Adronic 4 Concentrated Solution for IV Infusion: Each vial contains Zoledronic Acid Monohydrate BP 4.264 mg equivalent to Zoledronic Acid 4 mg supplied as 5 ml concentrated solution for IV infusion.
The active ingredient in Adronic is Zoledronic Acid, which belongs to a group of medicines called bisphosphonates. It is an inhibitor of osteoclast-mediated bone resorption. The action of bisphosphonates on bone is based on their high affinity for mineralized bone. Intravenously administered Zoledronic Acid is rapidly distributed to bone. Zoledronic Acid is not metabolized and is excreted unchanged via the kidney.
Zoledronic Acid is a bisphosphonate indicated for the treatment of:
Limitation of use:
The safety and efficacy of Zoledronic Acid have not been established for use in hyperparathyroidism or nontumor-related hypercalcemia.
Zoledronic Acid must not be mixed with calcium or other divalent cation-containing infusion solutions, such as Lactated Ringer’s solution. It should be administered as a single intravenous solution through a line separate from all other drugs.
Recommended Doses for Patients with Baseline Creatinine Clearance <60 mL/min
<table>
<thead>
<tr>
<th>Baseline Creatinine Clearance (mL/min)</th>
<th>Dose</th>
</tr>
</thead>
<tbody>
<tr>
<td>>60</td>
<td>4 mg (5 mL)</td>
</tr>
<tr>
<td>50–60</td>
<td>3.5 mg (4.4 mL)</td>
</tr>
<tr>
<td>40–49</td>
<td>3.3 mg (4.1 mL)</td>
</tr>
<tr>
<td>30–39</td>
<td>3 mg (3.8 mL)</td>
</tr>
</tbody>
</table>
Limited pharmacokinetic data are available for Zoledronic Acid in patients with severe renal impairment (creatinine clearance <30 mL/min).
The withdrawn concentrate must be diluted in 100 mL of sterile 0.9% Sodium Chloride USP or 5% Dextrose Injection USP. If the diluted solution is not used immediately, it should be refrigerated at 2–8°C to maintain microbiological integrity. Before administration, the refrigerated solution should be allowed to reach room temperature. The total time from dilution through refrigerated storage to the end of administration must not exceed 24 hours.
Aminoglycosides may have an additive effect to lower serum calcium for prolonged periods. Concomitant use of Loop diuretics with Zoledronic Acid may increase the risk of hypocalcemia.
Contraindicated in patients with known hypersensitivity to Zoledronic Acid.
The most common adverse events (greater than 25%) are nausea, fatigue, anemia, bone pain, constipation, fever, vomiting, and dyspnea.
Pregnancy:
Zoledronic Acid may cause fetal harm when administered to a pregnant woman. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus.
Nursing mothers:
It is not known whether Zoledronic Acid is excreted in human milk. Because many drugs are excreted in human milk, and because of the potential for serious adverse reactions in nursing infants from Zoledronic Acid, a decision should be made to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. Zoledronic Acid binds to bone long-term and may be released over weeks to years.
Pediatric use:
Zoledronic Acid is not indicated for use in children.
Geriatric use:
No significant differences in response rate or adverse reactions have been observed in patients aged 65 years or older receiving Zoledronic Acid as compared to younger patients. Because decreased renal function occurs more commonly in the elderly, special care should be taken to monitor renal function.
Store below 30 C. Keep in a dry place away from light. Keep out of the reach of children.