Alendonate
Undesirable reactions from the upper gastrointestinal tract
Alendronate can cause local irritation of the mucous membrane of the upper gastrointestinal tract. In connection with the possibility of worsening "of the underlying disease during admission, alendronate, caution should be exercised in prescribing patients with diseases of the upper gastrointestinal tract, for example, in dysphagia, esophageal disease, gastritis, duodenitis, ulcers, and serious gastrointestinal disease, in previous 12 months, for example, peptic ulcer, gastrointestinal hemorrhage, surgical operation on the upper gastrointestinal tract, with the exception of pyroloplasty. For patients with a diagnosed Barrett's esophagus, the question of the appointment of alendronate should be decided on an individual basis by assessing the relationship between the expected benefit and the potential risk.
In the treatment of alendronate, there are cases of adverse reactions from the side of the esophagus (esophagitis, ulcer or erosion of the esophagus), sometimes occurring in severe form, requiring in-patient treatment, and in rare cases complicated by formation, stricture. In connection with this, doctors need to pay special attention to any signs or symptoms; indicating a possible violation of the esophagus,and patients should be warned about the need to stop taking alendronate and consult a doctor. if symptoms of irritation appear; esophagus such as dysphagia, swallowing pain or chest pain, the appearance or intensification of the IZHOGA.
The risk of severe adverse events on the side of the esophagus is higher in those patients who violate the recommendations for alendronate and / or continue to take it when symptoms of esophageal irritation appear. It is extremely important; Inform patients about the importance of compliance with the rules of taking the drug and make sure that they understand this. It should be warned that the risk of developing an esophageal lesion increases in the event of failure: these recommendations.
Although increased clinical trials of alendronate did not increase the risk, post-marketing reports reported rare cases of development. The stomach and duodenal ulcers, sometimes severe and complicated.
Osteonecrosis of the jaw
In patients with cancer, which were treated with intravenous administration, bisphosphonates, there were cases of osteonecrosis of the jaw, caused mainly by the previous extraction of the tooth and / or local infection (including osteomyelitis).Many of them also received chemotherapy and glucocorticosteroids.
There are also cases of osteonecrosis of the jaw in patients with osteoporosis when ingested bisphosphonates.
When assessing the individual risk of developing necrosis of the jaw, the following risk factors should be considered:
- the action strength of the bisphosphonate (highest in zoledronic acid), the route of administration (see above), and the total dose;
- cancer, chemotherapy, radiotherapy, glucocorticosteroids, smoking;
- dental disease in history, poor oral hygiene, periodontal disease, invasive dental procedures and poorly selected dentures.
Before starting oral bisphosphonate therapy, patients with unsatisfactory dental status are recommended to have a dental examination and preventive medical measures.
During the course of bisphosphonates, it is recommended that such patients avoid invasive dental procedures whenever possible. If a patient develops osteonecrosis during bisphosphonate therapy, surgical dental treatment may worsen his condition. It is not known whether the discontinuation of bisphosphonate treatment reduces the risk of osteonecrosis of the jaw in patients,which require dental procedures; AT . In each case, the decision should be made by the attending physician on the basis of an assessment of the relationship between the expected benefit and the possible risk for the individual patient.
During therapy with bisphosphonates, patients should be told the importance of proper oral hygiene, preventive examinations, and warn them about the need to report any symptoms from the oral cavity, such as mobility of the teeth, pain or swelling.
Pain in the bones and muscles
It is known about cases of pain in the bones, joints and / or muscles during the course of bisphosphonates. In rare cases, these symptoms were expressed and / or caused disability during post-marketing use. The time of onset of symptoms varied from one day to several months after the start of treatment. In most patients, symptoms were resolved after discontinuation of treatment. In some of them, the symptoms appeared again with the resumption of the same drug or other bisphosphonate.
Atypical Hip Fractures
It is known about cases of susceptible or diaphyseal fractures of the thigh during treatment with bisphosphonates, mainly in patients receiving long-term therapy for osteoporosis.These transverse or oblique fractures can occur along the entire length of the thigh from the small trochanter of the femur to the supracondylar expansion. These fractures occur after or without minor trauma, some patients experience severe pain in the thigh or inguinal region, which often combines with x-ray symptoms of stress fractures, weeks or months before the full picture of hip fracture appears. Fractures are often bilateral, so in patients with a hip fracture, taking bisphosphonates, the second (contralateral) thigh should be examined. It is known that these fractures are poorly fused. If an atypical hip fracture is suspected, consideration should be given to stopping bisphosphonate therapy before an individual assessment of the relationship between expected benefit and possible risk occurs.
During therapy with bisphosphonates, patients should be advised to report any pain in the thigh or in the groin. All patients who have received such complaints should be examined for fracture of the hip.
Renal insufficiency
The drug FOS AVANS® FORTE is contraindicated in patients with renal failure at a glomerular filtration rate of less than 35 ml / min.
Bone and mineral metabolism
Other causes of osteoporosis should be taken into account, in addition to estrogen deficiency and age.
In the presence of hypocalcemia, the concentration of calcium in the blood should be normalized before starting treatment with the drug FOSAVANS® FORTE.
Other disorders of mineral. exchange (for example, vitamin deficiency D and hypoparathyroidism) should also be effectively treated before starting treatment with the drug FOSAVANS® FORTE. Vitamin content D in the preparation FOSAVANS® FORTE is not enough to correct hypovitaminosis D. In patients with these disorders during treatment with the drug FOSAVANS FORTE it is necessary to monitor the concentration of calcium in the serum and the symptoms of hypocalcemia.
Since alendronate increases the mineral content in the bones, a decrease in the level of calcium and phosphate in the blood serum can be observed, especially when taking glucocorticosteroids that reduce calcium absorption. Usually, such a decrease is small and asymptomatic .. However, there are rare cases of symptomatic hypocalcemia, which sometimes reached a severe degree and 
developed in patients with a corresponding predisposition (eg, hypoparathyroidism, hypovitaminosis D and calcium malabsorption).
This medication contains lactose and sucrose. Patients with rare hereditary diseases of intolerance to fructose and galactose, lactase deficiency, glucose-galactose malabsorption and sugar-isomaltase deficiency should not take this medication.