Index of drugs

Treatment of postmenopausal osteoporosis. Alendronic acid reduces the risk of vertebral and hip fractures.

1 tabl contains 70 mg of alendronic acid in the form of a sodium trihydrate.

A drug from the bisphosphonate group. It inhibits bone resorption through osteoclasts, without directly affecting bone formation. It binds preferentially in places of active bone resorption. The activity of osteoclasts is inhibited, without affecting the recruitment or adherence of osteoclasts. The bone quality produced during treatment with alendronate is normal. The bioavailability of alendronate given orally (after a night break in meals, 2 hours before breakfast) is 0.64%, and if the drug is used with a meal or up to 2 hours after it - it approaches zero. Plasma protein binding is approximately 78%. The drug is not metabolised. T_0,5 is about 10 years, due to its slow release from the bones. It is mainly excreted in the urine.

Hypersensitivity to alendronate or any of the excipients. Abnormalities in the construction of the esophagus and other factors delaying the emptying of the esophagus, such as stricture or achalasia. Inability to stand or sit straight for at least 30 minutes. Hypocalcaemia.

The preparation may cause local irritation of the mucous membrane of the upper gastrointestinal tract. Because there is a risk of worsening the course of the underlying disease, caution should be exercised in patients with current upper gastrointestinal problems such as dysphagia, esophageal disease, gastritis, duodenitis, ulcerations, or recent (last year) serious history of gastrointestinal disease, such as peptic ulcer disease and / or duodenum or active gastrointestinal bleeding or surgery in the upper gastrointestinal tract with the exception of pyloric flow. In patients with diagnosed Barrett's esophagus, the benefits and potential risks of alendronate should be considered. Patients should be monitored for adverse reactions in the esophagus and advised to stop treatment and consult a physician if signs of irritation in the esophagus occur, such as difficulty in swallowing, pain during swallowing, retrosternal pain, or worsening of heartburn. During treatment with bisphosphonates there is a risk of osteonecrosis of the jaw. When assessing this risk in individual patients, the following risk factors should be considered: the potency of the bisphosphonate drug (the highest in the case of zoledronic acid), the route of administration and the cumulative dose; cancer, chemotherapy, radiotherapy, taking corticosteroids, smoking; oral and dental diseases, improper oral hygiene, periodontal disease, invasive dental procedures and ill-fitting dental prostheses. Before oral oral treatment with bisphosphonates, a dental examination with appropriate preventive measures should be considered in patients with poor dental condition. During treatment, patients should avoid invasive dental procedures whenever possible. Patients with osteonecrosis of the jaw during bisphosphonate treatment may have exacerbated dental surgery. For patients requiring dental procedures, there is no data to indicate whether discontinuation of bisphosphonate therapy reduces the risk of osteonecrosis of the jaw. The treatment plan for each patient should depend on an individual physician's assessment based on an assessment of the benefit-risk ratio. Patients should be encouraged to maintain good oral hygiene, report to the dentist for routine reviews, and report any oral symptoms such as a moving tooth, pain or swelling. Pain in bones, joints and / or muscles was observed, these symptoms were rarely severe and / or causing disability. The first symptoms may occur on the first day of treatment and (or) many months after the start of treatment.In the majority of patients, symptoms disappeared after discontinuation of therapy. Relapse of symptoms occurred in some patients after re-admission of the same drug or after the use of another bisphosphonate. 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. It is recommended to discontinue bisphosphonates in patients with fractures from overload until the patient is evaluated, based on an individual assessment of the benefit / risk ratio. During treatment with bisphosphonates, patients should be instructed to report any case of thigh, hip or groin pain; patients with such symptoms should be examined for incomplete fracture of the femur. Alendronate should not be used in patients with renal failure with GFR <35 ml / min. Other causes of osteoporosis should be considered in addition to estrogen deficiency and age. Hypocalcaemia should be corrected before starting treatment with alendronate. Other disorders of mineral management (eg vitamin D deficiency and hypoparathyroidism) should be effectively treated. In patients with such disorders, serum Calcium and hypocalcemia should be monitored during treatment with the preparation. Due to the positive effect of alendronate on bone mineral density, a generally low and asymptomatic decrease in serum calcium and phosphate may occur during treatment, especially in patients treated with glucocorticosteroids, in whom calcium absorption may be reduced. Symptomatic hypocalcaemia, sometimes severe, has also been reported, often in patients with predisposing disorders (eg hypoparathyroidism, vitamin D deficiency and calcium absorption disorder). Therefore, it is particularly important to ensure sufficient intake of calcium and vitamin D, especially in patients taking glucocorticoids. It must not be used in children under 18 years of age as there are no data available on the safety and efficacy of osteoporosis in children. Alendronic acid 70 mg once a week was not evaluated for the treatment of glucocorticoid-induced osteoporosis.

Do not use during pregnancy and breast-feeding.

Very common: musculoskeletal pain (sometimes with acute course). Common: pain and dizziness, abdominal pain, dyspepsia, constipation, diarrhea, flatulence, oesophageal ulceration, dysphagia, acid content regurgitation, alopecia, pruritus, joint swelling, weakness, peripheral edema. Uncommon: disorders of taste, inflammation of the eye (uveitis, sclera, episcleritis), nausea, vomiting, gastritis, oesophagitis, oesophageal erosions, tarry stools, rash, erythema, transient symptoms as in the acute phase reaction ( muscle pain, malaise and rare fever), usually in the initial phase of treatment. Rare: hypersensitivity reactions (including urticaria, angioneurotic edema), symptomatic hypocalcaemia (often with predisposing factors), esophageal stricture, mouth and throat mucosa, ulceration or upper gastrointestinal bleeding, rash with hypersensitivity to light, acute reactions dermatoses (including Stevens-Johnson syndrome and toxic epidermal necrolysis), osteonecrosis of the jaw, fractures from congestion of the proximal femoral shaft.

Orally. Adults: 70 mg once a week. If you miss a dose, you should take the missed tablet in the morning as soon as you remember. Do not take 2 tables. on the same day, but again accept 1 tabl. once a week, on a selected date according to the previous schedule. No dosage adjustment is necessary for patients with impaired renal function with GFR> 35 ml / min or in the elderly. The optimal treatment time has not been established.The need for continued treatment for each patient should be periodically assessed based on the benefits and potential risks associated with the use of the preparation, especially after 5 years of therapy. Patients should additionally take supplements containing calcium and vitamin D if their supply in the diet is insufficient. The preparation is taken in the morning (immediately after getting up), at least 30 minutes before the first meal, drink or other medicine, with a full glass (not less than 200 ml) of ordinary water. After swallowing, do not lie down until the first meal. The tablets should be swallowed whole. They should not be crushed, chewed or allowed to dissolve in the mouth. Do not use before bedtime and before getting up from the bed.