Anastronat — Anastrozole 1 mg Tablets, 30 Tablets

Anastronat is supplied as film-coated tablets containing 1 mg of anastrozole.

Qualitative and Quantitative Composition per Tablet:

• Active Ingredient: Anastrozole — 1 mg.
• Excipients: Lactose monohydrate, povidone, sodium starch glycolate, magnesium stearate, hypromellose, macrogol, titanium dioxide.

Packaging and Presentation: White to off-white, round, biconvex film-coated tablets with debossing. 10 tablets per aluminum blister strip. 3 blister strips (total 30 tablets) are packaged in an outer carton displaying Anastronat (Anastrozole Tablets I.P.) 1 mg along with Natco Pharma corporate graphics and official prescribing information.

Pharmacodynamics:
Growth of many breast cancers is stimulated or maintained by estrogens. In postmenopausal women, the primary source of circulating estrogens is the conversion of androgens into estrogens via aromatase. Anastrozole is a potent and highly selective non-steroidal aromatase inhibitor that reduces plasma estradiol concentrations by over 80% (at a 1 mg dose), inhibiting tumor cell proliferation.

Pharmacokinetics:

• Absorption: Anastrozole is rapidly and almost completely absorbed from the gastrointestinal tract. Food intake slightly decreases absorption rate but does not affect overall bioavailability.
• Distribution: Plasma protein binding is low (~40%, primarily albumin).
• Metabolism: Extensively metabolized in the liver via N-dealkylation, hydroxylation, and glucuronidation into inactive metabolites.
• Elimination: Slow elimination with a terminal half-life of approximately 40–50 hours. Excreted predominantly renally (< 10% unchanged) and via feces.

Anastronat 1 mg is indicated in postmenopausal women for:

• Adjuvant Treatment: Treatment of early hormone-positive breast cancer in postmenopausal women.
• Extended Adjuvant Treatment: Continuation of therapy for early hormone-positive breast cancer following 5 years of prior adjuvant tamoxifen therapy.
• First-Line Therapy: Advanced hormone-dependent breast cancer in postmenopausal women.
• Second-Line Therapy: Advanced breast cancer following disease progression on prior tamoxifen therapy.

Anastronat 1 mg is administered orally once daily at the same time each day.

Administration Instructions: Tablets must be swallowed whole with a sufficient amount of water. Can be taken with or without food.

Duration of Therapy:
Recommended duration of adjuvant therapy is 5 years or until tumor relapse. For advanced disease settings, therapy continues until tumor progression.

Administration of Anastronat 1 mg is contraindicated in:

• Hypersensitivity: Known hypersensitivity to anastrozole or any inactive excipient.
• Endocrine Status: Women with premenopausal endocrine status.
• Pregnancy and Lactation: Strictly contraindicated in pregnant or breastfeeding women.
• Severe Renal Impairment: Creatinine clearance < 20 ml/min.
• Severe Hepatic Impairment: Moderate or severe hepatic impairment.
• Concurrent Medications: Co-administration with tamoxifen or estrogen-containing therapies.

Evaluated drug interactions for Anastronat include:

• Tamoxifen and Estrogens: Must not be co-administered with anastrozole as they diminish its pharmacological efficacy.
• CYP3A4 Inhibitors (cimetidine, ketoconazole): No clinically significant interactions identified as anastrozole utilizes multiple hepatic metabolic pathways.

Pregnancy:
Anastronat is contraindicated during pregnancy. Anastrozole exposure may cause fetal abnormalities. If pregnancy occurs during therapy, treatment must be discontinued immediately.

Lactation:
Excretion into human breast milk is unknown. The drug is contraindicated during lactation.

Adverse reactions are generally mild to moderate and stem from estrogen deprivation:

• Vascular & Thermoregulation (Very Common): Hot flashes, hyperhidrosis.
• Musculoskeletal System: Arthralgia, joint pain, arthritis, osteoporosis and increased fracture risk, myalgia.
• Nervous System: Headache, fatigue, somnolence, depression, insomnia, paresthesias, carpal tunnel syndrome.
• Gastrointestinal Tract: Nausea, diarrhea, vomiting, anorexia, dry mouth, elevated liver enzymes.
• Other: Skin rash, alopecia, vaginal bleeding (frequently in the first weeks following therapy switch), asthenia.

Symptoms:
Clinical overdose cases are rare. Single doses up to 60 mg were well tolerated in clinical trials.

Treatment:
No specific antidote exists. Supportive and symptomatic care should be initiated, including gastric lavage (if recent) and vital sign monitoring.

Storage Requirements for Anastronat 1 mg:

🌡️ Temperature Range: Store in a dry, light-protected place at temperatures not exceeding 25–30 °C.
• 💧 Moisture Protection: Keep in original blister packaging to protect tablets from moisture.
• 👶 Safety Precautions: Keep strictly out of reach of children.
• ⏳ Shelf Life: Stated on carton and blisters. Do not use past expiration date. Prescription-only medicine.

To verify authenticity of genuine Anastronat 1 mg manufactured by Natco Pharma, inspect the following features:

• ✅ Corporate Logo: Distinctive blue-green Natco Pharma corporate logo printed on the outer carton and blister foil.
• ✅ Packaging Markings: Clear factory printing displaying Batch No., Mfg. Date, Exp. Date, and product designation Anastronat (Anastrozole Tablets I.P.) 1 mg.
• ✅ Blister Quantity: Standard box contains exactly 3 blister strips of 10 tablets each (total 30 tablets).
• ✅ Print Quality: High-grade packaging artwork without color fading or typography errors.