Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2017 Publisher: Beacon Pharmaceuticals Limited, DCC Vital, Westminster Industrial Estate, Repton Road, Measham, DE12 7DT, England
Sodium clodronate is indicated for the management of osteolytic lesions, hypercalcaemia and bone pain associated with skeletal metastases in patients with carcinoma of the breast or multiple myeloma. Sodium clodronate capsules are also indicated for the maintenance of clinically acceptable serum calcium levels in patients with hypercalcaemia of malignancy initially treated with an intravenous infusion of sodium clodronate.
The recommended dose is 4 capsules (1600mg sodium clodronate) daily. If necessary, the dosage may be increased but should not exceed a maximum of 8 capsules (3200mg sodium clodronate) daily.
A daily dose of 1600 mg should be taken as a single dose. When higher daily doses are used, the part of the dose exceeding 1600 mg should be taken separately (as a second dose) as recommended below.
The single daily dose and the first dose of two should preferably be taken in the morning on an empty stomach together with a glass of water. The patient should then refrain from eating, drinking (other than plain water), and taking any other oral drugs for one hour.
When twice daily dosing is used, the first dose should be taken as recommended above. The second dose should be taken between meals, more than two hours after and one hour before eating, drinking (other than plain water), or taking any other oral drugs.
Clodronate should in no case be taken with milk, food or drugs containing calcium or other divalent cations because they impair the absorption of clodronate.
No special dosage recommendations. Clinical trials have included patients over 65 years and no adverse reactions specific to this age group have been reported.
Safety and efficacy in children has not been established.
Clodronate is eliminated mainly via the kidneys. Therefore, it should be used with caution in patients with renal failure; daily doses exceeding 1600mg should not be used continuously.
In patients with mild renal failure (50-80 ml/min) no dose reduction is recommended.
In patients with renal insufficiency with creatinine clearance between 10 and 30ml/min, the daily dose should be reduced to one half the recommended adult dose. Serum creatinine should be monitored during therapy. Sodium clodronate is contra-indicated in patients with creatinine clearance below 10ml/min
It is recommended that the clodronate dosage be reduced as follows:
| Degree of renal failure | Creatinine Clearance, ml/min | Dose |
|---|---|---|
| Mild | 50-80 ml/min | 1600 mg daily (no dose reduction recommended) |
| Moderate | 30-<50 ml/min | 1200 mg/daily |
| Severe | 10-30 ml/min | 800 mg/daily |
Adequate fluid intake should be maintained during treatment.
The oral bioavailability of bisphosphonates is poor. Bioequivalence studies have shown appreciable differences in bioavailability between different oral formulations of sodium clodronate, as well as marked inter and intra patient variability. Dose adjustment may be required if the formulation is changed.
Increases in serum creatinine and renal dysfunction have been reported with high intravenous doses of clodronate. It is theoretically possible that hypocalcaemia may develop up to 2 or 3 days following the overdose.
One case of acute renal failure and liver injury has been reported after accidental ingestion of 20,000 mg (50x400 mg) clodronate.
Management of overdose should be symptomatic. Adequate hydration should be ensured, and renal, hepatic function and serum calcium should be monitored. Serum calcium should be monitored and oral or parenteral calcium supplementation may be needed.
PVC/PVDC/aluminium blister packs: 3 years.
No special precautions for storage.
PVC/PVDC/aluminium Blister Packs containing 30, 60 or 120 capsules.
No special instructions.
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