Product image of Kyselina Zoledrónová Stada (Zoledronic Acid) supplied by GNH India

Kyselina Zoledrónová Stada

Active Ingredient:
Zoledronic Acid
Origin:
EU

Kyselina Zoledrónová Stada (Zoledronic Acid)

Zoledronic Acid, the active ingredient in Kyselina Zoledrónová Stada, is a bisphosphonate presented as an injectable solution for intravenous use. It is used to treat osteoporosis, Paget's disease of bone, bone metastases, and hypercalcemia of malignancy in adult patients.

GNH India supplies Kyselina Zoledrónová Stada as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, oncology centres, pharmacies and clinics worldwide, conforming to EU quality standards and distributed globally.

Manufacturer / TM Owner

Stada Arzneimittel Ag

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Indications & Clinical Uses

Zoledronic Acid is a bisphosphonate that inhibits bone resorption, making it useful in several bone‑related conditions.

  • Osteoporosis: reduces risk of vertebral and hip fractures by decreasing bone turnover.
  • Paget's disease of bone: normalizes bone remodeling and alleviates pain.
  • Bone metastases: prevents skeletal‑related events and reduces bone pain in cancer patients.
  • Hypercalcemia of malignancy: lowers elevated serum calcium levels rapidly.

How It Works

  • Zoledronic Acid binds to hydroxyapatite crystals at sites of active bone remodeling. When osteoclasts attach to bone, the drug is internalized and inhibits the enzyme farnesyl pyrophosphate synthase, disrupting the mevalonate pathway. This impairs osteoclast prenylation, leading to reduced bone resorption and apoptosis of osteoclasts, thereby stabilizing bone density.

Side Effects

Zoledronic Acid may be associated with a range of adverse reactions, which are generally categorized by frequency and severity.

Common Side Effects

  • Flu‑like symptoms: fever, chills, muscle aches.
  • Nausea or vomiting.
  • Transient elevation of serum creatinine.
  • Headache.
  • Arthralgia or joint pain.
  • Injection site discomfort.

Serious or Rare Side Effects

  • Osteonecrosis of the jaw (ONJ).
  • Atypical femoral fractures.
  • Severe renal impairment or acute renal failure.
  • Hypocalcemia.
  • Severe hypersensitivity reactions (anaphylaxis, angioedema).

Precautions & Warnings

When using Zoledronic Acid, several precautions should be observed to minimize risks.

  • Renal function assessment: evaluate baseline creatinine clearance before infusion.
  • Calcium and vitamin D status: correct deficiencies prior to treatment.
  • Dental health: perform dental examination and treat existing infections before therapy.
  • Concomitant medications: avoid concurrent nephrotoxic drugs when possible.
  • Pregnancy and lactation: contraindicated unless benefits outweigh risks; limited data available.
  • Store at ambient temperature: keep in original container, protect from moisture and light.

Avoid Interactions

Zoledronic Acid can interact with other medicines, affecting safety or efficacy.

Major Interactions (Avoid)

  • Nephrotoxic agents (e.g., aminoglycosides, NSAIDs): increase risk of renal injury.
  • Concomitant bisphosphonates: additive bone toxicity.
  • Calcium or vitamin D supplements administered within 30 minutes of infusion: reduce drug absorption.

Moderate Interactions (Monitor Closely)

  • Loop diuretics: may exacerbate hypocalcemia.
  • Antacids containing aluminum or magnesium: may interfere with infusion tolerability.
  • Corticosteroids: may increase risk of osteonecrosis of the jaw.
  • Chemotherapy agents (e.g., cisplatin): monitor renal function closely.

Frequently Asked Questions

Kyselina Zoledrónová Stada contains zoledronic acid, a bisphosphonate indicated for the treatment of osteoporosis, Paget's disease of bone, bone metastases, and hypercalcemia of malignancy in adult patients. It works by reducing excessive bone resorption, thereby strengthening bone and lowering calcium levels when they are abnormally high.

Zoledronic acid binds to hydroxyapatite at sites of active bone remodeling. Osteoclasts that attach to bone internalize the drug, which then inhibits farnesyl pyrophosphate synthase in the mevalonate pathway. This blocks prenylation of essential proteins, leading to reduced osteoclast activity, apoptosis, and ultimately decreased bone resorption.

The dose of zoledronic acid is individualized by the prescribing clinician based on the specific indication, patient renal function, and other clinical considerations. No fixed regimen is provided here; the prescriber determines the appropriate amount and frequency for each patient.

Safety data for zoledronic acid in pregnancy and lactation are limited. It is generally contraindicated unless the potential therapeutic benefit outweighs the risk to the fetus or infant. Women of child‑bearing potential should use effective contraception during treatment and for a period after the last dose.

To order, submit an enquiry on the product page at gnhindia.com, specifying the required quantity. GNH India supplies hospitals, pharmacies and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, shipping details (including any cold‑chain needs) and the necessary import documentation.

Zoledronic acid is a third‑generation, highly potent bisphosphonate that can be given once yearly or at other extended intervals, unlike older agents such as alendronate or risedronate that often require weekly or monthly dosing. Its greater potency may increase the risk of renal effects and osteonecrosis of the jaw, so monitoring is essential.

The product should be stored at ambient temperature, below 25 °C, in its original container. It must be protected from moisture and light, and should never be frozen or exposed to extreme temperatures. Proper storage helps maintain drug stability and efficacy.

Zoledronic acid is administered as an intravenous infusion, typically over 15 minutes, under medical supervision. The exact infusion rate, volume, and dilution are determined by the prescriber and pharmacy preparation guidelines to ensure safe delivery.

Serious adverse events include osteonecrosis of the jaw, atypical femoral fractures, severe renal impairment or acute renal failure, acute hypocalcemia, and severe hypersensitivity reactions such as anaphylaxis. Patients should be monitored for these conditions throughout therapy, and any signs should prompt immediate medical evaluation.

Zoledronic acid should be avoided in patients with severe renal impairment (creatinine clearance <30 mL/min), known hypersensitivity to the drug, active dental infections or recent invasive dental procedures, and in pregnant or breastfeeding women unless a compelling indication exists. Clinicians must assess individual risk before prescribing.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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