Clinical Pharmacology Details


Strontium Ranelate


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Indications & Dose:

Postmenopausal osteoporosis to reduce the risk of vertebral and hip fractures.


DOSAGE: 



2 g sachet once daily by oral administration, administered in-between meals, at bedtime, preferably at least two hours after eating in a glass of water.


Use in the elderly: No dosage adjustment is required in relation to age.


Use in renal impairment: No dosage adjustment is required in patients with mild-to-moderate renal impairment (30-70 ml/min creatinine clearance). Strontium ranelate is not recommended for patients with severe renal impairment (creatinine clearance below 30 ml/min).


Use in hepatic impairment: As strontium ranelate is not metabolised, no dosage adjustment is required in patients with hepatic impairment.


Use in children and adolescents: Not recommended for use in children and adolescents. 

Contraindications:

Hypersensitivity to the active substance or to any of the excipients. 

Side Effects:

Nervous system disorders


 Common: headache (3.3% vs, 2.7%)


Gastrointestinal disorders


Common: nausea (7,1% vs. 4.6%), diarrhoea (7,0% vs, 5.0%), loose stools (1,0% vs. 0.2%)


Skin and subcutaneous tissue disorders
Common: dermatitis (2.3% vs, 2,0%), eczema (1.8% vs. 1.4%)


Gastrointestinal disorders


Frequency unknown: vomiting, abdominal pain, oral mucosal irritation including stomatitis and/or mouth ulceration


Skin and subcutaneous tissue disorders


Frequency unknown: hypersensitivity skin reactions including rash, pruritus, urticaria, angioedema, Stevens-Johnson syndrome. Cases of severe hypersensitivity syndromes including drug rash with eosinophilia and systemic symptoms (DRESS).


Musculoskeletal and connective tissue disorders


Frequency unknown: musculoskeletal pain including muscle spasm, myalgia, bone pain, arthralgia and pain in extremity. 

Cautions:

Precautions:

Interaction:

Warnings:

Adverse Effects:

Lactations:

Pregnancy risk factor B, not used in breast feeding woman. 

Special Precautions:

Counselling:

Side Effects Or Adverse Reactions:

Patient And Carer Advice: