PRODUCT DESCRIPTION & SPECIFICATIONS
Brand / Manufacturer: Bioniche Pharma
Active Substance: Anastrozole (1 mg per tablet)
Form & Administration: Oral Uncoated Tablets
Chemical Properties:
- Molecular Formula: C17H19N5
- Molecular Weight: 293.374 g/mol
- CAS Registry Number: 120511-73-1
Regulatory & Packaging Details:
- Drug Class & Category: Non-steroidal Aromatase Inhibitor (AI)
- Prescription Status: Prescription Only Medicine (POM)
- Packaging: Bottle containing 50 tablets
Bioniche Pharma Anastrozole is a potent third-generation aromatase inhibitor initially engineered for targeted oncological therapy in postmenopausal breast cancer. In clinical and therapeutic settings, it serves to suppress endogenous estrogen production. It is also frequently utilized in specialized therapeutic protocols to mitigate estrogenic side effects associated with elevated aromatization.
CLINICAL PHARMACOLOGY
Bioniche Pharma Anastrozole selectively blocks the aromatase enzyme responsible for converting androgens into estrogens. Clinical evaluation demonstrates that daily administration can suppress circulating serum estradiol levels by up to 80%. Secondary endocrine effects include a compensatory upregulation of Luteinizing Hormone (LH) and Follicle-Stimulating Hormone (FSH) secretion, which can subsequently elevate total testosterone synthesis by up to 50% in male subjects.
INDICATIONS & CLINICAL USE
- Treatment of advanced or hormone receptor-positive breast cancer in postmenopausal women, including cases refractory to tamoxifen intervention using Bioniche Pharma formulations.
- Therapeutic management of male hypogonadism and estrogen-related hormonal imbalances, as determined by a qualified physician utilizing Bioniche Pharma products.
DOSAGE & ADMINISTRATION
Administration schedules for Bioniche Pharma Anastrozole must be tailored based on individual serum hormone profiles and medical supervision:
- Male Patients: Typical operational range varies from 0.5 mg to 3 mg daily. Due to its pharmacokinetic half-life, daily dosing is frequently divided into two to six equal administrations throughout the day to maintain stable plasma concentrations. Post-cycle recovery regimens typically begin at higher threshold doses before progressive downward titration over a 7- to 14-day duration.
- Female Patients: The recommended upper threshold is 1 mg per day to manage hyperestrogenism effectively using Bioniche Pharma Anastrozole.
CONTRAINDICATIONS
- Known hypersensitivity or allergic reaction to Bioniche Pharma Anastrozole or any excipients (manifesting as anaphylaxis, angioedema, or urticaria).
- Pregnancy or lactation due to high risk of fetal damage.
- Premenopausal women with breast cancer, where clinical efficacy has not been established.
PRECAUTIONS & CARDIOVASCULAR RISK
- Ischemic Heart Disease: Clinical trial data (ATAC study) indicate an elevated incidence of ischemic cardiovascular events in patients with preexisting ischemic heart conditions (17% vs 10% in comparative arms). A careful risk-benefit evaluation is required prior to initiating Bioniche Pharma therapy.
- Lipid Profile Alterations: Associated with an increased risk of elevated serum cholesterol concentrations relative to alternative therapies during Bioniche Pharma treatment.
- Bone Mineral Density: Estrogen reduction accelerates bone resorption, increasing the risk of osteopenia, osteoporosis, and bone fractures (particularly of the spine, hip, and wrist). Periodic bone density monitoring is advised during Bioniche Pharma therapy.
- Cognitive & Motor Impairment: May induce dizziness or somnolence. Patients should exercise caution when operating machinery or driving, particularly if co-administered with alcohol or CNS-depressing drugs during Bioniche Pharma administration.
ADVERSE REACTIONS
Rare / Severe Reactions (<0.01% incidence):
- Severe dermatological reactions, including ulcerative lesions or blistering.
- Systemic hypersensitivity causing angioedema of the face, lips, tongue, or pharynx leading to respiratory distress or dysphagia.
- Hepatic toxicity, hepatitis, and elevated liver enzymes, with or without clinical jaundice and abdominal distress associated with Bioniche Pharma use.
Common Adverse Effects (~10% incidence):
- Vasomotor symptoms (hot flashes), asthenia, and fatigue reported during Bioniche Pharma therapy.
- Musculoskeletal pain, arthralgia, back pain, and joint stiffness.
- Cardiovascular and metabolic disturbances, including hypertension and peripheral edema.
- Gastrointestinal distress (nausea, vomiting), headache, insomnia, mood disturbances/depression, pharyngitis, dyspnea, rash, and lymphedema experienced by Bioniche Pharma patients.
DRUG INTERACTIONS
- Warfarin: Clinical trials indicate no significant alteration in exposure ($C_{max}$ or $AUC$) or clinical anticoagulant activity (PT, aPTT, TT) for either R- or S-enantiomers when co-administered with Bioniche Pharma Anastrozole.
- Cytochrome P450 System: In vitro and in vivo studies indicate low potential for meaningful inhibition of major CYP450 isoenzymes, minimizing metabolic interactions with concomitant medications during Bioniche Pharma therapy.
STORAGE CONDITIONS
Store Bioniche Pharma products between 15°C and 25°C in a dry environment. Protect from direct light exposure. Keep out of reach of unauthorized persons and children.