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:
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