Postmenopausal osteoporosis to reduce the risk of vertebral and hip fractures. Treatment of osteoporosis in men at increased risk of fracture.
1 sachet diluted in half a glass of water taken once daily.
|||Method of administration: For oral use.
The granules in the sachets must be taken as a suspension in a glass containing a minimum of 30 ml [approximately one third of a standard glass] of water.
Although in-use studies have demonstrated that strontium ranelate is stable in suspension for 24 hours after preparation, the suspension should be drunk immediately after being prepared.
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It increases bone formation in bone tissue culture as well as osteoblast precursor replication and collagen synthesis in bone cell culture; and reduces bone resorption by decreas- ing osteoclast differentiation and resorbing activity.
Not recommended in patients with a creatinine clearance below 30ml/min due to lack of data. Use with caution in patients at increased risk of venous thromboembolism (VTE) including patients with a history of VTE. Use inductively coupled plasma atomic emission spectrometry or an atomic absorption spectrometry method to assess blood and urinary calcium concentrations as strontium interferes with colorimetric methods. In case of hypersensitivity induced cutaneous manifestations therapy should be stopped immediately and not re-started. Use with caution in patients with phenylketonuria, as it contains phenylalanine.
Hypersensitivity to the active substance or to any of the excipients; patients with current VTE or a history of VTE, as well as patients who are temporarily or permanently immobilised.
Nausea, diarrhoea, loose stools, headache, dermatitis, eczema, memory loss, seizures.Skin reactions: Life-threatening cutaneous reactions such as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) and drug rash with eosinophilia and systemic symptoms (DRESS) have been reported with the use of Strontium Ranelate.Patients should be advised of the signs and symptoms and monitored closely for skin reactions. The highest risk for occurrence of SJS or TEN is within the first weeks of treatment and usually around 3-6 weeks for DRESS. If symptoms or signs of SJS or TEN (e.g. progressive skin rash often with blisters or mucosal lesions) or DRESS (e.g. rash, fever, eosinophilia and systemic involvement (e.g. adenopathy, hepatitis, interstitial nephropathy, interstitial lung disease) are present, Strontium Ranelate treatment should be discontinued immediately.The best results in managing SJS, TEN or DRESS come from early diagnosis and immediate discontinuation of any suspect drug. Early withdrawal is associated with a better prognosis. The outcome of DRESS is favorable in most cases upon discontinuation of Strontium Ranelate and after initiation of corticosteroid therapy when necessary. Recovery could be slow and recurrences of the syndrome have been reported in some cases after discontinuation of corticosteroid therapy.If the patient has developed SJS, TEN or DRESS with the use of Strontium Ranelate, the drug must not be re-started in this patient at any time.
||| Drug interactions: Food, milk & derivatives, Ca- containing drugs, antacids, oral tetracyclines, quinolone antibiotics.
||| The absorption of strontium ranelate is reduced by food, milk and derivative products and therefore, it should be administered in-between meals. Given the slow absorp- tion, strontium ranelate should be taken at bedtime, preferably at least two hours after eating. Patients treated with strontium ranelate should receive vitamin D and calcium supplements if dietary intake is inadequate