity. It is commonly used in bodybuilding to combat estrogenic side effects from anabolic steroids and enhance cutting phases. This product is not approved for all indications and should be administered under medical supervision.

**2 DOSAGE AND ADMINISTRATION**
**2.1 Recommended Dosage**
Administer orally, preferably with food to enhance absorption.
– Males: 0.5 mg to 2.5 mg daily, adjusted based on estrogen levels and response.
– Females: 0.25 mg to 1 mg daily, if used for estrogen control in specific medical contexts.
Continue as needed during anabolic steroid cycles or post-cycle therapy. 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 2.5 mg letrozole, supplied in bottles of 30 tablets.

**4 CONTRAINDICATIONS**
LETROMED 2,5 is contraindicated in:
– Patients with hypersensitivity to letrozole or excipients (e.g., lactose monohydrate).
– Premenopausal women, as it is ineffective in the presence of functional ovaries.
– Pregnant women (Category X).

**5 WARNINGS AND PRECAUTIONS**
**5.1 Bone Density Loss**
Letrozole may significantly reduce bone mineral density, increasing the risk of osteoporosis or fractures. Monitor bone mineral density periodically, especially in long-term use or patients with risk factors.
**5.2 Lipid Changes**
May increase LDL cholesterol and decrease HDL cholesterol, raising cardiovascular risk. Monitor lipid profiles during treatment.
**5.3 Fatigue and Hot Flashes**
Common side effects include fatigue, hot flashes, and joint pain, which may affect quality of life. Monitor patient comfort and adjust dosage if necessary.
**5.4 Hepatic Effects**
May cause elevated liver enzymes in some patients. Perform liver function tests before and during therapy; discontinue if significant abnormalities occur.

**6 ADVERSE REACTIONS**
Reported adverse reactions include:
– General: Hot flashes, fatigue, increased sweating.
– Musculoskeletal: Joint pain, arthralgia, muscle stiffness.
– Nervous System: Headache, dizziness.
– Hepatic: Elevated liver enzymes (rare).
– Cardiovascular: Increased cholesterol levels.
Serious reactions may include osteoporosis or cardiovascular events.

**7 DRUG INTERACTIONS**
**7.1 Estrogens**
Concurrent use with estrogens may antagonize letrozole’s effects, reducing efficacy. Avoid co-administration of estrogen-containing medications.
**7.2 CYP3A4 Inducers**
Strong CYP3A4 inducers (e.g., rifampin) may reduce letrozole plasma levels, decreasing efficacy. Monitor estrogen levels and adjust therapy as needed.

**8 USE IN SPECIFIC POPULATIONS**
**8.1 Pregnancy**
Category X: May cause fetal harm due to estrogen suppression. 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**
Limited data available; monitor for age-related organ dysfunction, particularly bone density and cardiovascular health.

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

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

**11 DESCRIPTION**
LETROMED 2,5 contains letrozole, a potent non-steroidal aromatase inhibitor that reduces estrogen production. Supplied as 2.5 mg tablets for oral use. Excipients include lactose monohydrate, microcrystalline cellulose, and magnesium stearate. Half-life: Approximately 2 days.

**12 CLINICAL PHARMACOLOGY**
**12.1 Mechanism of Action**
Letrozole inhibits aromatase, drastically reducing estrogen synthesis, which enhances testosterone-to-estrogen ratio and minimizes estrogenic side effects.
**12.3 Pharmacokinetics**
Rapidly absorbed orally; peak plasma levels in 1-2 hours; half-life approximately 2 days; metabolized in the liver via CYP3A4; excreted primarily in urine.

**13 NONCLINICAL TOXICOLOGY**
Animal studies suggest potential carcinogenicity, including hepatic tumors; no human data available. Use caution due to long-term risks.

**16 HOW SUPPLIED/STORAGE AND HANDLING**
Tablets, 2.5 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*