Index of drugs

Treatment of severe osteoporosis in postmenopausal women and adult men. The preparation is intended for use in patients at high risk of fractures in which treatment with other medicines approved for the treatment of osteoporosis is not possible, eg due to contraindications or intolerance. In post-menopausal women, strontium ranelate reduces the risk of vertebral and hip fractures. The decision to prescribe strontium ranelate should be based on an assessment of the overall risk for an individual patient.

1 sachet contains 2 g of strontium ranelate. The drug contains aspartame.

The drug restores bone turnover balance in favor of the bone reconstruction process. It increases the replication of osteoblast precursors, collagen synthesis and bone reconstruction in bone cell cultures and reduces bone resorption by reducing osteoclast differentiation and reducing their resorptive activity. The bioavailability of strontium ranelate is approximately 25%. C_max is achieved after 3-5 h after a single dose of 2 g. The supply of strontium ranelate with Calcium or food reduces its bioavailability by about 60-70% compared with the use of 3 h after a meal. Steady state is achieved after 2 weeks of treatment. Plasma protein binding is 25%. Strontium has a high affinity for bone tissue. It is not metabolized. T_0,5 in the elimination phase, it is about 60 hours. Strontium is excreted in urine and faeces.

Hypersensitivity to strontium ranelate or any of the excipients. Active or traveled venous thromboembolism (VTE), including deep vein thrombosis and pulmonary embolism. Temporary or permanent immobilization of the patient caused by, for example, convalescence after a surgery or prolonged patient staying in a supine position. Active or in history of diagnosed ischemic heart disease, peripheral artery disease and / or cerebrovascular disease. Uncontrolled hypertension.

It is not recommended for patients with severe renal insufficiency (creatinine clearance <30 ml / min). Periodic studies should be performed to assess renal function in patients with chronic disability. The possibility of continuing treatment with the preparation in patients who have experienced severe renal impairment should be considered individually. Use with caution in patients at risk of venous thromboembolism (VTE). When treating patients> 80 years with VTE risk, the need to continue treatment with the preparation should be re-evaluated. Use of the drug should be discontinued as soon as possible in case of illness or condition leading to immobilization of the patient and appropriate preventive measures should be taken. Therapy should not be restarted until this condition is resolved and the patient is fully started. If VTE occurs, the medicine should be discontinued. Patients should be informed about signs and symptoms and careful monitoring of skin reactions. The highest risk of Stevens-Johnson syndrome (SJS) or toxic epidermal necrolysis (TEN) occurs in the first weeks of treatment, and drug eruption with eosinophilia and general symptoms (DRESS) usually after about 3-6 weeks. If symptoms of SJS occur, TEN or DRESS, treatment should be stopped immediately. If you have had SJS, TEN or DRESS after taking the medicine, you must not restart the treatment with this patient. A higher incidence of hypersensitivity reactions, including rash, SJS or TEN, although still rare, has been reported in Asian patients. In most cases, after discontinuation of the preparation and initiation of corticosteroid therapy if necessary, the prognosis for DRESS is successful. It has been reported that recovery has been slow, and in some cases, after discontinuation of corticosteroid therapy, the team has been converting. In pooled randomized placebo-controlled trials in postmenopausal women with osteoporosis, a significantly increased incidence of myocardial infarction was observed in the patients treated with the formulation compared to patients treated with placebo.Before starting treatment and at regular intervals during therapy (generally every 6-12 months), patients should be evaluated for cardiovascular risk. Patients with significant risk factors for cardiovascular events (eg hypertension, hyperlipidemia, diabetes, smoking) should be treated with strontium ranelate only after careful consideration. Treatment should be discontinued if the patient has ischemic heart disease, peripheral arterial disease, cerebrovascular disease or if hypertension can not be controlled. The safety and efficacy of the medicine in children below 18 years have not been established. The drug contains aspartame, a source of phenylalanine, which may be harmful for people with phenylketonuria.

There are no data on the use of strontium ranelate in pregnant women. The drug should be discontinued if it was accidentally taken during pregnancy. Strontium ranelate is excreted in milk. The drug should not be used during breast-feeding.

Very common: skin hypersensitivity reactions (rash, pruritus, urticaria, angioneurotic edema), musculoskeletal pain (muscle spasm, muscle and bone pain, pain in the joints and limbs). Common: hypercholesterolemia, insomnia, headache and dizziness, impaired consciousness, memory loss, paresthesia, nausea, diarrhea, loose stools, vomiting, abdominal pain, stomach and intestinal pain, gastro-intestinal reflux, dyspepsia, constipation, flatulence, eczema, venous thromboembolism, elevation of creatine phosphokinase in the blood, myocardial infarction, bronchial hyperreactivity, hepatitis, peripheral edema. Uncommon: generalized enlargement of lymph nodes (in connection with cutaneous hypersensitivity reactions), confusion, seizures, inflammation and / or oral ulceration, dry mouth, increased serum aminotranferase activity (in combination with cutaneous hypersensitivity reactions), dermatitis, alopecia, fever (in combination with cutaneous hypersensitivity reactions), malaise. Rare: bone marrow failure, eosinophilia (in combination with cutaneous hypersensitivity reactions), drug erosion with eosinophilia and general symptoms (DRESS). Very rare: severe cutaneous adverse reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis).

Treatment should only be started by a doctor who has experience in the treatment of osteoporosis. Orally. Adults: 1 sachet (2 g) once a day. The drug should be used in the evening, at bedtime, at least 2 h after a meal. No dosage adjustment is required based on age, in patients with mild or moderate renal impairment (creatinine clearance 30-70 ml / min) and in patients with impaired hepatic function. The granules must be taken as a suspension in a glass containing at least 30 ml of water (approximately 1/3 of the standard glass). The suspension should be drunk immediately after preparation. Strontium ranelate is intended for long-term treatment. Patients should receive vitamin D and calcium supplements if its supply in the diet is insufficient.