Zoclast
Generic Name
Zoledronic Acid
Manufacturer
Incepta Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| zoclast 4 mg injection | ৳ 6,500.00 | N/A |
Description
Overview of the medicine
Zoclast 4 mg Injection contains Zoledronic Acid, a bisphosphonate used to treat hypercalcemia of malignancy (high blood calcium levels due to cancer) and to prevent skeletal-related events (e.g., fractures, spinal cord compression) in patients with advanced malignancies involving bone. It is also indicated for the treatment of multiple myeloma and bone metastases from solid tumors, and in some cases, for osteoporosis.
Uses & Indications
Dosage
Adults
Hypercalcemia of malignancy: 4 mg as a single intravenous infusion over at least 15 minutes. Repeat dose may be considered after 7 days. Bone metastases/multiple myeloma: 4 mg intravenous infusion over at least 15 minutes every 3-4 weeks. Osteoporosis: 5 mg IV infusion once yearly (separate product often, but Zoclast 4mg might be used off-label or for specific cases).
Elderly
No specific dosage adjustment is required based on age alone. However, renal function should be carefully monitored.
Renal_impairment
Dosage adjustment is necessary based on creatinine clearance (CrCl). Not recommended for CrCl < 30 mL/min. For CrCl 30-60 mL/min, reduced doses (e.g., 3.5 mg, 3.3 mg, 3 mg) are typically used, as per specific guidelines.
How to Take
Zoclast 4 mg Injection is administered intravenously as a single infusion over at least 15 minutes. It should be diluted in 100 mL of 0.9% sodium chloride or 5% glucose solution (if not ready-to-use solution). Adequate hydration is essential before and during treatment.
Mechanism of Action
Zoledronic acid is a highly potent bisphosphonate that primarily inhibits osteoclast-mediated bone resorption. It binds to the hydroxyapatite crystals in the bone mineral and reduces the activity of osteoclasts, leading to a decrease in bone turnover and bone loss. This action helps to normalize elevated serum calcium levels and reduce skeletal complications.
Pharmacokinetics
Onset
For hypercalcemia of malignancy, calcium reduction typically begins within 2-3 days, with normalization occurring by day 7. For SREs, benefits are seen over prolonged treatment.
Excretion
Approximately 3-4% of the administered dose is excreted in the urine as unchanged drug over 24 hours. The remaining dose is largely taken up by bone.
Half life
Initial rapid elimination phase (plasma half-life 0.3-1.4 hours), followed by a prolonged terminal elimination phase (plasma half-life approximately 146 hours), primarily reflecting dissociation from bone.
Absorption
Rapidly distributed to bone, where it accumulates. Plasma levels decline rapidly after intravenous administration.
Metabolism
Not metabolized in humans. Primarily eliminated unchanged.
Side Effects
Contraindications
- Hypersensitivity to zoledronic acid, other bisphosphonates, or any component of the formulation
- Hypocalcemia
- Severe renal impairment (creatinine clearance < 30 mL/min)
- Pregnancy and lactation
Drug Interactions
Loop diuretics
Concurrent use with loop diuretics may increase the risk of hypocalcemia.
Aminoglycosides
May prolong the duration of hypocalcemia.
Other nephrotoxic drugs
Increased risk of renal toxicity when co-administered with other potentially nephrotoxic drugs.
Thalidomide (in multiple myeloma)
Increased risk of renal dysfunction with concomitant use.
Storage
Store at room temperature (20-25°C). Do not freeze. Protect from light. Once reconstituted or diluted, store at 2-8°C and use within 24 hours.
Overdose
Overdose of zoledronic acid may lead to clinically significant hypocalcemia, hypophosphatemia, and hypomagnesemia. Symptomatic hypocalcemia should be corrected by intravenous administration of calcium gluconate. Other electrolyte disturbances should be managed appropriately.
Pregnancy & Lactation
Zoclast is contraindicated in pregnancy and lactation due to potential for fetal harm and unknown excretion into breast milk. Use only if the potential benefit justifies the potential risk to the fetus/infant and alternative treatments are not suitable.
Side Effects
Contraindications
- Hypersensitivity to zoledronic acid, other bisphosphonates, or any component of the formulation
- Hypocalcemia
- Severe renal impairment (creatinine clearance < 30 mL/min)
- Pregnancy and lactation
Drug Interactions
Loop diuretics
Concurrent use with loop diuretics may increase the risk of hypocalcemia.
Aminoglycosides
May prolong the duration of hypocalcemia.
Other nephrotoxic drugs
Increased risk of renal toxicity when co-administered with other potentially nephrotoxic drugs.
Thalidomide (in multiple myeloma)
Increased risk of renal dysfunction with concomitant use.
Storage
Store at room temperature (20-25°C). Do not freeze. Protect from light. Once reconstituted or diluted, store at 2-8°C and use within 24 hours.
Overdose
Overdose of zoledronic acid may lead to clinically significant hypocalcemia, hypophosphatemia, and hypomagnesemia. Symptomatic hypocalcemia should be corrected by intravenous administration of calcium gluconate. Other electrolyte disturbances should be managed appropriately.
Pregnancy & Lactation
Zoclast is contraindicated in pregnancy and lactation due to potential for fetal harm and unknown excretion into breast milk. Use only if the potential benefit justifies the potential risk to the fetus/infant and alternative treatments are not suitable.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 2-3 years (24-36 months) from the manufacturing date, consult product leaflet for exact duration.
Availability
Hospitals, Clinics, Pharmacies
Approval Status
Approved
Patent Status
Expired (for generic)
WHO Essential Medicine
YesClinical Trials
Extensive clinical trials have demonstrated the efficacy of zoledronic acid in reducing skeletal-related events in patients with bone metastases and multiple myeloma, as well as in treating hypercalcemia of malignancy. Studies have compared it to other bisphosphonates (e.g., pamidronate) and placebo, showing superiority or non-inferiority in various outcomes.
Lab Monitoring
- Serum calcium, phosphate, magnesium, and creatinine levels before each dose and periodically during treatment
- Complete blood count (CBC) periodically
- Dental examination before initiation, especially in cancer patients at risk for ONJ
Doctor Notes
- Confirm normal renal function before each dose and adjust dosage for renal impairment as per guidelines.
- Ensure patient is adequately hydrated to minimize risk of renal toxicity.
- Administer infusion over at least 15 minutes to reduce renal toxicity risk.
- Educate patients about symptoms of ONJ and atypical femoral fractures; advise reporting new pain in jaw, thigh, hip, or groin.
- Monitor serum calcium, phosphate, magnesium regularly. Correct hypocalcemia if present before administration.
Patient Guidelines
- Ensure adequate hydration before and during treatment as advised by your doctor.
- Maintain good oral hygiene and regular dental check-ups, especially if you are a cancer patient.
- Report any new or unusual pain in your thigh, hip, or groin immediately to your doctor.
- Inform your doctor about all medications, supplements, and herbal products you are taking.
- Contact your doctor if you experience any flu-like symptoms, fever, or severe bone/muscle pain after the injection.
Missed Dose Advice
Since Zoclast 4 mg Injection is administered by a healthcare professional on a scheduled basis, a missed dose is unlikely. If a scheduled dose is missed, contact your doctor or healthcare provider immediately to reschedule.
Driving Precautions
Zoclast 4 mg Injection may cause dizziness or visual disturbances. Patients should be advised to exercise caution when driving or operating machinery until they know how the medicine affects them.
Lifestyle Advice
- Maintain a balanced diet rich in calcium and vitamin D, or take supplements if advised by a doctor.
- Engage in regular weight-bearing exercise, if appropriate for your condition, to support bone health.
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