CLODRONIC ACID SANDOZ ® is a drug based on clodronic acid sodium salt.
THERAPEUTIC GROUP: Drugs affecting bone metabolism - BisphosphonatesIndicationsAction mechanismStudies and clinical effectiveness Usage and dosage instructionsWarnings Pregnancy and lactationInteractionsContraindicationsUndesirable effects
Indications CLODRONIC ACID SANDOZ ® - Clodronic acid
CLODRONIC ACID SANDOZ ® is mainly used in the treatment of neoplastic hypercalcaemia, primary hyperparathyroidism and bone lesions secondary to osteoporosis and neoplastic diseases.
Action mechanism CLODRONIC ACID SANDOZ ® - Clodronic acid
Clodronic acid is a bisphosphonate, used clinically in the prophylaxis and treatment of osteoporosis and associated osteolytic lesions.
Administered by parenteral route, it reaches the bone tissue where it is absorbed on hydroxyapatite crystals and subsequently bound mainly by osteoclastic cells.
Through molecular mechanisms that are not yet entirely clear, this active principle seems to inhibit the activity of these cells, blocking the processes of osteodeposition without interfering in any way with those of neo-deposition sustained by osteoblasts instead.
This balance of cellular activities takes the form of a significant improvement in bone mineral density and some biochemical parameters such as blood calcium concentrations and alkaline phosphatase.
Once its action is over, the clodronic acid is eliminated mainly through the urine.
Studies carried out and clinical efficacy
1. ANTITUMORAL PROPERTIES OF BIPHOSPHONATES
Experimental studies show how enzymatic precursors of bisphosphonates can present an important antitumor activity, thus contributing to the therapeutic resolution of cancer patients.
2. CLODRONATE AND TREATMENT OF OSTEOLITHIC LESIONS
Clinical case in which complete recovery of myeloma-induced osteolytic lesions was observed following clodronate administration.
3. COMPARATIVE THERAPEUTIC SCHEMES
Study that characterizes the metabolic bone effects of various clodronate therapeutic protocols. The identification of the correct therapeutic regime, such as to make the administration of this drug less burdensome, could be important from the point of view of therapeutic efficacy.
Method of use and dosage
SANDOZ ® CLODRONIC ACID
Solution for injection for intramuscular use of 100 mg clodronate disodium
Solution for injection for intravenous use of 300 mg clodronate disodium:
the treatment of neoplastic osteolysis and primary hyperparathyroidism generally involves a phase of intravenous attachment followed by a maintenance phase characterized by the intake of clodronic acid intramuscularly every 2-3 weeks.
The precise dosage and the relative dosing schedule depend on the clinical condition of the patient and on the treatment established by the specialist doctor.
Warnings SANDOZ ® CLODRONIC ACID - Clodronic acid
Clodronic acid treatment should be supervised by a specialist doctor both in the dosage definition phase and throughout the therapeutic process.
In light of the particular pharmacokinetic and pharmacodynamic properties, the administration of this active ingredient must be preceded and accompanied by the periodic evaluation of hepatic and renal function, and of the blood content of calcium, magnesium and phosphate, providing for immediate correction of the values or suspension. of therapy in case of significant alterations.
Contextual supplementation with Vitamin D and Calcium in patients undergoing treatment with clodronic acid and not affected by hypercalcemia, could be useful to safeguard the blood concentrations of this element and avoid the onset of pathological conditions such as tetany or paresthesia.
Treatment with bisphosphonates, especially when prolonged over time, could be associated with the increased risk of osteonecrosis of the jaw, thus becoming a potentially dangerous condition for any dental treatment.
PREGNANCY AND BREASTFEEDING
CLODRONIC ACID SANDOZ ® is contraindicated during pregnancy and lactation given the ability of the active ingredient to overcome the placental barrier and the breast filter, thus reaching both fetal and newborn circulation.
At the moment there are no studies able to define active ingredients whose contextual assumption could alter the pharmacokinetic and pharmacodynamic properties of clodronic acid.
Contraindications CLODRONIC ACID SANDOZ ® - Clodronic acid
CLODRONIC ACID SANDOZ ® is contraindicated in case of renal insufficiency and hypersensitivity to the active ingredient or to one of its excipients.
Undesirable effects - Side effects
Parenteral administration of clodronic acid has been associated with minor side effects such as nausea, diarrhea and allergic dermatological reactions.
The presence of local lesions and inflammations at the injection site may also appear following the intake of CLODRONIC ACID SANDOZ ® intramuscularly.
CLODRONIC ACID SANDOZ ® can be sold only under strict medical prescription.