Index of drugs

Treatment of osteoporosis in postmenopausal women to reduce the risk of vertebral fractures. Treatment of diagnosed osteoporosis in postmenopausal women to reduce the risk of femoral fractures. Treatment of osteoporosis in men at high risk of fractures.

1 tabl powl. contains 35 mg of risedronate sodium (equivalent to 32.5 mg of risedronic acid). The drug contains lactose.

A drug from the bisphosphonate group (pyridinyl bisphosphonate). It binds to bone hydroxyapatite and inhibits bone resorption through osteoclasts, while osteoblast activity and bone mineralization are preserved. Sodium risedronate in a dose-dependent manner increases bone mass and improves the biomechanical endurance of the skeleton. In postmenopausal women with osteoporosis, the reduction of biochemical markers of bone transformation occurs after 1 month, and the maximum effect after 3-6 months of treatment. In men with osteoporosis, an analogous decrease in the concentration of biochemical markers of bone transformation was observed at the earliest after 3 months and continued after 24 months. After oral administration, the absorption occurs relatively quickly (T_maxafter about 1 hour) and is independent of the dose. The average bioavailability after oral administration is 0.63% and decreases when risedronate sodium is administered with food. Plasma protein binding is 24%. There is no evidence of systemic risedronate sodium metabolism. Approx. half of the absorbed dose is excreted in the urine within the first 24 hours and about 85% of the intravenous dose is detected in the urine after 28 days. The unabsorbed sodium risedronate is eliminated unchanged with faeces. After oral administration, the time-concentration curve shows three excretion phases with T_0,5 in the final phase of elimination of 480 h.

Hypersensitivity to the active substance or to any of the excipients. Hypocalcaemia. Pregnancy and lactation. Severe renal impairment (creatinine clearance <30 ml / min).

Food, drinks (other than ordinary water) and medicines containing multivalent cations (such as Calcium, Magnesium, iron and aluminum) affect the absorption of bisphosphonates and should not be taken at the same time as the preparation. The efficacy of bisphosphonates in the treatment of osteoporosis is associated with low bone mineral density and / or fractures. Older age or the occurrence of only clinical fracture risk factors can not be the basis for initiating osteoporosis treatment with a bisphosphonate. Data confirming the efficacy of bisphosphonates, including risedronate, in very elderly patients (> 80 years) are limited. The use of bisphosphonates was associated with the occurrence of esophagitis, gastritis, ulceration of the mucous membrane of the esophagus and the stomach and duodenum. Therefore, caution should be exercised: in patients with oesophageal dysfunction that causes a history of a history of delayed passage of the esophagus, such as esophageal stricture or achalasia; patients who are unable to maintain their upright position for at least 30 minutes after taking the tablet; if risedronate is administered to patients with active or recently-experienced abnormalities of the esophagus or the upper gastrointestinal tract (including patients diagnosed with Barrett's esophagus). Particular attention should be paid to compliance with the dosing instructions. Patients should be instructed to seek medical attention if symptoms of irritation in the esophagus occur such as difficulty swallowing, swallowing pain, retrosternal pain, or worsening of heartburn. Hypocalcemia should be treated before starting treatment. Other disorders of bone metabolism and mineral metabolism (eg parathyroid dysfunction, vitamin D deficiency) should be treated during the start of treatment with the preparation. Due to the risk of osteonecrosis of the jaw before treatment with bisphosphonates in patients with concomitant risk factors (e.g.cancer, chemotherapy, radiotherapy, corticosteroids, and incorrect oral hygiene), a dental examination with appropriate dental prophylaxis should be considered. If possible, patients should avoid invasive dental procedures during treatment. Patients who develop osteonecrosis of the jaw while on bisphosphonate therapy may have a worsening condition. For patients requiring dental surgery, no data are available to suggest whether discontinuation of bisphosphonate therapy reduces the risk of osteonecrosis of the jaw. Clinician's clinical assessment should be the basis for establishing a treatment regimen for each patient, based on an individual benefit-risk assessment. There have been reports of atypical subtrochanteric fractures and femoral shaft in persons using bisphosphonates, mainly in patients who have been treated for a long time due to osteoporosis. This type of fracture occurs after minimal injury or without injury, and some patients experience thigh pain or groin pain. In imaging examinations, the features of fractures from overload are often visible for a few weeks or months before a complete fracture of the femur. Fractures often occur on both sides, therefore, in patients with bisphosphonates treated with a fracture of the femoral shaft, the femoral bone should be examined in the other limb. Poor healing of these fractures has also been reported. Based on an individual benefit / risk assessment for patients suspected of an atypical hip fracture, discontinuation of bisphosphonates should be considered pending evaluation. Patients should be advised to report any pain in the thigh, hip, or groin area during treatment with bisphosphonates, and any patient reporting such symptoms should be screened for incomplete fracture of the thigh bone. Due to insufficient data on safety and efficacy, risedronate is not recommended for children and adolescents under 18 years of age. The product contains lactose - should not be used in patients with rare hereditary problems of galactose intolerance, lactase deficiency (Lapp type) or malabsorption syndrome glucose-galactose.

The drug should not be used in women during pregnancy and breastfeeding.

Common: headache, constipation, indigestion, nausea, abdominal pain, diarrhea, musculoskeletal pain. Uncommon: iritis, gastritis, esophagitis, difficult swallowing, duodenitis, esophageal ulceration. Rare: tongue inflammation, esophageal stenosis, abnormal liver function tests. In men with osteoporosis, side effects were similar to those seen in studies involving women. Some patients have early, transient, asymptomatic and mild reductions in serum Calcium and phosphate at the beginning of treatment. After placing the medicine on the market - frequency unknown: iritis, uveitis, osteonecrosis of the jaw, hypersensitivity and skin reactions (including angioneurotic edema, generalized rash, urticaria and bullous skin reactions, sometimes severe, including isolated cases of Stevens syndrome - Johnson, toxic epidermal necrolysis and leukocytoclastic vasculitis), hair loss, anaphylactic reaction, severe hepatic disorders (in most cases reported, patients were also treated with other drugs causing liver disorders); rare: unusual subtrochanteric fracture and femoral shaft (an adverse reaction in the bisphosphonate group).

Orally. Adults: the recommended dose is 1 tablet. 35 mg once a week. The tablet should be taken on the same day each week. To ensure proper absorption, patients should take the preparation: before breakfast - at least 30 minutes before the first meal, other medicine or drink (other than water) on a given day. If the dose is omitted, take 1 tablet. on the day when the patient remembers it. Patients should then return to accepting 1 tabl. once a week, the day they usually received it. Do not take 2 tables. same day. The tablet should be swallowed whole, it should not be sucked or chewed.To help the tablet reach the stomach, the tablet should be taken upright with a glass of plain water (≥120 ml). Patients should not lie down for 30 minutes after taking the tablets. In the case of insufficient supply of calcium and vitamin D in the diet, consideration should be given to taking appropriate supplements. No dose adjustment is necessary in the elderly or in patients with mild to moderate renal impairment. The optimal duration of bisphosphonates in the treatment of osteoporosis has not been established. The benefits and potential risks of using the medicine and the need for further treatment for each patient should be evaluated regularly, especially after 5 years from the start of therapy.