Aclasta 5 mg/100 ml

Description

Indications

Aclasta is prescribed for:

• Treatment and prevention of osteoporosis in postmenopausal women
• Increasing bone mass in men with osteoporosis
• Managing glucocorticoid-induced osteoporosis
• Treatment of Paget’s disease of bone in both men and women

Usage Limitation: The optimal duration of treatment has not been established. For patients at low fracture risk, discontinuation after 3 to 5 years should be considered.

Pharmacology Zoledronic Acid is a bisphosphonate that selectively targets bone to inhibit osteoclast-mediated resorption. Its high affinity for mineralized bone allows for rapid distribution and long-lasting effects. The primary molecular target is farnesyl pyrophosphate synthase, contributing to its sustained action in bone metabolism.

Dosage

• Postmenopausal Osteoporosis (Treatment): 5 mg IV infusion once a year
• Postmenopausal Osteoporosis (Prevention): 5 mg IV infusion every 2 years
• Osteoporosis in Men: 5 mg IV infusion once a year
• Glucocorticoid-Induced Osteoporosis: 5 mg IV infusion once a year
• Paget’s Disease: Single 5 mg IV infusion

Re-treatment for Paget’s Disease: Considered based on increased serum alkaline phosphatase levels or symptom recurrence.

Calcium & Vitamin D Supplementation Patients should ensure adequate calcium and vitamin D intake, particularly for the 2 weeks following treatment:

• Osteoporosis: 1200 mg calcium & 800-1000 IU vitamin D daily
• Paget’s Disease: 1500 mg calcium & 800 IU vitamin D daily

Administration

• Must be infused over at least 15 minutes
• Ensure proper hydration before administration
• Inspect solution visually for clarity and particulate matter
• Follow IV infusion with a 10 mL saline flush
• Acetaminophen may reduce acute-phase reaction symptoms

Drug Interactions

• Aminoglycosides: Prolonged serum calcium reduction
• Loop Diuretics: Increased risk of hypocalcemia
• Nephrotoxic Drugs: Use cautiously
• Renally Excreted Drugs: Monitor renal function

Contraindications

• Hypocalcemia
• Severe renal impairment (Creatinine clearance <35 mL/min)
• Hypersensitivity to Zoledronic Acid or excipients

Side Effects Common adverse reactions (>10%) include fever, myalgia, headache, and joint pain. Other reactions may include nausea, vomiting, flu-like symptoms, diarrhea, and eye inflammation.

Pregnancy & Lactation

• May cause fetal harm; not recommended during pregnancy
• Contraindicated for nursing women

Precautions & Warnings

• Hypocalcemia: Patients should receive adequate calcium and vitamin D supplementation
• Renal Function: Monitor creatinine clearance before each dose
• Osteonecrosis of the Jaw (ONJ): Dental examination recommended before initiation
• Atypical Femur Fractures: Assess for unexplained thigh or groin pain
• Bone, Joint, and Muscle Pain: Discontinue if severe pain occurs

Use in Special Populations

• Pediatrics: Not indicated for children
• Geriatrics: Monitor renal function carefully
• Renal Impairment: Contraindicated if creatinine clearance <35 mL/min
• Hepatic Impairment: No dose adjustment needed

Overdose Management Monitor for renal impairment, hypocalcemia, hypophosphatemia, and hypomagnesemia. Administer calcium gluconate, phosphate, or magnesium sulfate as needed.

Therapeutic Class Bisphosphonate preparations

Storage Conditions Store below 30°C, protected from moisture and light. Keep out of reach of children.