GNH USA

Europe — EMA

Madras

Clodronate Disodium and Lidocaine Hydrochloride, the active ingredients in Madras, are a bisphosphonate and a local anesthetic presented as an injection for intramuscular use. They treat osteoporosis, Paget disease of b…

Clodronate Disodium, Lidocaine Hydrochloride

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What is Clodronate Disodium, Lidocaine Hydrochloride?

Clodronate Disodium and Lidocaine Hydrochloride, the active ingredients in Madras, are a bisphosphonate and a local anesthetic presented as an injection for intramuscular use. They treat osteoporosis, Paget disease of bone, bone metastases, and provide rapid local pain relief through intramuscular anesthesia in adult patients.

GNH USA supplies Madras as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, oncology centres, clinics and pharmacies worldwide, adhering to rigorous quality standards and regulatory requirements. The product is manufactured according to EU GMP standards.

What is Clodronate Disodium, Lidocaine Hydrochloride used for?

Madras combines a bisphosphonate and a local anesthetic to address bone‑related disorders and provide intramuscular analgesia.

- Osteoporosis: reduces osteoclast‑mediated bone resorption, helping maintain bone density. - Paget disease of bone: normalizes abnormal bone remodeling and alleviates associated pain. - Bone metastases: limits skeletal complications and provides local pain control. - Local bone pain: delivers rapid analgesia through lidocaine‑mediated nerve blockade.

What are the side effects of Clodronate Disodium, Lidocaine Hydrochloride?

Madras may cause a range of adverse reactions, varying from mild to severe.

Common Side Effects: - Injection site pain: mild to moderate discomfort at the administration site. - Erythema or swelling: localized redness or edema. - Nausea: transient feeling of queasiness. - Dizziness: brief episodes of light‑headedness. - Headache: mild to moderate tension‑type headache. - Flushing: temporary warmth or reddening of the skin.

Serious or Rare Side Effects: - Anaphylaxis: severe allergic reaction with airway compromise. - Hypocalcemia: significant drop in serum calcium levels. - Renal impairment: acute kidney injury or worsening of pre‑existing renal disease. - Cardiac arrhythmia: irregular heart rhythm potentially linked to lidocaine toxicity. - Severe hypotension: marked drop in blood pressure requiring intervention. - Osteonecrosis of the jaw: rare bone necrosis associated with bisphosphonate exposure.

What precautions apply to Clodronate Disodium, Lidocaine Hydrochloride?

Before prescribing Madras, clinicians should evaluate patient-specific factors and follow these precautions.

- Renal function: assess baseline kidney function and adjust use in severe impairment. - Calcium levels: correct hypocalcemia prior to initiating therapy. - Pregnancy: avoid unless the potential benefit justifies the risk to the fetus. - Concomitant bisphosphonates: do not use with other bisphosphonate agents to prevent excess exposure. - Allergy: contraindicated in patients with known hypersensitivity to clodronate or lidocaine. - Store at 2-8°C: keep refrigerated, protect from light, do not freeze or shake.

What does Clodronate Disodium, Lidocaine Hydrochloride interact with?

Madras can interact with other medicines; awareness of major and moderate interactions helps ensure safe use.

Major Interactions (Avoid): - Concurrent bisphosphonates: additive inhibition of bone resorption may increase toxicity. - Nephrotoxic drugs (e.g., aminoglycosides, amphotericin B): heightened risk of renal injury. - Strong CYP450 inhibitors (e.g., ketoconazole, erythromycin): may raise lidocaine plasma concentrations.

Moderate Interactions (Monitor Closely): - NSAIDs: may further compromise renal function when combined.

Information provided on this page is for educational use by procurement and clinical professionals. Always consult a licensed healthcare provider for medical advice and prescribing decisions. GNH USA supplies this product subject to applicable regulatory and licensing requirements.

Product details

Drug
Clodronate Disodium, Lidocaine Hydrochloride
Route
Intramuscular Use
Manufacturer
S.F. Group Srl
Origin
EU

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