Bonviva pills 150mg №1

Packaging

1 PC.

Mechanism of action

Bonviva has an inhibitory bone resorption effect. Ibandronic acid is a highly active nitrogen-containing bisphosphonate, an inhibitor of bone resorption and osteoclast activity. Ibandronic acid prevents bone destruction caused by blockade of the function of the sex glands, retinoids, tumors and extracts of tumors in vivo. Ibandronic acid does not violate the mineralization of bone tissue when prescribed in therapeutic doses for the treatment of osteoporosis and does not affect the process of replenishing the osteoclast pool. The selective effect of ibandronic acid on bone tissue is due to its high affinity for hydroxyapatite, which constitutes the mineral matrix of bone. Ibandronic acid inhibits bone resorption in a dose-dependent manner and does not directly affect the formation of bone tissue. In women in menopause, it decreases the increased rate of bone tissue renewal to the level of reproductive age, which leads to a general progressive increase in bone mass, a decrease in bone collagen splitting (concentration of deoxypyridinoline and cross-linked C- and N-telopeptides of type I collagen) in urine and blood serum, fracture rates and an increase in bone mineral density (BMD).High activity and a wide therapeutic range provide the possibility of a flexible dosing regimen and an intermittent administration of a drug with a long period of no treatment at relatively low doses.

Indications and usage

Postmenopausal osteoporosis to prevent fractures.

Contraindications

Hypersensitivity to ibandronic acid or other components of the drug.
Hypocalcemia. Prior to starting Bonviva, as well as the appointment of all bisphosphonates used to treat osteoporosis, hypocalcemia should be eliminated.
Severe renal dysfunction (serum creatinine> 200 mcmol / L (2.3 mg / dL) or creatinine clearance <30 ml / min).
Pregnancy and lactation period.

Pregnancy and Breastfeeding

Pregnancy 
During preclinical studies, no signs of direct embryotoxic or teratogenic action were found. The adverse effects of ibandronic acid in reproductive toxicity studies in animals were the same as in all bisphosphonates - reducing the number of embryos, disrupting the process of childbirth, increasing the frequency of visceral abnormalities (narrowing of the pelvic-ureter segment).
Experience of clinical use of the drug Bonviva in pregnant women do not.
Breastfeeding period 
It is derived from milk in animals. After 24 hours, the concentration of ibandronic acid in the blood plasma and milk is the same and corresponds to 5% of the maximum.
It is not known whether ibandronic acid is excreted in breast milk in women.

Dosage and Administration

The drug should be taken orally, entirely, washing down with a glass (180–240 ml) of pure water in a sitting or standing position, one should not lie down for 60 minutes after taking Bonviva. At 150 mg (1 tab.) 1 time per month (preferably on the same day of each month), 60 minutes before the first meal of the day, liquid (except water) or other drugs and food additives. pills can not be chewed or dissolve due to possible ulceration of the upper GI tract. Do not use mineral water that contains a lot of Calcium. In the case of skipping a planned reception should be taken 1 table. Bonviva 150 mg, if before the scheduled intake is more than 7 days, then continue to take Bonviva once a month in accordance with the established schedule. If before the next scheduled reception is less than 7 days, you must wait until the next reception plan and then continue the reception in accordance with the established schedule, since you can not take more than 1 table. in Week.

Adverse reactions

Bonviva, like other bisphosphonates, when administered intravenously may cause a short-term decrease in serum calcium levels.
From the gastrointestinal tract (GIT): dyspepsia (nausea, abdominal pain, flatulence), diarrhea, constipation, gastritis, gastroenteritis.
Musculoskeletal system: arthralgia, myalgia, pain in the limbs and bones, osteoarthritis.
From the nervous system and mental sphere: headache, dizziness, insomnia, depression.
From the skin and its appendages: rash.
The body as a whole: flu-like syndrome, weakness, reactions at the injection site, phlebitis, thrombophlebitis, nasopharyngitis, cystitis, urinary tract infections, bronchitis, upper respiratory tract infections, hypertension, hypercholesterolemia, uveitis, scleritis.
Hypersensitivity Reactions: angioedema, urticaria.
Very rarely, osteonecrosis of the jaw was observed when prescribing ibandronic acid.

Special notes

Osteoporosis can be confirmed by detecting a low BMD (T index <-2 SD [Standard deviation]), a fracture (including a history) or low bone mineral density (T index <-2.5 SD) in the absence of confirmed fracture.
Before starting Bonviva, hypocalcemia and other disorders of bone tissue metabolism and electrolyte balance should be corrected. Patients should consume enough calcium and vitamin D. If the patient is not getting enough calcium and vitamin D from food, they should be taken as supplements.
Before each injection, serum creatinine should be determined.
Patients with concomitant diseases who receive nephrotoxic therapy, who may have impaired renal function, should be carefully monitored.
Osteonecrosis of the jaw was observed when prescribing bisphosphonates. Most cases were registered in cancer patients during dental procedures, a few cases in patients with postmenopausal osteoporosis or other diseases.Risk factors for osteonecrosis of the jaw include an established diagnosis of cancer, concomitant therapy (chemotherapy, radiation therapy, glucocorticosteroids) and other disorders (for example, anemia, coagulopathy, infections, gum disease in history).
Surgical dental intervention with bisphosphonate therapy may enhance osteonecrosis of the jaw. It is not known whether the risk of osteonecrosis reduces the removal of bisphosphonates. The decision to conduct treatment must be made for each patient individually after assessing the risk / benefit ratio.
When taking bisphosphonates, including Bonviva, the occurrence of severe pain syndrome: pain in the joints, bones and muscles. Pains occurred both a day and several months after the start of the drug, most patients resolved after stopping the therapy, some of them had symptoms recurring after the same or another drug was given repeatedly.

Drug Interactions

Ibandronic acid does not affect the activity of the main isoenzymes of the cytochrome P450 system. At therapeutic concentrations, ibandronic acid weakly binds to plasma proteins, and therefore, it is unlikely that it will displace other drugs from protein binding sites. Ibandronic acid is derived only through the kidneys and is not subjected to any biotransformation.Apparently, the route of ibandronic acid elimination does not include any transport systems involved in the elimination of other drugs.

Overdosage

Possible symptoms: hypocalcemia, hypophosphatemia, hypomagnemia.
Treatment: no specific information. A clinically significant reduction in serum calcium, phosphate and Magnesium can be corrected i / v with calcium glucose, potassium or sodium phosphate and magnesium sulfate, respectively.
Dialysis is ineffective if administered 2 hours after drug administration.

At a temperature not higher than 30 ° C.

2 years.