Index of drugs

Treatment of osteoporosis in postmenopausal women with an increased risk of fractures. A reduction in the risk of vertebral fractures has been demonstrated; effectiveness in preventing femoral neck fractures has not been determined.

1 tabl powl. contains 150 mg of ibandronic acid (and 88.60 mg of lactose).

A drug from the bisphosphonate group. It acts selectively on the bone tissue, selectively inhibiting osteoclast activity without directly affecting the bone synthesis process. It does not affect the mobilization of osteoclasts. In postmenopausal women, ibandronic acid results in a stronger bone mass structure and reduced fracture rate by inhibiting bone turnover to pre-menopausal levels. The primary pharmacological action of ibandronic acid on bone is not directly related to the actual concentration of the drug in the blood. Ibandronic acid is quickly absorbed from the digestive tract. Bioavailability on an empty stomach is about 0.6%. Food and drinks (other than water) significantly reduce the absorption of the drug. In 85-87% it is bound to plasma proteins. Ibandronic acid is rapidly bound by bones. The remaining part of the absorbed dose is excreted unchanged in the urine, while the unabsorbed part of the dose - with faeces (also unchanged). T_0,5 in the elimination phase is 10-72 h.

Hypersensitivity to ibandronic acid or to any of the excipients. Hypocalcaemia. An abnormality in the esophagus leading to a delay in its emptying, such as narrowing or contraction of the lower esophagus. Inability to maintain standing or sitting position for at least 60 minutes.

Do not use in patients with creatinine clearance <30 ml / min. Use with caution in patients with active disease of the upper gastrointestinal tract (eg Barret's esophagus, dysphagia, other esophageal diseases, gastritis, duodenitis or ulcer), as well as in patients taking NSAIDs at the same time (increased risk of irritation of the gastrointestinal tract). Patients who use bisphosphonates should understandably receive all the recommendations regarding the proper administration of the drug. The drug should be discontinued if dysphagia, diarrhea, retrosternal pain, heartburn or aggravation or other symptoms suggestive of irritation of the esophagus occur. Osteonecrosis of the jaw has been reported in patients with osteoporosis receiving bisphosphonates. The occurrence of this side effect is generally associated with tooth extraction or local infection (including osteomyelitis). In patients with concomitant risk factors (eg cancer, chemotherapy, radiotherapy, use of corticosteroids, improper oral hygiene, periodontal disease) before commencing treatment with bisphosphonates, a dental examination and appropriate prophylaxis should be considered. In this group of patients, if possible, invasive dental procedures should be avoided. Dental surgical interventions may cause deterioration in patients with osteonecrosis of the jaw treated with bisphosphonates. There are no data suggesting whether termination of bisphosphonate therapy reduces the risk of osteonecrosis of the jaw. The management of each patient should be based on a clinical judgment based on an individual assessment of the benefit / risk ratio. Cases of atypical trochanteric fractures and femoral shafts have been reported in people using bisphosphonates (mainly in patients who have been on long-term treatment for osteoporosis), therefore patients treated with the product should be monitored for signs such as thigh, hip or groin, and if Symptoms, the patient should be examined for the presence of incomplete fracture of the femur. Fractures often occur on both sides, so if you find a fracture of the femoral shaft, examine the femur 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. Before starting treatment with ibandronic acid, hypocalcemia should be corrected and other mineral disorders disturbed (eg vitamin D deficiency, hypoparathyroidism). It is important to ensure adequate supply of Calcium and vitamin D. Due to the lactose content, the drug should not be used in patients with rare hereditary galactose intolerance, Lapp lactase deficiency or malabsorption of glucose-galactose.

Do not use during pregnancy and breast-feeding.

Common: headache, esophagitis, gastritis, gastro-oesophageal reflux, dyspepsia, diarrhea, abdominal pain, nausea, rash, joint pain, muscle pain, musculoskeletal pain, muscle spasms, musculoskeletal stiffness, flu-like symptoms. Uncommon: dizziness, ulcer and esophageal stricture, dysphagia, vomiting, flatulence, back pain, fatigue. Rarely: hypersensitivity reactions, inflammation of the eye (uveitis, episcleritis and scleritis), duodenitis, angioedema, facial edema, urticaria, unusual subtrochanteric fracture and femoral shaft. Very rare: anaphylactic reaction, shock, osteonecrosis of the jaw.

Orally. Adults: 150 mg (1 tabl.) Once a month (on the same day each month). If you forget to take a dose, take 1 tablet. Next morning, if more than 7 days have been left until the next scheduled dose; then return to taking the medicine once a month according to the current dosing schedule. If you have less than 7 days to the next scheduled dose, wait for the next dose and continue to take 1 tablet. once a month according to the previous scheme. Do not take 2 tablets in the same week. The optimal duration of bisphosphonate therapy has not been established. The need for further treatment should be periodically assessed in each patient individually, especially after 5 years of therapy. Patients should receive calcium supplementation and / or vitamin D if their content in the diet is insufficient.Special groups of patients. In patients with mild or moderate renal impairment (CCr> 30 ml / min), no dose adjustment is necessary; do not use the drug in patients with CCr <30 ml / min. In patients with liver dysfunction or in the elderly, dose adjustment is not required. There are no indications to use the drug in patients <18 years.Way of giving. The drug should be taken after an overnight fast (at least 6 hours from the last meal), 1 hour before the first meal or drink (other than water) on a given day or any other oral medicine or supplement (including calcium). Tablets should be swallowed whole with a glass of water (180-240 ml), upright (sitting or standing). Do not use water with high calcium content. If there is a concern that there is a high concentration of calcium in tap water (so-called hard water), it is recommended to use water with a low content of mineral salts. Water is the only drink that should be taken with the medicine. After taking the drug, do not take a lying position for 1 hour. Do not chew or suck tablets because of the potential risk of mouth ulcers and sores.