Description of the active substance:
This information is a reference and it is not enough that the drug has been prescribed by a doctor ..
PHARMACHOLOGIC EFFECT
Inhibitor of bone resorption, nitrogen-containing bisphosphonate. Has a selective effect on bone tissue, which is due to high affinity for hydroxyapatite, which is the mineral matrix of bone. Ibandronic acid suppresses bone resorption and does not directly affect the formation of bone tissue.
Ibandronic acid prevents bone destruction caused by the termination of the function of the gonads, retinoids, tumors and extracts of tumors in vivo.
Postmenopausal women reduce the increased rate of bone tissue renewal to the reproductive age, which leads to a progressive increase in bone mass.
Ibandronic acid prevents the development of new ones and reduces the growth of bone metastases that already exist. It has a dose-dependent inhibitory effect on tumor osteolysis.
PHARMACOKINETICS
After oral administration, ibandronic acid is rapidly absorbed into the upper gastrointestinal tract. The time to reach C max is 0.5-2 h after taking an empty stomach, the absolute bioavailability is 0.6%. Simultaneous intake of food or drinks (except pure water) reduces the bioavailability of ibandronic acid by 90%. The consumption of food or drinks 30 minutes after the intake of ibandronic acid reduces its bioavailability by 30%. When taking ibandronic acid 60 minutes before eating, a significant reduction in bioavailability is not observed. Bioavailability of ibandronic acid is reduced to 75% when it is taken 2 hours after eating.
The concentration of ibandronic acid in plasma increases in proportion to the dose taken orally (at a dose of up to 100 mg) or administered iv in a dose of up to 6 mg of the drug.
After entering the systemic circulation, ibandronic acid binds rapidly in the bone tissue or is excreted in the urine. Apparent final V d - 90 l, the amount of active substance in the bone tissue, usually reaches 40-50% of the circulating blood in the dose. Binding to plasma proteins at therapeutic concentrations is 87%.
The data that ibandronic acid is metabolized (both in humans and in animals) is not.
40-50% of the amount of ibandronic acid circulating in the blood penetrates into bone tissue and accumulates in it, the remaining quantity is excreted unchanged by the kidneys. The apparent apparent T 1/2 value varies within a wide range (10-60 hours) and depends on the dose and sensitivity of the assay. The concentration of ibandronic acid in the blood decreases rapidly and reaches 10% of C max at 3 h after IV introduction.
The total clearance of ibandronic acid is 84-160 ml / min. Kidney clearance (60 ml / min in healthy women in menopause) accounts for 50-60% of the total clearance and depends on QC. The difference between general and renal clearance reflects the capture of matter in bone tissue.
INDICATIONS
Postmenopausal osteoporosis in order to prevent fractures.
Metastatic bone damage in order to reduce the risk of hypercalcemia, pathological fractures, reduce pain, reduce the need for radiotherapy with pain syndrome and the threat of fractures.
Hypercalcemia in malignant neoplasms.
DOSING MODE
Applied inside or / in.
The dose and the scheme of application depend on the indications and the clinical situation.
SIDE EFFECT
On the part of the digestive system: often - dyspepsia (nausea, abdominal pain), flatulence, diarrhea, constipation, gastritis, gastroenteritis, ingestion - esophagitis, gastroesophageal reflux disease; rarely with ingestion - esophagitis, including ulceration of the esophagus or stricture, dysphagia, vomiting; rarely - duodenitis.
From the nervous system and psyche: often - headache, dizziness, insomnia.
From the skin and subcutaneous tissues: often - a rash.
Allergic reactions: rarely - angioedema, edema of the face, urticaria.
From the musculoskeletal system: often - arthralgia, myalgia, pain in the extremities, osteoarthritis, back pain, musculoskeletal pain; infrequently - pain in the bones;rarely - atypical susceptible and diaphyseal fractures of the femur (typical for the bisphosphonate class); very rarely - osteonecrosis of the jaw.
From the side of the organ of vision: rarely - inflammatory diseases of the eyes.
On the part of the body as a whole: often - the flu-like syndrome, weakness; infrequently, asthenia.
Other: often - nasopharyngitis, cystitis, urinary tract infections, bronchitis, upper respiratory tract infections, arterial hypertension, hypercholesterolemia; infrequently - reactions at the injection site, phlebitis, thrombophlebitis; rarely - hypersensitivity reactions; when in / in the introduction of a short-term decrease in the level of calcium in the blood serum.
CONTRAINDICATIONS
For oral and / or induction: hypocalcemia, severe renal dysfunction (CK <30 ml / min), esophageal damage leading to a delay in its emptying, such as stricture or achalasia (for oral administration), pregnancy, lactation feeding), children and adolescents under 18 years of age, hypersensitivity to ibandronic acid.
For oral administration: lesions of the esophagus, leading to a delay in its emptying, such as stricture or achalasia; inability to sit or stand for 60 minutes.
PREGNANCY AND LACTATION
Contraindicated in pregnancy and lactation.
APPLICATION FOR FUNCTIONS OF THE LIVER
Contraindicated in severe renal failure (serum creatinine level> 5 mg / dl, or 442 Ојmol / L).
APPLICATION FOR CHILDREN
Clinical experience of use in children is absent.
SPECIAL INSTRUCTIONS
Use with caution in patients with hypersensitivity to other bisphosphonates.
During the treatment should monitor the function of the kidneys, calcium, phosphorus and magnesium levels in the blood plasma. It is recommended to avoid excessive hydration in patients with circulatory failure.
It should be borne in mind that the use of bisphosphonates can cause bronchospasm in patients with bronchial asthma and with increased sensitivity to acetylsalicylic acid.
Do not allow intra-arterial administration.
Products containing calcium and other polyvalent cations (for example, aluminum, magnesium, iron), incl. milk and solid foods, can interfere with the absorption of ibandronic acid (they should be consumed no earlier than 30 minutes after oral intake of the drug).
DRUG INTERACTION
With simultaneous use with aminoglycosides, hypocalcemia may develop (because these active substances reduce serum calcium levels for a long time);hypomagnesemia is possible.
TERMS AND CONDITIONS OF STORAGE
[MSK] 01.04 in the RK is not registered.
