Xtane — Exemestane 25 mg Tablets, 30 Tablets

Xtane 25 mg is supplied in the form of film-coated tablets for oral administration.

Qualitative and Quantitative Composition per Tablet:

• • Active Ingredient: Exemestane — 25 mg.
• • Excipients: Mannitol, crospovidone, polysorbate 80, hypromellose, magnesium stearate, colloidal silicon dioxide, titanium dioxide, macrogol.

Packaging and Presentation: Round, biconvex, film-coated tablets. Supplied in a plastic bottle containing 30 tablets with a protective cap. The bottle is packaged in a outer printed carton displaying Exemestane Tablets I.P., brand name Xtane 25 mg, and Natco Pharma corporate graphics.

Pharmacodynamics:
In postmenopausal women, estrogens are produced mainly from the conversion of androgens into estrogens by the aromatase enzyme in peripheral tissues. Exemestane blocks this process by irreversibly binding to the catalytic site of aromatase. It lowers serum estrogen concentrations in postmenopausal females by 85–95%, depriving estrogen-sensitive breast tumor cells of growth stimulation.

Pharmacokinetics:

• • Absorption: Rapidly absorbed from the GI tract after oral intake. Co-administration with food increases bioavailability by approximately 40%. Peak plasma concentrations occur within 2 hours.
• • Distribution: Extensively distributed into tissues and 90% bound to plasma proteins.
• • Metabolism: Extensively metabolized in the liver via oxidation by CYP3A4 and reduction of the keto group. Metabolites are inactive or weakly active.
• • Elimination: Terminal elimination half-life is around 24 hours. Excreted equally in urine and feces within 1 week.

Xtane 25 mg is indicated in natural or induced postmenopausal women for:

• • Adjuvant Treatment: Early estrogen-receptor positive breast cancer following 2–3 years of initial tamoxifen therapy.
• • Advanced Breast Cancer: Advanced hormone-receptor positive breast cancer progressing after anti-estrogen (tamoxifen) or non-steroidal aromatase inhibitor therapy.

Xtane 25 mg should be taken orally as 1 tablet (25 mg) once daily.

Administration Instructions: The tablet must be taken after a meal (preferably at the same time each day) swallowed whole with a sufficient amount of water. Food significantly enhances systemic absorption.

Duration of Therapy: Treatment is continued long-term (in adjuvant settings, up to a total endocrine duration of 5 years or until disease recurrence) as directed by an oncologist.

Administration of Xtane 25 mg is contraindicated in:

• • Hypersensitivity: Known hypersensitivity to exemestane or any inactive excipient.
• • Premenopausal Status: Women with premenopausal endocrine status.
• • Pregnancy and Lactation: Contraindicated in pregnant or breastfeeding women.
• • Pediatric Population: Safety and efficacy in children under 18 years have not been established.

Evaluated drug interactions for Xtane include:

• • CYP3A4 Inducers: Co-administration with potent CYP3A4 inducers (e.g., rifampicin, phenytoin, carbamazepine, St. John's wort) may decrease exemestane plasma exposure. Dose adjustment may be required.
• • Estrogen-Containing Therapies: Should not be co-administered with estrogens or hormone replacement therapy, as they negate the pharmacological effect of exemestane.

Pregnancy:
Xtane 25 mg is strictly contraindicated during pregnancy. Exemestane causes fetal harm and embryo-fetal toxicity.

Lactation:
Contraindicated in nursing mothers. Breastfeeding must be discontinued during therapy.

Adverse effects are predominantly related to estrogen deprivation. Most common side effects include:

• • Vascular and Thermoregulation: Hot flashes, hyperhidrosis (increased sweating).
• • Musculoskeletal System: Arthralgia, myalgia, pain in extremities, bone mineral density loss (osteoporosis, increased fracture risk).
• • Nervous System: Fatigue, headache, insomnia, depression, dizziness, carpal tunnel syndrome.
• • Gastrointestinal Tract: Nausea, abdominal pain, dyspepsia, diarrhea, constipation.
• • Other: Alopecia, peripheral edema, elevated hepatic enzyme levels.

Symptoms:
Clinical overdose data are limited. Higher doses may exacerbate known pharmacological side effects (severe hot flashes, extreme fatigue, nausea).

Treatment:
No specific antidote exists. Supportive and symptomatic management should be initiated, with regular monitoring of vital signs.

Storage Requirements for Xtane 25 mg:

• 🌡️ Temperature Control: Store at temperatures below 25 °C (77 °F).
• 💧 Moisture Protection: Keep in original bottle protected from moisture and direct light. Keep bottle tightly closed.
• 👶 Safety Precautions: Keep out of reach of children.
• ⏳ Shelf Life: Stated on the bottle label and outer carton. Do not use past expiration date. Prescription-only medicine.

To verify the authenticity of original Xtane 25 mg produced by Natco Pharma, verify the following details:

• ✅ Manufacturer Logo: Official blue-green Natco Pharma corporate logo on outer box and bottle label.
• ✅ Packaging Details: Clearly printed Batch No., Mfg. Date, Exp. Date, and product designation Exemestane Tablets I.P. Xtane 25 mg.
• ✅ Tamper Evident Seal: Intact protective seal ring on bottle cap and foil inner seal underneath the cap.
• ✅ Print Quality: Crisp typography without smudging, utilizing Natco Pharma’s signature oncology branding layout.